Benefit is a valued or desired outcome; an advantage. 

Minimal Risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 

45 CFR 46.111 (a)

(1) Risks to subjects are minimized: 

(i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and 

(ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. 

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. 

Initial Review Application

You will be asked  to select all procedures that will be conducted for research purposes as directed by the study protocol:

• Analysis of information or specimens collected for reasons other than this project (medical records, student records, research records collected for another study, analysis of left-over specimens, etc.)
• Non-invasive procedures to collect information or specimens (interviews, questionnaires, observation, vitals, oral swabs, urine collection, etc.)
• Collection of blood by finger stick, heel stick, ear stick, or venipuncture
• Use of xrays or microwaves
• With the exception of collection of blood by finger stick, heel stick, ear stick, or venipuncture, collection of information or specimens when the collection requires penetration of tissue (tissue biopsy, implantation of a device, etc.)
• Use of medical drugs or devices in a manner already approved by the FDA
• Use of medical drugs or devices in a manner not approved by the FDA

Your selection will assist in routing the application for the appropriate level of review.

Research Protocol

Describe the known risks related to participation in research. Describe any actions taken to minimize risk. Clearly state which procedures are being done specifically for research purposes and which are done as standard of care or normal practice.  

Describe any anticipated benefits the research subjects may receive from participation in the research. For minimal risk research, there is no requirement of direct benefit to research subjects; it is acceptable to state that there is no anticipated benefit to subjects. When research is greater than minimal risk, the anticipated benefits must justify the known risks.  Please note that compensation for participation in research may not be listed as a benefit. 

Consent Documents

Describe the known risks and anticipated benefits in laypersons terms. List all risks and benefits that are described in the research protocol.   

When making this determination in research with adult populations, the IRB weighs the risks to participants against the anticipated benefits (either direct or indirect) of the research. When vulnerable subjects take part, the regulations place limits on the extent of risk permitted. Children may only participate in greater than minimal risk research when there is a prospect for direct benefit. The IRB will: 

• Identify and compare the risks associated with the research from the risks of therapies or alternatives to participation in research. 
• Determine that the risks will be minimized. 
• Identify the anticipated benefits to be derived from the research. 

• Determine that the risks are reasonable in relation to be benefits to subjects, if any, and the importance of the knowledge to be gained. 
• Verify research participants will be provided with an accurate and fair description (during the consent process) of the risks and/or the anticipated benefits. 

In human subjects research, research is categorized into two categories:

1. Minimal risk; or

2. Greater than minimal risk

Research is considered minimal risk when the risks of the research are not greater than those experienced in regular daily life. Researchers are responsible for identifying any possible risks of the research and minimizing risks to subjects whenever possible. Some common types of risks are: 

• Economic risks: Payment by subjects for procedures not otherwise required, loss of wages or other income and any other financial costs, such as damage to a subject’s employability, as a consequence of participation in the research. 
• Loss of Confidentiality: In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Subjects have the right to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data. In order to minimize the risk for loss of confidentiality, investigators should only collect personal information that is absolutely essential to the research activity. If personal data must be collected, it should be coded as early in the activity as possible and securely stored so that only the investigator and authorized staff may access it. Identities of individual subjects must never be released without the express consent of the subject. In addition, if an investigator wishes to use data for a purpose other than the one for which it was originally collected and the data are still identifiable (e.g. a code list for the data still exists), the investigator may need to obtain consent from the subjects for the new use of the data. 

• Legal risks: Legal risks exist when the research methods are such that the subject or others will be liable for a violation of the law, either by revealing that the subject or others have or will engage in conduct for which the subject or others may be criminally or civilly liable, or by requiring activities for which the subject or others may be criminally or civilly liable.  
• Physical risks: Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. A physical risk may result from the involvement of physical stimuli such as noise, electric shock, heat, cold, electric magnetic or gravitational fields, etc. Engaging a subject in a social situation which could involve violence may also create a physical risk. 
• Psychological risks: The potential for negative affective states such as anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Sensory deprivation, sleep deprivation, use of hypnosis, deception or mental stresses are examples of psychological risks. 
• Social risks: The potential for alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others. 

Strategies for Minimizing Risks

Eliminating Risks 

Risks are eliminated by limiting research procedures or data collection to those that are necessary for the research. Some examples: 

• Recording data without identifiers.
• Collecting the minimum data necessary for the research.
• Performing only procedures that are necessary to achieve the study objectives. 
• Collecting the fewest specimens with the least volume necessary. 

When risks cannot be eliminated, there are often opportunities to decrease the risk to research subjects. Some examples: 

• Use of existing records or specimens.
• Use of a blood-drawing IV instead of separate venipunctures for a PK study.
• Obtaining a certificate of Confidentiality to minimize the likely of forced disclosure of sensitive materials.
• Coding data and samples to conceal identifiers.
• Using REDCap to secure data that includes PHI. 
• Limiting access to research data.

Combining research procedures with clinical care 

If procedures can be timed to take place at the same time as a clinically indicated procedure or if clinical test results can be used instead of repeating the measurements, the risks are often greatly reduced. Some examples:

• Timing research blood draws, X-rays or other procedures to occur at the same time as clinical procedures. 
• Limiting research MRI, PET, CT or other scans, to those having a clinically indicated study, particularly when sedation or general anesthesia is required.  

Nancy King has defined three types of benefit that may occur in the context of clinical research (J Law Med Ethics. 2000 Winter;28(4):332-43) 

Direct Benefit

A benefit arising from receiving the intervention being studied.

Indirect Benefits 

• Collateral Benefit is a benefit arising from being a subject, even if one does not receive the experimental intervention (for example, a free physical exam and testing, free medical care and other extras, or the personal gratification of altruism).
• Aspirational Benefit is a benefit to society and or future patients, which arises from the results of the study.

Research with a direct benefit 

Any study that involves an intervention could have an anticipated direct benefit. In these studies, participants may receive some intervention (medical, behavioral, or other), that they would not otherwise receive. The purpose of the research is typically to test the effectiveness of the intervention. When describing the anticipated benefits of research in the consent document, it is important that researchers make subjects aware that the benefits of the intervention are not known, and that the research is being conducted to evaluate the effectiveness of the intervention. Whenever possible, the researcher should provide any known information about the probability and magnitude of the anticipated benefit.  

Research with an indirect benefit 

When research does not involve an intervention there is little opportunity for direct benefit. When the risks of the research are no greater than those encountered in the everyday life, there is no requirement for direct benefit. When the research risks are greater than minimal risk, then the researcher must provide justification that explains how the anticipated benefits of the research justify the risks to the subjects. 

• Coercion is the practice of persuading someone to do something by using force or threats. Coercion will generally involve physical force. No relationship between the two individuals need exist for coercion to occur. 
• Subject selection means the process of identifying potential research subjects based on specific inclusion or exclusion criteria.  
• Recruitment is a component of the consent process. The process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment. 
• Undue influence means influence by which a person is induced to act otherwise than by their own free will or without adequate attention to the consequences. Undue influence will generally involve mental pressure in which one person takes advantage of the unequal relationship they have with the other person (e.g. supervisor/employee, doctor/patient,etc.).  

45 CFR 46.111 (a)(3)

Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

Initial Review Application

On the Recruitment Information page, mark any methods that will be used to identify and recruit study participants. Below is the list of options provided, as well as definitions. You should select all that apply.

• Advertisements (flyers, social media, clinical trials websites, etc): Potential subjects will respond to advertisements and contact the study team if they are interested in participating.  An example of any recruitment materials must be included in the application as a separate file and approved by the IRB before they are used.

• Medical record review: Researchers will review medical charts or other clinical information to identify potential subjects. Researchers must request a Waiver of HIPAA Authorization for subject recruitment.
• From a database of participants who have given prior permission to be contacted for research studies: Potential subjects have prospectively consented to be contacted regarding research opportunities. The WRG-HS number of the study in which they originally gave consent to be contacted for future research should be provided in the protocol.
• From personal contacts: Individuals whom you know personally or professionally.
• Referrals: Potential subjects identified by non-investigator healthcare providers or participants referring other participants. Investigators may provide their colleagues with a “Dear Patient” letter or a “Dear Potential Study Participant” letter describing the study, or researchers may provide Information Sheets to colleagues or associates.
• Other 

 On the Consent Language page, you will be asked if it is possible that you will enroll participants who are unable to speak or read English. Generally, any research that holds the prospect of direct benefit should allow the enrollment of those unable to read English. Review “Overcoming Language Barriers” guidance on this page to learn more about enrolling non-English speaking subjects.

Research Protocol

Describe the inclusion and exclusion criteria for your study sample.  Include the age range of individuals who may enroll in the research. Consider that if children are enrolled in the research, you may be required to obtain parental permission.  List any other defining criteria for enrollment in the research. For secondary analysis research, list the criteria you will use to identify your dataset or specimens.  

Recruitment and/or Screening Materials

Submit all information meant to be seen or heard by potential subjects to the IRB for review before they are used.  Any additions or changes to these documents must be submitted via WRG-HS as modifications to the study before it is used.

The research team and the IRB will need to consider the following criteria when evaluating subject selection and recruitment strategies: 

• Equitable selection of participants: Does the recruitment strategy help ensure that selection of research participants is equitable and appropriate for the study? 
• Respect for privacy: Does the recruitment strategy respect an individual’s reasonable expectations for privacy? If the research team asks questions to screen potential participants, will the questions be asked in a private setting where others will not overhear the answers? Will patients who are recruited from a recruitment database in the clinic have given their permission beforehand for this use of their individual medical information? 
• Voluntariness: Is the study introduced in a way that allows subjects ample time to consider participation, with no undue pressure? Is the timing reasonable? Who makes the request? How the request is made? Does the study offer excessive inducements? Will students be hesitant to say “no” to a professor? Will patients be put in a situation where they may hesitate to say “no” to their own physicians? Will adolescents whose parents give permission for them to be in a study feel they cannot now say “no”? How will pressure be minimized? 
• Unbiased presentation: Is all information accurate, balanced, and free of any misleading emphases that make the study excessively attractive? Is the information as complete as is appropriate for each stage of recruitment? 
• The “Therapeutic Misconception:” Patients tend to believe a clinical trial—or anything proposed by health care providers—will benefit them, even if they’re told there is no assured benefit to their participation. Does the recruitment strategy minimize the potential for misconception? 
• Conflicting concerns:  
• Students may feel obliged to participate in a researcher’s study if that researcher is also their teacher/professor. 
• Although prospective participants may prefer that someone involved in their care contact them about research, they may find it hard to say “no” to a care provider. 
• Clinicians may find their clinical judgment in conflict with a desire to enroll patients in their own studies.
• Keeping Information Confidential: Often the greatest risk of obtaining information during the recruitment and/or screening process is the loss of confidentiality. The researcher must consider and describe how the confidentiality of this data will be maintained. Whenever possible, information obtained during this process should not be connected with subject identifiers.  As noted above, the amount of data collected should be limited. Once collected it should be kept secure. 
• Telephone Scripts: In studies such as telephone surveys, an initial recruitment call sometimes leads directly into the consent. In such studies, the script should include, at least, the names of the persons responsible for the study, a description of the types of questions that will be asked, an estimate of the time it will take to complete the interview, and the direct question of whether or not a person wishes to participate. The interviewers also should have available an investigator’s telephone number in case the prospective subjects have questions about the study that the interviewer cannot answer, and the IRB phone number if there are questions about a research subject’s rights. 
• Keeping Information about Refusers: In general, identifiable information may not be kept about prospective subjects unless they consent to even this limited participation. Describe how consent will be obtained for retention of personally identifiable information. Non-personally identifying information about refusers may be used for research purposes.

Unacceptable Recruitment Methods 

• Direct Recruitment by Study Sponsors: In general, WCM does not permit its researchers to provide subject contact information to sponsors. Sponsors may not directly contact prospective subjects based on information from WCM researchers. However, WCM does permit researchers to be part of a national or local multi-site study which may include a national or local advertising campaign by the study sponsor to recruit. 
• Use of Incentives and Referral Fees: Per-patient incentive payments or referral fees, whether paid for each referral or each enrollment, are not allowable. Such payments may encourage recruiters to put inappropriate pressure on prospective subjects and are illegal in New York. Lump-sum payments not tied to the number of patients referred or enrolled may be allowed in particular studies. Investigators should include all information about incentives and/or referral fees in the recruitment section of the iRIS submission.

Often researchers wish to use existing records or specimens to identify and recruit potential research subjects. The research team must consider if this private identifiable information has been provided by individuals for a specific purpose, such as clinical care, and the individuals have not consented to its use for research. These records are protected by laws and policies to ensure they are not misused. When accessing existing records for research, the following should be taken into consideration:

• The use of academic records for purpose of identifying, contacting, and recruiting participants is subject to the rules set forth in the Family Educational and Rights Privacy Act (FERPA). See Academic Records under Additional Considerations. 
• Use of medical records or clinical information for the purpose of identifying, contacting, and recruiting participants is subject to HIPAA. 
• The use of existing research records to identify, contact, and recruit subjects for additional research must comply with the privacy and confidentiality commitments made when the research subjects consented to participate.  

The following are general types of recruitment materials the IRB must review before they are used to recruit research subjects.

• Letters to or Information Sheets for Subjects: Any letter to or information sheet for subjects or their representatives.  
• Advertisements: The text of all advertisements in all media, including flyers, posters, newspaper ads, radio or television announcements, and informational pamphlets. However, investigators are not required to submit to the IRB the final version of an advertisement as long as the template, actual text or script has been approved and does not modify what was approved. Investigators are responsible for maintaining copies of the final product in the research files. 
• Scripts: All scripts or guides that will be used for in-person or telephone recruitment.  
• Web Postings or Pages: Submit text of postings or pages used for direct recruitment of subjects. 
  Note, web site postings that are limited to basic study information, such as title, purpose of the study, basic eligibility criteria and study site location, intended for informational purposes and not solely for recruitment may not require IRB review and approval. 

Advertisements to recruit subjects are normally limited to the following information to determine eligibility and interest. The following elements are suggested but not required. The information should be worded to be informative but not coercive, overly enticing or promising of benefit. 

• Indication that the recruitment is for a “Research Study” 
• Name and address of researcher and/or research facility 
• Condition under study or the purpose of the research 
• Criteria that will be used to determine eligibility (in summary form) 
• A brief list of significant risks, if any 
• A brief description of benefits of participation, if any 
• Payment, if any 
• Time commitment required 
• The location of the research 
• Person or office to contact for further information 

For clinical trials

• Whether or not the investigational agent is FDA-approved for the given indication 
• Indication that the study participant may receive a placebo, when applicable 

Limitations to recruitment materials:  Researchers and the IRB must ensure that all materials used for recruitment do not: 

• Characterize payment as a benefit, be the focus of the material, emphasize payment by using a larger font or bold type, or promise a bonus for completion of the study 
• State or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent 
• Include any exculpatory language that appears to waive any rights of the prospective participants or indicate that the investigator or WCM/Montefiore cannot be held liable or at fault for any research-related injury 

For clinical trials, recruitment materials should not  

• Make any claims, either explicitly or implicitly, that the experimental agent is known to be safe or effective, or equivalent or superior to any currently available treatment or other drugs, biologics or devices. 
• Promise a certainty of cure or of other favorable outcomes or benefits beyond what is outlined in the consent and the protocol 
• Use terms such as “new treatment,” “new medication” or “new drug” 
• Promise “free treatment” when the intent was only to say participants would not be charged for taking part in the study 
• Allow for compensation towards the investigational agent once FDA approved.

Posting Recruitment Materials at Other Sites: The investigator is responsible for obtaining appropriate prior permission from agencies/institutions at which recruitment materials will be posted. Example: Veterans Administration facilities require consultation with the local VA IRB to determine if flyers for non-VA-initiated research may be posted/disseminated.

Initial Contact: Prospective research subjects should be contacted by someone who is 

• Thoroughly knowledgeable about the study, 
• Able to answer questions, 
• Trained in the voluntary nature of research participation and 
• The most appropriate person to contact prospective subjects 

Family Member Recruitment 

In cases when a family member is asked to recruit another family member or members into a study, the researcher should consider how best to protect and respect the privacy of family members who may be identified as potential participants. 

One way to respect and preserve the privacy of family members is for the researcher to develop a strategy that allows the family member who is already in the study to provide information sheets that explain the study to other family members. This allows the potential participant to contact the research team to express interest. 

There are other methods to protect the privacy of the family. Whatever method is used should be carefully considered and described in the IRB application. 

WCM Employee and/or Student Recruitment 

If a researcher wishes to enroll his/her own students or people, whom he/she supervises into a study, there are special provisions that need to be considered and implemented so that the students or employees do not feel obliged or pressured to participate in the study. Investigators should carefully consider the appropriateness of enrolling individuals they directly supervise or instruct and will require explicit justification in the IRB application. 

If WCM employees and/or students are asked to participate in a research study, the investigator may be asked to provide written assurance in the WRG-HS submission and indicate in the informed consent form that willingness to enroll in the research study will in no way affect subjects’ grades, employment, or standing within the organization. 

Recruiting Researchers’ Students and Staff: In order to avoid undue influence or pressure on a prospective subject, researchers should not directly ask their students or staff to be research subjects. It may be difficult to refuse such a request. Rather, researchers should post flyers or provide information sheets that allow volunteers to initiate contact about the study. 

Recruitment in Classrooms: If researchers wish to recruit students other than their own students in a classroom the researchers must make it very clear that research is voluntary and will not be tied to grades or extra credit. It must be clear that there will be no stigmatization or ostracization of students who decline to participate. If class time will be taken for research participation, alternative activities should be provided for those who decline (especially in pre-college levels).

Screening activities are generally defined as: 

• Any interaction or intervention with the subjects to determine eligibility that would not otherwise have been performed if not for the study, or 
• Accessing the results of prior interventions that were performed for purposes other than the study. 

Collecting data directly from prospective subjects  through written screening tools or oral responses to questionnaires, or accessing private information for purposes of determining eligibility for research (screening) constitutes a research intervention or interaction that is part of the research activity and therefore requires IRB review. Screening activities are reviewed as part of the overall recruitment and consent process and evaluated with respect to the protection of privacy and confidentiality of those who are screened. In order to protect the privacy of potential participants, you should collect only the minimum information necessary for screening.

Informed Consent means a research subject’s voluntary agreement to participate in research.

Informed Consent Form (ICF) is a written document that provides research subjects with all necessary information to make an informed choice regarding participation in research.

Legally Authorized Representative (LAR) is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

45 CFR 46.111(4)

Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, §46.116   General requirements for informed consent.

General Requirements for informed consent, whether oral or written:

1. Before involving a human subject in research, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative, unless the requirement for informed consent has been waived by the IRB.
2. An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
3. The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.
4. The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
5. Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
6. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
7. No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Basic Elements of Informed Consent

Unless the IRB waives one or more elements, the following information must be included in the informed consent document:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others that may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled;
9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

• A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
• A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

 Additional Elements of Informed Consent

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
5. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject
6. The approximate number of subjects involved in the study;
7. A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.

1. A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
2. A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
3. A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);
4. Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
5. Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and
6. An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.

The potential research subjects must be able to understand the information presented in the consent document. Follow these guidelines to improve the readability of the consent document:

• Write at or below an 8th grade reading level
• Use short sentences; < 15 words
• Use the active form (first person)
• Use 12 point font
• Avoid jargon and acronyms

Format information to improve visual understanding by using:

• Tables
• Bulleted lists
• White space

Additional Resources

• IRB Guides: Checking Readability Scores
• US Government Plain Language Checklist
• KP Washing Program for Readability in Science & Medicine (PRISM)
• Presenting Information for Effective Communication (Video, PDF)
• OHRP: What’s New in Informed Consent: Revisions to the Common Rule (26:50)

The consent document must include accurate information. Compare the consent document to the protocol (and investigators brochure, when applicable) to ensure that procedures, risks and other information are correct, complete and consistent throughout all documents.

The IRB must approve your consent form before you use it. A stamped version of the approved consent forms will be provided in Reviews section of WRG-HS.

If you make revisions to your protocol or if new risk information is obtained, you may need to revise the consent document so it is accurate and complete. According to Office for Human Research Protections (OHRP) Guidance, you cannot enroll participants into a study if the consent document is inaccurate or incomplete.

Whenever you revise the consent document, you must submit the revised version to the IRB as a modification and the IRB must approve the new version before the version can be used.

Unless otherwise instructed by the IRB in writing, you must use the most current approved version of the consent document when enrolling participants.

Freely given informed consent must be obtained from every decisionally capable, potential adult subject before any research procedures begin, unless the IRB has waived some or all of the consent requirements. Informed consent is not just a form or a signature, but a process of information exchange that takes place between the prospective subject and the investigator before, during, and sometimes after the study, which includes subject recruitment materials, verbal instructions, written materials, question and answer sessions, and agreement documented by signature

The Principal Investigator is required to submit to the IRB for each protocol the names of the individuals authorized to obtain informed consent from the subjects in the study. All of these individuals must be knowledgeable about the study and must have completed the CITI training program required by WCM. The PI must obtain the IRB’s approval prior to adding additional individuals to the authorized list. The PI remains responsible for ensuring that adequate informed consent is obtained from each subject enrolled in the study protocol.

45 CFR 46.117(a)

Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy shall be given to the person signing the informed consent form.

Per 45 CFR 46.116, in order for an IRB to waive or alter consent, the IRB must find and document:

1. The research involves no more than minimal risk to the subjects;
2.  The research could not practicably be carried out without the requested waiver or alteration;
3.  If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Requirement (ii) is met when:

1. it will not be possible to obtain informed consent from participants because the research is not engaging in interactions or interventions with participants and it is not possible to obtain consent through other means; or
2. in the rare circumstances when bias will be introduced into the results unless data about all eligible participants is required.

In addition to the waiver of consent allowed for minimal risk research, the FDA regulations allow research involving humans to take place under the following conditions:

1. Planned research in emergency situations when there is no time to obtain informed consent – Emergency Exemption from Prospective IRB approval for Investigational Drug, Biologics, and Devices (for more information click here)
2. Unplanned use of an investigational drug, device or biologic in an emergency (for more information click here)

The IRB may waive the requirement consent specifically for the purposes of screening, recruiting, or determining eligibility. An investigator may obtain information or biospecimens for such purposes without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:

1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

The IRB may waive the requirement for the investigator to obtain a signed informed consent form if it finds any of the following:

1. That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research

Initial Review Application

On the Consent page, you will be asked “Which of the following are involved? (Check all that apply)”

• Signed Informed Consent: Research subjects will be informed about the research and will sign a consent document prior to enrolling in the research.
• Information Sheet or Oral Consent: Research subjects will be informed about the research and will agree to participate but will not sign a consent document. Appropriate for some exempt research or with an IRB issued Waiver of Documentation of Consent.
• No consent process: Research subjects will not be informed about research and will not have an opportunity to agree to participate. Appropriate for some exempt research or under an IRB issued Waiver of Consent.

Select “Signed Informed Consent” to indicate that potential research subjects (or their LAR) will be given information about the research and, after having an appropriate amount of time to decide, will sign a consent document if they choose to enroll in the research. This is appropriate for all greater than minimal risk research and for minimal risk research that does not qualify for a waiver of documentation.

Select “Information Sheet or Oral Consent” if potential research subjects (or their LAR) will be given information about the research and, after having appropriate time to decide, will chose whether to enroll in the research, but they will NOT sign a consent document. The information may be presented orally or in writing. This process is appropriate for some exempt research or when research qualifies for a waiver of documentation of consent. This is often used for research involving interviews, online surveys, or when anonymous sensitive information is collected, and you do not want any paperwork that links the subject to the research study. Note that this is not the same as electronic signature of consent. See additional guidance under “Documentation of Consent”.

If you select “Information Sheet or Oral Consent” you will be asked for the following study details.

• Does this research involve any procedures for which written consent is usually required? For example, surgery, imaging, release of educational records, etc.
• Is the consent document the only document linking the participant to the research?
• Are the research subjects members of a distinct cultural group or community in which signing forms is not the norm?

Select “No consent process” to indicate that there is no consent process for your research. This means that research subjects (or their LAR) will not receive information about the research and will not decide whether to participate. Generally, this option is only used for secondary analysis of private identifiable data or specimens.

If you select “No consent process” you will be asked if any of the following are true. Select all that apply.

• The research team will have no direct contact with potential research subjects.
• Obtaining consent could pose a risk to subjects’ privacy, physical safety, or psychological wellbeing.
• Failure to obtain a complete or representative data set would prevent this study from drawing reliable conclusions.
• Other

Consent Documents and Information Sheets

The WCM IRB provides several template consent documents for your use. Download any template and customize the details to describe your specific research. These templates contain standard language and instructions to assist researchers in providing potential subjects all necessary information for a complete consent process. For each new study, the IRB must confirm that all elements of consent are present in the informed consen

While the elements of consent are consistent for research, the setting in which consent is obtained varies depending upon the study. There are times when an in-person consent process is not feasible. In these cases, the IRB will consider if a remote consent process is appropriate and acceptable.

Telephone Consent and Consent Using Facilitated Technology (e.g. Zoom)

Research does not need to be specifically approved for telephone consent; however, the research team must ensure they have resources to obtain a signed consent form prior to the research subject completing any study related activities unless the study has been granted a waiver of documentation of consent. When consent is done remotely, the requirements are the same as if the research team were conducting the consent process in person. The research subject or LAR should be provided a copy of the consent document. After having the research team provide the potential subject or LAR information about the study, the subject/LAR should have an opportunity to ask questions and be given adequate time to make an informed decision about participation.

Faxing of Signed Consent Forms

When consent is conducted over the phone or using facilitated technology (e.g. Skype), it is permissible for subjects to fax a signed copy of the consent form to the research team. If there are questions and/or check boxes embedded throughout the document for the subject to complete, the research team should check to ensure that these pages are included. Good Clinical Practice (GCP) or other guidelines may require that the study team receive a complete copy of the signed consent form. In cases where subjects are faxing a consent form to the research team, the subject need not provide the investigator with the original signed consent document.

Online Consent

For web-based surveys or questionnaires, the consent form may be presented online, and require participants to perform some action, such as clicking “I agree,” before proceeding with any research activities (e.g., answering survey questions on a website). This is an acceptable approach for minimal risk research conducted online. However, be aware that this method does not document informed consent and therefore may only be used if the IRB has waived documentation of consent for the study.

For research that poses more than minimal risk, the research team should consider how they will be able to evaluate a subject’s understanding of the procedures and risks related to their participation. Tools to evaluate this understanding could include a comprehension quiz requiring a score of 100% in order to proceed, or the provision of contact information of a member(s) of the study team, in order to enable direct communication for subjects who have questions or concerns, among other options.

Confirming Identities in Online Research

A study’s data validity or reliability could be fallible without verifying subjects’ identities. Examples include when there are critical eligibility criteria, or when there is a likelihood of repeat or fraudulent participation, whether for mischief or to collect multiple payments. When designing a research study, investigators should take into consideration the importance of identity to their study.

Studies that pose more than minimal risk, or that involve the transmission of sensitive information, may consider implementing a process by which they confirm identities using authentication that relies upon multiple factors, for example a password that is delivered to subjects by telephone or by postal service, or by using identity verification software.

For FDA-regulated studies, if any or all of the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method of identity verification. Acceptable examples include state-issued ID, biometric methods, visual methods, or personal questions.

ICH Good Clinical Practice (GCP) defines an Impartial Witness as “a person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.” This definition contains four parts, all of which must be met. Here they are presented separately for emphasis and analysis:

• “Who is independent of the trial:” This could be a person who is a family member. It would not be a member of the site staff involved with the study.
• “Who cannot be unfairly influenced by people involved with the trial:” This would be a person free from potential coercion or undue influence or conflicted interest.
• “Who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read:” This emphasizes the participation of the witness throughout the consent process, not just when the subject signs. A robust informed consent process will likely result, on the part of the person obtaining consent.
• “Who reads the informed consent form and any other written information supplied to the subject:” This responsibility has the witness confirming the subject was presented sufficient information to assure truly informed consent of the subject.

When a prospective participant is competent but cannot read because of blindness or other reason, you should:

1. Ensure an impartial witness is present during the consent process
2. Read the entire consent document to the prospective participant
3. Answer all of the participant’s questions
4. Ask the participant questions to assess comprehension
5. Obtain agreement from the participant only after assessing that the participant comprehends the information in the consent document
6. Obtain the signature (or mark) and date from the participant
7. Obtain a signature and date from the witness
8. Sign and date the consent document as the individual obtaining consent
9. These statements should be included in the research record:

• A statement indicating that informed consent took place;
• A statement indicating the participant (or LAR) could not read the consent document and the document was read to the participant in the presence of an impartial witness;
• The participant (or LAR) apparently understood the information and voluntarily agreed to participate;
• A copy of the signed and dated consent document was provided to the participant or LAR;
• The time and date the process took place.

In rare instances, a potential participant may be competent to provide consent but may not be able to sign and date the consent document because of a physical impairment.  In these instances, you should conduct the consent process in the presence of an impartial witness who will attest that the participant comprehended the information and agreed to participate but was unable to sign and date the consent document.  You should also document the consent process and include a statement indicating the reason for the participant’s inability to sign the document and a statement that an impartial witness was present during the process. 

Unless written consent has been waived as a requirement for the study, the subjects who do not speak English must be provided with:

• A written consent document in a language understandable to them, and
• An interpreter fluent in both English and the subject’s spoken language to aid in the consent process (Note: The interpreter should sign and date the consent form. For greater than minimal risks studies, the time should be included as well.)

Depending upon the research, the written consent document can be either a translation of the entire English version of the IRB approved consent document, or a “short form” consent document stating that the elements of consent have been fully presented orally. 

A fully translated consent form is required for studies that anticipate enrolling more than 5 subjects speaking the same non-English language. A fully translated consent form is also required once 5 subjects speaking the same non-English language have been enrolled via the short form procedure.

If a study has the potential for direct benefit to subjects, it should not exclude non-English speaking subjects. If you will exclude non-English speaking subjects, you must provide justification in the IRB application.

Examples of situations that require a translated consent form:

• The investigator is targeting a non-English speaking group
• Research will be done in a foreign country
• The investigator anticipates that more than 5 subjects who speak the same non-English language will want to enroll in the study

Translations can be obtained through a translation service of the investigator’s choice. An “Affidavit of Accuracy” is required. Alternatively, the translation can be prepared “in house.” This method requires that one individual translate the document into the appropriate language and another individual convert the translated document back into English. The two English documents can then be compared side by side for accuracy and completeness. For the “in house” translation, both the translated and back-translated consent forms must be submitted to the IRB, along with the names and qualifications of the individuals involved in the process.

Since any changes made by the WCM IRB to the submitted English version of the informed consent document must be included in the translation of the informed consent document, investigators are advised to have the translation completed after WCM IRB approval of the English version of the informed consent document.

For each clinical trial conducted or supported by a Federal department or agency that received initial IRB approval on or after January 21, 2019, one IRB-approved informed consent form used to enroll subjects must be posted on either ClinicalTrials.gov or Regulations.gov.

The informed consent form must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

Privacy is the state or condition of being free from being observed or disturbed by other people. Privacy is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. 

Confidentiality is the state of keeping or being kept secret or private. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. 

46.111(a)(7)

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. 

Initial Review Application 

On the Data Confidentiality page, you will be asked about the type of data you will store and the security in place to maintain the confidentiality of the data.  You will provide an answer by answering a series of questions on the Initial Review Application.

Data Collected

You will be asked, once the data has been collected or received by this PI, how will it be maintained?

The data will be:

• Identifiable – Data or specimens will be labeled with identifying information.
• Coded with linking key – Data will be stripped of identifiers and assigned a code. The research team will maintain a key that links the identifiers to the data set.
• Coded without linking key – Data will be stripped of identifiers and assigned a code. The research team will not have access to a key that links the identifiers to the data set and will not attempt to re-identify the data.
• All identifiers will be destroyed. There will be no way to link the data to an individual.

Data Protection

Only authorized persons should be granted access to participants’ identifiable information. You will be asked to indicate how you will protect research subjects’ identities and information.

Select all that are true:

• Identifiable data maintained in paper format and/or specimens labeled with identifiers will be kept in a locked area with limited access.
• Identifiable electronic data will be maintained on a password protected, encrypted device.
• Identifiable electronic data will be maintained on a password protected, secured cloud service appropriate for the sensitive of data collected.
• NA – No identifiable data or specimens will be created or stored for this this research.

Data Transfer Protections

If you will be transferring data between locations, you will be asked to describe your plan to protect the data.  or example, using lock boxes or locked cars when conducting field work or transferring data between sites)

Sensitive Data

In a yes or no question you will be asked:

If the confidentiality of the research data were compromised, could it reasonably place subjects at risk of criminal or civil liability or otherwise be damaging to the subjects’ financial standing, employability, educational advancement, or reputation?

The following issues will be considered during IRB review: 

• The proposed recruitment methods: How are potential participants identified and contacted? Does the recruitment plan involve access to private information, such as a medical record or student record? Where are potential subjects being approached? 
• Sensitivity of the information being collected – the greater the sensitivity, the greater the need for privacy and confidentiality. 
• Method of data collection (focus group, individual interview, covert observation)  
• Will subjects feel comfortable providing the information in this manner? 
• If passively observing the subject; could the individual have an expectation of privacy (e.g., chat room for breast cancer patients)? 
• Will the researcher collect information about a third–party individual that is considered private (e.g., mental illness, substance abuse in family)? If yes, informed consent should be obtained from the third–party. 
• Are the activities appropriate for the proposed subject population?  
• What are the cultural norms of the proposed subject population? Some cultures are more private than others. 
• What are the ages of the proposed subject population? There may be age differences in privacy preferences (e.g., teenagers less forthcoming than older adults) 
• Do you have safeguards to maintain data confidentiality as described in the Initial Review Application? 
• Do you plan to share data collected for research with individuals outside this institution?  
• Do you plan to maintain identifiable data or specimens for future use?

Please visit the WCM ITS web page for eConsent.

From the JCTO webpage:

WCM currently supports one system, DocuSign, which is 21 CFR Part 11 compliant and therefore can be used to collect signatures on informed consent forms and essential regulatory documents (i.e. FDA Form 1572, financial disclosure forms, delegation of authority logs, etc.) for FDA-regulated studies. Documents that would have been signed on paper can now be available on a computer or touch-screen device to be signed electronically either in-person or remotely.  

REDCap, WCM/NYP’s primary data capture system can also facilitate the collection of signatures on electronic consent forms (eConsent). REDCap is not currently FDA compliant and therefore can only be used for non-FDA regulated studies. The IRB-approved informed consent form can be built into REDCap and routed to the participant and investigator for signatures, but the system cannot manage the collection of signatures for regulatory documents.

Data and Safety Monitoring Plan (DSMP) is a written description of the procedures for reviewing accumulated data in an ongoing research protocol to ensure the safety of research participants, validity, and scientific merit of the study protocol.

Data and Safety Monitoring Board (DSMB) is a formal committee of experts who review accumulating data from one or more ongoing clinical trials

Medical Monitor is an individual expert who reviews accumulating data from one or more ongoing clinical trials

Non-Compliance means failure to comply with the requirements of an applicable law, regulation, or institutional policy pertaining to the protection of human subjects, and/or with the requirements or determinations of an IRB.

Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO) is an incident, experience, or outcome that meets all of the following criteria:

• Unexpected (in terms of nature, severity or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and the characteristics of the subject population being studied;
• Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.

46.111(a)(6)

When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

Initial Review Application

On the Monitoring for Safety and Compliance page you will be asked how this research will be monitored for safety?

• Medical Monitor
• Data Safety Monitoring Committee
• Not Applicable/Minimal Risk
• Other

You will also be asked to describe your monitoring plan. If the research protocol includes a detailed monitoring plan, simply reference the location of the information in the protocol.  Subject safety monitoring plans should reflect the risk profile of the research. For minimal risk research, informal monitoring may be adequate. Greater than minimal risk research requires a formal monitoring plan. For clinical trials initiated by a research sponsor, the sponsor often includes the monitoring plan in the research protocol. For investigator-initiated studies, the researcher will need to establish an independent monitor or monitoring committee to regularly review research data for subject safety. When monitoring subject safety, the discovery of new risk information must be reported to the IRB within 5 business days.

The WCM Research Integrity and Compliance Team conducts both random and for cause audits for research compliance. The research team maintains responsibility for ensuring the research is conducted according to the IRB-approved protocol. Any time the research team fails to comply with the requirements of an applicable law, regulation, or institutional policy pertaining to the protection of human subjects, and/or with the requirements or determinations of an IRB, it should be reported to the IRB as an allegation of non-compliance.  Researchers should have a plan to avoid non-compliance and ensure the research is being conducted in accordance with the protocol.  Allegations of non-compliance must be reported to the IRB within 10 business days.

The IRB will consider the following:

• Is there a detailed and documented plan in place to monitor the safety of the research participant according to the risk level of the research?
• Will the investigator have enough information to notify the IRB of any:
• Changes to risk information
• Unanticipated problems involving risks to subjects or others;
• Allegations of non-compliance

Directory Information means information contained in an Education Record of a student that would not generally be considered harmful or an invasion of privacy if disclosed. It includes, but is not limited to, the student’s name, address, telephone listing, electronic mail address, photograph, date and place of birth, major field of study, dates of attendance, grade level, enrollment status (e.g., undergraduate or graduate; full-time or part-time), participation in officially recognized activities and sports, weight and height of members of athletic teams, degrees, honors and awards received, and the most recent educational agency or institution attended.

Disclosure means to permit access to or the release, transfer, or other communication of Personally Identifiable Information contained in Education Records to any party, by any means, including oral, written, or electronic means.

Education Records means records that contain information directly related to a student and that are maintained by an educational agency or institution or by a party acting for the agency or institution. These include, but are not limited to, academic evaluations, including student examination papers, transcripts, test scores and other academic records; general counseling and advising records; disciplinary records; and financial aid records, including student loan collection records.

Eligible student means a student who has reached 18 years of age or is attending an institution of postsecondary education.

Personally Identifiable Information is the student’s (or family member’s) name, address, personal identifier, and personal characteristics or other information that would make the student’s identity easily traceable.

Record means “any information recorded in any way, including, but not limited to, handwriting, print, computer media, video or audio tape, film, microfilm, and microfiche.”

Federal regulations require FERPA compliance.

FERPA requires prior consent to disclose personally identifiable information from an education record. When accessing education records for research purposes, investigators are responsible for compliance with FERPA in addition to general human subject protection regulations (IRB requirements).

FERPA stipulates that an educational institution has the authority to determine what information may be accessed from an Education Record. If an institution denies an investigator access to information in an Education Record, the IRB cannot overrule the decision. 

Note that projects aimed at educational improvement for the instructor’s own students, without the intention of applying the information learned to a broader population or in other settings, does not meet the definition of research. When conducting course evaluation and improvement programs that do not meet the definition of research, there is the possibility of approval to access identifiable records without consent. This involves being recognized as a Campus Official performing assigned duties relating to improving WCM students’ education.

For information about students at WCM please contact the school’s registrar to find out more about their requirements.

There are three ways to comply with FERPA when accessing student records for research:

1. Obtain Consent to Access Education Records for Research
2. Access Education Records as a Campus Official
3. Receive De-identified Data

Obtain Consent to Access Education Records for Research

When a researcher wishes to access identifiable education records solely for research purposes, FERPA consent will be required. FERPA consent is an additional protection and should not be confused with consent for participation in the research.  The researcher must document the FERPA consent by having the parent or Eligible Student sign and date a FERPA Waiver of Records Release .

Access Education Records as a Campus Official

When a research project has the dual aims of educational improvement for the instructor’s own students and generation of knowledge that can be applied broadly outside of the research setting, there is the possibility of approval to access identifiable education records without consent. This involves being recognized as a Campus Official performing assigned duties relating to improving WCM students’ education. 

Receive De-identified Data

Education records may be released without consent under FERPA if all personally identifiable information has been removed including:

• Student’s name and other direct personal identifiers, such as the student’s social security number or student number.
• Indirect identifiers, such as the name of the student’s parent or other family members; the student’s or family’s address, and personal characteristics or other information that would make the student’s identity easily traceable; date and place of birth and mother’s maiden
• Biometric records, including one or more measurable biological or behavioral characteristics that can be used for automated recognition of an individual, including fingerprints, retina and iris patterns, voiceprints, DNA sequence, facial characteristics, and
• Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable
• Note: The US Department of Education indicates that “data that cannot be linked to a student by those reviewing and analyzing the data are not ‘personally identifiable.’ As such, the data are not “directly related” to any students. Accordingly, a document containing only non-personally identifiable data, even when originally taken from a student’s Education Record, is not a part of the student’s Education Records for purposes of FERPA.”

New Projects

Effective January 1, 2020, all new minimal risk research must comply with the Revised Common Rule, regardless of funding.

Effective January 19, 2019 all new federally-funded research must comply with the Revised Common Rule.

Existing Projects

The revisions to the Common Rule will have no effect on greater than minimal risk research that is already IRB approved. All existing greater than minimal risk research may continue uninterrupted and must follow the Old Rule (the rule in effect before 2018). Investigators must continue to submit continuing review/progress reports before the administrative due date, as is the current practice.

If an investigator wants the IRB to apply the 2018 Common Rule to existing research that is not due for continuing review, the investigator may submit a modification to the IRB. If the study is open to enrollment or requires access to private identifiable data or specimens, changes may be required to comply with the 2018 Common Rule.  To modify a study to comply with the 2018 Common Rule researchers must:

• Update the research consent form to comply with the 2018 Common Rule. Visit the IRB Forms page to find consent form templates that comply with the Revised Rule. They are denoted with “2018 Common Rule Compliant” at the end of their name.
• Update the justification for a waiver of consent for access or use of private identifiable information or biospecimens by explaining why the research cannot practicably be conducted using anonymous or coded data or biospecimens.

For federally-funded research, the 2018 Common Rule requires one consent form to be posted on a publicly available federal website for any clinical trial conducted or supported by a Common Rule department or agency.  The consent form must be posted no later than 60 days after the last study visit by any subject. The consent form must have been used in enrolling participants in order to satisfy this new provision. The compliance date for this provision is January 21, 2019.

At this time, two publicly available federal websites have been identified to satisfy the consent form posting requirement: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). OHRP has launched a website explaining how to upload consent forms to the Federal Docket to satisfy the requirement for public posting at 45 CFR 46.116(h)(1) under the 2018 Common Rule.  HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement.

Additional federal websites satisfying the 2018 Common Rule’s clinical trial consent form posting requirement might be identified in the future.

The term “Broad Consent” as defined by the Revised Rule applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, our institutions (WCM and NYP) are not pursuing broad consent at this time.  Investigators can continue to use biospecimens that are coded or to seek a waiver of consent for use of biospecimens with identifiers retained consistent with current practices 

The 2018 Common Rule states that federally-funded studies where the study will be conducted at more than one domestic site must use a single IRB, unless the federal agency has documented that single IRB review is not required.  The single IRB provision compliance date is January 21, 2020. WCM-Montefiore researchers do not need to comply with this provision at this time unless the study is federally funded. The NIH has documented specific requirements for when studies they fund must be reviewed by a single IRB. Additional information about NIH single IRB requirements can be found  here.

The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed. The FDA still requires annual continuing review for FDA-regulated studies, even those FDA-regulated studies involving only minimal risk.

All Studies

• The research consent form must comply with the Revised Rule. Visit the IRB Forms page to find consent form templates that comply with the Revised Rule. They are denoted with “2018 Common Rule Compliant” at the end of their name.
• Researchers requesting a waiver of consent for access to or use of private identifiable information or identifiable biospecimens must explain why the research cannot practicably be conducted without the use of identifiers.

Federally-funded Studies

• Clinical trials must post one IRB-approved informed consent form which was used to consent subjects to a publicly available Federal website within 60 days of the last study visit by any subject.
• Single-IRB review must be used for multisite research.

A biological product, as defined in section 351(i) of the Public Health Service Act, is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.

A cosmetic is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body. . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.

A dietary supplement (as defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994) is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.

• The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.
• Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.

A drug:

• Is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
• Is intended to affect the structure or any function of the body of man or other animals.

Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

A medical device:

• Is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
• Is intended to affect the structure or any function of the body of man or other animals.
• Does not achieve its primary intended purposes through chemical action within or on the body of man or other animals.
• Is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).

For FDA-regulated research involving investigational drugs and biologics investigators are required to abide by the following:

• Restrictions on promotion of investigational drugs
• Requirements for general responsibilities of investigators
• Requirements for control of the investigational drug
• Requirements for investigator recordkeeping and record retention
• Requirements for investigator reports
• Requirements for assurance of IRB review
• Requirements for inspection of investigator’s records and reports

The rules apply to protected health information (PHI), which is defined as individually identifiable health information that is transmitted or maintained in any form or medium (electronic, oral, or paper) by a covered entity or its business associates, excluding certain educational and employment records.

In most instances, health information is considered individually identifiable when any of the following identifiers are included with the information:

• Names
• Telephone numbers
• Fax numbers
• Email addresses
• Social Security numbers
• Medical record numbers
• Health plan beneficiary
• Vehicle identifiers and serial numbers, including license plate numbers
• Account numbers
• Certificate/license numbers
• Device identifiers and serial numbers
• Web Universal Resource Locators (URLs)
• Internet Protocol (IP) addresses
• Biometric identifiers, including finger and voice prints
• Full-face photographs and any comparable images
• Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification
• All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP code, and their equivalent geocodes, except for the initial three digits of the ZIP code if, according to the current publicly available data from the Bureau of the Census:
• The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; and
• The initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer people is changed to 000.
• All elements of dates (except year) for dates that are directly related to an individual, including birth date, admission date, discharge date, death date, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older.

One of the main purposes of HIPAA is to require health plans to accept electronic transactions from health care providers. The Privacy and Security Rules are means to the risk to individual privacy when the electronic transactions are processed.  The Rules apply to all PHI held by covered entities, which are health plans (health insurance companies), health care providers and health care clearing houses (companies that facilitate electronic transactions.  WCM and NYP are health care providers and is a covered entity under HIPAA.

When research involves the use or disclosure of PHI by entities subject to the regulations, the rules will apply. Researchers have legitimate needs to use, access, and disclose PHI to carry out a wide range of health research studies. In most instances, the Privacy Rule requires an authorization from the individual or a waiver of authorization from an IRB or Privacy Board before a covered entity can access, use or disclose PHI for research purposes. In general, there are two types of human research that would involve PHI:

• Studies involving review of medical records as a source of research information.
• Studies that create new medical information because a health care service is being performed as part of the research.

What Is Required for Research in order to access, use or disclose Protected Health Information (PHI)?

Researchers may access, use, and/or disclose PHI for research purposes from the Electronic Medical Record (EMR) once there is an approved waiver from an IRB or other applicable authority or a signed HIPAA Authorization from the patient. 

Waiver criteria:

(1) Use or disclosure involves no more than minimal risk to the privacy of individuals because of the presence of at least the following elements:

(a) An adequate plan to protect health information identifiers from improper use or disclosure.

(b) An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them.

(c) Adequate written assurances that the PHI will not be used or disclosed to a third party except as required by law, for authorized oversight of the research study, or for other research uses and disclosures permitted by the Privacy Rule.

(2) Research could not practicably be conducted without the waiver or alteration.

(3) Research could not practicably be conducted without access to and use of PHI.

Health Insurance Portability and Accountability Act (HIPAA) Authorization

• The Privacy Rule establishes the right of an individual, such as a research subject, to authorize a covered entity to use and disclose his/her PHI for research purposes. This requirement is in addition to the informed consent to participate in research required under the HHS Protection of Human Subjects Regulations and other applicable Federal and State law.
• HIPAA Authorization for Research (Version 2017) are available at the Office of Research website.

In most instances, researchers at our institution use the WCM HIPAA Research Authorization to use and share PHI for research purposes. However, in some instances, the Privacy Rule allows an IRB to waive the requirement for a signed authorization from the individual for use of PHI in research.  WCM researchers complete the applicable section of the electronic Initial Review Application when they need access to PHI without obtaining an authorization from the individual.

It is always preferred to obtain authorization to use an individual’s PHI.  In order to waive the requirement for an authorization, the IRB must determine that the study meets the following criteria:

• The use or disclosure of the identifiers involves no more than minimal risk (An adequate plan to protect identifiers from improper use and disclosure must be included in the research proposal)
• There is an adequate plan to destroy the identifiers at the earliest opportunity.
• The project could not practicably be conducted without a waiver
• The project could not practicably be conducted without use of PHI
• The IRB receives written assurances that PHI will not be re-used or disclosed for other purposes

Definition

Children  are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

What is the requirement?

Research must be specifically approved to include children. The regulations that the WCM IRB follows when reviewing research involving children include: 

• Subpart D – Additional Protections for Children Involved as Subject in Research 
• 46.404    Research not involving greater than minimal risk.
• 46.405    Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
• 46.406    Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.

How do I comply with this requirement?

Initial Review Application: On the Vulnerable Participants page of the Initial Review Application, select the box for “children” if your research will include this group. You will be asked for additional details about the research. 

Regulations require that research fall under an approval category before children can be included. Please select the applicable category for your research and provide protocol specific justification for inclusion. 

• Minimal Risk Research 
• Greater than Minimal Risk Research with prospect of direct benefit 
• Greater than Minimal Risk with no prospect of direct benefit 

Parental Permission: Unless the IRB has issued a waiver, parental permission will be required. Generally, one parent’s signature is required for minimal risk research or greater than minimal risk research with the prospect of direct benefit to the child. In contrast, both parents’ signature are required for greater than minimal risk research with no prospect of direct benefit to the child.

Assent: Assent should be obtained whenever the children involved in the research are capable of comprehension and agreement. Below is the list of options provided, you should select all that apply: 

• Assent will be obtained from all children capable of assenting 
• Assent will not be obtained from children capable of providing assent 
• Assent will not be obtained from any children

If assent will not be obtained from some or all of the children, you will need to provide justification in a free text field in the initial review application. The WCM IRB does not generally require a separate assent document. Assent is documented in the Children’s Signature Block on the consent template. 

Ethical Considerations

The research team and the IRB will need to consider the following criteria when evaluating research involving children: 

• Risks presented to the children are not greater than minimal unless the adequate provisions are in place. 
• In greater than minimal risk research involving children, the risk is justified by the prospective benefit. 
• The anticipated benefit is favorable to the subjects 
• There are adequate provisions in place regarding assent and parental permission

In the case of greater than minimal risk research has no prospect of direct benefit to subjects, but will likely generate generalizable knowledge , the IRB must also consider whether: 

• The risk is a minor increase over minimal risk 
• The research procedures presented to the subjects are commensurate to those in their actual or expected medical or educational situations 
• Generalizable knowledge is likely to be obtained 
• Adequate provisions are in place for assent and parental permission 
• Research with no prospect of direct benefit will present an opportunity to understand, prevent, or alleviate a serious problem 

Definition

A Prisoner is any individual involuntarily confined or detained in a penal institution. 

What is the requirement?

Research must be specifically approved to include prisoners. The regulations that the WCM IRB follows when reviewing such research include: 

Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 

• 46.306    Permitted research involving prisoners

How do I Comply with this requirement?

Initial Review Application: On the Vulnerable Participants page of the Initial Review Application, select the box for prisoners if this group may be recruited for your research. Note, the state of California does not allow state prisoners to be enrolled in clinical trials or other biomedical studies.  

Ethical Considerations

Along with the requirements of subpart A, an IRB must make the following seven additional findings required by the regulations in order to review and approve research involving prisoners: 

• The proposed research must fall into one of the categories under 45 CFR46.306(a)(2); 
• The advantages associated with participation in the research should not be of such a magnitude that his or her ability to weigh the risks of the research against the value of receiving such advantages in the limited-choice prison environment is impaired; 
• The risks are commensurate with risks that would be accepted by non–prisoner volunteers; 
• Selection of subjects in the prison are fair to all prisoners, unless justification is provided by the principal investigator; 
• The information presented in language that is understandable; 
• Adequate assurances are in place that prevent a prisoners participation in the research to be taken in account by the parole board; 
• If there is a need for follow-up with the prisoner after the research has concluded, provisions will be put in place for those examinations, and prisoners will be informed of this beforehand.

Definitions

The term, "Person with Limited Decision-Making Capacity" means a person who has reached the legal age of consent but lacks the decision making capacity to comprehend the consent process and voluntarily choose to participate in research.  

Legally Authorized Representative (LAR) means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non–research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research. 

What is the requirement?

Adults with limited decision-makiing capacity may only be enrolled in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions specific to the research subjects when the necessary study cannot be conducted using subjects who are not cognitively impaired. 

How do I comply with this requirement?

Initial Review Application: On the Vulnerable Participants page of the Initial Review Application, select the “Persons with LImited Decision-Making Capacity”  box when some or all of the research subjects may be adults who lack capacity to provide consent for participation in research. You will be asked to provide the following details about your consent process: 

• Describe your process for determining whether an adult has capacity to consent: 
• Will assent be obtained from all adults who lack capacity to consent and are capable of assenting? 
• If research subjects regain capacity, will you obtain their consent? 

Ethical Considerations 

The IRB may approve the use of a LAR only in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of the research subjects when the necessary study cannot be conducted using subjects who are not cognitively impaired. 

Note: 

Some populations require additional protections only in specific situations. 

Targeted participants are groups that are capable of providing informed consent, however, there are additional considerations if the category of participant is targeted for research or if subjects’ status as a member of the population is recorded as part of the research data. The Initial Review Application will ask you to identify any of the following categories of vulnerable participants that will be targeted for prospective research: Pregnant participants/fetuses; students or direct reports of the PI; undocumented individuals; members of underserved communities; members of populations underrepresented in scientific research; members of populations experiencing disparities in health and/or access to health care.. Research does not need to be specifically approved to include populations listed under targeted participants. However, if these populations are specifically targeted for recruitment as part of the research, then the IRB must take this into account during review. 

Definitions

A woman is assumed pregnant if she exhibits any of the qualified signs of pregnancy, such as missed menses, until the results of a pregnancy test are shown negative or until delivery. 

What is the requirement? 

The regulations that the WCM IRB follows when reviewing  such  research,  include:  

Subpart B – Additional Protection for Pregnant Women, Human Fetuses and Neonates in Research  

• 46.204    Research involving pregnant women or fetuses. 
• 46.205    Research involving neonates. 
• 46.206    Research involving, after delivery, the placenta, the dead fetus or fetal material. 
• 46.207    Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.

How do I Comply with this requirement?

Initial Review Application: On the Targeted Participants page of the Initial Review Application, select the box for “Pregnant Women/Fetuses” only if your research is targeting recruitment of either group or if a participant’s pregnancy status will be recorded as part of the research data. If are not targeting enrollment of pregnant women/fetuses and your research does not allow you to determine a woman’s pregnancy status, you do not need to select the box. 

Ethical Considerations 

Research must be considered ethically justified and satisfy a variety of conditions:   

• Reasonable prospects the investigation will produce the desired results;  
• A balance of potential benefits in relation to the potential risks;  
• A justification for why the research is necessary;  
• Monitoring for outcomes and the protection of human subject; and  
• The benefits and burdens of the research are distributed evenly among potential subject groups. 

What is the Requirement?

Investigators should not use students of their classes as a convince sample for research. Whenever possible, researchers should collect information from participants who are not subject to the power dynamic of a teacher-student relationship.  

How do I Comply with this Requirement? 

Initial Review Application: On the Targeted Participants page, select the “Students or Direct Reports of The Principal Investigator” box only when the research seeks to enroll students or direct reports of the PI. If your research is not targeting either of these populations and the data you are collecting does not allow you to determine if the participants are students of the PI, you do not need to select the box. 

Ethical Considerations

Because of the power relationship between students and their teachers, students may feel pressured to participate in research. Similarly, because of the power relationship between a supervisor and their direct reports, direct reports may feel pressured to participate in research. The IRB will determine if there are adequate protections to allow participants to choose to enroll in research without undue influence or coercion.  

Significant financial interest means anything of significant monetary value, including but not limited to:

• Salary or other payments for services;
• Equity interests (e.g., stocks, stock options or other ownership interests);
• Intellectual property rights (e.g., patents, copyrights and royalties from such rights); or
• Holding a position as an officer, director, agent, or employee of a business entity.

Significant financial interest also includes such interests held by a Principal Investigator or other Investigators and by their spouses, domestic partners and/or dependent children.

For non-PHS funded Investigators, significant financial interest does NOT include:

• Salary, royalties, or other remuneration from the institution.
• Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
• Income from service on advisory committees or review panels for public or nonprofit entities.
• An equity interest in a public company that represents less than a 5% ownership interest and less than $10,000 in value as determined through reference to public prices.
• Annual salary, royalties or other payments from any source other than those referenced in subparagraphs (1) and (2) above that individually or when aggregated do not exceed $10,000 over the next twelve months.
• Income from mutual funds and/or pension funds;
• Interest in a business entity if the business entity is an applicant for Phase I support under the Small Business Innovation Research (SBIR) Program.

All Investigators responsible for the design, conduct or reporting of the research must submit required disclosures to the Institution via the COI Office.  They will be able to describe the institutional guidelines for COI disclosure..

For New Projects, disclosure is required if:

• The study is PHS-funded
• The study is privately funded or supported
• The study is FDA-regulated
• Any Investigator has a significant financial interest when the research is unfunded and not FDA-regulated

It is recommended that all investigators visit the WCM COI Office webpage in order to ensure compliance with our policies.

When applying for initial review of a new project, Investigators should notify the IRB of any required disclosures that have been submitted to the COI Office. When completing the Related Financial Interest page of the Initial Review Application you will be asked if any personnel involved in the design, conduct or reporting of the protocol have a positive financial disclosure.  Select “yes” if any personnel have a positive disclosure. Complete the appropriate disclosures with the COI Office.