Quality Assessment/Improvement (QA/QI)
I am conducting a quality assessment/improvement (QA/QI) project; do I need IRB approval?
QA/QI (quality assessment/quality improvement) involves, “systematic, data-guided activities designed to bring about immediate (or nearly immediate) improvements in health care delivery.” QA/QI is a significant and necessary part of the functioning of a medical institution. Many quality improvement projects do not constitute human subjects research, and, thus, do not require IRB review. However, sometimes, quality improvement activities accomplish a research purpose as well as the purpose of improving the quality of care. In these cases, the regulations for the protection of subjects in research (45 CFR part 46) would apply. The intent to publish, by itself, is an insufficient criterion for determining whether a quality improvement activity involves research. It is important to understand whether a quality improvement involves research prior to initiation to ensure that human subjects research is not conducted without IRB approval. If you are planning a quality improvement project and need guidance determining whether a protocol is needed, please complete this QA/QI determination form and email it to IRB@med.cornell.edu.
Who Can Be an Investigator
Who can be a Principal Investigator (PI) on an IRB protocol?
Full time WCMC faculty employees can be PIs on all categories of IRB protocols. Employees of New York Presbyterian Hospital (Pharmacists, RNs and Fellows) can be PIs on IRB protocols that involve retrospective reviews or surveys. They are not permitted to be PIs on protocols that involve patient care. This serves to clarify the information that is in our existing IRB policy guide that can be found on our website.
Can students be investigators on IRB protocols?
Students 18 years and older can be student investigators on IRB protocols. Students under the age of 18 are not permitted to conduct human subject research at WCMC. Student volunteers are required to complete and submit a volunteer form.
How do I submit to the IRB?
Beginning August 15, 2013, the IRB process for initial submissions has changed. The Clinical Study Evaluation Committee (CSEC) now handles eIRB's 'Create New Protocol' functionality. For more information: http://jcto.weill.cornell.edu/investigators/study-activation-and-conduct/navigating-the-csec-and-irb.
What documents do I need to submit for a new study to be reviewed by the IRB?
All IRB protocol applications (initial, continuing review, CIRB, facilitated, immediate report form, protocol exception and request for complete or partial HIPAA waiver) have been incorporated into eIRB. In addition, the requests for human tissue and Investigational Pharmacy forms have also been incorporated into the system. However, depending on the type of protocol, certain documents will need to be uploaded. These include the following:
1. Consent/Assent forms/Oral Consent Script
2. Recruitment Notices/Advertisement materials
3. HIPAA authorization form
5. Data Collection Sheets, Surveys, Questionnaires, Psychological Tests, Interview Forms, Scripts, Etc.
6. FDA Correspondence (if applicable)
7. Sponsor Protocol (if applicable)
8. Investigator Brochure (if applicable)
9. Grant (NIH or other) (if applicable)
Please note, the HIPAA Preparatory to Research Form (Form 8) is not submitted through eIRB, but should be sent as a PDF to email@example.com.
- What happens once I submit through eIRB?
Once CSEC approves your study, you will be given the opportunity to complete the rest of your application in eIRB. After you’ve completed your application in eIRB and submit your protocol, you will receive a personalized email confirmation of receipt indicating that your submission has submitted into routing. The protocol will be routed to the Department Chair, or their designee, for approval. Only after the Department Chair approves the protocol, will it then be routed to the IRB office for processing. You will receive email notification once the IRB office has received the protocol.
- How do I keep track of where my protocol is in the routing process?
Under the protocol options tab, click the tab that says, "Where is my protocol." A box will open up that will enable you to trace the movement of the protocol through all approvers and to the IRB office.
- What is the average time for a new full board protocol to be reviewed and approved?
Most protocols take an average of 2 meeting cycles, which equals 6-8 weeks. Some may take more time. Please take this schedule into consideration to allow adequate time for your submission to be reviewed and approved.
- My protocol came back from the IRB meeting with "Modifications Required" (formerly known as "Non-substantive Issues"). Does this mean it is required to go to another meeting?
No, once you submit your response (also known as “RTQ” or “Response to Questions”), your response will be reviewed via expedited review. Response must be received within 60 days of the date the letter is issued or an extension must be requested. Be sure to include a cover memo with a detailed point-by-point response to all issues raised. This memo should indicate how the issue was addressed, changes to the text, and where in eIRB the changes can be found. If you disagree with an issue that was raised by the IRB, please provide justification for why you are not making the requested changes. This memo should be uploaded in the Attachments section. Also, a highlighted and clean copy of any documents that required changes (e.g., informed consent, HIPAA Authorization, etc.) should be uploaded in the attachments section. Once the response is complete, go to “Submissions Options” and select “Submit for Review.” Please note that anyone with editing rights to the submission (including the research coordinator) will be able to submit the response.
- My protocol came back from the meeting "Deferred" (formerly known as "Substantive Issues"). Does this mean it is required to go to another meeting?
Yes, response to deferrals will need to be reviewed at another convened meeting. Response must be received within 60 days of the date the letter is issued or an extension must be requested. Be sure to include a cover memo with a detailed point-by-point response to all issues raised. This memo should indicate how the issue was addressed, changes to the text, and where in eIRB the changes can be found. If you disagree with an issue that was raised by the IRB, please provide justification for why you are not making the requested changes. This should be uploaded in the Attachments section. Also, a highlighted and clean copy of any documents that required changes (e.g., informed consent, HIPAA Authorization, etc.) should be uploaded in the attachments section. Once the response is complete, go to “Submissions Options” and select “Submit for Review.” Unlike a response to modifications required, response to deferrals must be submitted by the PI.
- What can put a hold on IRB approval release?
1. The Human Research Billing Analysis Form
2. Resolution of conflicts as instructed by the Conflicts Management Office.
3. Contract execution (between WCMC and sponsor).
4. Study personnel who have not taken the CITI course/refresher course in the Protection of Human Research Subjects or its equivalent.
How do I submit an amendment to my protocol?
You must submit an amendment to make a change to any sections of the protocol or the documents associated with the study (e.g. consent form, HIPAA Authorization, etc.). Locate the protocol within the “All Active Protocols” tab to open the protocol and create an Amendment by clicking “Amendment” underneath “Protocol Options.” Please note that only one Amendment or one Continuing Review can be submitted at a time. Please note when co-investigators are being added, they will have to certify the protocol and pass the CITI Course, “Biomedical Research Investigators and Key Personnel.”
If the protocol will be expiring within 2 months from when you are submitting the amendment, a pop-up box will appear suggesting that you submit a continuing review with an amendment as only one Amendment or one Continuing Review can be submitted at a time.
Responses to Issues Letters
- When are responses to issues letters due?
If your protocol received a status of "modifications required" or "deferred," the issues letters must be responded to within 60 days of receipt of the letter. This response can be in the form of either a full response to all of the issues in the letter, or a request for a 30 day extension.
Enrolling Non-English Speaking Subjects
- How do I enroll non-english speaking subjects?
Expected enrollment of non-English speaking subjects: For those studies where the recruitment efforts will target a certain population such that the PI expects a significant proportion of subjects will be non-English speaking, the IRB shall require a translated consent document to be prepared. In order to ensure that the translation is accurate, an affidavit of accuracy from the translation service or a back translation from the translated consent to English by a third party (i.e., an individual not an investigator on the protocol) is required. When non-English speaking subjects enroll, they must be given a copy of the translated consent document. Subjects and witnesses must sign the translated document.
Unexpected enrollment of a non-English speaking subjects: If a PI decides to enroll a subject into a protocol for which there is not an existing IRB-approved informed consent document in the prospective subject's language, the procedure for obtaining oral consent of non-English speaker may be used. A short form consent document in both English and the subject's language must be reviewed and approved by the IRB. A certificate of accuracy or a back-translation of the short form by a third party should be included with the submission. An English short form consent and translated versions can be found on our intranet website.
- I received a priority score and I qualify for a "just in time" grant from the NIH. How do I get the grant reviewed by the IRB?
Submit an amendment to include the new funding source, the grant in its entirety, and any necessary changes to the IRB protocol. All deadlines and corresponding IRB meeting dates apply to grant reviews.
- I need a 310 Form, how do I go about obtaining it?
In order to obtain a 310 form, your grant must be reviewed by the IRB. You must submit an amendment to include the new funding source, the grant in its entirety, and any necessary changes to the IRB protocol to carry out the research. All of the human subjects research described in the grant must be covered by an IRB approved protocol. More than one protocol can be used to cover human subjects research in a grant.
- Can I submit a grant for review if I do not yet have an approved protocol at WCMC?
Yes, you will need to submit the new protocol for review at the same time you are submitting the grant for review.
- What does expedited review mean?
Expedited review means the submission (e.g. new protocol, amendment and/or continuing review) will be reviewed by one member of the IRB. As such, expedited submissions do not have specific submission deadlines. It is important to note that expedited review does not necessarily mean that the submission will be reviewed quicker than a full board review. Please allow a minimum of 10 business days for issues raised/approval to be communicated to the research team.
- What type of study qualifies for expedited review?
Expedited reviews are reserved for minimal risk studies that fall into designated categories.
Compassionate vs. Emergency Use
- What is Compassionate Use?
The FDA does not include the phrase "compassionate use" in its regulations, but it is commonly used by the research community. FDA has mechanisms to allow for access to investigational drugs or devices for patients who do not meet the inclusion requirements for a clinical investigation of an investigational drug or device but for whom the treating physician believes the drug or device may provide a benefit in treating and/or diagnosing their disease or condition. Expanded access can be sought for an individual patient or group of patients. Granting access to investigational drugs or devices for such patients requires prior FDA approval and IRB concurrence. Also, the sponsor must agree to provide the investigational drug or device for the expanded access. Patients must have a serious disease or condition for which there is no alternative treatment. For access to Investigational New Drugs (IND), FDA refers to compassionate use requests for individual patients as "single patient IND" studies (wider use would usually takes place under a "treatment IND" or "treatment protocol" under an existing commercial IND). For access to investigational devices, the FDA regulations allow for "compassionate use" with prior FDA approval and the approval of the investigational device sponsor and review by the IRB. Depending on the IND or IDE, compassionate use of drug or device may require submission of an IRB application and review by a convened IRB. The following FDA regulations and guidance pertain to "compassionate use": Food, Drug, and Cosmetic Act; Section 561 Expanded Access to Unapproved Therapies and Diagnostics; Regulation-21 CFR 812.35(a); Guidance.
- What is Emergency Use?
Emergency use allows physicians to use unapproved drugs or devices in emergency situations. Importantly, emergency use can only happen once per drug or device per institution; any additional use requires an Investigational Device Exemption (IDE) or an Investigational New Drug (IND) application and the submission of a research protocol to the IRB. Although emergency use is not research, it does require reporting to the IRB and concurrence (but not approval) by the IRB chairperson. All of these criteria must be satisfied for emergency use:
1. The patient has a life-threatening disease or serious condition requiring immediate use
2. No generally accepted alternative for treating the condition is available
3. The physician has substantial reason to believe that the patient will benefit
4. There is no IND or IDE in place and no time to use existing procedures to obtain FDA approval of an IDE or IND
5. The physician is not part of an IND or IDE study of the drug or device
6. Independent assessment form an uninvolved physician
- How do I obtain an approval for Emergency Use of an unapproved drug or device?
Prior to administering the drug or device or within five days after the emergency use of the drug or device, the physician must submit an emergency use request through eIRB. To create an emergency use protocol, email the CSEC at GeneralCSEC@med.cornell.edu or CancerCSEC@med.cornell.edu and request that an emergency use protocol be initiated. Please cc firstname.lastname@example.org on this email request. The CSEC will then respond to the email with the protocol number. Complete the remaining sections of the emergency use protocol and submit for review and the IRB office will process accordingly.
The following FDA regulations and guidance pertain to emergency use: Regulation: 21 CFR 56.104(c), 21 CFR 50.23, 21 CFR 812.35(a)(2), 21 CFR 812.150(a)(4); Guidance: Federal Register/vol.50, No. 204/Tuesday, October 22, 1985
Acknowledgement of Receipt
- The study's sponsor has sent me an Investigator's Brochure (IB) that I need the IRB to acknowledge. What do I need to include when I send it to the IRB office?
If the changes to the IB will require a change to the informed consent or protocol application, this would constitute an amendment and should be submitted as such. See the FAQ above regarding submission of an amendment.
If the updated IB does not require changes to the informed consent or protocol application, please send a copy of the IB and a new memo attesting that the changes to the IB do not require a change to the protocol or the consent. This request should be sent for acknowledgment to the IRB office at email@example.com. You will receive an acknowledgement letter from the IRB office within 5-10 business days of submission.
- What do I need to submit for the continuing review of my study?
Locate the protocol within the “All Active Protocols” tab to open the protocol and create a Continuing Review (CR) by clicking “Continuing Review” underneath “Protocol Options.” Please note that only one amendment or one CR can be submitted at a time. Please note that all investigators will have to recertify the protocol at the time of CR. Furthermore, the PI will have to submit all Continuing Review submissions.
- How far in advance of the expiration date of my study should I submit the materials for a continuing review?
The IRB suggests that you submit any materials at least two meeting cycles (6-8 weeks) before the study expires.
- I just realized that my study has expired, what do I do?
It depends on how long the study approval has lapsed. Submit your continuing review as soon as possible. No study related activities can continue beyond the WCMC IRB expiration date, including subject recruitment, enrollment, intervention and data analysis. “If the approval period for the study has lapsed more than fourteen days, please contact Alavy Sos, Director of the Institutional Review Board, 646-962-8200 / firstname.lastname@example.org for guidance.
However, OHRP guidance suggests that study intervention for subjects already enrolled can continue past the expiration date if the IRB determines that it is in the best interests of subjects already enrolled to continue participating in the research (for example, when the research interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to the subjects). While this determination may initially be made by the investigator, WCMC requires that the investigator must seek confirmation that the IRB agrees with this determination as soon as possible.
If you submit your continuing review such that the IRB will be unable to conduct continuing review prior to the expiration date, and you believe it is in the best interest of the subjects to continue study intervention, please send your request to the IRB. If the IRB agrees that it is in the best interests of the subjects to continue with the study intervention, then the request for an extension will be granted. If the IRB concludes that it is not in the best interest of the subjects to continue the study intervention, or that there will not be an increased risk to the subjects, then the request will not be approved. All requests for continuing review and approval submitted after current approval expiration must include an explanation of why the approval lapsed and the steps the investigator will take to ensure it does not happen in the future.
- What are the key elements I need to include in an advertisement?
When writing/designing a flier, brochure, or any other form of advertising, it is important to remember the audience you are writing for. Since you are writing to recruit potential research subjects, keep the language as simple as possible (lay terms) so potential subjects understand what you are advertising and whether it applies to them. The key elements to include in any advertisement are:
• The words 'research study' must appear at or immediately near the top/beginning of the advertisement
• The main purpose of the research (and/or condition under study) must be stated
• Provide the basic eligibility criteria (e.g. age range, sex, healthy individual)
• State the tests/procedures involved in the study (not just acronyms, i.e. not MRI, but instead magnetic resonance imaging (MRI)
• Give the time or other commitment requirements
• State 'compensation' will be provided and not 'pay' if subjects are to be given money/gift for their participation in the study
• Have a contact name (i.e. Research Coordinator or Principal Investigator) and phone number listed for more information
• If applicable, state that this is an experimental drug (not approved by the FDA)
• If applicable, state that there is a placebo arm of the study and what is meant by 'placebo' (i.e. inactive drug)
• At the bottom of the advertisement, provide the IRB protocol number and date of approval of the advertisement
• If applicable, any possible benefits should be presented in a conservative manner without exaggeration
• Do not use terms like "treatment", "medication", "doctor", instead use research terms like "study drug", "researcher/research team", etc. Potential subjects must not get the impression that the study will be a course of treatment for them.
• Do not suggest to potential subjects that they are in danger if they do not participate.
If you are adding a recruitment tool that has not been previously approved by the IRB, an amendment must be created for submission of the recruitment tool for review. Make sure to update the IRB protocol to include this new method of recruitment.
Adverse Events (including Adverse Events and Protocol Deviations)
- What is an Immediate Report?
An Immediate Report is an incident (e.g., adverse event, protocol deviation, confidentiality breach, subject complaint) or a piece of information (e.g., clinical hold, Investigator's Brochure listing a new risk of study participation) that requires prompt action by means of an IRB amendment or through prompt action on the part of the investigator in coordination with the IRB.
- Someone participating in my study has had an adverse event. What do I need to do?
First, make sure that a record of the adverse event is kept in the research subject's files and added to the study's AE/IND Cumulative Table. Then, you need to determine whether the adverse event has to be immediately reported (within 7 calendar days or 24 hours) to the IRB (and IBC, WCMC DSMB, or CTSC's TRAC, as applicable) according to the Immediate Reporting Policy. For adverse events, we have provided you with an Adverse Event Decision Tree at that same link to help you determine whether a given adverse event is immediately reportable. You can also use it as a source document to keep in your research records as evidence that a co-investigator reviewed the AE to make the determination.
To submit an Immediate Report (including adverse events and protocol deviations) to the IRB, please submit the required documentation as a PDF file to email@example.com.
-If you are using the Clinical and Translational Science Center (CTSC), send a PDF version of your Immediate Report to firstname.lastname@example.org
-If you are using the Weill Cornell Medical College Data Safety Monitoring Board (WCMC DSMB), send a PDF version of your Immediate Report to email@example.com
-If your protocol is subject to the requirements of the Institutional Biosafety Committee (IBC), send a PDF of your Immediate Report to firstname.lastname@example.org
Using The Cooperative Agreement
- I would like to submit a protocol involving an institution that we have a cooperative agreement with. What do I need to do to get it approved here at WCMC?
• When creating a new protocol, choose The Cooperative protocol.
• Include copies of all approved paperwork from the cooperative institution (i.e. the approval letter, their stamped consent form, the protocol approved by the institutions' IRB; for protocols from Columbia, this includes the Human Subjects Protocol Data Sheet and the Human Subjects Study Description Data Sheet). Do not forget to include clean copies of all documents that need the WCMC IRB stamp.
• If you plan to recruit out of WCMC, submit a copy of the WCMC consent form you plan to use here at WCMC.
• If you plan to advertise at WCMC, attach a copy of the advertisement/flier.
• Because WCMC is considered a covered entity per the HIPAA security law, all protocols that take place at WCMC need to have a separate HIPAA determination.
• Submit the Human Research Billing Analysis Form for WCMC.
Once you are done with the form and attachments, then you must go to "Submission Options" and select "Submit for Review." Please note, the PI will have to submit all Cooperative agreement submissions.
Submitting a Protocol from the NCI CIRB
- How do I submit a Protocol from the NCI CIRB?
The CIRB is the sole IRB of record responsible for both the study review as well as review of the local context consideration for WCMC.
These studies will still require review by the CSEC and submission to the eIRB system. Once the protocol has been approved by the CSEC and WCMC has been approved as a site by the CIRB, please complete the requested sections in eIRB. Once the submission is complete, please have the PI submit the application for acknowledgement.
Certificate of Confidentiality (CoC)
- What is a Certificate of Confidentiality?
A Certificate of Confidentiality (CoC) helps researchers protect the privacy of human research participants enrolled in sensitive research. They are issued by the National Institutes of Health to protect identifiable research information from forced disclosure, allowing researchers and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative or other proceeding, whether at the federal, state or local level.
Sensitive information includes, but is not limited to, information relating to sexual attitudes, preferences, or practices, information relating to the use of alcohol, drugs, or other addictive products, information pertaining to illegal conduct, information that, if released, might be damaging to an individual's financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination, information pertaining to an individual's psychological well-being or mental health. genetic information or tissue samples.
Researchers should apply for CoCs after IRB approval. Subjects must be told about the protections afforded by the CoC and any exceptions to those protections in the informed consent form. If a certificate is granted after a study has already begun to collect data from subjects, that data would also be covered by the certificate once it is issued. While there is no requirement to re-consent subjects if the information was not included in the original informed consent document, researchers are encouraged to provide information about the protections given by the CoC to those subjects who were not told about the protections when they were first consented.
How do I apply for a CoC?
If the NIH funds the research, applying for a CoC is through the funding institute. If research is not supported by the NIH, applications should be sent through the NIH Institute or Center that funds research in an area similar to the project.
- Does all human subjects research require review by the IRB?
Some human subjects research does not require IRB review. The Office of Research Integrity and Assurance makes the final exempt status determination; the PI and/or research team should not determine for themselves that a study is exempt. When creating a new protocol, indicate the study is minimal risk and complete the additional forms. Studies qualify for exemption if they fulfill one of the following categories:
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices. Examples include: a) Research on regular and special education instructional strategies, orb) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and b) Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under number 2 (above) of this section, if: a) The human subjects are elected or appointed public officials or candidates for public office; or b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: a) Public benefit or service programs; b) Procedures for obtaining benefits or services under those programs: c) Possible changes in or alternatives to those programs or procedures; or d) Possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies: a) If wholesome foods without additives are consumed; or b) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Increasing Study Enrollment
- What do I do if I want to increase enrollment or increase the number of charts I will be reviewing as part of my research study?
You must submit an amendment to increase enrollment or increase the number of charts reviewed. Specifically, you will need to update the Subject Population and Recruitment Methods section of eIRB and, if applicable, the Informed Consent Form. If you require immediate approval, then please submit a protocol exemption request and then separately submit an amendment to increase the number of subjects to be enrolled. If you have already enrolled more subjects than approved, you will also need to submit a protocol deviation form in addition to the amendment.
Case Reports for the IRB
- Do Case reports have to be reviewed by the IRB?
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. A case report would have to be reviewed by the IRB is if it meets the criteria for human subjects research, specifically, the definition of research. According to the Common Rule (45CFR46, Subpart A), research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Most case reports, because they only involve one patient report, would not be considered to be a systematic investigation, and therefore would not qualify as human subjects research that needs to undergo IRB review.
However, the decision as to whether a case report needs to be reviewed by the IRB should not be made by the author(s), but by the Office of Research Integrity and Assurance. If you have a case report that you would like to publish, please send the completed manuscript to Alavy Sos, Director of the Institutional Review Board at email@example.com. He will consult with the Chairs of the IRB and the Institutional Official to determine if the case report qualifies as human subjects research that needs IRB review. The decision is usually made in 24 to 48 hours. If it is determined that it does not need IRB review, you will receive an e-mail stating this. If it is determined that IRB review is necessary, then an IRB application will need to be submitted for review.
Emailing patient/research subject information
- Can I send patient or research subject information over WCMC email?
This is not permitted. When handling patient or research subject information, do not use email. Use only the messaging functionality within EPIC, or WCMC Transfer Service.