Human Research Protections

FAQs

Below are some answers to the questions we get asked the most about human research protections and the IRB, sorted by type.  If there is a question you don't see addressed here, please reach out to us at irb@med.cornell.edu so we can get your answer to you!

ClinicalTrials.gov

FAQS related to this topic are located on our ClinicalTrials.gov Program web page on our site.

Exempt Research

Does audio/video recording of interviews mean that my study cannot be exempt?

No.  Audio/video recording is not considered in the application of these exempt categories and is a permitted activity in most cases. However, if audio/video recording increases risk, it may be reviewed at the Expedited level of review. An example of audio/video recording increasing risk would be an interview in which employees disclose negative opinions of their supervisors. 

What does “normal education practice” mean?

A normal educational setting and practice may include a class in a grocery store, professional development workshops, or skills development in children’s summer camps. It is not necessarily limited to primary and secondary public/private educational settings. However, studies that involve new experimental educational practices or settings may not fit into this category and may need to be reviewed at a higher level.

Are observations in public schools considered public observations?

No. Classrooms, hospitals, and other similar settings are not considered public. 

Can I have prisoners and/or children in my Exempt research?

No. Research involving prisoners and/or children must be reviewed by the full board.

If my survey is completely anonymous but may pose a risk to participants, can it still be exempt?

Maybe.  If a disclosure of a human's subject’s responses outside the research could reasonably place them at risk but the data are completely anonymous, exempt category 2 may apply. A determination for a higher level of review may be made at the discretion of the WCM IRB on a case-by-case basis. However, even when responses are anonymous, if the study presents a risk of causing distress to the subject, the IRB may determine that review of the study by an expedited or full board procedure is appropriate. Example: An anonymous online survey about suicidal ideation.

Can my study be exempt in more than one category?

Yes. All research activities that involve human subjects must fit within one or more of the exempt categories in order to be given an exempt determination. 

Can my study be exempt if it involves documents/records/biological specimens that do not yet exist but will be collected...

...once they become available?

No. For a research study to be exempt, all data, documents, specimens, and records must already exist at the time the PI submits the research protocol. Prospective data collection, i.e., data collected as they become available, will need to be reviewed at the expedited or full board level. 

Do exempt studies have to be reviewed by the IRB?

Yes. Exempt studies are so named because they are exempt from some, but not all, of the federal regulations. However, they are not exempt from state laws, institutional policies, or for the requirements for ethical research. 

FDA-Regulated Research

Can I submit my IRB application before I know if I need an IND?

Yes, it is possible to submit an IRB application for a clinical study before an IND submission; however, if the IRB determines an IND may be needed, the study may not proceed until confirmation of IND exemption or acknowledgment of IND receipt is obtained from FDA and the 30-day review period has passed.

I’m using both a drug and a device on my study and I do not qualify for exemption. Do I need both an IND and an IDE? 

No. Whether you need an IND, or an IDE depends on which product is the primary mode of action in the study. If an investigational drug product is the primary mode of action, you may need an IND. If an investigational device product is the primary mode of action, you may need an IDE. Product accountability and assessment of safety events should still occur for secondary (and other) investigational products.  

I submitted an IDE application and 30 days have passed. Can I start my study? 

No. Unlike an IND, IDEs require approval by the FDA before the study can commence.

How do I obtain a device study risk determination? 

The Sponsor or Sponsor-Investigator of the study should make and document an initial risk determination. The risk determination should take into account the use of the device on the protocol. This risk determination should be presented to the IRB. The IRB also needs to make a risk determination. If the IRB deems the device to be of non-significant risk, the Sponsor or Sponsor-Investigator will hold an abbreviated IDE. If the IRB determines the device to be of significant risk, the investigator must submit an IDE application to the FDA. 

Do I need an investigator’s brochure and what should it include? 

An investigator’s brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) relevant to the IND/IDE. If an IND/IDE includes more than one investigational product, clinical and nonclinical data on each investigational product should be included. A medically qualified person should generally contribute to the authoring of an IB.

General Questions

Email Encryption: How do I encrypt emails so only the recipient can see the contents?

Encrypting an email is a more secure way to send emails containing confidential information.   Emails that contain sensitive information, such as Personal Health Information (PHI), should always be encrypted before being sent.  Instructions for encrypting emails in Outlook are available from ITS, but it is as simple as typing "#encrypt" as the first word in your Subject line. This will prevent messages from being forwarded or copied by the recipient.

Who can serve as a Principal Investigator (PI) on a protocol?

WCM paid faculty can serve as PIs on all categories of protocols. Voluntary faculty cannot serve as PIs, but may serve as co-investigators.

In addition, employees of NewYork-Presbyterian Hospital/Weill Cornell Medical Center (only pharmacists, nurses, dieticians) can serve as PIs on protocols, except clinical trials that include an intervention with human subjects. However, medical residents cannot serve as PIs, but may serve as co-investigators.

Can students serve as investigators on protocols?

Students may not serve as Principal Investigators on protocols. However, students may serve as "co-investigators" or research personnel on protocols.

When can I add a non-WCM/non-NYP co-investigator to my study?

The WRG-HS IRB Application includes a section for external non-affiliated personnel (non-WCM/NYP). Non-WCM/NYP investigators should only be added to this section when the WCM IRB will serve as the IRB of record and an IRB Authorization Agreement has been executed. This agreement can only be executed between IRB offices. The WCM IRB will not provide oversight for non-WCM/NYP investigators without an IRB Authorization Agreement.

The WRG-HS IRB Application will not allow the addition of external non-affiliated personnel if WCM is not serving as the IRB of record.

If you wish to collaborate with non-WCM/NYP investigators, you must:

  1. Include details of the collaboration in the protocol document and informed consent form;
  2. Confirm with the non-WCM/NYP investigators that they have consulted their local IRB(s) on whether their research activities on the WCM protocol require local oversight; and
  3. Confirm that WCM requirements for data/specimen sharing, such as the Data User Agreement (DUA) or Materials Transfer Agreement (MTA), have been met.

If I am collaborating with the Cornell University Ithaca campus, which IRB should I submit to?

The WCM IRB and Cornell-Ithaca IRB have a reliance agreement in place for cross-campus collaborations. Refer to our SOP document 103.1 Reliance Process and Single IRB on the Institutional Policies & Procedures page for more information.

For additional information regarding Ithaca-WCM efforts, please contact singleIRB@med.cornell.edu and visit the Office of Academic Integration.

If I am collaborating with a PI from NYP-Queens Hospital or NYP-Brooklyn Methodist Hospital, which IRB should I submit to?

Oncology Network Trials

The WCM IRB serves as the IRB of Record for oncology trials conducted at WCM, NYP-Queens and NYP-Brooklyn Methodist under an existing IRB Authorization Agreement. Submit to the WCM IRB for review and approval. In accordance with this agreement, NYP-Queens and NYP-Brooklyn Methodist require designation of a local site PI for each location and an administrative approval from their respective IRB offices.

COVID-19 Studies Led by WCM

The WCM IRB serves as the IRB of Record for COVID-19 studies led by WCM and conducted at WCM, NYP-Queens and NYP-Brooklyn Methodist under an existing IRB Authorization Agreement. Submit to the WCM IRB for review and approval. In accordance with this agreement, NYP-Queens and NYP-Brooklyn Methodist require designation of a local site PI for each location and an administrative approval from their respective IRB offices.

All Other Studies

These studies must be submitted separately to each IRB office for separate IRB approval.

For questions related to NYP-Queens, please contact Nancy Garcia, IRB Manager, NYP-Queens.

For questions related to NYP-Brooklyn Methodist, please contact Pearlia Fullard, IRB Coordinator or Dr. Ted Gaeta, IRB Chair, NYP-Brooklyn Methodist.

Does my study qualify for exemption?

To understand whether your study may be eligible for exemption, consult these decision charts from the U.S. Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP). Only the WCM IRB office can make a determination.

Click here to view exemption decision charts pertaining to studies approved by the IRB prior to January 21, 2019.

What does "expedited review" mean and how long will it take for me to hear back from the IRB about an expedited submission?

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. Expedited reviews are reserved for minimal risk studies that fall into designated categories as prescribed by the federal regulations. It is also used for minor amendments (those that do not affect study design or risk to subjects) and some Continuing Reviews.

It is important to note that expedited review does not necessarily mean that the submission will be reviewed more quickly than a submission reviewed at a convened IRB meeting. Please allow a minimum of 10 business days for issues raised/approval to be communicated to the research team.

How can I establish the use of electronic informed consent, or eConsent, for my research protocol?

All use of eConsent must be IRB approved before it can be implemented. Use of DocuSign is required for FDA-compliant research, whereas REDCap can be used in other cases. For complete eConsent guidance, requirements, and template language to use when submitting to the IRB, visit the eSignature page on the JCTO website. Still have questions? Contact econsent-support@med.cornell.edu.

Where can I find the status of my submission?

All submissions in WRG submitted after March 27, 2020 include a "Submission Progress" tool  that provides you with a visual of where your submission is in the PRMC and IRB review process.

What could delay the release of IRB approval?

The following may delay the release of an IRB approval letter and documents:

Study team members should also check the Study Activation Status Page (SASP) for their study to ensure all applicable approvals are obtained PRIOR to starting human research activities. The SASP page is your "one-stop" location for all required approvals.

My protocol came back with a status of "Directive Modifications Required." Is it required to go to another meeting?

No. Once you submit your response (also known as “RTQ” or “Response to Questions”), it will be reviewed via expedited review procedures. Responses must be received by the IRB office within 60 days of the date the letter is issued. An extension to respond can be requested by emailing the IRB team who sent the letter.

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 the changes can be found (e.g., in the protocol document, IRB application, attachments, etc.) 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 in WRG-HS.

My protocol came back with a status of "Substantive Modifications Required." Is it required to go to another meeting?

Yes, once you submit your response (also known as “RTQ” or “Response to Questions”), it will be reviewed by the same committee at the next scheduled convened meeting. Responses must be received by the IRB office within 60 days of the date the letter is issued. An extension to respond can be requested by emailing the IRB team who sent the letter.

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 the changes can be found (e.g., in the protocol document, IRB application, attachments, etc.). 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 in WRG-HS.

Which documents receive an IRB approval stamp?

The documents stamped by the WCM IRB include forward facing/patient facing documents. If you believe a document should receive an IRB stamp, please work with your assigned analyst to obtain.

What are my responsibilities after IRB approval?

The PI/Study Team must conduct the study in accordance with the WCM IRB-approved protocol and policies.  

There are reporting requirements post IRB approval that require further submission to the IRB:

  • Amendments: Any modifications to the study must be approved by the WCM IRB prior to implementation.  Click here for the Amendments to Previously Approved Research Procedure policy document 
  • Continuing Review: IRB review is required at least annually for all non-exempt research, unless a shorter approval period was determined by the WCM IRB.  Click here for the Continuing Review Procedure policy document 
  • Reportable Events: Serious Adverse Events, Unanticipated Problems, Protocol Deviations and other events must be reported as detailed in the following Unanticipated Problems Procedure document and Other Reportable Events Procedure document
  • Study Closure: Studies should be closed in accordance with the policies set forth by your department and chair

What if my protocol's IRB approval has expired?

Submit your Continuing Review (CR) or Post-Approval Monitoring Report-Annual Review (PAM-AR) as soon as possible, unless 90 days have past since the expiration, in which case the IRB's Guidance on Lapses in IRB Approval should be followed. This guidance is available for download from our Forms, Templates, & Guidance page. 

If it has been less than 90 days since expiration, all requests for Continuing Review/PAM-AR and approval 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. No study related activities can continue beyond the WCM IRB expiration date, including subject recruitment, enrollment, intervention and data analysis. 

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 (e.g., 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, WCM requires that the investigator must seek confirmation that the IRB agrees with this determination as soon as possible.

If you submit your Continuing Review or PAM-AR 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 irb@med.cornell.edu.

  • 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.

IRB Review Application

Is there a specific IRA for studies that consists of biological, chart/questionnaires, and specimens, or should all 3 be used?

If your study includes several elements for which there are specific IRAs, pick the IRA that you consider the most suitable and complete just the one. The IRB will evaluate your responses, and will only ask you questions that may have been missed, rather than completing a second/additional IRA form.

How will CRs and amendments be processed through the system after the IRA goes live?

The CR and amendment applications will remain the same. If your protocol being amended used an IRA in the initial submission, you may be asked or expected to attach an amended IRA document.

Informed Consent Form: Key Information Section

Tell me about the Key Information section of the consent document.

The Key Information section is a new regulatory requirement under the Revised Common Rule that potential subjects be first presented 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”. Sample Key Information sections are integrated into our consent templates, available on our Informed Consent Templates page.

Do I have to begin a consent document and presentation with a concise summary of Key Information?

Full Board and Expedited studies approved after April 4, 2019 are required to include AND begin with a concise and focused presentation of the key information relevant to the study

If your study received initial approval between January 20, 2019 and April 3, 2022, you must add the Key Information section to your existing ICF and submit it with your next Continuing Review, or as an Amendment.

Exception: For an expedited study that received initial approval between January 20, 2019 and April 3, 2022 that also has an ICF six pages or shorter (including the signature blocks), a Key Information section is not required, but strongly encouraged.

Is the Key Information section required for all consent documents?

If your study is minimal risk (expedited) AND your consent form is six pages or shorter (including the signature blocks), the new Key Information section is not required.  However, we  strongly encourage you to submit a revised consent form with the new section when we publish the revised template in the Summer of 2022.

When does this new requirement go into effect?

Beginning April 4, 2022, all studies approved by Full Board or Expedited review after January 20, 2019 will be required to submit updated consent documents at their next continuing review (CR), but may choose to submit an amendment prior to CR submission.

For PAM-AR eligible studies (expedited), an amendment will be required after the PAM-AR report is submitted.

Do I need to revise my existing IRB-approved consent document?

The new section is required for all studies approved by Full Board or Expedited review after January 20, 2019. Studies that received Full Board review prior to January 20, 2019, but did not receive final IRB approval until after January 20, 2019 are also subject to this requirement. Expedited studies that have consent forms six pages or shorter (including the signature blocks) are not subject to this requirement.

Any study that received final IRB approval prior to January 21, 2019 will not need to amend its consent documents to meet this requirement.

Are there any samples of this section that I can review?

Yes.  Sample key information sections for different types of studies are below:

For Biorepository Studies: 

You or your child are being asked to take part in this research study because you have XXX. 

The purpose of this study is to collect and store data and samples, such as blood and saliva, for future research (about XXX). The future research will include genetic testing. You will not receive results from any of the tests that are performed as part of future research studies.  

If you agree to take part, you will need to give a blood or saliva samples once. We will also review your medical records. The information from your medical record will be collected once a year (Or other frequency).  

Your data and samples will be shared with other researchers at CHOP as well as researchers at other institutions or for profit companies. Before sharing your data or samples, all information that can identify you will be removed. These researchers, who use your samples for future research, will not know who you are.  

The main risks from this study are related to bleeding or infection from the blood draw and risks related to a possibility of a breach of confidentiality of your samples and data. Every precaution will be taken to secure your personal information to ensure confidentiality.  

You will not benefit directly from taking part in this study.  

If there is anything in this form you do not understand, please ask questions. Please take your time. You do not have to take part in this study if you do not want to. If you take part, you can leave the study at any time. If you do not choose to take part in this study, you can discuss treatment options with your doctor. You may also be eligible for a different research study (only if applicable).  

Please see below for additional details about the study.  

For Minimal Risk Studies

You or your child are being asked to take part in this research study because you have XXXX.  Briefly include the major reasons why the subject is being approached to participate. For example, “…you have been diagnosed with sickle cell disease and are scheduled to have an MRI.”   

This is a research study to learn more about how XXXX effects/relates to/changes XXXX.  

You will be asked to come to CHOP for X study visit(s) that will (each) last about XX hours. If you take part, you will be asked to (this listing of procedures should be limited to the most burdensome and/or main procedures that a reasonable person would want to know): 

  • Complete cognitive function tests and questionnaires; 
  • Have a research blood draw; 
  • Perform computer tasks. 

The main risks of this study are from the cognitive assessments. These include fatigue and embarrassment.  

You will/not benefit directly from participating in this study (if there are direct benefits, describe them).  

If there is anything in this form you do not understand, please ask questions. Please take your time. You do not have to take part in this study if you do not want to. If you take part, you can leave the study at any time. If you do not choose to take part in this study, you can discuss treatment options with your doctor. You may also be eligible for a different research study (only if applicable).  

Please see below for additional details about the study. 

For Greater than Minimal Risk Studies

You or your child are being asked to take part in this research study because you have [DISEASE/CONDITION].  

The purpose of this study is to find out if the study drug works better than current drug. The study drug is not approved by the FDA. 

If you agree to take part, your participation will last for XXX and will involve XX study visits. You will need to take the study drug or placebo for XXX weeks. A placebo is an inactive substance. There are differences between this study and your usual care. As a participant in this research you will: 

  • Receive a study drug or a placebo; you will not know which 
  • Stop your regular medication 
  • Have X extra research clinic visits;  
  • Complete a double-blind food challenge; 
  • Have research blood tests, skin prick allergy tests, and other procedures. 

The main risks of this study are from the study drug. These include: allergic reaction and skin irritation.  

You may benefit if drug ABC or XYZ proves to be more effective. OR – You will not benefit directly from participating in this study.  

If there is anything in this form you do not understand, please ask questions. Please take your time. You do not have to take part in this study if you do not want to. If you take part, you can leave the study at any time. If you do not choose to take part in this study, you can discuss treatment options with your doctor. You may also be eligible for a different research study (only if applicable).  

Please see below for additional details about the study. 

Does the information provided in the Key Information section have to be exactly what is in the WCM template?

Not verbatim. The intent of the rule is to consider what key information a potential subject would need to know up front. It is the most important information that would influence a potential participant to say “Yes” and the most important thing that would influence a potential participant to say “No” to participation. This allows the individual to weigh the key pros and cons of volunteering early in the process.

Isn't the reason someone would or wouldn't participate always going to be a risk or benefit?

Not always, but it depends. The most significant deterrent could be a serious potential risk or a number of benign but unpleasant risks. In other cases, it may be merely inconvenience. The key reason to participate could be a personal gain or to help advance science. A proven alternative treatment may be considered more advantageous that an experimental treatment. The most influencing factor could be the implication of the risk. A breach of confidentiality may have minor repercussions for a survey study, while the same occurrence with genetic testing could affect family planning. The idea is not to present all considerations first, but start with the most influential pros and cons to participation.

How do I know what information would be key to someone's decision to participate or not?

The choice may be based on the investigator’s experience with the study population. Support groups or associations may provide insight into participant perceptions. You may also search for empirical research (e.g., Participant perception of risks and benefits of genetic research; or Participant perceptions on data sharing). The patient-centered and participant-centered movements have prompted considerable research on subject perceptions of research consent.

Single IRB

FAQS related to this topic are located on our SingleIRB/Reliance web page on our site.

Weill Cornell Medicine Human Research Protections 575 Lexington Avenue New York, NY 10022 Phone: (646) 962-8200