Student Guide for Human Subjects Research

Using IRES

IRES IRB is the electronic submission and review system you will use for submitting your protocol.  If you are accessing IRES from off-campus, you will need to be on the VPN.

Yale IRB has a handy overview of the submission process available on Box.

Prepare Your Protocol

The research protocol describes the scope of your study, details how you will conduct your research, and discusses how you will ensure the protection of the rights of human subjects participating in your study.  It consists of several key components:

• Protocol form
• Informed consent
• Supplementary materials relevant to your research design
• Checklist for international research (if applicable)

Protocol form

Within IRES, these documents can be found under [Library/Protocol Templates].  There are three main templates that you will likely need to choose from:

• Exemption Request Form (HRP-503D)
• Secondary Data Analysis Template (HRP-503H)
• Social Behavioral Research (Protocol Template: Social Behavioral Research - This form is on page 2 of the Protocol Templates tab)

Informed consent

Unless you are engaging in a form of secondary data analysis, you will need to provide a consent form for subjects to review before they agree to participate in your study.  Depending on your use case, you should use one of the following templates available from [Library/Consent Forms] (even if you are you applying for an exemption):

• Consent Template Social Behavior and Educational Research (Not for HIPPA information)
• Compound Authorization and Consent Template_SBE (if you are collecting HIPPA information)

If you will be seeking verbal consent from student participants, Yale has also has a handy Verbal Consent Template.

Supplementary materials

Depending on your use case, you will need to submit additional documents related to your research.  In the case of interviews, this is frequently a list of questions or an interview guide that you will follow when interviewing subjects.  In the case of surveys, this would include a copy of the survey you intend to administer to study participants.

You will also need to provide, either on the protocol form itself or as a separate document, some discussion of how you will recruit subjects for your research.

International research

If you will be conducting part of your research abroad (e.g., interviewing individuals in-person in another country), you will also need to complete the 'International Research Checklist' ([Library/Other Forms]).

If you will be interviewing over the phone or virtually from your computer anywhere in the United States, you do not need to submit the international research checklist (even if the subjects are located in a foreign country at the time of the interview)

Find a Faculty Advisor

In order to serve as Principal Investigator (PI) on your research protocol, you must have the sponsorship of a Yale faculty member who is eligible to serve as a PI.

Eligibility criteria for faculty sponsor

An eligible sponsor is any faculty member belonging to one of the following classes:

• Assistant Professor
• Associate Professor
• Full Professor
• Research Scientist
• Senior Research Scientist

AND has also:

• taken the appropriate human subjects protection training,
• completed HIPAA training (if applicable), and
• completed the University required conflict of interest disclosure.

Process

Once you have identified a faculty advisor who meets the above criteria:

• Provide documentation from a faculty advisor/mentor who agrees to take the responsibility of serving in that role. The form to be used can be found in IRES IRB at [Library/Other Forms/Faculty Advisor Agreement].  
• Upload this in the 'Other Attachments' section of the 'Local Site Documents' tab in IRES IRB.  
• Add this individual to the ‘Study Team Member’ section of the IRES record, and indicate that their role is as your faculty advisor.

Get Trained

You must complete the Yale University Human Subjects Protection Training in order to conduct any human subjects research. This includes exempt protocols!

The easiest way to complete your training is to take the CITI Basic Training Program.

You must be logged in to the VPN to access the training.

Note: The continuing education requirement can be met by attending any Human Research Protection Program educational session, or by completing any one of the Yale human research modules, or any one of the CITI continuing education modules available through the training and certification website.

Complete Other Required Compliance Documents

Conflict of Interest form

Use the following link to access the COI disclosure system. On the home screen on the left spine under the 'Conflict of Interest' option click on the Access the External Interests Disclosure link.

TL;DR

Pressed for time and/or want to zoom out a bit?  Here is a checklist of forms and tasks you will need to complete in order to get your research approved by Yale IRB:

• [ ] Protocol form
• [ ] Informed consent
• [ ] Audio-visual consent form (if applicable)
• [ ] Supplementary research materials
• [ ] International research checklist (if applicable)
• [ ] Faculty advisor form
• [ ] Complete human subjects training
• [ ] Conflict of interest disclosure

Please note that this list is subject to change and may vary slightly depending on your specific use case.  Always follow the explicit instructions and guidance provided to you by Yale IRB once you begin the process of preparing and submitting your protocol.

References

• Yale HRPP Investigator Manual, Version 2.0 (revised 2023-4-28).
• UCSF Waiver of Signed Consent FAQ

Change Log

• 2023-09-08: COVID-19 Protocol no longer required; modify headings

Q: The research project I'm doing is entirely of my own design and I will be the only person executing the protocol. Do I still need a faculty sponsor to fill out the Faculty Advisor Agreement?

Yes, you do!  All students--irrespective of protocol creation and/or execution--need a faculty advisor to fill out the advisor form!

Q: Is my research exempt?

It depends on several factors, but based on the kinds of research projects law students typically approach the library about, chances are pretty good that your research will be eligible for an exemption as long as the following conditions apply:

• Your subject population does not include prisoners or children
• You will be administering a survey, conducting interviews, or observing public behavior
• At least one the criteria listed in this Human Subject Regulations Decision Chart (chart 4) is met.

If your research meets all of these conditions, you can likely proceed in applying for a Category 2 exemption from form HRP-503D (Exemption Request Form)

If you're still unsure whether your research would qualify for an exemption, please reach out to us at ylsdata@yale.edu to schedule a brief consult.

Q: I am applying for restricted-access secondary data from a third-party organization or research data repository like ICPSR or NACJD. Their data application process requires a letter of exemption from Yale's IRB. It is a request for secondary data, but I also think it should be exempted.  Which form should I use?

The Exemption Request (HRP-503D) and Secondary Data Analysis (HRP-503H) forms are both acceptable, but IRB would prefer the secondary data analysis form on account of the additional information it asks folks to provide.

The secondary data analysis form can still be exempted by the reviewer if he/she think it is appropriate.

Q: Do I need verbal or written consent from study participants?

Deciding between verbal or written consent from study participants often depends on the nature of your research question and the manner in which you will be collecting data from participants.  For most interviews, it is usually acceptable (and more convenient) to obtain verbal consent immediately prior to beginning the interviews with participants.  

For internet-based surveys, however, it will make more sense to obtain written consent in in the preamble of the survey since participants will be engaging with the study via a computer or smart device.

In some cases, federal regulations permit the IRB to waive the requirement for obtaining signed, written consent in favor of verbal or electronic consent.  The requirement for signed, written consent can be waived if:

1. The informed consent form would be only record linking the subject to the research and the principal risk would be potential harm resulting from a breach of confidentiality OR.
2. 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 or harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

Examples where signed consent could be waived include:

• The identities of subjects will be completely anonymous if the consent form is unsigned, and subject participation in the study poses minimal risk.
• Obtaining written consent from subjects would be either inappropriate or infeasible given the cultural norms of the community being studied, and subject participation in the study poses minimal risk.
• Signing the consent form could subject the participant to possible legal, social, or economic risks (e.g., a study of immigrants who could be identified as being illegal aliens from their written consent).

Q: How long will it take for the IRB to approve my protocol?

This is hard to say without knowing the specifics of your proposed research study (not to mention how many other protocols are awaiting IRB review at the time you submit), but there are a couple of general patterns we've noticed in our time working with students and other researchers:

• Exempt protocols tend to take less time than proposals requiring expedited or full board review.
• An expedited review may take less time than a full board review since it is only being reviewed by a single designated IRB reviewer and does not need to wait for the next scheduled meeting of the full IRB board.

Regardless, it is best to start the process as soon as possible.  There is also a handy guidance document on the Yale IRB website that covers things you can do in preparing your protocol to ensure a smooth review process.  Take a look at Top Twelve Ways to Streamline Review on SBE Protocols.