The Committee on the Use of Humans as Experimental Subjects (COUHES) serves as MIT’s institutional review board (IRB). All studies involving human subjects — including all online surveys and experiments conducted by MIT-affiliated researchers — must receive COUHES approval before they can begin.
This webpage provides a summary of important COUHES policies and procedures. We encourage you to read through the following sections, then visit the COUHES website to learn more and to download the application materials that you need.
Before applying for COUHES approval, please consider whether your proposed study might qualify for exempt status. Exempt studies do not carry an expiration date and are not subject to continuing review by COUHES.
A study may be considered exempt if it meets both of the following criteria:
- The study presents no more than minimal risk to participants. “Minimal risk” means that “the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations and tests”.
- No personally identifiable information will be collected as part of the study. This includes photographs, videotapes, audio recordings, and textual data (e.g., names, email addresses) that can reveal the identity of participants. Please be aware that in some cases, pieces of information that are not personally identifiable when considered alone can be combined to uniquely identify an individual.
While there are other circumstances in which a study may receive exempt status, they do not pertain to the types of research the BRL supports.
If you believe that your study is exempt, please submit an “Exempt Status Form” as part of your COUHES application (see below). COUHES reserves the right of final decision on a study’s exempt status.
The COUHES Committee meets once a month to review submitted applications. In order to receive a review, applications must be submitted approximately three weeks prior to any given meeting. Please visit the “Dates & Deadlines” page of the COUHES website to see a list of all upcoming meeting dates and their respective submission deadlines.
However, for exempt studies, as well as any non-exempt studies that present no more than minimal risk to participants (as determined by the Chairman of COUHES), a full Committee review may not be necessary. Instead, an expedited review may be performed by the Chairman of COUHES or a designated member of the COUHES Committee.
The following documents should be included in your COUHES application:
- Application form — Complete either an “Exempt Status Form” or a “Standard Form”, depending on whether you think your study qualifies for exempt status. Both application forms ask for details about your study procedures, target population, data handling practices, research personnel, etc.
- Informed consent — You must obtain informed consent from all participants in your study. For lab studies, printed consent forms should be presented to participants for signature at the beginning of each lab session. Participants in online studies should be asked to read and agree to a consent statement before starting a survey or experiment. Please provide COUHES with a copy of the consent form or statement that you plan to use.
- Research materials — Provide copies of any questionnaires, standardized tests, or interview outlines that you plan to use in your study.
- Recruitment materials — Provide copies of any recruitment flyers, emails, or advertisements associated with your study. If you hope to recruit participants from the BRL participant pool, please ask the BRL Coordinator for a copy of the study promotion email that will be sent to all Sona users (see the “Participant Pool” page of our website for details).
- Research proposal — This is required if your study is funded by an external sponsor. A draft of the research proposal is acceptable.
- IRB approval from collaborating institutions — For research involving collaboration with external institutions (such as when a co-author is affiliated with another university), IRB approval from those institutions (if required) should be forwarded to COUHES.
- Other application documents — Please also submit a “Supplement for Disclosure of Financial Interest”, an “Authorization for Release of Protected Health Information”, and/or proof of PI status if any of these documents apply to you or your study.
- “Checklist for Standard Form Application” — This checklist shows all the documents mentioned above. You only need to submit the checklist itself if you are completing a standard application.
Please visit the “Forms & Templates” page of the COUHES website to download application forms, informed consent templates, and other necessary application materials.
We also recommend visiting the “Guidelines” page of the COUHES website because it contains helpful information on how you can protect the rights of human subjects in various facets of your research, from participant recruitment to informed consent to data handling and so on. These guidelines may prompt you to adjust certain research methods and procedures so as to bring your study into compliance with COUHES policies.
You must submit three copies of your full application package — one electronically to firstname.lastname@example.org and two by mail to the COUHES office at E25–143B. One of your hard copy submissions must contain original signatures.
If your application is incomplete or needs revision, COUHES will contact you to request a resubmission. This process may continue until your proposed study meets all acceptance criteria set forth by COUHES.
Once your study is approved by COUHES, please email a copy of the approval letter to the BRL Coordinator.
Before engaging in human subjects research, all research personnel must complete an online training course offered by the CITI Program. COUHES broadly defines “research personnel” as anyone who has direct or indirect interaction with human subjects or the information they provide. In the context of behavioral research, this includes, but is not limited to, all principal investigators, co-investigators, visiting scholars, research coordinators, research assistants, and data analysts.
Individuals who are conducting research through the BRL must complete the “Social & Behavioral Research Investigators” training course (other CITI courses may be helpful, but are not required). If a researcher once took this course at another institution, he or she should then complete a “refresher course” on the same topic. The refresher course should also be completed by anyone who took the original course more than three years ago (whether at MIT or elsewhere).
A list of individuals who have completed any of the CITI training courses is posted on the COUHES website. Prior to the start of your study, the BRL Coordinator will check this list to confirm that everyone in your research group has received the appropriate training.
(MIT web certificate required)
Ongoing Reporting Requirements
Over the course of your study, you are required to submit certain reports and applications to COUHES regarding adverse events, protocol amendments, approval renewals, and study closure. All the documents mentioned below can be downloaded from the “Forms & Templates” page of the COUHES website. You must submit two copies of each document — one electronically to email@example.com and the other by mail to the COUHES office at E25–143B. The hard copy submission must contain original signatures.
In the event that a participant drops out of a lab study, suffers an injury, experiences a medical emergency, or displays any other adverse reactions, the researcher who is overseeing the lab session must do both of the following:
- Notify the BRL Coordinator immediately, either orally or by email.
- Submit an “Adverse Event Reporting Form” to COUHES within 48 hours. This form should also be submitted if a researcher discovers an unanticipated problem that may cause harm or pose risks to participants.
If you wish to make changes to any aspect of your study protocol (e.g., methods, procedures, personnel) after receiving COUHES approval, you must do both of the following:
- Discuss your proposed changes with the BRL Coordinator. In some cases, the BRL Coordinator may not approve or endorse certain changes because they do not adhere to our policies or best practices.
- Inform COUHES of your proposed changes by submitting an “Application for Changes to an Approved Protocol”. If the changes are minor and involve no more than minimal risk to participants, an expedited review may be performed. Otherwise, a full Committee review will be conducted. After COUHES approves your protocol amendments, please email a copy of the approval letter to the BRL Coordinator.
Protocol approvals are typically valid for one year. However, for research involving more than minimal risk to participants, the approval timespan may be shorter.
Two months before your approval expires, you will receive a letter from COUHES reminding you to fill out a “Continuing Review Questionnaire”. You should submit this questionnaire by the submission deadline for the next COUHES meeting (i.e., the last meeting before your approval expires). Once your approval is renewed, please email a copy of the renewal confirmation to the BRL Coordinator.
Please note that you only need to submit a Continuing Review Questionnaire if you plan to perform any research activities (which include data analysis) after the approval expiration date.
You are required to fill out a “Final Report Closure Form” when you have completed all research activities (i.e., finished collecting and analyzing all data) or if you decide to discontinue your study for any reason. This form must be submitted within 30 days of study closure.