New protocol submissions to COUHES after January 21, 2019 are subject to the Revised Common Rule, also known as the New Rule, and must fulfill the requirements outlined under the New Rule.
Investigators with existing protocols approved prior to the effective date must follow the policy outlined under the Old Rule section unless otherwise directed by COUHES.
New Rule: This page has been updated to reflect the New Rule effective January 21, 2019.
Old Rule: For existing protocols approved prior to January 21, 2019, follow the policies outlined on the Old Rule section.
- Why do I need to apply to COUHES?
- Who needs to apply to COUHES?
- What types of research must be reviewed by COUHES?
- What is exempt research?
- If I am only working with data, blood, tissue or cells, do I need COUHES approval?
- Is all human subjects research conducted at MIT reviewed by COUHES?
- Am I required to take the human subjects training course?
- How do I take the human subjects training course?
- How often am I required to take the human subjects training course?
- How often and when does COUHES meet?
- Is there a deadline for submitting applications to COUHES?
- Which application form do I use when applying to COUHES?
- What happens if I miss the deadline for submitting applications to COUHES?
- What happens if I want to start my research before the next COUHES meeting?
- What happens if my application is not approved?
- For how long is my study approved?
- Is my study subject to periodic review?
- What happens if I miss the CRQ deadline?
- What if I am collaborating with other institutions?
- What happens if I go on leave or on sabbatical?
- What if I need to modify my study after it has been approved?
- Am I required to obtain written informed consent from all study subjects?
- If my study involves a survey, a questionnaire or an interview, do I need to obtain written informed consent?
- In preparing informed consent forms, must I use the COUHES templates?
- What do I do with the completed informed consent forms?
- What do I do if a study subject suffers an adverse event?
- Can I use students as subjects?
- What if I am studying minors?
- If I am audio- or videotaping subjects, are there any special requirements?
- Can I pay subjects for participating in a study?
- What do I do with my files if I leave MIT?
- What is HIPAA?
- How does the HIPAA Privacy Rule affect my study?
- When does the HIPAA Privacy Rule come into effect?
- Do I need HIPAA training?
- How can I learn more about my responsibilities under HIPAA?
- Do I have to disclose any financial interest I have in the research?
- How do I disclose my financial interests?
- What happens once I disclose a financial interest?
- Who can be Principal Investigator (PI) on MIT human subject protocols?
Why do I need to apply to COUHES?
Federal regulations (45 CFR 46) and longstanding MIT policy require that COUHES review and approve ALL non-exempt research involving human subjects that is performed under the auspices of MIT.
Who needs to apply to COUHES?
Any faculty member, employee or student at MIT who conducts human subjects research must apply to COUHES if the research involves any form of MIT involvement or support, including funding, personnel, facilities, academic credit or access to experimental subjects.
What types of research must be reviewed by COUHES?
ALL types of human subjects research are reviewed by COUHES, including investigations of new drugs, and medical, radiological, engineering, physiological, behavioral, sociological and nutritional studies. Projects involving human tissues, blood or images and questionnaires, interviews and other procedures are subject to COUHES review.
The following activities are not deemed research and do not require a COUHES submission:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected;
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority [with limitations];
- Collection & analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes;
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
[45 CFR 46.102(l)]
What is exempt research?
Research activities that fall into one or more of the exempt categories defined by the federal regulations.
If I am only working with data, blood, tissue or cells, do I need COUHES approval?
You need COUHES approval if (1) the data, blood, tissue or cells were obtained specifically for your proposed study from a living individual, and (2) you are able to identify the individuals from whom the data, blood, tissue or cells were obtained.
Is all human subjects research conducted at MIT reviewed by COUHES?
Yes. Although Federal regulations may exempt certain types of research from institutional review board review, all human subjects research at MIT, whether or not exempt under Federal regulations, must be reviewed by COUHES.
Am I required to take the human subjects training course?
Yes. MIT policy and Federal regulations require that any study personnel involved in human subjects research take and pass the training course. This requirement extends to principal investigators, associate investigators, student investigators, study coordinators and lab technicians and assistants, and its scope encompasses all types of interactions with human subjects, including direct and indirect contact and analysis of data, blood or tissue. All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be training in Good Clinical Practice (GCP).
How do I take the human subjects training course?
Follow the link on the main menu to Human Subjects Training.
How often am I required to take the human subjects training course?
You must take the human subjects training course when you first become involved in human subjects research. You must subsequently take and pass the course every 3 years from the date you first took the course.
How often and when does COUHES meet?
COUHES meets monthly generally on the third Thursday of every month. For a schedule of dates, follow the link to Meeting dates.
Is there a deadline for submitting applications to COUHES?
Yes. The deadline is generally 3 weeks before COUHES’s next monthly meeting. For a schedule of deadlines, follow the link to Deadline dates.
Which application form do I use when applying to COUHES?
If your study involves tests, surveys, observation of public behavior, or the collection or study of existing data, or the study of instructional strategies or techniques, then you should use COUHES Connect. For all other studies, you should use the Comprehensive Review Application.
What happens if I want to start my research before the next COUHES meeting?
If the study involves only minimal risk to the participants, then the Chairman may conduct an expedited review that may enable you to start your research as planned. A letter of explanation as to why the research should be considered for expedited review should be submitted with the application. If it is determined that the study involves more than minimal risk, then approval must wait until the next scheduled COUHES meeting.
What happens if my application is not approved?
If the study does not meet COUHES criteria for acceptance or if an application is incomplete, COUHES will inform you with suggested modifications and request revision and re-submission. The study cannot proceed until the revisions are approved.
For how long is my study approved?
Full Board Meeting approval is for one year. Expedited approval requires an annual progress report. For research involving more than minimal risk, COUHES will exercise its discretion to determine the duration of approval, which may be for less than one year.
Is my study subject to periodic review?
All studies approved by COUHES require continuing review. Approximately 60 days before approval expires, COUHES will send the principal investigator notification that a Continuing Review Questionnaire (CRQ) must be completed and returned to COUHES prior to the next COUHES meeting that is scheduled to convene before your expiration date.
What happens if I miss the CRQ deadline?
Your study will be automatically terminated and research grants related to the study will be suspended. You cannot conduct any further human subjects research under the terminated protocol.
What if I am collaborating with other institutions?
Your collaborators must obtain the approval of their institutional review board (that is, the COUHES counterpart at their own institution). COUHES will need to see the approval of all collaborating institutions. See Request Single IRB Review for more information.
What happens if I go on leave or on sabbatical?
If you are a principal investigator and are away from the campus for an extended period of time, such as during a sabbatical or a formal leave of absence, then you must either suspend your human subjects studies or name as co-principal investigator another qualified MIT faculty or staff member to assume responsibility for direct supervision of the protocol. COUHES must approve the designated co-principal investigator.
What if I need to modify my study after it has been approved?
You must inform and obtain COUHES approval for any change that affects the rights of human subjects. This includes changes that impact discomfort or risk and changes in study personnel, the time required by subjects, confidentiality of data, the privacy of subjects, or other parameters relevant to the rights of subjects. If the change is minor and involves no more than minimal risk to subjects, then an expedited review may be performed.
Am I required to obtain written informed consent from all study subjects?
Yes. However, COUHES may waive this requirement when the research activities present no more than minimal risk of harm to subjects.
If my study involves a survey, a questionnaire or an interview, do I need to obtain written informed consent?
Yes. However, COUHES may waive the written informed consent requirement in cases where surveys, interviews and questionnaires involve no more than minimal risk and the investigator provides sufficient reasoning as to why consent is not needed. Requests for waiving the consent form requirement must be done using the Waiver or Alteration of Informed Consent Request.
Nevertheless, all surveys and questionnaires should begin by stating (1) that participation is voluntary; (2) that subjects may decline to answer any and all questions and withdraw their participation at any time; and (3) that confidentiality and/or anonymity are assured. This must also be done for studies conducted online.
What do I do with the completed informed consent forms?
They must be retained in a secure place for at least 3 years after completion of the study. However, COUHES encourages investigators to keep informed consent forms for longer periods, if practical.
What do I do if a study subject suffers an adverse event?
All serious or unexpected adverse reactions or injuries must be reported to COUHES orally or by email within 48 hours. All other adverse events should be reported in writing within 10 days.
Can I use students as subjects?
Yes, but care must be taken to ensure that students are not pressured or coerced into participating in studies. Additionally, when a pedagogical change is introduced into an academic course for research purposes, the instruction acquires a research aspect that will require COUHES review.
What if I am studying minors?
In Massachusetts, a minor is anyone under 18. Research involving minors requires the written informed consent of a parent as well as the suitably documented assent of the minor, if the child is over 7 years old.
If I am audio- or videotaping subjects are there any special requirements?
Yes, the informed consent form must specifically state that audio- or videotaping will take place, indicate who will have access to the recordings, and state the final disposition of the recordings.
Can I pay subjects for participating in a study?
Yes. However, the payment must be made as compensation for the time and trouble associated with participating in a study, rather than as inducement for participation. It must be reasonable and must not be coercive. If a study subject withdraws from a study, payment must be prorated.
What do I do with my files if I leave MIT?
You must turn your files over to the administrator of your department, who should retain these in accordance with COUHES record keeping policies.
What is HIPAA?
HIPAA is an acronym for the Health Insurance Portability and Accountability Act of 1996, a federal privacy law that was modified by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH). Under HIPAA, the Department of Health and Human Services has developed and continues to refine:
- Privacy regulations, known together as “the Privacy Rule,” which govern permissible uses and disclosures of individually identifiable health information, also known as Protected Health Information (PHI); and
- Security regulations, known together as “the Security Rule,” which require application of physical and electronic protections on PHI used, maintained or stored by entities subject to HIPAA.
How does the HIPAA Privacy Rule affect my study?
If your study involves health information from MIT Medical about a research subject, then your study may be subject to HIPAA requirements. If you plan to share or disclose private health information (PHI) obtained from or about a research subject in connection with a research study subject to HIPAA, you must first obtain the permission of the subject. This permission, called an Authorization for Release of Protected Health Information, must specify precisely what information will be released for research purposes, why it is being released, and from and to whom it is being released. The subject must complete this Authorization in addition to a standard informed consent form in order to participate in the research.
COUHES, however, may permit the disclosure of PHI without a subject’s prior authorization if COUHES determines that (1) the research cannot be practically conducted without access to PHI and (2) the disclosure of PHI would involve no more than minimal risk to the privacy of the research subject. Under these circumstances, COUHES may grant a Waiver of Authorization, and PHI may be disclosed without the subject's permission.
Additionally, if PHI is de-identified and stripped of all direct and indirect subject identifiers, as specified in the HIPAA regulations, it is exempt from HIPAA and prior authorization is not required to use or disclose the information for research purposes.
If HIPAA applies to your research study, any failure to comply with HIPAA will result not only in the termination of your study and the suspension of related research grants, but also potentially in criminal and/or civil penalties to you and MIT.
Please note: HIPAA does not apply to PHI collected from outside MIT Medical.
Do I need HIPAA training?
Yes, if you use or disclose PHI. Follow the link to Human Subjects Training which includes a section on HIPAA.
How can I learn more about my responsibilities under HIPAA?
Follow the link in the main menu to HIPAA and to the COUHES HIPAA Guidance Document. Additionally you should feel free to contact the COUHES office with any questions.
Do I have to disclose any financial interest I have in the research?
Yes. The Principal Investigator, any co-investigator and key personnel involved in the study, must disclose any financial interest they or their spouses, domestic partners, or dependent children have in the research.
How do I disclose my financial interests?
You must complete the Supplement for Disclosure of Financial Interest for each individual with a financial interest and for each entity in which they hold a financial interest.
What happens once I disclose a financial interest?
The Supplement is reviewed by the COUHES Chairman, the Director of the Office of Sponsored Programs and the Vice President for Research. If it is determined the financial interest does not compromise the integrity of the research and that the research may proceed, COUHES may further evaluate the study to determine whether the financial interest needs to be disclosed to the subjects.
Who can be Principal Investigator (PI) on MIT human subject protocols?
At MIT three categories of people have automatic PI status: Faculty, Senior Research Scientists (SRS), and Principal Research Scientist (PRS). MIT personnel who do not hold these appointments may obtain PI status on a specific project, if his or her Department Chair requests and receives permission from the relevant Dean. Per MIT policy, any MIT personnel who do not hold faculty, SRS, or PRS appointment must present confirmation of approval of their PI status from their Dean for each protocol application (i.e., a Dean may not confer “blanket” PI status).