Frequently Asked Questions
Why do I need to apply to COUHES?
Federal mandate (45 CFR 46) and longstanding MIT policy require that COUHES review and approve ALL research involving human subjects that is performed under the auspices of MIT.
Who needs to apply to COUHES?
Any faculty, 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. This includes investigation of new drugs, and medical, radiological, engineering, physiological, behavioral, sociological and nutritional studies. This includes projects involving human tissues, blood or images and questionnaires, interviews and other procedures.
If I am only working with data, blood, tissue or cells, do I need
COUHES approval?
You need COUHES approval if the data, blood, tissue or cells were
obtained specifically for your proposed study from a living individual,
and 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 the Federal regulations permit for certain types of research to be exempt from institutional review board review, all human subjects' research at MIT, whether exempt or not under Federal regulations, must be reviewed by COUHES.
Do I have to take the human subjects training course?
Yes, if you or any study personnel are involved in human subjects research, then MIT policy and Federal regulations require that all study personnel take and pass the training course. This requirement extends to principal investigators, associate investigators, student investigators, study coordinators and lab technicians and assistants, and encompasses all types of interactions including direct and indirect contact, and analysis of data, blood or tissue.
How do I take the human subjects training course?
Follow the link on the main menu to Human Subjects Training.
How often do I have 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 when 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. Generally 3 weeks before the next meeting of COUHES. 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 use the exempt status form. For all other studies use the standard form.
What happens if I miss the deadline for submitting applications to COUHES?
You must wait until the following scheduled meeting before your application will be considered.
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 and enable you to start your research as planned. If 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.
How long is my study approved for?
For research involving minimal risk approval is for one year. For research involving more than minimal risk COUHES will 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 meet 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 (the COUHES equivalent). COUHES will need to see the approval of all collaborating institutions.
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, change in study personnel, the time required by subjects, confidentiality of data, the privacy of subjects, or other rights. If the change is minor and involves no more than minimal risk to subjects, then an expedited review may be performed.
Do I have to obtain written informed consent from all study subjects?
Yes. However, COUHES may waive this requirement where the research is subject to exempt review or presents 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?
Usually not. However, COUHES may require written informed consent where interviews and questionnaires involve more than minimal risk. Nevertheless, all questionnaires should begin by stating: that participation is voluntary; that subjects may decline to answer any and all questions and withdraw their participation at any time; and that confidentiality and/or anonymity are assured.
In preparing informed consent forms must I use the COUHES templates?
Yes, unless COUHES specifically waives this requirement.
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 practicable.
What do I do if a study subject has 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 there is no coercion when instructors inform students of studies they may enroll in. Additionally, when a pedagogical change is introduced into an academic course for research purposes, the research aspect of this joint teaching-research enterprise should be recognized as such.
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, payment must be for the time and trouble associated with participating in a study. 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 these over to the administrator of your department who should retain these in accordance with COUHES record keeping policies.
What is HIPAA?
HIPAA is the Health Insurance Portability and Accountability Act 1996. Under this Act the Department of Health and Human Services has developed the Privacy Rule that gives research subjects the right to know how their identifiable health information is used and disclosed, and assures them this information will be protected.
How does the HIPAA Privacy Rule affect my study?
If your study involves identifiable health information about a research subject, then you MUST comply with the Privacy Rule. If you plan to share or disclose a subject's protected health information outside of MIT, and not just use it within MIT, then under the Privacy Rule, you must first obtain the permission of the subject. The subject must complete an Authorization for Release of Health Information, in addition to an informed consent form.
If however, COUHES is satisfied the disclosure involves no more than minimal risk to the privacy of the subject it may grant a Waiver of Authorization and individual health information may be disclosed without the subject's permission. Additionally if the health information is de-identified and stripped of all direct and indirect subject identifiers it is exempt from the Privacy Rule.
When does the HIPAA Privacy Rule come into effect?
April 14, 2003. All subjects enrolled in research prior to this date are grandfathered in if they have completed an informed consent form. However, any subjects consented or re-consented after April 14, 2003, under a new or an existing COUHES approved protocol, MUST complete both an informed consent form and an authorization form for the release of health information.
Do I need HIPAA training?
Yes, if you use or disclose protected health information. 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.
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