- What is an IRB?
- What is Human Subject Research?
- Who needs to submit an application?
- When is MIT considered Engaged?
- What type of application do I need to submit?
- When do I submit an application?
- How do I submit an application?
- Do I need training to conduct human subject research?
- I have an additional question. Who should I contact?
What is an IRB?
IRB is an acronym for Institutional Review Board. An IRB is an administrative body established to protect the rights and welfare of human research subjects taking part in human subject research activities conducted under the institution with which it is affiliated. In accordance with federal regulations, IRBs have the authority to review, approve, disapprove, monitor, and require modifications for all human subject research activities that fall within its jurisdiction.
IRB’s oversight of human subject research is also guided by the Ethical Principles and Guidelines for the Protection of Human Subjects, generally known as the Belmont Report.
Review and approval of human subject research prior to initiation of the study is required for all research regulated by the Department of Health and Human Services (DHHS), the Food and Drug Administration (FDA) and as part of MIT policy.
The Committee on the Use of Humans as Experimental Subjects (COUHES) serves as MIT’s IRB.
What is Human Subject Research?
COUHES reviews research proposals which meet the federal definition of both “human subject” AND “research”.
Human Subject
DHHS defines a human subject as:
A living individual about whom an investigator conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e)(1))
- “About whom” indicates that a researcher is interacting with,obtaining data from,and/or obtaining data about another living person to gain knowledge about that person
- An "Intervention" includes physical procedures and manipulations of the subject or the subject's environment that are performed specifically for research purposes.
- An "Interaction" includes any communication or interpersonal contact between investigator and subject. Interactions include both in-person and remote interactions.
- “Identifiable private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place (ex. private residence, public bathroom) and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (ex. a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. This includes coded data where the investigator retains access to a linking code.
Research
DHHS defines research as:
a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(d))
- A "systematic investigation" is an activity that involves a prospective plan that incorporates data collection and data analysis to answer a question.
- Research contributes to “generalizable knowledge” when a study is designed to generate new information that is either added to a body of scientific literature or relevant beyond a single individual, group, or program. Results may be used to draw broad conclusions, inform policy, or demonstrate the use of an instrument, construct or methodology which may be applied to others beyond the study population. To promote generalizability, systematic design and implementation procedures are required to reduce bias and appropriately identify small differences. While publication is often considered an end goal of many projects, intent to generalize is the key component which constitutes research, regardless of publication.
Research includes, but is not limited to, interactions, observations, formal interviews, responses to questionnaires, and related activities that may be quantified as part of study data. Research is defined broadly. However, the regulations designate specific activities which do not meet the federal definition of research.
Download the flowchart: Is my study human subject research?
Who needs to submit an application?
Any investigator conducting human subject research who is affiliated with MIT or Lincoln Laboratory when MIT is considered engaged in the proposed research project should submit an application to COUHES.
When is MIT considered Engaged?
MIT is considered engaged in research when its employees or agents, for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.
Investigators engaged in multi-site research or with external collaborators may be required to enter into a joint review arrangement, rely upon the review of another qualified IRB or make similar arrangements for avoiding duplication of effort. See Single IRB review guidelines for guidance. MIT uses the SMART IRB Online Reliance System to process reliance requests for participating institutions.
What type of application do I need to submit?
Investigators are required to obtain approval from COUHES prior to the start of any research activities. There are three types of review: Exempt, Expedited, and Full Committee.
To qualify for Exempt status, investigators must first submit an Exempt Evaluation to receive an exempt determination. Studies must meet at least one of the federal exempt categories.
Applications which do not meet the criteria for exempt review require a Comprehensive Application submission. COUHES will determine if the proposed research qualifies for expedited review or will require Full Committee review.
Download the flowchart: What type of application do I need to submit to COUHES?
When do I submit an application?
Applications must be submitted to COUHES prior to initiation of the human subject study and its associated research activities, such as recruitment, subject screening, data collection, or consenting subjects.
Non-exempt applications are reviewed at monthly meetings by the full COUHES Committee. COUHES meets monthly, generally on the third Thursday of every month. Meeting dates and times can be found on Dates & Deadlines. However, at the discretion of the Chairman, where there exists no more than minimal risk to subjects AND the activities fall under one of the federal expedited categories, an expedited review may be performed. Expedited approvals occur on a rolling basis.
COUHES recommends submitting an application 6-8 weeks prior to your anticipated start date.
How do I submit an application?
All applications must be submitted through our electronic IRB system COUHES Connect.
In-depth guidance is available on the COUHES website: User Guides
Do I need training to conduct human subject research?
MIT requires all personnel who are directly involved in human subject research to complete Human Subjects Protection Training. Certain projects may require additional training, such as Good Clinical Practice (for NIH-sponsored clinical research) or the Responsible and Ethical Conduct of Research (RECR). These courses are not substitutes for human subject protection training.
I have an additional question. Who should I contact?
The COUHES website provides guidance for researchers on a large variety of research related topics as well as our COUHES connect platform.
For all other questions: Contact Us