These definitions apply to existing protocols approved prior to January 21, 2019. Follow the policies outlined on the Old Rule page.
To see definitions, click on items below.
- Human subject
- Under the auspices of MIT
- Minimal risk
- Exempt status
- Full Committee review
- Expedited review
- Protected Health Information
- Authorization for Release of Protected Health Information
- Waiver of Authorization
- De-identified Data
- Limited Data Set
- Key personnel
- Financial interest
- Principal Investigator
Federal regulations relating to human subjects research (45 CFR § 46.102(d)) define "research" as:
"a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
Research includes formal interviews, responses to questionnaires, and related activities that may be quantified as part of study data. Research does not include interviews used to provide quotes or illustrative statements — as in journalism or related projects.
COUHES does not consider surveys, questionnaires or interviews to be research if (1) they are carried out as part of the administrative responsibility of the investigator, AND (2) the data gathered are non-sensitive and will be used for MIT purposes only. For these purposes, “sensitive” data include, but are not limited to, data relating to academic performance, religion, ethnicity, sex, alcohol consumption and the use of illegal drugs.
Federal human subjects research regulations (45 CFR § 46.102(f)) define "human subject" as:
"a living individual about whom an investigator (whether professional or student) conducting research obtains:
"Intervention" includes “both physical procedures by which data are gathered” (e.g., drawing blood) and “manipulations of the subject or the subject's environment that are performed for research purposes.”
"Interaction" includes communication or interpersonal contact between investigator and subject.
COUHES does not consider research to involve "human subjects" where the research uses only coded private data, specimens or cells: provided that (1) the data, specimens or cells were not collected specifically for the proposed research by an intervention with a living individual, AND (2) the researcher cannot identify the individual(s) from whom the data, specimens or cells were obtained (for example, because the key to decipher the code has been destroyed or an agreement exists prohibiting the release of the key to the investigators)
COUHES also takes jurisdiction over research involving blood, tissue or other specimens derived from human subjects.
COUHES is responsible for reviewing research performed “under the auspices of MIT or any part of MIT,” as well as research involving any form of MIT support, such as funding, personnel, facilities, academic credit or access to experimental subjects. Such research is subject to COUHES review wherever it is performed.
COUHES is required to review research conducted by full-time or part-time faculty employees or students at MIT in which affiliation with MIT is noted by investigators. This includes research in which MIT personnel play "support" roles (e.g., site coordinator, co-author, data analysis) in studies directed by lead investigators at other institutions.
“Minimal risk” (45 CFR § 46.102(i)) 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.”
COUHES may grant “exempt status” for research activities in which, per 45 CFR § 46.101(b), “the only involvement of human subjects will be in one or more of the following categories”:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under [the preceding paragraph 2], if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Determination of exempt status rests with COUHES.
“Full committee review” is a review of an application for research involving human subjects that is carried out by COUHES at one of its regular monthly meetings.
“Expedited review” is a review of an application for research involving human subjects that is carried out by the Chairman of COUHES or a COUHES Committee member designee. COUHES may approve an application by expedited review if the protocol described in the application involves minimal risk or entails minor changes to a previously approved protocol. In the course of conducting expedited review, the reviewer(s) may exercise all the authority of the Committee, except the reviewer(s) may not disapprove the research. Only the full Committee can disapprove a research application.
“Key personnel” includes co-investigators, associate investigators, student investigators, study coordinators, visiting scientists, consultants, and other individuals involved in the design, conduct or reporting of the research.
A researcher may have a “financial interest” in:
- an item (e.g., drug, device, software, technology, method) subject to evaluation in the course of the research, or
- an entity that is a sponsor of the research or would reasonably appear to be affected by the research.
Financial interests include, but are not limited to, the following:
- a position as director, officer, partner, trustee, consultant or employee of, or any position of management in, a related entity;
- an investment or ownership interest in a related entity, including stocks, bonds, warrants and options;
- receipt of income from a related entity (including but not limited to salaries and wages, consulting income, honoraria for services performed, per diem expenses, reimbursement for travel or other expenses, rental income, dividends and interest, and proceeds from sales);
- a loan from a related entity;
- a gift from a related entity; or
- an ownership interest in a patent, patent application or copyright that is related to the proposed research (including but not limited to intellectual property rights assigned or licensed to M.I.T.).
- anything that meets the definition of Significant Financial Interest per the MIT Conflict of Interest Policy. Definition available at: https://coi.mit.edu/policy/definitions#letters
An individual’s interests also include interests held by their Family, which means their spouse, domestic partner or dependent child.
At MIT three categories of researchers have automatic Principal Investigator (“PI”) status: Faculty, Senior Research Scientists (“SRS”), and Principal Research Scientist (“PRS”). An individual who does not hold any of these three appointments may nonetheless obtain PI status on a specific project, if the individual's Department Head requests and receives permission from the applicable Dean. MIT requires that anyone beyond faculty, SRS, or PRS must provide confirmation of approval from their Dean for PI status with each protocol application to COUHES (i.e., there is no “blanket PI status”).
See Section 5 of MIT Policies and Procedures.