Definitions
To obtain definitions, click on items below.
Research
Federal guidelines (45 CFR 46) define "research" as:
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"a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
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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 – used in journalism or related projects.
COUHES does not consider surveys, questionnaires or interviews to be research if they carried out as part of the administrative responsibility of the investigator, AND the data gathered are non-sensitive and will be used for MIT purposes only. Sensitive data includes, but is not limited to, academic performance, religion, ethnicity, sex, alcohol consumption and the use of illegal drugs.
Human subject
Federal guidelines (45 CFR 46) define "human subject" as:
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"A living individual about whom an investigator (whether professional or student) conducting research obtains:
- data through intervention or interaction with the individual, or
- identifiable private information."
"Intervention" includes both physical procedures by which data are gathered (for example, 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 the
data, specimens or cells were not collected specifically for the
proposed research by an intervention with a living individual, and
provided 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.
Under the auspices of MIT
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 included 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, etc.) in studies being directed by lead investigators at other institutions
Minimal risk
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.
Exempt status
Exempt status may be granted for research activities in which 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 paragraph (b)(2) of this section, 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
Full committee review is a review of an application for research involving human subjects that is carried out by COUHES at its regular monthly meetings.
Expedited review
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 designated by the Chairman, of programs involving minimal risk or entailing minor changes to a previously approved protocol. In carrying out this review, the reviewer(s) may exercise all the authority of the Committee, except that they may not disapprove the research. Such disapproval may only be made by the full Committee.
Protected Health Information
Protected Health Information under the HIPAA Privacy Rule means any health information that might directly or indirectly identify an individual, and that is maintained or transmitted in any form or any medium.
Protected Health Information includes:
- Names
- Addresses
- Names of relative(s)
- Names of employer(s)
- Dates
- Social security numbers
- Medical record numbers
- Health Plan or account numbers
- Telephone or fax numbers
- E-mail addresses
- Vehicle or device serial numbers
- Certificate or license numbers
- Internet Protocol addresses
- Web URLs
- Biometric identifiers, including finger and voice prints
- Photographs (full face)
- Any other unique identifying number, characteristic or code
Protected Health Information excludes education or employment records.
Authorization for Release of Protected Health Information
An Authorization for the Release of Protected Health Information is a written document a research subject must sign at the time of executing an informed consent document that specifically authorizes the researcher to disclose the subject's protected health information.
The Authorization must be written in plain language and specify:
What information will be disclosed:
- The names the persons or organizations authorized to disclose the information
- The names of the person or organization authorized to receive the information
- Why the disclosure is being made
- The date the authorization will expire
- That the subject may revoke the authorization at any time
- That the subject cannot participate in the research if they do not sign the Authorization
The Template for Authorization for Release of Protected Health Information may be downloaded here.
Waiver of Authorization
A Waiver of Authorization is the permission granted to a researcher by COUHES to use or disclose a subject's protected health information without the subject's prior authorization. COUHES will grant a Waiver if the following criteria are met:
- Use or disclosure of the protected information involves no more than a minimal risk to the privacy of individuals based on:
- A plan to protect identifiers from improper use and disclosure
- A plan to destroy identifiers from improper use and disclosure
- Written assurances the health information will not be reused or disclosed to others
- The research cannot be conducted without the waiver
- The research cannot be conducted without access to and use of the protected health information
De-identified Data
Health information that has been de-identified is no longer subject to the HIPAA Privacy Rule. To meet the standard for de-identification the information must not include any of the following:
- Names
- All geographical subdivisions smaller than a state
- All elements of dates directly related to an individual (except year)
- Telephone numbers
- Fax numbers
- E-mail addresses
- Social security numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate or license numbers
- Vehicle identifiers and serial numbers
- Device identifiers and serial numbers
- Web URLs
- Internet Protocol address numbers
- Biometric identifiers including finger and voice prints
- Full face photos
- Any other unique identifying number, characteristic or code
Limited Data Set
A limited data set is de-identified health information that eliminates all personal identifiers but allows for the inclusion of dates and geographic information to the level of city or zip code. A limited data set can only be used or disclosed if the researcher has completed a formal data use agreement with COUHES governing the disclosure of the information.
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.
Financial interest
Such interest may be in:
- any item (drug, device, software, technology, method etc) being evaluated, or
- an entity that is a sponsor of the research or is an entity that 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.
Any income from a related entity. This includes but is not limited to, salaries and wages, consulting income, honoraria for services performed, per diem, 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.
An intellectual property interest on a patent, patent application or copyright that is related to the proposed research. This includes intellectual property assigned or licensed to M.I.T.
An individual’s interests also include interests held by a spouse, domestic partner or child.
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