Definitions

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.

Term Definitions

 

Research

Research is defined as a

“…systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”  [45 CFR 46.102(l)]

Research includes, but is not limited to, observations, 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 activities.

COUHES does not consider surveys, questionnaires or interviews to be research if (1) they are carried out as part of an administrative responsibility of the investigator AND 2) the use is limited to MIT purposes only.

The following activities do not meet the definition for research and do not require a COUHES submission:

  1. 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;
  2. Public health surveillance activities, including the collection & testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority [with limitations];
  3. Collection and 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;
  4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 

Human Subject

Human subject is defined as

"… a living individual about whom an investigator (whether professional or student) conducting research obtains (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)]

"Intervention" includes “both physical procedures by which information or biospecimens” (e.g., drawing blood) and “manipulations of the subject or the subject's environment that are performed for research purposes.” (45 CFR § 46.102(2))

"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.

Engaged in Research

In general, an institution is considered engaged in a particular human subjects research project 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.

Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e. awardee institutions) are considered to be engaged in human subjects research, even where all activities involving human subjects are carried out by employees or agents of another institution.

Please see OHRP guidance on Engagement of Institutions in Human Subjects Research

See sample scenarios: Engaged in Research: Scenarios

IRB Review Types

COUHES reviews all protocols that fall within the definition of human subjects research in the Federal Regualtions that govern the conduct of human subjects research (45 CFR 46.102).

Investigators are required to obtain approval from COUHES prior to the start of any research activites. There are three types of review: Exempt, Expedited, and Full Committee.

Exempt Review

Exempt status research is excluded from the requirements of the Regulations and from policies dictacted by the Common Rule. Exempt status research must however, comply with COUHES Policy, as outlined in the  Investigator Responsibilities for Exempt Research.

To qualify for Exempt status, research activities must be:

  1. Minimal risk
  2. The only involvement of human subjects will be in one or more of the exempt categories detailed below
  3. Not involve use of drugs or devices

To qualify for Exempt status, investigators must submit an Exempt Evaluation using COUHES Connect, and must be granted Exempt status before initiating their research activities. Research conducted prior to receiving an exempt determination is a violation of MIT policy. Investigators approved for the conduct of Exempt status research are required to comply with the policies as outlined in the Investigator responsibilities for Exempt Research.

If the Exempt Evaluation process determines that the research activities do not meet the exempt criteria then investigatiors are required to submit a Comprehensive Review application.

Categories of Exempt

Note: Research that qualifies for Limited IRB Review (see Category 2.3, Category 3.i.C, Category 7 and 8) as well as Category 4.ii and 4.iv must submit a comprehensive application for full review by COUHES.

Some of the exempt categories do NOT apply to research involving children. All of the exempt categories do NOT apply to research involving prisoners. For more information, see Exemptions (2018 Requirements.

Category 1: Education Research

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. [§__.104(d)(1)]

Category 2: Surveys, Interviews, Educational Tests, and Public Observations

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

  1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
  2. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation;
  3.  The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subject, and an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7). [§__.104(d)(2)]  

Category 3: Benign Behavioral Intervention

  1. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
    1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
    2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
    3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
  2. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
  3. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. [§__.104(d)(3)(i)]

Category 4: Analysis of Existing Data or Biospecimen

Secondary research, for which consent is not required, uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

  1. The identifiable private information or identifiable biospecimens are publicly available;
  2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
  3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. [§__.104(d)(4)]  

Category 5: Public Benefit or Service Program

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

  1. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. [§__.104(d)(5)]

Category 6: Taste & Food Quality Studies

  1. If wholesome foods without additives are consumed, or
  2. 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. [§__.104(d)(6)]

Category 7: Storage or Maintenance of Identifiable Data\Biospecimens

Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).  [§__.104(d)(7)]

Category 8: Use of Identifiable Data\Biospecimens

Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

  1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
  2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
  3. An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
  4. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results. [§__.104(d)(8)]

Note: Research that qualifies for Limited IRB Review (see Category 2.3, Category 3.i.C, Category 7 and 8) as well as Category 4.ii and 4.iv must submit a comprehensive application for full review by COUHES.

Some of the exempt categories do NOT apply to research involving children. All of the exempt categories do NOT apply to research involving prisoners. For more information, see Exemptions (2018 Requirements.

Expedited Review

Studies that involve no more than minimal risk, AND fall under one of the expedited review categories may be eligible for Expedited Review. Researchers are required to submit a Comprehensive Review application to start the review process. For a full list of categories that may be reviewed through Expedited Review, see "Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)"

By submitting a Comprehensive Review application, your research will be evauated by the COUHES staff to determine if the research is eligible for Expedited Reivew. At the time of submission, researchers are encouraged to include a statement justifying consideration for Expedited Review.

If COUHES determines that the research does NOT qualify for Expedited Review, the application will be considered for full committee review.

Research that qualifies for Expedited Review is reviewed and approved on a rolling basis and is not subject to monthly Full Board meeting dates and deadlines.

Full Committee Review

If a proposed research study does not qualify for Exempt Status or Expedited Review, as defined above, it will be subject to a Full Committee Review. Researchers are required to submit a Comprehensive Review application to start the review process.  “Full Committee Review” is a review of an application for research involving human subjects that is carried out by COUHES Committee at one of its regular monthly meetings. See this schedule of Deadline dates

Key Personnel

“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. All personnel are required to complete the human subjects training.

Minimal Risk

“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.”

Principal Investigator

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.

Financial Interest

A financial interest is defined as a monetary conflict of interest that may have the appearance of compromising an individuals’ judgement or integrity in reporting, conducting, supervising or proposing research. Research personnel with financial interests must submit a Disclosure of Financial Interest Supplement for each individual with a financial interest.

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
  • 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:

  • Position as director, officer, partner, trustee, consultant or employee of, or any position of management in, a related entity
  • 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)
  • Loan or gift from a related entity
  • 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 MIT)
  • Interests held by an individual’s family (e.g. spouse, domestic partner or dependent child)
  • 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

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