45 part 46 - Protection of Human Subjects Flashcards
45 part 46?
Protection of human subjects
45 part 46 part A?
Basic HHS policy for protection of human subjects research
To what does the 45 part 46 part A policy apply?
All research involving human subjects conducted supported or otherwise subject to regulation by any federal department or agency
When research is conducted in foreign countries procedures normally followed to protect human subjects may differ from those set forth in 45 part 46 part A policy. What happens in this situation?
If a dept or head agency determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in the policy, the dept or head agency may approve the substitution of the foreign procedures in lieu of the procedural requirements in this policy
The following categories of human subjects research are exempt from Basic HHS Policy for Protection of Human Research Subjects
(1) 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.
(2) 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)
(3)(i) 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
(4) Secondary research for which consent is not required
(5) Research and demonstration projects that are conducted or supported by a Federal department or agency
(6) Taste and food quality evaluation and consumer acceptance studies:
(7) 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).
(8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or
identifiable biospecimens for secondary research use,
(a) The Secretary of HHS has established, and published as a Notice in the FEDERAL REGISTER, a list of categories of research
that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every _______ years
and amend it, as appropriate, after consultation with other federal departments and agencies and after publication in the FEDERAL
REGISTER for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any
successor office.
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What is 46.110
Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor
changes in approved research.
An IRB may use the expedited review procedure to review the following
(i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer determines
that the study involves more than minimal risk;
(ii) Minor changes in previously approved research during the period for which approval is authorized; or
(iii) Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).
(2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more
experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers
may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may
be disapproved only after review in accordance with the nonexpedited procedure set forth in §46.108(b).
(c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research
proposals that have been approved under the procedure.
(d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution’s or IRB’s use
of the expedited review procedure.
What is 46.111
Criteria for IRB approval of research.
In order to approve research covered by this policy the IRB shall determine that all of the following requirements are
satisfied:
(1) Risks to subjects are minimized
(2) Risks to subjects are reasonable in relation to anticipated benefits
(3) Selection of subjects is equitable
(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative
(5) Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of
subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
data.
What is 46.113
Suspension or termination of IRB approval of research
An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the _________________
investigator, appropriate institutional officials, and the department or agency head.
(a) Cooperative research projects are those projects covered by Basic HHS Policy for Protection of Human Research Subjects that involve___________
more than one institution
Any institution located in the United States that is engaged in cooperative research must rely upon approval_______________ for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal
department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the
Federal department or agency supporting the research
single IRB
The following research is not subject to cooperative research
(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official
governing body of an American Indian or Alaska Native tribe); or
(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents
that the use of a single IRB is not appropriate for the particular context.
(c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into
a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.
46.115 (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including
the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample
consent forms, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB;
the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in
or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise
would not require continuing review as described in §46.109(f)(1).
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in §46.108(a)(2).
(6) Written procedures for the IRB in the same detail as described in §46.108(a)(3) and (4).
(7) Statements of significant new findings provided to subjects, as required by §46.116(c)(5).
(8) The rationale for an expedited reviewer’s determination under §46.110(b)(1)(i) that research appearing on the expedited
review list described in §46.110(a) is more than minimal risk.
(9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake
to ensure compliance with the requirements of this policy, as described in §46.103(e).
(b) The records required by Basic HHS Policy for Protection of Human Research Subjects shall be retained for at least ____ years, and records relating to research that is conducted
shall be retained for at least ____ years after completion of the research.
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