THE COMMON RULE: 38 CFR PART 16–PROTECTION OF HUMAN SUBJECTS …
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The Common Rule is identical to Subpart A of 45 CFR 46.
45 CFR 46 also includes Subparts B, C and D, which are not part of the Common Rule
Sec. 16.101 To what does this policy apply?
16.101(a) Applies to all federally supported or regulated human research
16.101(a)(1) When research is conducted or supported by federal agency or department
16.101(a)(2) When research is specifically regulated by federal agency or department
16.101(b) Categories of exempted research
16.101(b)(1) Exemption for educational research
16.101(b)(2) Exemption for educational tests, surveys, interviews, observations
16.101(b)(3) Exemption for educational tests, surveys, interviews, observations of public officials
16.101(b)(4) Exemption for research on existing data, unlinked to subjects
16.101(b)(5) Exemption for research on public benefit programs
16.101(b)(6) Exemption for research on taste and food quality
16.101(c) Agency head may make final judgment on exemption
16.101(d) Agency heads may require that additional research be governed by this policy
16.101(e) Additional federal laws also apply
16.101(f) Additional state or local laws may also apply
16.101(g) Additional foreign laws may also apply
16.101(h) Department or agency head decides if procedures of foreign institutions may be substituted
16.101(i) Department or agency head may waive provisions of this policy
16.101(i) Footnote: Institutions with assurances must abide by 45CFR46 subparts A-D.
Subparts B-D contain exceptions to exemptions.
16.102(a) Department or agency head
16.102(b) Institution
16.102(c) Legally authorized representative
16.102(d) Research
16.102(e) Research subject to regulation
16.102(f) Human Subject, Intervention, Interaction, Private Information
16.102(g) IRB
16.102(h) IRB approval
16.102(i) Minimal risk
16.102(j) Certification
16.103(a) Institutions must provide written assurance when engaged in covered research
16.103(b) Departments must get assurance and certification to support covered research.
16.103(b)(1) Statement of principles
16.103(b)(2) Designation of IRB
16.103(b)(3) IRB membership
16.103(b)(4) Written procedures for initial & continuing review, determining term of approval, for changes in research activity
16.103(b)(5) Written procedures for reporting problems, suspensions, terminations
16.103(c) Assurance is to be executed by authorized official
16.103(d) Department or agency head will evaluate assurances
16.103(e) Department or agency head may approve, disapprove or negotiate assurance and limit term of approval
16.103(f) Covered research must be certified by an IRB before receiving federal support
16.107(a) Each IRB must have at least 5 members with appropriate expertise and from diverse groups
16.107(b) Both genders and a variety of professions should be included
16.107(c) Scientific and non-scientific members
16.107(d) Unaffiliated member
16.107(e) Members with conflicts of interest may not participate in review
16.107(f) Expert consultants may be used
Sec. 16.108 IRB functions and operations.
16.108(a) IRBs must follow written procedures
Sec. 16.109 IRB review of research.
16.109(a) IRB authority
16.109(b) IRB requires appropriate informed consent
16.109(c) IRB may require or waive documentation of consent
16.109(d) Notification of IRB decisions
16.109(e) Continuing review
16.110(a) Some categories of research may be reviewed by expedited review
16.110(b) Expedited review procedure
16.110(b)(1) Research is minimal risk and appears on the list
16.110(b)(2) Minor changes in approved research
16.110(b) Expedited review procedure
16.110(c) All IRB members must be advised of expedited approvals
16.110(d) Department or agency may restrict use of expedited review
Sec. 16.111 Criteria for IRB approval of research.
16.111(a) For IRB approval the following must be determined:
16.111(a)(1) Risks are minimized
16.111(a)(2) Risk/benefit balance is reasonable
16.111(a)(3) Subject selection is equitable
16.111(a)(4) Appropriate informed consent will be sought
16.111(a)(5) Informed consent will be appropriately documented
16.111(a)(6) Safety will be appropriately monitored
16.111(a)(7) Privacy and confidentiality will be protected
16.111(b) Additional safeguards included for vulnerable subjects
Sec. 16.112 Review by institution.
Institution may not approve research without IRB approval
Sec. 16.113 Suspension or termination of IRB approval of research.
IRB has authority to suspend or terminate research with appropriate notifications
Sec. 16.114 Cooperative research.
Each institution is responsible to protect subjects, but may arrange for joint IRB review
16.115(a) IRB activities must be documented & records maintained
16.115(a)(1) Documents related to proposals
16.115(a)(2) IRB Minutes
16.115(a)(3) Continuing review
16.115(a)(4) Correspondence
16.115(a)(5) IRB Membership
16.115(a)(6) IRB Procedures
16.115(a)(7) Statements of significant new findings given to subjects
16.115(b) Records to be retained for 3 years
Sec. 16.116 General requirements for informed consent.
16.116(a) Unless explicitly waived, consent must include these elements
16.116(a)(1) Explanation of research
16.116(a)(2) Description of risks
16.116(a)(3) Description of benefits
16.116(a)(4) Alternative treatments
16.116(a)(5) How confidential records will be maintained
16.116(a)(6) Compensation for injury (research involving more than minimal risk)
16.116 (a)(7) Whom to contact
16.116(a)(8) No penalty for refusal to participate
16.116(b) Additional elements may be required:
16.116(b)(1) Unforeseeable risks
16.116(b)(2) When investigator may terminate participation
16.116(b)(3) Additional costs
16.116(b)(4) Consequences of withdrawal
16.116(b)(5) New findings will be provided
16.116(b)(6) Number of subjects in study
16.116(c) Public benefit research waiver: IRB may waive or alter some or all elements, for
16.116(c)(1) Research on public service programs, which
16.116(c)(2) Cannot be carried out without a waiver or alteration
16.116(d) Minimal risk research waiver: IRB may waive or alter some or all elements, for research for which
16.116(d)(1) There is no more than minimal risk
16.116(d)(2) The waiver will not harm subjects’ rights and welfare
16.116(d)(3) Consent is not practicable
16.116(d)(4) Subjects will receive information later
16.116(e) Other federal, state or local laws may apply
16.116(f) Physician’s authority to provide emergency medical care is not limited by this policy
Sec. 16.117 Documentation of informed consent.
16.117(b) Documented consent may take two forms:
16.117(b)(1) Full consent with all required elements
16.117(b)(2) Short form consent: Requirement for witness, additional signatures and copies
16.117(c) IRB may waive requirement for documentation if:
16.117(c)(1) Consent form is the only record with subject’s identity and this poses a risk
16.117(c)(2) Research is minimal risk and involves procedures not normally requiring written consent
Sec. 16.118 Applications and proposals lacking definite plans for involvement of human subjects.
Sec. 16.119 Research undertaken without the intention of involving human subjects.
16.120(a) Department or agency head will evaluate protections for subjects in grant proposals
16.120(b) Department or agency head may reject or approve proposals on this basis
Sec. 16.121 [Reserved]
Sec. 16.122 Use of Federal funds.
No federal funds may be expended for human research if these requirements have not been met
Sec. 16.123 Early termination of research support: Evaluation of applications and proposals.
16.123(a) Funding may be withdrawn if an institution has not complied with this policy
16.123(b) Funding decisions may be based on past history of compliance with this policy
Additional conditions may be imposed by an agency or department head to protect human subjects
http://www.researchtraining.org/referencedocuments/humanrefs/ORCACompendium/Files/38CFR16.htm
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