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Human Subjects Protection: Creation and Maintenance of an IRB Regulatory Requirements & Recommendations 45 CFR part 46 Freda E. Yoder Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) March 30, 2005 NARCH Researchers - PI & PD Meeting Indian Health Service November 9, 2005
Outline • Regulatory Background • IRB Membership & Responsibilities • Written IRB Procedures • IRB Records • Resources
Regulations for Protection of Human Subjects in Research • HHS regulations at Title 46 CFR part 46 • Subpart A – common rule or federal policy • Subparts B, C, & D provide additional protections to certain vulnerable classes of subjects
Applicability of Regulations • Protections apply to all non-exempt humansubjectresearch • conducted or supported by a Federal Department or Agency that has adopted the regulations, OR • covered by an Assurance
Prerequisite for HHS Conduct or Support of Research HHS will conduct or support covered research only if: the institution has an applicable assurance, and only if the institution certifies to the department or agency [conducting/supporting research] that IRB has reviewed and approved the research, and research will be subject to continuing review 46.103(b)
Assurance of Compliance • Documentation of institutional commitment to comply with regulation • Principal method of compliance oversight for OHRP • Other Federal Departments and Agencies accept a Federalwide Assurance on file with OHRP, in lieu of requiring their own Assurance
Assurance of Compliance Includes • Statement of principle governing conduct of research • Designation of one or more IRB • established in accordance with the regulations and • for which provisions are made for • meeting space • sufficient staff to support the IRB’s review and record keeping duties • List of IRB members & relevant information • Written IRB & institutional procedures §46.103(b)
When is an Assurance Required? Each institution engaged in research, covered by the [Federal] policy, which is conducted or supported by a Federal Department or Agency shall provide written assurance, satisfactory to the Department or Agency head that it will comply with the requirements of the policy. §46.103(a)
Institutional Review Board (IRB) A committee charged with review of covered human subjects research to assure that the subject’s rights and welfare are adequately protected.
IRB Members Regulatory criteria for membership: • minimum of 5 members • background & expertise appropriate to review research conducted by institution • qualification & diversity … to promote respect for its advice and counsel • ability to ascertain acceptability of research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice • representation for vulnerable subjects, when appropriate §46.107(a)
IRB Members (cont) Regulatory criteria for membership: • not entirely of same sex and may not consist entirely of members of one profession • at least one with primary concerns in scientific areas & at least one in nonscientific areas • at least one not affiliated and not immediate family member of anyone affiliated with institution • may not participate in review of any project in which member has a conflicting interest • invite other expert to supplement review §46.107(b-f)
Scientist vs. Non-Scientist • Scientists include: individuals whose training, background, and occupation would incline them to view scientific activities from the standpoint of a behavioral or biomedical research discipline • Non-Scientists include: anyone whose primary concerns are in non-scientific areas
IRB Responsibilities, among others Review covered research • Must be substantive • Criteria for approval at §46.111 (and if applicable, subparts B, C, and D) must be satisfied for all covered research • Authority to approve, require modifications, or disapprove all covered research §46.109(a) • Authority to suspend or terminate approval of research • not conducted in compliance • associated with unexpected serious harm to subjects
IRB Responsibilities, among others Type of Review • Review at convened meeting of IRB • majority of members present, including non-scientist • review & vote on each protocol separately • majority present must vote in favor, to approve • notify investigators & institution in writing of IRB action/determinations
IRB Responsibilities, among others Type of Review, cont. • Expedited review consistent with §46.110 • may be used for • minor modifications to approved research • research no greater than minimal risk & fits category on list (see resource slide) • review by chair or by one or more experienced IRB member • authority to approve - may not disapprove • advise all members of approvals • notify investigators & institution in writing of IRB action/determinations
IRB Responsibilities, among others (cont) • When must IRB review research? • initial review • continuing review • prior to initiation of changes to approved research • When may expedited review be used? • initial review – categories 1 through 7 • continuing review – categories 8 & 9 • minor changes to approved research
Written IRB Procedures §46.103(b)(4-5) OHRP Guidance at: http://www.hhs.gov/ohrp/humansubjects/guidance/irbgd702.htm
Required Elements Procedures IRB will follow for: • conducting initial review of research • conducting continuing review of research • reporting the IRB’s findings and actions to investigators and the institution §46.103(b)(4)(i)
Operational Details Initial & continuing review - description of: • any primary reviewer system • documents distributed for review & timing • expedited review procedure • any processes supplementing IRB review • range of possible actions by the IRB
Operational Details Reporting IRB actions - description of: • how notify investigator & how address investigator response • which institutional official is notified & how accomplished
Required Elements Procedures for: • determining which projects require review more often than annually • determining which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review§46.103(b)(4)(ii)
Required Elements Procedures for: • ensuring prompt reporting to the IRB of proposed changes in a research activity • ensuring that such changes in approved research may not be initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject§46.103(b)(4)(iii)
Required Elements Procedures for: • ensuring prompt reporting to the IRB, appropriate institutional officials, the Department of Agency head, and OHRP of any • unanticipated problems involving risks to subjects or others • any serious or continuing noncompliance • any suspension or termination of IRB approval§46.101(b)(5)
Suggested Additional Elements Among others, • any further review by institution • procedures for determining exemptions • procedures for implementing other relevant federal, State, & local laws/regulations • training and education programs for IRB members, investigators, & staff • procedures for selecting IRB members & chairs • procedures for dealing with conflict of interest
Suggested Additional Elements (Cont.) • IRB review of research in emergency situations & settings • procedures for ensuring IRB knowledge of local research context • description of required elements of informed consent and criteria for altering or waiving these requirements • consideration for date stamping informed consent documents • procedures for documenting required IRB findings/determinations
IRB Records - Regulatory Requirements 1. Copies of • research proposals reviewed • scientific evaluations, if any • approved sample consent documents • progress reports submitted by investigator • reports of injuries to subjects §46.115(a)(1)
IRB Records - Regulatory Requirements (cont.) 2. Minutes of IRB meetings - in sufficient detail to show • attendance at meetings • actions taken by the IRB • votes on actions [separately for each protocol] • basis for requiring changes in or disapproving research, and • a written summary of controverted issues & their resolution §46.115(a)(2)
IRB Records - Regulatory Requirements (cont.) 3. Records of continuing review activities 4. Copies of all correspondence between the IRB and the investigators • List of IRB members in the same detail as described in§46.103(b)(3) §46.115(a)(3–5)
List of IRB Members Members identified by: • name • earned degree • representative capacity • indication of experience such as board certification, licenses, etc., sufficient to describe each members expected contribution to IRB deliberations, and • any employment or other relationship between each member and the institution §46.103(b)(3)
IRB Records - Regulatory Requirements (cont.) 6. Written procedures for the IRB in the same detail as described in §46.103(b)(4) & (5) 7. Statements of significant new findings provided to subjects as required by §46.116(b)(5) §46.115(a)(6–7)
OHRP recommends the IRB recordsalso include documentation of any actions, determinations, findings, orrequirements made by the IRB
IRB Records - Regulatory Requirements (cont.) Retention of records: Records required by the HHS regulations shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. §46.115(b)
Records Retention (cont.) Some state or local jurisdictions, professional organizations, and institutions may have policies requiring longer retention of research records.
IRB Records - Regulatory Requirements (cont.) Accessibility All records shall be accessible for inspection and copying by authorized representatives of the Department or Agency at reasonable times and in a reasonable manner §46.115(b)
Human Subject Protections Institutions Sponsor IRB Subjects Research Team Investigator Advocates Family Government Public
Resources • Significant Findings of Noncompliance http://www.hhs.gov/ohrp/compliance/findings.pdf • Expedited review categories:http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm • Institution’s written IRB procedures are posted at web pageshttp://www.hhs.gov/ohrp/humansubjects/guidance/irbgd702.htm • OHRP educational conferences/meetings http://www.hhs.gov/ohrp/education/conference.html • IRB Guidebookhttp://www.hhs.gov/ohrp/irb/irb_guidebook.htm
Resources Visit OHRP website:http://www.hhs.gov/ohrp Join List Serve:http://www.hhs.gov/ohrp/news/index.html E-mail OHRP:email@example.com Phone #:(240) 453-6900 Fax #: (240) 453-6909