A sample of IRB’s comprehensive training manual
References expand learning
The human research protection office at Washington University in St. Louis has a 43-page training tool that covers general and specific research protection information and tasks for new IRB staff.
The following are some sample items in the tool’s section on criteria for review of risks, monitoring:
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Risks are minimized.
- Review the assessing risk guideline on the IRB website under biomedical guidelines, risk and data monitoring guidelines.
- See myIRB section VI (participants) section VII (project description) and section VIII (risks).
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Risks are reasonable.
- Read the Belmont Report found on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/index.html.
- Read the IRB policies and procedures on unanticipated problems found under policies on the IRB website in the policies and procedures document.
- On the OHRP website, review “Reviewing and Reporting Unanticipated Problems Involving Risks to others and Adverse Events; Withdrawal of Subjects from Research” at http://www.hhs.gov/ohrp/policy/investigators/index.html.
- See myIRB section VIII (risks) and section IX (benefits).
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The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
- On the OHRP website, http://www.hhs.gov/ohrp/policy/index.html, review the guidelines found under “For Investigators” documents that will be of particular interest to research investigators, such as how to handle subject withdrawal from a protocol, how to assess unanticipated problems and adverse events that may occur during the conduct of research, and the general responsibilities of research investigators.
- On the IRB website, under “Risk and Data Monitoring Guidance,” review the data monitoring guideline.
- See myIRB section VIII (risks).
In another example, the sample items for criteria for review and participant selection, recruitment, and consent include the following:
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Participant selection is equitable.
- On the OHRP website, http://www.hhs.gov/ohrp/policy/index.html, review the guidelines found under the vulnerable populations, including guidance addressing vulnerable groups such as children, prisoners, and subjects for whom a certificate of confidentiality may offer appropriate additional protections
- Review 45 CFR 46, subparts B, C, and D: http://www.hhs.gov/ohrp/humansubjects/index.html.
- Review 21 CFR 50, subpart D: http://1.usa.gov/1pbjWBf.
- - See myIRB section VI (participants) and section VII.D (recruitment and consent).
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Recruitment methods are fair, appropriate, and designed to allow to ensure equitable selection of subjects.
- Review the FDA recruiting study subjects — information sheet at http://1.usa.gov/1TZX7wB.
- Review OHRP guidance research participants — employees in the workplace.
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With your manager, discuss the following recruitment issues:
- What does the IRB need to see?
- What should be in an advertisement; what is an acceptable ad?
- Use of SS# to recruit or follow-up.
- Use of Facebook and such.
- Use of commercial groups to recruit.
- Recruitment vs. engagement in the study.
The human research protection office at Washington University in St. Louis has a 43-page training tool that covers general and specific research protection information and tasks for new IRB staff.
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