How to Obtain Institutional Review Board (IRB) Approval Richard Wagner Associate Director UCSF Human Research Protection Program August 14, 2008

2 Topics to be covered What the IRB is looking for Tips for obtaining IRB approval Types of review/application required

August 14, UCSF Acronyms of Relevance IRB = Institutional Review Board (generic) CHR = Committee on Human Research— the IRB for UCSF, SFGH, VAMC, SFDPH... HRPP = Human Research Protection Program

August 14, Addressing Human Research Protection Issues NIH Application Essay-like discussion CHR Application Multiple detailed check boxes and questions Embedded guidance Application supplements for specific issues (Prisoners, surrogate consent, waiver of consent for some types of study)

August 14, Determinations the IRB Must Make (1) Risks to subjects are minimized Procedures are consistent with sound design and do not unnecessarily expose subjects to risk Study utilizes procedures already performed for diagnosis/treatment Risks to subjects are reasonable in relation to anticipated benefits, if any, and to the importance of the knowledge that may reasonably be expected to result from the study Selection of subjects is equitable Inclusion/exclusion criteria are adequate Research purpose and setting is appropriate Recruitment process is fair

August 14, Determinations the IRB Must Make (2) Informed consent will be sought in accordance with regulations Informed consent will be documented in accordance with regulations Provisions for monitoring collected data are adequate to ensure the safety of subjects Provisions to protect privacy of subjects are adequate Provisions to maintain confidentiality of data are adequate Vulnerable populations are adequately protected by additional safeguards

August 14, Determinations the IRB Must Make (3) More complete list of determinations has 74 items. The study cannot be approved unless the CHR determines the study meets the above criteria. If substantive clarifications or modifications are needed before the application can satisfy the criteria, the study must be returned to the committee for additional review

August 14, Tips for Success: #1 Sound Science * Scientific review or scholarly review, by peers or a mentor, should occur before submitting to the CHR.

August 14, #2 Level of Review/Type of Application * Level of review and type of application are determined by level of risk. Full Committee more than minimal risk, including social risks Expedited minimal risk, specific categories subject contact—yes or no

August 14, Determine the Level of Review (continued) Exempt Minimal risk, specific categories, usually no identifiers recorded You must have formal certification of exemption from CHR! No Human Subjects Research does not meet definition of human research No identifiers seen

August 14, Determining Level of Review: Is IRB Approval Needed? See decision tree on CHR website: e.pdf In general, for specimens and data if the researcher: does not access identifiers: no human subjects does not record identifiers: may be exempt records identifiers: expedited review

August 14, #3 Current Forms, Supplements and Consent Templates * Full Committee Application Expedited–Subject Contact Expedited—No Subject Contact Exempt Supplements Human Biological Specimen Collection and/or Banking Human Gene Transfer Human Stem Cell Investigational Drugs Investigational Devices Inclusion of Minors Inclusion of Prisoners Surrogate Consent Waiver of Consent Biomedical Consent Biomedical Cancer Consent Social or Behavioral Simple Blood Draw Assent Download the most current CHR Application Forms from the HRPP website. Check to see which Application Supplements are needed. Use and follow the most current consent and assent templates.

August 14, #4 The Audience * Not all IRB members are scientists. The scientists are your peers, but may not know your field. Spell out acronyms at first use. Write consent form at 8 th grade reading level. Use lay language in consents forms and study summary.

August 14, #5 Consistency * Make sure that  All sections within the CHR application are consistent with each other (i.e., purpose, benefits, alternatives)  All sections within the consent form are consistent.  CHR application matches the group or sponsor protocol.  Protocol and consent form are consistent. Use the same name for the subjects groups throughout submission. Use the same name for the study drugs throughout the submission.

August 14, #6 Important Explanations Explain what happens to subjects in study that is different than those who do not participate. Distinguish procedures being performed purely for research from standard of care. Describe procedures in chronological order. Describe each study group clearly. Describe how risks will be minimized and managed. Discuss Data Safety Monitoring Plan, and Data Safety Monitoring Board if required.

August 14, Provide a detailed discussion of the who, what, when, where and how of recruitment and consent. Submit copies of all recruitment materials and consent documents, including scripts and text of ads. Consider and address special populations:  Children and minors  Cognitively impaired  Those who do not read, speak or understand English Justify any alterations of consent  Waiver of signed consent  Waiver of consent #7 Recruitment and Consent

August 14, #8 Cover Letter * Use a cover letter to Explain and highlight any difficult or sensitive issues. Inform the CHR if you have special time constraints.

August 14, #9 Final Review * Do one last review before submitting. If you are not the PI, make sure the study PI has read the application and consent documents before he or she signs the application.

August 14, #10 Ask Questions Along the Way * Ask your mentor Ask the CHR:  Main Line:  Analyst of the Day:   Research Online: To check status of applications and for online training

August 14, Bonus Tip: Don’t Overload * Do not group related studies into a complicated application. Get separate CHR approval for each discrete study. You may have several CHR approvals for a single grant.