Human Subjects Research: IRB Resources
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1 Research Compliance Office Human Subjects Research: IRB Resources Kristin B. Frazier HRPP Educational Specialist IRB Resources June 4, 2008
2 Topics Stanford Institutional Review Boards (IRB) Charge of IRB Human Subject Research Overview of Stanford IRBs The Stanford Human Research Protection Program (HRPP) Protocol Application and Review Cycle Research Compliance Office 2
3 Overview Stanford IRBs - Institutional Review Boards 8 IRBs Nonmedical (1) and Medical (5) Monthly convened meeting by each IRB Two IRBs devoted to expedited and exempt protocols IRB 6 (medical) & IRB 8 (nonmedical and medical) No convened meetings rolling approvals Meeting Schedule on website Research Compliance Office 3
4 Overview of Stanford IRBs Each IRB must have at least 5 members Diverse and experienced professions Sensitive and knowledgeable regarding community attitudes & vulnerable subject populations Knowledgeable of institutional commitments, regulations, applicable laws, and standards of professional conduct Each IRB must include at least one member whose primary concerns are in scientific areas whose concerns are in nonscientific areas who is not otherwise affiliated with the institution All proceedings are confidential Research Compliance Office 4
5 Charge of the IRB Review and approval human subject research Authority vested through FWAs (Federalwide Assurances) Our FWA covers research conducted at: Stanford University, Stanford Hospital and Clinics, LPCH, VA and PAIRE Research Compliance Office 5
6 Defining HS Research Research -A systematic investigation designed to develop or contribute to generalizable knowledge Human Subject -A living individual about whom an investigator (whether professional or student) conducting research obtains: Data through intervention or interaction with the individuals, or Identifiable private information 45 CFR (d) and (i) Research Compliance Office 6
7 Protocol Application & Review Cycle eprotocol Application Medical or Nonmedical Protocol Review Types IRB Review Approval Subsequent Protocol Events Research Compliance Office 7
8 eprotocol Information Paperless submission system eprotocol system Access via Human Subjects website or Requires SUNet ID to access eprotocol Research Compliance Office 8
9 eprotocol Information Tips for success in eprotocol Allow pop-ups Save frequently Read instructional text in each section Access Help from within the eprotocol application eprotocol training available Research Compliance Office 9
10 Protocol Events Initial Review Continuing Review (Renewal) Modification (Revision) Reportable Events Final Report Research Compliance Office 10
11 Protocol Review Types Regular review (Presented at convened IRB meeting) All regulations apply Drug or device study, research involving sensitive questions, specific subject populations, invasive procedures Expedited review Minimal risk research Non-sensitive information Surveys, noninvasive procedures, venipuncture, voice, video, digital, or image recordings made for research purposes Exempt review (minimal risk) Research exempt from regulations (continuing review) Not generally applicable to medical research because of HIPAA Research Compliance Office 11
12 eprotocol Application Form Research Compliance Office 12
13 Human Subjects Training CITI (Collaborative IRB Training Initiative) Web-based program ( Refresher course every two years Create a username and password (these are not your SUNet ID and password) Remember user name and password to take refresher course Print out completion certificate for your records Research Compliance Office 13
14 eprotocol Protocol Information Research Compliance Office 14
15 Pre-Review IRB Process Submitted protocol is reviewed for completeness by intake staff Incomplete protocols will be returned Assigned to IRB for review & meeting date IRB review, issuance of comments, if any Voting for approval at convened meeting Protocols or events subject to regular review Approval by single reviewer (online) Protocols subject to expedited and exempt review Research Compliance Office 15
16 IRB Review Ethical Principles & Regulations The Belmont Report The Common Rule FDA Test Articles HIPAA State Law Research Compliance Office 16
17 The Belmont Report Published in 1979 Filled a void of ethical oversight Ethical principles and guidelines for the protection of human subjects of research Consists of three basic principles Respect for persons Beneficence Justice Foundation for later regulations Research Compliance Office 17
18 The Belmont Report Respect for Persons Informed Consent Obtain & document informed consent Voluntariness/ coercion Protect privacy Consider additional protections for those with limited autonomy Beneficence Risks & Benefits Procedures with least risk Risks reasonable in relation to benefits Maintain confidentiality Monitor data for more than minimal risk research Justice Enrollment Select participants equitably Avoid exploitation of vulnerable or convenient populations Research Compliance Office 18
19 IRB Approval Means... Risks minimized, research design sound Risks reasonable with regard to benefits Participant selection equitable Informed consent (from participant or representative) Informed consent documented Plan for monitoring safety and data Plan for privacy and confidentiality Vulnerable participants safeguarded Research Compliance Office 19
20 Finding What You Need Human Subjects Website Policies and procedures Human research Protection Program (HRPP) Guidance CITI information eprotocol Information Template consent, assent and HIPAA documents IRB contact information Research Compliance Office 20
21 Research Compliance Staff Interacting with the Research Compliance Office (RCO) staff facilitates IRB approval IRB Manager & IRB Associate per panel See Human Subjects website Contact Us page eprotocol HRPP Education and IRB Training Specialists Senior RCO Management Research Compliance Office 21
22 Contact Us HRPP Education Specialist , eprotocol eprotocol Help Human Subjects website Research Compliance Office 22
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