Primum non Nocere Research with Human or Animal Subjects
Office of Research & Grants
Compliant with common rule.
Not compliant.
Do No Harm
! Honoring Creation.
! Honoring the imago Dei in humanity, the creative agency of God in the animal world.
! Research with human subjects the purview of Institutional Review Board (IRB).
! Research with animal subjects the purview of Institutional Animal Care and Use Committee (IACUC).
! Both exist to ensure human or animal subjects are adequately protected.
! Compliance Partners.
! IRB and IACUC are your compliance partners at APU.
! Compliance with what?
! Federal guidelines for ethical research with human or animal subjects.
! As such, these entities serve as proxies for the federal government.
! IRB Trigger Events, Compliance Standards.
! Trigger event: Nazi human experiments.
! Compliance standard: Nuremberg Code (1947).
! Trigger event: Tuskegee syphilis study.
! Compliance standard: Belmont Report (1978), Common Rule (1991).
! CITI certification will provide you with excellent detail.
! Belmont Report.
! 1. Respect: Treat individuals as autonomous agents, do not use people as means to an end, allow individuals to choose for themselves, provision of additional protection for those with diminished autonomy.
! 2. Beneficence: Do no harm, maximize possible benefits while minimizing risks.
! 3. Justice: Treat people with fairness, equitably share burdens and benefits of research.
! IACUC Compliance Standards.
! More gradual implementation of federal regulations, consolidated in the 1960s.
! Federal agencies include NIH Office of Laboratory Animal Welfare (OLAW) and USDA.
! Public Health Service (PHS) of the federal government applies specific standards on the humane care and use of animals, understood to exclude invertebrates.
! CITI certification will provide you with excellent detail.
! Getting Oriented, Getting Certified.
! http://www.apu.edu/researchandgrants/ethics/
! IRB & IACUC info, including handbook, supplementary documents, and CITI certification links can be found at this site.
! Please note that MS Word IRB forms for application are available on the home.apu.edu page.
! Materials provided are comprehensive and detailed, outlining steps to follow for IRB or IACUC applications.
! This workshop augments website content.
! IRB 201 (intermediate/advanced).
! Let’s take a look at a current issue in human subjects research ethics.
! Please download IRB handbook for reference.
! Review Federal Definition of Research section on webpage.
! Issue: International research.
! Problem: Western researchers leveraging NGOs or other access points for international “rogue research” outside of IRB review.
! IRB 201 (intermediate/advanced).
! Example: Uganda.
! War weary nation with internal tribal factions.
! In the news because of atrocities committed by Joseph Kony and his Lord’s Resistance Army.
! Western researchers behaving badly, taking advantage of chaotic geopolitical situation for personal ends.
! IRB handbook p. 13.
! IRB 201 (intermediate/advanced).
! Does Belmont Report and common rule apply to Western research conducted in a place like Uganda?
! Do standard IRB application categories (i.e., exempt, expedited, full board) apply to Western research conducted in a place like Uganda?
! Case Study.
! IACUC 201 (intermediate/advanced).
! Let’s take a look at current issues in animal welfare ethics.
! Issue: Field studies involving threatened and/or extinct species (i.e., “nontraditional” animal subjects)
! What, if any, involvement should IACUC have with field studies involving higher vertebrates?
! PHS guidelines are principally aimed at laboratory studies of vertebrates such as mice.
! IACUC 201 (intermediate/advanced).
! Problem: Fieldwork sometimes requires adaptation in the field.
! Example: Bat ray (Myliobatis californica) tagging project in Tomales Bay, California.
! Protocol involved capture and tagging of bat rays to study migratory and spawning behaviors.
! Animal capture using baited hooks anchored on the seafloor beneath floating buoy.
! IACUC 201 (intermediate/advanced).
! Without intending to, nearly half of these rigs captured an endangered Pacific rockfish (genus Sebastus).
! Poorly understood species, rare opportunity to tag a threatened animal for conservation research.
! What to do? Not realistic to file a IACUC amendment from the middle of Tomales Bay!
! Case study.