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.