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.