Ann Billetz, Ph.D.

11/6/09

Excerpt from MCLA’s IRB policy

Nazi Medical War Crimes (1939-1945)

Nuremberg Code – First International code of research ethics

www.nvic.org

www.uveitis.org

Syphilis Study at Tuskegee (1930’s-1972)

Development of an advisory panel by the Department of Health, Education, and Welfare

National Research Act of 1974HHS Policy for Protection of Human SubjectsNational Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research

Three principles essential to the ethical conduct of research with humans:

Respect for personsBeneficenceJustice

Excerpt from nihtraining.com

Informed Consent - Make sure that potential participants comprehend the risks and potential benefits of participating in research.

Avoid influencing potential participants’ decisions either through coercion or excessive compensation.

Excerpt from nihtraining.com

Persons requiring additional protections.

ChildrenDevelopmental disabledPregnant womenFetuses & neonatesPrisoners

Excerpt from www.nihtraining.com

Do no harm

Maximize possible benefits and minimize possible harm

Excerpt from www.nihtraining.com

Requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research.

Excerpt from www.nihtraining.com

Am I sure that any participant I might have in my research project can read and fully understand my informed consent materials for the study?

To what extent do my research materials solicit personally identifying features of participants so that there is a risk of them being known only through their research materials?

If data were accidentally lost or made public, what risk of embarrassment or loss of privacy would a participant face?

Have I checked with others to ascertain if items in my research materials might be perceived as embarrassing, culturally offensive, or overly-invasive to participants?

If I collect data on sensitive topics (e.g., sexual abuse), include protected populations (e.g., minors), or become aware of a participant's potential harm to self or others (e.g., intent to commit suicide), do I know my obligations to act (if any) under institutional policies and state laws concerning the protection of minors or mentally ill persons?

If a participant starts to experience discomfort because of some of the questions on my instruments, have I made arrangements and appropriate referral services available to the person if the discomfort continues or is severe?

Can I make myself readily available to all participants during my research via an array of contact avenues (e.g., phone, fax, e-mail, fixed mailing address)?

Can I safely store my data in a locked location away from any eyes except those qualified co-investigators approved by IRB?

Can I make sure that incentives (e.g., extra

credit, money, other valuables) are evenly and equitably available to all participants, and that any incentive I use does not unduly entice a disadvantaged group or protected population to accept an unreasonable risk in participating in order to gain the incentive?

Excerpt from Prieto L (2005) The IRB and Psychological Research: A Primer for Students. Eye on Psi Chi.

All proposed research involving human participants must be reviewed and approved by the IRB before any research can be started.

The IRB defines human subjects as living individuals about whom an investigator, student or faculty, conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information, who volunteer to participate in research.

Excerpt from MCLA’s IRB Policy

January start date!