Ethical Issues in Research Christian A. Meissner, Ph.D. Chair, Institutional Review Board University of Texas at El Paso

What is the IRB? The Institutional Review Board (IRB) is a committee representing various research disciplines that oversees all research involving human subjects conducted by faculty, students, or staff who might use any University property or non-public information to contact human research subjects.

Why is the IRB important? Federal law (45 CFR 46) and the Assurance document signed by Universities and the Office for Human Research Protections (OHRP) require that an IRB be established to review all studies involving human subjects (both funded and unfunded protocols). Failure to comply with these regulations could lead to a suspension of all university research activities involving human subjects and a loss of federal funding.

The Belmont Report… The Belmont Report was issued April 18, 1979, after a conference held in February 1976 at the Smithsonian Institution’s Belmont Conference Center in Maryland. The repot identified three basic ethical principles that should govern human subject research, specifically: Respect for Persons Beneficence Justice

Respect for Persons Each research subject is an individual capable of making up his or her own mind about whether to participate in a research study. Research subjects that have a diminished capability (whether they are immature, incarcerated or incapacitated) are vulnerable and they receive special protection under federal law (45 CFR 46).

Beneficience Comes from the Hippocratic maxim “do no harm.” Subjects in a research study should be protected from research risks, have their decisions respected and their well-being assured. Researchers need to maximize possible benefits and minimize possible risks to subjects.

Justice Implies that subjects should be selected equitably. No one group of subjects, such as the economically disadvantaged or the institutionalized, should continually bear the burden of research.

Three Important Issues to Consider when Conducting Research… Informed Consent Use of Deception Confidentiality & Data Protection

It is a process, not a document! Informed Consent… It is a process, not a document!

Informed Consent… purpose of the research, the likely duration, and relevant procedures right to decline to participate and to withdraw from the research once participation has begun factors that may be expected to influence the willingness to participate such as potential risks, discomfort, or adverse effects

Informed Consent… any prospective research benefits procedures for safeguarding confidentiality incentives for participation contact for questions about the research and research participants' rights

Use of Deception…

Use of Deception… Might the information to be withheld influence prospective subjects’ decisions regarding participation in the research? Does the use of deception place the participant at greater than minimal risk during the study? Would the researcher be unable to scientifically evaluate the phenomenon if the subject were fully informed prior to participation?

Confidentiality & Data Protection…

Confidentiality & Data Protection… Federal laws (such as HIPAA and FERPA) protect the disclosure of individually identifiable health, educational, and economic information Issues of data confidentiality typically come into play when biomedical, social or behavioral science research involves data collection on identifiable individuals. Protections should be developed consistent with the study design and the potential risk of harm from breaches of confidentiality.

Confidentiality & Data Protection… What steps could you take to protect the confidentiality of a participant? How might you protect your data from unauthorized access or distribution?

One last thought… Even when clear ethical standards and principles exist, there will be times when the need to do accurate research runs up against the rights of potential participants. No set of standards can possibly anticipate every ethical circumstance. As you work with your IRB to resolve such issues, keep in mind the Belmont principles of Respect for Persons, Beneficence, and Justice, and thoughtfully place yourself in the subject’s position.

Thanks for your attention and participation! Christian A. Meissner, Ph.D. Associate Professor of Psychology Chair, Institutional Review Board University of Texas at El Paso Email: cmeissner@utep.edu Telephone: 915-747-6056