Generally, Institutional Review Boards (IRBs) require investigators clearly and accurately inform human subjects about research during the recruitment and consent process. Human subjects are defined as a living individual about whom an investigator conducting research obtains (1) Data through intervention…
IRB Membership
The Common Rule (45 CFR part 46) published in 1991 is used by 15 Federal departments and agencies to provide protections for human subjects involved in research activities. The Common Rule also provides guidelines for the administration of the IRB…
Role of Culture and Issue of Autonomy and Informed Consent
Role of Culture and Issue of Autonomy and Informed Consent Author: Alice Yick Flanagan, Ph.D. When conducting research with other cultural groups and those from racial and ethnic minority groups, it is important for researchers to take into account how…
Do We Have a Moral Obligation to Conduct Prisoner Research?
Perspectives from an IRB Prisoner Research Representative In the scientific community, the pendulum of opinion concerning prisoner research has swung from conducting research without concern for harm, using prisoners as guinea pigs for a wide variety of studies, to conducting…
Maintaining Neutrality and Objectivity: Outsourcing the IRB
Competitive organizations constantly seek ways to streamline costs and utilize resources effectively. For organizations involved in research, outsourcing the Institutional Review Board (IRB) to an external IRB can provide significant savings. All IRBs must comply with Department of Health…
Protecting Participant Data
Evaluators and researchers must take steps to protect data collected from participants/patients. Individually identifiable information may not always be collected, however, if it is, a plan for the protection of the data is needed. This is one way to demonstrate…
Conducting research with children and FERPA
As the school year begins, research and evaluation including schools and children often increases. The following information is intended as a review of Family Education Rights and Privacy Act (FERPA) for researchers and evaluators working with this population. A future…
Informed Consent Quick Tip #2- Exculpatory Language
Preparation of the informed consent form can be a challenge for researchers and evaluators. Inclusion of exculpatory language is not permissible according to OHRP. What does this mean? According to 45 CFR 46.116 and 21 CFR 50.20 participants language that…
Do’s and Don’ts of Informed Consent Tip #1
Informed consent is almost always required of studies, but there are instances in which all or part of the consent can be waived. Today’s tip focuses on the signed consent form and guidelines the Institutional Review Board (IRB) will consider…
Recent Comments