Bioethics & Subject Advocacy

Consultation, education & training on research ethics.

The Bioethics and Subject Advocacy Program (BSAP) works with researchers, trainees, and leadership to support ethical research and effective communication with patients and research participants. It also provides training and education on the responsible conduct of research.

Consultation

We offer free, timely, confidential consults to researchers, administrators, and leadership on research ethics and data safety monitoring. In these consultations, we can clarify and address ethical issues that arise in planning, conducting, and analyzing translational research. These issue include topics such as informed consent; return of results; biobanking; health information; research with minors; community engagement; and more.

The consultations are available to researchers, research staff, IRBs, and others at all partner campuses of Indiana CTSI.

Questions addressed in recent consultations, collaboration, and research include:

  • When should researcher return individual research results to study participants?
  • What should individuals be told when asking them to contribute a biosample and share their medical information with researchers through a “biobank”?
  • Should minors be allowed to participate in research on preventing AIDS without the consent of their parents?
  • How can researchers respect the rights of children and adolescents when enrolling them in projects that may carry risk
  • How can research using large amounts of data support medical breakthroughs while protecting the privacy and confidentiality of patients?

All clinical studies that involve some risk to the participants are required to have some data and safety monitoring. Our team can help investigators determine the frequency and rigor of the monitoring that will satisfy the requirements of the IRB or funding agency.

Studies that pose greater than minimal risks may require a data safety monitoring board. If this is the case for your study, we can help with the organization and composition of the board. Our aim wis to reduce unnecessary burden for the investigator.

The Bioethics and Subject Advocacy Program (BSAP) of the Indiana CTSI partners with the IU Center for Bioethics to provide training to future researchers in Responsible Conduct of Research.

Learn more about RCR training offerings.

Contact

  • Peter Schwartz, MD, PhD
    Director

    Nicolas Oliver, MA
    Program Manager
    Email