Resources

Forms and Policy Examples for Clinicians Conducting Research in Clinical Settings:

Center Research Policies Template

Research Consent Form Template

Worksheet for Case Reports Using Existing Data

Example of Research Consent Language for a Treatment Agreement

We have found the following resources helpful in the formation or ongoing work of our IRB:

Office for Human Research Protections (OHRP) – Federal office that oversees ethical and regulatory issues in biomedical and behavioral research. OHRP manages the registration process and oversight for federally registered IRBs and hosts training programs on research ethics and compliance.

Information on how to obtain Federal Wide Assurance

NIH Office of Extramural Research, Protecting Human Research Participants Training – This is the free human subjects training we use at BHRC.

Public Responsibility in Medicine and Research (PRIM&R) – Professional organization for people involved in research ethics and oversight. Provides online educational resources and sponsors research ethics conferences. Also offers a certificate program for IRB Professionals.

IRB Forum (sponsored by PRIM&R) – Online discussion forum that is free and is open to past and current members of research ethics committees and review boards, as well others involved in research.

hrp Consulting Group – Private consulting firm with expertise in research ethics and compliance, including IRB management and functions that we have consulted with in forming the IRB and developing new policies.

Apgar and Associates – Private consulting firm with expertise in HIPAA privacy, information security, and regulatory compliance.

Sprague, Israel, Giles, Inc. – Insurance broker who provided us with our liability policy. Those who are interested in forming their own IRB might consider contacting them as we needed to contact several insurance brokers before we able to find one that was willing to cover the services of an IRB.

Publications we have found useful in forming and running the IRB:

  • Amdur, R. J. & Bankert, E. A. (2011). Institutional review board: Member handbook, Third Edition. Boston: Jones and Bartlett Publishers.
  • Bankert & R. J. Amdur (2006), Institutional review board: Management and function, Second Edition (pp. 101-105). Boston: Jones and Bartlett.
  • Barkham, M., Hardy, G. E., & Mellor-Clark, J. (Eds.). (2010). Developing and delivering practice-based evidence: A guide for the psychological therapies. John Wiley & Sons.
  • The Belmont Report
  • Borkovec, T. D., Echemendia, R. J., Ragusea, S. A., & Ruiz, M. (2001). The Pennsylvania Practice Research Network and future possibilities for clinically meaningful and scientifically rigorous psychotherapy effectiveness research. Clinical Psychology: Science and Practice,8, 155-167.
  • Boswell, J. F., Kraus, D. R., Miller, S. D., & Lambert, M. J. (2015). Implementing routine outcome monitoring in clinical practice: Benefits, challenges, and solutions.Psychotherapy Research, 25, 6-19.
  • Castonguay, L. G. & Muran, J. C. (Eds.). (2016). Practice-oriented Research in Psychotherapy: Building Partnerships Between Clinicians and Researchers. Routledge.
  • Committee on Publication Ethics (2014). Institutional review board approval required? Retrieved from https://publicationethics.org/case/institutional-review-board-approval-required.
  • HHS Protection of Human Subjects, 45 C.F.R. 46 (2009).
  • Hoffman, S. & Berg, J. W. (2005). The suitability of IRB liability. University of Pittsburg Law Review, 67, 365-428.
  • Icenogle, D. L. (2003). IRBs, conflict and liability: Will we see IRBs in court? Or is it when? Clinical Medicine & Research, 1, 63-68.

“Science is built up of facts, as a house is built of stones; but an accumulation of facts is no more a science than a heap of stones is a house.” -Henri Poincaré, Science and Hypothesis, 1905