HUMAN SUBJECTS PROTECTION PROGRAM (HSPP)

Human Subject Researchers' Responsibilities

As of January 1, 2001, for greater than minimal risk studies*, the principal investigator, co-principal investigator, sub-investigator(s), study coordinator(s) and any other person obtaining consent must successfully complete the Human Subjects Protection Program. For minimal risk studies click here.

Program Content

This is a self-study program consisting of an informational textbook and an examination. The textbook [Dunn, C.M., & Chadwick, G.L. (2004). Protecting Study Volunteers In Research: A Manual for Investigative Sites (3rd ed.). Boston: CenterWatch, Inc. ] was developed by UR faculty and staff and reviewed by an external (national) advisory committee. The advisory committee included government regulators, renowned clinical researchers (biomedical and behavioral) and bioethicists. It will take approximately 7 hours to read the manual and take the examination. Health care professionals successfully completing the program may apply for CME credit or Nursing Contact Hours.

Program Availability

• The HSPP program has been available since March, 1999.

HSPP program materials can be obtained by calling Janice Taylor at 273-4127.

You will receive notification of your pass/fail status by mail. If you pass, this notification will include your HSPP number. This HSPP number will be required on all Institutional Review Board (IRB) submissions, after January 1, 2001.

Program Renewal

Individuals will need to renew their HSPP number every three years. We have selected an on-line program called the Collaborative Institutional Training Initiative (CITI Program). This refresher course will take approximately 1.5 to 2 hours to complete. Approximately 60 days before your current HSPP number expires you will receive by e-mail full details on how to access the refresher course.

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* According to Federal regulations, minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Examples of minimal risk procedures include electrocardiography, collection of blood by venipuncture from healthy adults who are not pregnant, moderate exercise testing, and administration of psychological tests involving a minor level of stress.