Human Subject Protection Program Frequently Asked Questions

I am going to be part of a research team involved in a clinical study and was told I need to take a human subject protection program. What's the difference between the HSPP and EPRP training and which one should I take?

The University has developed formal human subject protection programs to protect the safety and well being of research subjects. By University policy, the study principal investigator, co-principal investigator, sub-investigator(s), study coordinator(s) and any persons obtaining consent for a study involving human subjects must successfully complete the appropriate program. OHSP administers this program. Additionally, the University supports and believes in strong mentoring programs, on-the-job training and collaborative efforts at improving researcher skills.

There are two programs: The Human Subject Protection Program (HSPP) and the Ethical Principles in Research Program (EPRP).

The HSPP program is required for those persons involved in conducting research that poses greater than minimal risk to human subjects (e.g. clinical trials). The HSPP program has two tracks, a biomedical and behavioral. The biomedical track provides training for research involving investigational drugs, devices and medical procedures such as surgery. The behavioral track covers research that involves the use of interviews, surveys and questionnaires, which ask study participants questions of a sensitive nature (i.e., could be damaging to employability, reputation or result in criminal or civil liability). The HSPP is a self-study program consisting of an informational textbook, “Protecting Study Volunteers In Research: A Manual for Investigative Sites” and an examination. If you successfully pass the exam you are assigned an HSPP number with 3-year expiration date. The HSPP number allows you to participate as study personnel in studies of all risk levels (i.e., you don’t need both HSPP and EPRP).

The EPRP program is required for those persons involved in conducting research that poses no greater than minimal risk to human subjects. Examples of minimal risk procedures include most surveys, record reviews, moderate exercise testing, and administration of psychological tests involving a minor level of stress. The EPRP is a self-study program, which consists of reading the Belmont Report and additional supporting articles and an examination. If you successfully pass the exam you are assigned an EPRP number with a 3 year expiration date. Passing the EPRP only permits the involvement in studies that present no greater then minimal risk.

I am going to renew my HSPP number. If I do the HSPP Biomedical modules on the CITI web site, do I need to do also the HSPP Behavioral modules? The studies in which I am involved cover both areas.

No, you don’t need to do both. The HSPP biomedical modules cover all the material contained in the behavioral modules.

How do I obtain the continuing education credit offered for completing the program?

The HSPP program offers both CME category 1 credit and nursing contact hours. Simply check the box on the answer sheet for the credit you want. Nursing credits are offered at no charge and are issued by our office. CME credits are offered from the University Office of Continuing Professional Education for a modest fee.

I have misplaced my certification letter stating that I successfully completed the EPRP program, which contained my EPRP number and expiration date. I do not remember my number or expiration date and my administrator is requesting verification that I have a current number. Can you send me a copy of the letter?

We do not keep copies of the individual certification letters. We can generate a new letter if necessary, however, if an individual only needs to know their number and expiration date, they can call our office. We will also provide this information directly to your administrator, coordinator or principal investigator.

If your human subject certification information is required for a federal grant, the Office of Research and Project Administration (ORPA) has a form letter that they prepare verifying this information, which is submitted with the grant.

I renewed my HSPP number in the CITI program. I did not receive an e-mail confirmation. Did your office receive the e-mail confirmation?

To successfully complete the CITI renewal program, you must achieve an overall score of at least 85% on the quizzes. OHSP will receive a confirmation only if you achieve a score of at least 85%. You will know that you have achieved this when you see on your screen in bright red message saying, “Modules Completed ” Also in bright red, you will see “Print Completion Report” which allows you print the report. If you do not see these, it indicates that you either did not complete all the modules or that you did not receive an overall score of at least 85%. You can go back online and complete any incomplete modules, as well as go back and look at your quiz scores for each module and answer any incorrect questions.