Short Courses Offered

OHRP Leadership to speak at IUPUI regarding the Federal Perspective on the Conduct of Research Involving Human Subjects

The Clinical Trials Program of the IU School of Medicine is pleased to announce that Dr. Bernard Schwetz, the new Director of the Office of Human Research Protection (OHRP) and Mr. George Pospisil (Division of Education and Development, OHRP) have agreed to speak to clinical researchers and their support staff on our campus this month. We are fortunate to have this unique opportunity to hear directly from OHRP leadership regarding the federal perspective on human subjects research and its oversight. Mark your calendars and please join us!

Content:

The Federal Perspective on the Research Enterprise; an update on the federal perspective on research involving human subjects outlining key issues of concern to OHRP and investigators - Dr. Bernard Schwetz

Perceived Obstacles to Research; IRB oversight puts some restrictions on research, but not all of the restrictions you think - George Pospisil

Target Audience: Clinical researchers, research support staff, IRB members, research compliance staff, anyone engaged in human subjects research governed by the Dept. of Health and Human Services.

Additional information:

The Office for Human Research Protections (OHRP) provides leadership on human research subject protections and implements a program of compliance oversight for Department of Health and Human Services (HHS) regulations for the protection of human subjects - Title 45, Part 46 of the Code of Federal Regulations (45 CFR part 46). http://www.hhs.gov/ohrp/

Dr. Bernard A. Schwetz, D.V.M., Ph.D., was appointed in April 2004 as the director of the Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services (HHS). OHRP leads the department's efforts to ensure the responsible conduct of research involving human subjects. The office monitors programs at more than 10,000 HHS-funded universities, hospitals and other medical and behavioral research institutions in the United States and abroad. Prior to his appointment, Dr. Schwetz had served as OHRP’s acting director since February 2003.

George Pospisil, M.A., C.I.M., C.I.P, Public Health Analyst, works in the Education Division of the Office for Human Research Protections (OHRP). He has served the Department of Health and Human Services (DHHS) for 27 years. He has served in various capacities in the National Institute of Mental Health, National Institute on Drug Abuse, and National Institute of Neurological Disorders and Stroke (NINDS). Immediately prior to coming to OHRP, George was the policy analyst for the NINDS Clinical Trials Group where he joined with 4 other Institutes to create the web-based “Human Subjects Protection Education Program” for the use of NIH grantees.

For additional information contact:
Pam DeWeese, Administrative Director
Clinical Trials Program
278-2865
pdeweese@iupui.edu

Scientists and Subjects: An Online Seminar on the Ethics of Research with Human Subjects

Registrations are now being accepted for the sixth annual Scientists and Subjects Online Seminar.

Scientists and Subjects is a unique and innovative Internet-based seminar designed for busy researchers and research administrators who are concerned with the responsible conduct of research with human subjects. The seminar is open to junior and senior researchers, members of Institutional Review Boards and other administrators, and college and university faculty members who teach future researchers.

Five years of experience offering the Scientists and Subjects seminar has allowed us to develop an intensive, focused curriculum addressing core issues in human subjects research. To maximize interaction and attention to each seminar member's concerns, each cohort will be limited to 17 members on a first-come, first-served basis. The seminar fee is $200. Continuing Medical Education credits are available for an additional processing fee of $50 (16 credits).

Prospective participants must submit a check or purchase order to cover the registration fee and complete an application form, available on the Web at http://poynter.indiana.edu/sas/, no later than Friday, December 10, 2004.

For more information, contact: Kenneth D. Pimple, SAS Project Director, Poynter Center, Indiana University, 618 East Third Street, Bloomington, IN 47405-3602; (812) 856-4986; FAX 855-3315; pimple@indiana.edu; http://poynter.indiana.edu/sas/.

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