Research Subjects
Review Board
"... to protect the rights and welfare of human research subjects at the
University of Rochester. To accomplish this, we review, approve the initiation of,
and conduct periodic review of research involving human subjects."
Research Education
and Training
GCP Training - offered on-line through CITI...
ROSS Training ....
RSRB ROSS training 3rd Monday of every month from 2pm to 3pm. Please Click HERE to sign up.
Quality Improvement
"To assess and assist the Investigator (PI) in assuring the rights and wellbeing of human subjects are protected and that the study is being conducted in accordance with IRB requirements, the approved protocol, applicable Federal regulations, U of R policies and best practice (GCP) standards."Greater Than Minimal Risk Research
Note: If your intent is to renew your HSPP or EPRP certification click here.
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 Subject 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. Protecting Study Volunteers In Research: A Manual for Investigative Sites (4th 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.
Program Availability
The HSPP program has been available since March, 1999.
HSPP program materials can be obtained by calling Janice Taylor at 585-273-4127.
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.
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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.
Ethics Certification
Seminars
ROSS Training
Investigator Education
- Listserv Signup
- Basic Guidelines
- Investigator Responsibilities
- IND Information for Investigators
- Statistics and Study Design
Coordinator Education
- Listserv Signup
- Professional Certification
- 3-day Workshop
- Advanced Workshops
- Study Self Audit Tools
- SCORE Group
- Shipping Biologicals and Hazardous Materials
- Library
