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."IND Information for Investigators
The number of U of R Researchers who are opening their own Investigator-Sponsor INDs is increasing. It is important for these individuals to fully understand that they assume the regulatory responsibilities of the sponsor in addition to the responsibilities of being the investigator.
The following resources can aid the Investigator-Sponsor in meeting their regulatory responsibilities.
Guidance Documents:
- IND Training Course
- Investigational New Drug (IND) Application Process
- "Protecting Study Volunteers in Research" Chapter 5, FDA Regulated Research
FDA Contacts:
FDA Info Sheets - FAQ #56
Which FDA office may an IRB * contact to determine whether an investigational new drug application (IND) or investigational device exemption (IDE) is required for a study of a test article?
For drugs , the IRB may contact the Drug Information Branch, Center for Drug Evaluation and Research (CDER), at (301) 827-4573.
For a biological blood product, contact the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), at 301-827-3518.
For a biological vaccine product, contact the Office of Vaccines Research and Review at 301-827-0648.
For a biological therapeutic product, contact the Office of Therapeutics Research and Review, CBER, at 301-594-2860.
For a medical device , contact the Program Operation Staff, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), at (301) 594-1190.
If the IRB is unsure about whether a test article is a "drug," a "biologic" or a "device," the IRB may contact the Health Assessment Policy Staff, Office of Health Affairs, at (301) 827-1685.
* Although this question is addressed to the IRB, the agency welcomes questions regarding INDs from Investigators.
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
