- Investigator Responsibilities at the University of Rochester
- Miner Digital Library
- Office of Research and Project Administration
- Office of Human Subject Protection
- Research Subjects Review Board
- University of Rochester Medical Center
- University of Rochester School of Medicine & Dentistry
- Western Institutional Review Board (contracted)
Clinical Trials Information
- ClinicalTrials.gov: ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov gives the public information about a trial's purpose, who may participate, locations, and phone numbers for more details.
- CenterWatch: This site focuses on industry supported trials and contains a wealth of information about clinical research, including listings of more than 41,000 active industry and government-sponsored clinical trials, as well as new drug therapies in research and those recently approved by the FDA. This site is designed to be an open resource for patients interested in participating in clinical trials and for research professionals.
- Reporting Guidelines for Adverse Events: Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Includes adverse event information applicable to all clinical trials regardless of chronicity or modality.
- The Food and Drug Administration (FDA): The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
- FDA Operations: FDA inspections of Institutional review boards, clinical investigators, and clinical investigator regulatory sanctions. This site also includes information on audits/inspections.
- Office for Civil Rights – HIPAA: Medical Privacy - National Standards to Protect the Privacy of Personal Health Information Office of the Secretary; Standards for Privacy of Individually Identifiable Health Information; Proposed Rule [HIPAA; 45 CFR Parts 160 and 164]
- MedicineNet.com: MedicineNet is a network of U.S. Board Certified Physicians and Allied Health Professionals. This site is a good source for easy-to-understand descriptions of medical terminology and medical information.
- Drug Application – Information for Clinical Investigators: This website is housed under the Center for Drug Evaluation and Research and provides guidance for conducting clinical trials with investigational drugs and information for compliance with the regulations of the Food and Drug Administration.
- Guidance for Institutional Review Boards and clinical investigators: Information Sheets: 1998 Update: A compilation of answers to questions asked of FDA regarding the protection of human subjects of research.
- National Institutes of Health: Health information (resources, clinical trials, drug information); grant and funding opportunities; scientific resources; and NIH institutions, centers and offices.
- NIH Guidance on Adverse Events Reporting: NIH guidance on reporting adverse events to institutional review boards for NIH-supported multicenter clinical trials. Release date: June 11, 1999
- NIH guidelines on inclusion of women and minorities as subjects in clinical research: Notice: OD-00-048, August 2, 2000
- National Library of Medicine: The National Library of Medicine (NLM), on the campus of the National Institutes of Health in Bethesda, Maryland, is the world's largest medical library. The Library collects materials in all areas of biomedicine and health care, as well as works on biomedical aspects of technology, the humanities, and the physical, life, and social sciences. The collections stand at more than 7 million items—books, journals, technical reports, manuscripts, microfilms, photographs, and images.
Research Subject Guidelines
- Guidelines for the conduct of research involving human subjects at the NIH
- Office of Research Integrity: The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration. Organizationally, ORI is located within the Office of Public Health and Science (OPHS) within Office of the Secretary of Health and Human Services (OS).
- Public Responsibility in Medicine & Research (PRIM&R): PRIM&R is dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research. PRIM&R's conferences, educational programs, and training resources serve the full array of individuals and organizations involved in biomedical and behavioral/social science research.
- U.S. Department of Health & Human Services (DHHS): DHHS is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The department includes more than 300 programs, covering a wide spectrum of activities.
- Regsource Clinical Investigator’s Page: This site organizes worldwide regulatory, clinical, toxicological, CMC, and other drug/device development-related information on the Internet. This site also includes include complete European Regulatory coverage as well as extensive Clinical Research information.
- Western Institutional Review Board (WIRB): The WIRB is the oldest and most experienced independent IRB in America. The University of Rochester is currently using this IRB in many industry-sponsored protocols.
- National Center for Research Resources (NCRR): The NCRR is a component of the National Institutes of Health. NCRR supports primary research to create and develop critical resources, models, and technologies. This site contains information on research funding opportunities, access to scientific resources and publications, plans, and other reports.
- Office for Human Research Protections (OHRP): The Office for Human Research Protections (OHRP) provides leadership and implements a program of compliance oversight for DHHS regulations for the protection of human. This site includes: IRB regulations and assurances; regulations and policy guidance (Belmont Report, 45 CFR 46); compliance and educational resources; and international issues (ethical codes, regulatory standards).
Other specific links located under individual navigation component topics (for example, Data Safety Monitoring links) will be found under Research Subject Advocates component.
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