Additional Links

Internal Links

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
Study Coordinators' Group website
University of Rochester Medical Center
University of Rochester School of Medicine & Dentistry
Western Institutional Review Board (contracted)

External Links

Biological Sampling

NCI sample consent form for use of tissue for research

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.

FDA Links

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.

HIPAA

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]

Informed Consent

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.

Investigational Drugs

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.

NIH Links

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: PDF document.
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.

Regulatory Links

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 Advocate component.