Federal Research Offices
- Clinical Trials.gov
- U.S. Department of Health and Human Services (DHHS) Regulations
- U.S. Food and Drug Administration
- FDA Device Advice
- Regulatory Guidance
- Office for Human Research Protections (OHRP) - Advises the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology.Formerly the Office for Protection from Research Risks (ORRR). OHRP has primary responsbility for developing, monitoring and overseeing compliance with Health and Human Service (HHS) regulations for the protection of human subjects in research conducted or supported by any component of the Department of Health and Human Services, including the NIH.
Research that Requires Access to Penn Medicine Systems
Penn Medicine has great resources for researchers who need to access Penn Medical records either in preparation for research or for retrospective data analysis. The Data Analytics Center will work with you one on one to ensure you can obtain the data you need and stay compliant with HIPAA and IRB regulations. Working with the Data Analytics Center during protocol development is likely to shorten the amount of time it takes for the IRB to approve your project.
Click here to download informative brochures about:
President's Counsel of Bioethics
Advises the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology. In connection with its advisory role, the mission of the Council includes the following functions: to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology; to explore specific ethical and policy questions related to these developments; to provide a forum for a national discussion of bioethical issues; to facilitate a greater understanding of bioethical issues; and to explore possibilities for useful international collaboration on bioethical issues.
Ethical, Legal, and Social Implications (ELSI) of Human Genetics Research. Part of the Human Genome Project (HGP), the ELSI Program seeks to identify, analyze and addres the ethical, legal and social implications of human genetics research at the same time that the basic scientific issues are being studied.
NIA Glossary of Clinical Research Terms
The NIA Glossary contains definitions of commonly used terms within clinical research.
Click Here to download guidance from The University of Pennsylvania Office of the General Counsel regarding MMAS Research ( MORISKY MEDICATION ADHERENCE SCALE (MMAS-4 and MMAS-8)