The Office of Regulatory Affairs Important Links

Related Offices at Penn
Human Subjects (IRB) Links
Animal Subjects (IACUC) Links

Related Offices at Penn

 

Office of Research Services
Oversees the administrative support of the University's externally funded research and is responsible for implementation of University policies established for this purpose. 

 

Office of Human Research
Seeks to promote human research for the advancement of healthcare while ensuring the highest level of research participant safety and facilitating the highest quality research. 

 

Center for Bioethics
Seeking to advance scholarly and public understanding of ethical, legal, social and public policy issues in health care. 

 

University Laboratory Animal Resources
Handles care and husbandry of laboratory animals. Access to the ULAR web site is restricted to those users who are attempting to view it from an ON-CAMPUS computer. For further information, contact ULAR via This e-mail address is being protected from spam bots, you need JavaScript enabled to view it . 

 

Office of Environmental Health and Radiation Safety
Oversees and approves use of biological and chemical hazards in University's research programs. 

 

Center for Technology Transfer
Handles issues involving intellectual property and relationships with industry. 

 

Office of the Vice Provost for Research
Develops and promulgates University research policies. Provides information on external and internal funding sources.

 

PennKey
A PennKey and password are required to access many of the University's electronic services

 

Office of Human Research Protections (OHRP)
Formerly the Office for Protection from Research Risks (OPRR). OHRP has primary responsibility 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; see also:

• Federal Wide Assurances
• DHHS Regulations
• Guidance Documents 

FDA - the main menu of the Food and Drug Administration; see also: 

• Center for Drug Evaluation and Research (CDER) --
  • CDER Home
  • Regulatory Guidance 
  • IND - Guidance on the preparation of an investigator-held Investigational New Drug (IND) Application.
    
  • FDA drug development& approval process
    
  
  
• Center for Devices and Radiological Health (CDRH) --
  • CDRH Home
  • Device Advice
  • IDE - Guidance on how to obtain an investigational device exemption (IDE).
  
  
• Center for Biologics Evaluation and Research (CBER) --
  • CBER Home
  • Guidance and Guidelines
  
  
• Clinical Trials & GCP --
  • Clinical Trials Home
  • Guidance and Information Sheets
  
  
• FDA Regulations
• Guidance for Institutional Review Boards and Clinical Investigators - Compilation of current FDA Guidance documents for IRBs, including investigator responsibilities. Includes information on both drug and device studies.
  

President's Council on 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. 

 

Public Responsibility in Medicine and Research/The Applied Research Ethics National Association ( PRIM&R/ARENA) - Advancing strong research programs and the consistent application of ethical precepts in both medicine and research. 

 

Clinical Trials:

• CenterWatch - a private organization posting information on ongoing private sector clinical trials. 
• ClinicalTrials.gov - the NIH's directory of (mostly) publically-funded clinical trial

The IRB Discussion Forum - (previously known as "MCWIRB") promotes the discussion of ethical, regulatory and policy concerns with human subjects research.

 

AAHRPP - The Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) works to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.

 

 

Animal Subjects (IACUC) Links

Practical guidelines for aseptic surgery in rodents and the management of surgical facilities in a laboratory. - This article is from the newsletter of the Australian/New Zealand LAS journal. It is a great reference for aseptic surgery in rodents. 

Office of Laboratory Animal Welfare (OLAW) - contains guidance rules and regulations governing IACUC operations for PHS (NIH) research. 

Report of the AVMA Panel on Euthanasia (2013)

IACUC Tutorial - A web-based tutorial for new animal care and use committee members, institutional administrators, investigators, animal care personnel, veterinarians, or others who are interested in learning about the PHS Policy on Humane Care and Use of Laboratory Animals. 

AAALAC International - The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) programs.. 

AALAS - The American Association for Laboratory Animal Science, an organization of animal care technicians, veterinarians and other interested in laboratory animal welfare. 

AWIC - The Animal Welfare Information Center, maintained by the USDA, provides access to databases on alternatives for animal use. 

The Animal Welfare Act - Fact Sheet. Regulations: Definitions (Part 1.1); Regulations (Part 2); Standards (Part 3); and Rules of Practice (Part 4). 

Controlled Substances Act - The Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal foundation of the government's fight against the abuse of drugs and other substances.

Foundation for Biomedical Research - Dedicated to improving human and animal health by promoting public understanding and support for the humane and responsible use of animals in medical and scientific research 

 The Guide (8th edition) - complete text of "The Guide for the Care and Use of Laboratory Animals" from the National Research Council's Institute of Laboratory Animal Research (ILAR). 

The Guide (1996 edition) - complete text of "The Guide for the Care and Use of Laboratory Animals," from the National Research Council's Institute of Laboratory Animal Research (ILAR). 

National Association for Biomedical Research (NABR) - A not-for-profit organization advocating public policy that recognizes the vital role of humane animal use in biomedical research, higher education, and product safety testing 

Pennsylvania Society for Biomedical Research (PSBR) The goal of the PSBR is to educate Pennsylvanians about biomedical research and the importance of using animals to improve the health and well being of both humans and animals.

USDA APHIS - The Animal and Plant Health Inspection Service, the arm of the US Department of Agriculture charged with the regulatory enforcement of the Animal Welfare Act.