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Ethics, Policy, & Regulation

Penn State CTSI aligns its ethics with the university's core values of Integrity, Respect, Responsibility, Discovery, Excellence, and Community. These principles guide their work, including ethical research practices like obtaining informed consent, protecting participant privacy, and minimizing harm. The CTSI is committed to honesty, transparency, and acting accountably in all endeavors.

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Health Policy Impact

The CTSI offers health policy impact consultations to support policy-relevant research and promote its translation between researchers and regulators. These consultations are open-ended and can be tailored to specific questions. The following are examples of how previous investigators have used consultations:

  • Identifying policy objectives of relevant regulatory agencies

  • Supporting researchers in increasing the policy relevance of proposed projects

  • Discussing policy-relevant dissemination opportunities

  • Providing education and educational opportunities on legal and regulatory issues related to health policy

  • Reviewing grant applications to identify ways to enhance policy relevance

Regulatory

The CTSI helps to facilitate the process by which novel research ideas are transformed into scientifically and ethically sound research study protocols that are in compliance with regulatory requirements. We involve both investigators and regulators in a partnership where values of efficiency, appropriate attention to ethical research conduct, and regulatory compliance are continuously balanced. Consultations include:

  • Education and mentorship on the regulatory and ethical research

  • Considerations of the regulatory and ethical implications of a research project

  • Promotion of scholarship in ethical research

  • Obtaining informed consent

  • Addressing privacy issues in data-driven research

  • Development of research questions related to specific regulatory or ethical concerns to incorporate in study design

Research Ethics

The CTSI provides research ethics consultations to maximize the benefits and minimize potential harms of research to society. The institute involves both investigators and regulators, where values of efficiency, appropriate attention to ethical research conduct, and regulatory compliance are continuously balanced. Consultations can help researchers and others involved in the research process identify practical solutions to ethical, policy, and social challenges. The institute also provides education through seminars and facilitated discussions on a variety of research ethics topics, including the responsible conduct of research (research misconduct, informed consent, and authorship), ethical and social issues surrounding genomic research, biobanking, and privacy and confidentiality in an era of broad data sharing and data-driven research. Research ethics consultations are part of the institute's Research Methods core service area.