Policy on the Protection of Human Subjects in Research
Public Comment Period: January 30, 2023 – February 24, 2023
Implementation: March 31, 2023
Overview: The policy establishes procedures for the review of Human Subjects Research by the Lehigh University Institutional Review Board (IRB). The policy is designed to safeguard the rights and wellbeing of human subjects and to ensure that the principles of respect for persons, beneficence, and justice are met by proposed activities involving human subjects. This is a revision to an existing policy that was originally effective March 21, 2018. The principles of safeguarding the rights and wellbeing of human subjects have not changed.
Who is impacted by this change: Those primarily impacted include faculty and/or staff who supervise undergraduate students who wish to conduct research with human subjects while physically located in an international setting. Stakeholders include the Office of Research Integrity, the Institutional Review Board (IRB), the Office of the Vice Provost for Research, the Office of International Affairs, the Associate Deans for Research, the Office of Creative Inquiry, and the Provost.
Timing: The revised policy will be effective on March 31, 2023, following a public comment period which ran from January 30, 2023 to February 24, 2023. During the public comment period, a redlined version of these revisions to the policy is posted to the Research Integrity website, any appropriate communications will be issued, and comments may be submitted by email to email@example.com. The IRB is the faculty committee providing conferral on and approval of this policy.
Summary of revisions:
- The type of research requiring review by the full IRB committee has been expanded to include research that both:
- includes human subjects physically located in international settings, and
- includes undergraduate students as study personnel who conduct one or more of the following activities while physically located in an international setting:
- Intervene for research purposes with any human subjects by performing invasive or noninvasive procedures.
- Intervene for research purposes by manipulating the environment.
- Interact with a human subject for research purposes.
- Obtain consent of human subjects.
- Researcher Training has been updated to describe the current training tutorial administered by CITI Program.
Draft: Policy on the Protection of Human Subjects in Research