Research Ethics Advice and Consultation Service

This free service offers timely consultation on ethical issues in the design and conduct of research (including but not limited to research involving human participants). It’s available for Geisinger investigators, program managers and other members of the research community.

How is it used?

Research ethics consultation is a relatively new service. It’s becoming increasingly available at major academic medical centers and other research institutions. This service offers a valuable way to get advice on:

• Ethical issues in the design and conduct of research, including:
  • Recruitment
  • Participant selection and incentives
  • Consent
  • Study design
  • Return of primary or additional results prior to IRB review (it can save time by identifying potential ethical issues and developing a plan to address them before submission to the IRB)

• Ethical issues involving human subjects research that may fall outside the mandate of the IRB, including: 
  • Data sharing
  • Publication ethics
  • Responsible communication of results
  • Concerns about risks of the research to non-participants like stigmatization or conflicts of interest

• Activities not subject to, or exempt from, IRB or other formal review, including:
  • QA/QI
  • Research using decedent data, existing non-identifiable data or specimens, or public data (stem cell research or chimeras)

Anyone at Geisinger engaged in or considering research or another learning activity may request a consult at any time.

Advisory review: What to know

Unlike IRB and similar compliance reviews, this service is advisory only. Advice given isn’t a substitute for IRB, IACUC, or other required institutional review. And complying with said advice doesn’t guarantee later approval by these committees. Similarly, research ethics advice doesn’t constitute legal advice, even if regulations such as the Common Rule or HIPAA are discussed. Finally, the service isn’t designed to “pre-review” consent documents or protocols prior to IRB submission. The research ethics consultant collaborates directly with investigators and other personnel who have questions or concerns about consent, protocols or other research aspects. 

In some particularly complex cases, the IRB may request that an investigator obtain a consultation prior to initial IRB review, resubmission or continuing review. When a project implicates both research and clinical practice, the research ethics advice and consulting service may work jointly with the clinical ethics advice and consulting service to provide advice. Consultation requests, communication and meetings are kept confidential to the extent allowable by law.