Research Ethics Advice and Consulting Service
This free service provides Geisinger investigators, program managers, and other members of the research community with timely consultation on ethical issues in the design and conduct of research (including but not limited to research involving human participants).
Research ethics consultation is a relatively new service increasingly available at major academic medical centers and other research institutions. It can be valuable in the following scenarios:
- Advice on ethical issues in the design and conduct of research (e.g., recruitment, participant selection and incentives, consent, study design, return of primary or additional results) prior to IRB review (it can save time if ethical issues are identified and a considered plan to address them is proposed prior to IRB protocol submission)
- Advice on ethical issues involving human subjects research that may fall outside the mandate of the IRB (e.g., data sharing, publication ethics, responsible communication of results, concerns about risks of the research to non-participants such as stigmatization, conflicts of interest)
- Advice regarding activities that are not subject to, or are exempt from, IRB or other formal review (e.g., QA/QI; research using decedent data, existing non-identifiable data or specimens, or public data; stem cell research; chimeras)
Unlike IRB and similar compliance reviews, this service is advisory only. Advice given does not in any way substitute for IRB, IACUC, or other required institutional review, nor does complying with said advice guarantee later approval by these committees. Similarly, research ethics advice does not constitute legal advice, even if regulations such as the Common Rule or HIPAA are discussed. Finally, the service is not designed to “pre-review” consent documents or protocols prior to IRB submission; rather, the research ethics consultant works directly and collaboratively with investigators and other personnel who have particular questions or concerns about consent, protocols, or other aspects of research.
Anyone at Geisinger who is engaged in or considering research or other learning activity may request a consult at any time. 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 in providing advice. Consultation requests, communication, and meetings are kept confidential to the extent allowable by law.