ISBER Working Groups

Informed Consent Procedures for the Collection of Biospecimens
Organizer: Scott Jewell

There is a wave of interest throughout the research medical centers around the world to develop biospecimen banks to represent all patients that enter a hospital system. There is clear direction that most governments require patients to be consented or at least attempts to consent are conducted to fulfill this endeavor. Because biospecimen bank personnel are integrally involved in the understanding and possibly the process to consent patients for the donation of biospecimens to research, it would be helpful to establish the most commonly used methods and the respective justifications for the processes. Some example questions include; when is it most appropriate to consent patients for the gifting/donation of biospecimens to research? For tissues should this happen during a clinic visit (first, second), pre-surgery, or post-surgery. What methods of educating and informing the patient are commonly used? What are the ethical issues surrounding the choices and justifications? Many approaches to informed consent are being used and if multiple methods could be used to maximize the process of consenting all patients a greater success rate would result. ISBER is a broad body of specialist who could help further define and harmonize these procedures.


Issues
• Which institutions provide a "front door" consent to patients for the donation of biospecimens to a general research use or a specific designated research use. What were the ethical arguments used? Which institutions have decided not to allow this activity, why?
• For institutions that gather informed consent for any collection of biospecimens, when is the consent administered, by whom, why or why not, i.e., methods used to educate patients, and instructions when not to consent a patient? This data should be categorized by the biospecimen use consent types (general use and specific use).
• Would a survey tool for ISBER members and their institutions be a good approach to gathering this data?

Outcomes
A white paper to help guide institutions on procedures for informed consent for biospecimens could result form this analysis and a more refined guideline in the ISBER Best Practices could be published.





 

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