Obtaining explicit consent for the use of archival tissue samples: practical issues

Area of Science:

• Medical research ethics
• Biobanking and tissue archiving

Background:

• Research ethics committees increasingly require explicit consent for archival tissue use.
• Current UK guidance on obtaining consent for archival tissue research is based on
• practicality,
• but lacks clear evidence or experience for ethics committees to assess this.

Purpose of the Study:

• To assess the practicality of obtaining general consent for the research use of surplus renal transplant biopsy tissue.
• To evaluate patient willingness for surplus tissue research use.

Main Methods:

• A study was conducted to obtain general consent for research use of surplus tissue from renal transplant biopsies.
• The study targeted the entire patient population of a renal transplant unit in Leicester.

Main Results:

• 495 letters were sent, and attempts were made to contact non-responders during outpatient clinic visits.
• After one year, the opinions of 26% of patients regarding consent for research use of their tissue remained unobtained.

Conclusions:

• The majority of patients are amenable to the use of surplus biopsy material for research.
• Mandatory explicit consent for archival tissue research can significantly delay or obstruct research, potentially harming patient interests and public good.
• The challenge in the UK has shifted from preventing unauthorized tissue use to preventing authorized tissue use due to consent requirements.