Simplifying informed consent for biorepositories: stakeholder perspectives.
OBJECTIVE
Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository.


METHODS
We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important.


RESULTS
On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage.


CONCLUSIONS
The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.
Beskow
Laura M
LM
Center for Genome Ethics, Law & Policy, Duke Institute for Genome Sciences & Policy, Duke University, Durham, North Carolina 27708, USA. laura.beskow@duke.edu
Friedman
Joëlle Y
JY
Hardy
N Chantelle
NC
Lin
Li
L
Weinfurt
Kevin P
KP
D000328:Adult; D018070:Biological Specimen Banks; D002986:Clinical Trials as Topic; D032962:Consent Forms / Q000592:standards*; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D018907:Privacy