Informed Consent for Biorepositories: Assessing Prospective Participants' Understanding and Opinions

Abstract

Purpose: Obtaining informed consent for the collection, storage, and future research use of biospecimens is challenging, as potentially complex and controversial information must be communicated clearly. We gathered input on a consent template developed for the Duke Biorepository from individuals representative of those who might one day consider contributing specimens. Methods: Forty subjects were recruited from the Durham, NC area and screened to achieve diversity by race/ethnicity, education, age, and sex. Cognitive interviews assessed participants' (a) understanding of information in the template, and (b) opinions about that information. Participants also completed a survey assessing trust in medical researchers. Results: Interviewees seemed to understand the template. Although responses were diverse, majority views emerged: more than half were comfortable with indefinite biospecimen storage, periodic contact to update information and to inform participants of additional research opportunities, the prospect that commercial products could be developed, and the fact that profits would not be shared. More than half were willing to provide medical record access, although this was a primary concern for others. More than two thirds were comfortable with not receiving individual research results as a matter of routine, but many thought they should be informed of findings with serious health implications. Lack of trust in researchers was associated with declining certain consent options. Conclusions: Protecting and promoting trust in research is essential to fostering widespread participation in biorepositories. Biorepositories should also devise ways to communicate clearly about the research being conducted and what is being learned. (Cancer Epidemiol Biomarkers Prev 2008;17(6):1440 -51)

The awareness and perception about the Ethical concerns related to the Biobanks among Medical and Dental practitioners- A questionnaire based study

“…i.e, limiting to oneself and not disclosing to others. [10][11][12][13][14] These findings were in agreement with the study done by Kaufman DJ 2009 and Hansson MG in 2011 15,16 which stated that the fundamental concern about privacy is usually also the main concern of the participants when they are deciding whether to donate their samples to Biobanks. Their study showed that up to 90% of people were concerned about their privacy Thus, concluded that consequences of breaking privacy could substantially affect public's willingness to participate and substantially delay the research.…”

Understanding of informed consent by parents of children enrolled in a genetic biobank

“…This supports previous studies of informed consent understanding for adults consenting to participate in research studies. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] However, our study is the first to measure actual and perceived understanding of informed consent for parents who gave permission for their children to participate in a biobanking study. More than half of the parents were uncertain or responded incorrectly to the main questions of the study, including those regarding the use and storage of samples and the handling of results from the study.…”

Researchers’ opinions towards the communication of results of biobank research: a survey study

“…13 Others also found participants to express a strong desire to be informed about research results. 14,[16][17][18] Once recruited by biobanks, participants will not always want the information they initially desired. Therefore, taking into account that participants may change their minds during the course of the study, assessing information preferences is an ongoing process.…”