Traditional and electronic informed consent for biobanking: a survey of U.S. biobanks.

Biobanks face unique challenges obtaining consent from biospecimen contributors. Electronic consent (e-consent) presents one option for streamlining the biobank consent process, and improving contributor understanding of consent information. An e-mail survey was conducted to establish the extent of current biobank e-consent and interest in future use of e-consent. A total of 235 biobanks were surveyed and 65 (28%) responded with a fully completed survey. Few of these 65 biobanks (8%) reported using e-consent; however, the majority (75%) were interested in e-consent. Many (48%) biobanks were in discussions with institutional stakeholders about using e-consent in the future. Anticipated benefits of e-consent included improved efficiency and increased enrollment. Perceived barriers to e-consent adoption included lack of funding, issues with human subjects approval, and factors affecting user uptake (e.g., computer literacy). Biobanks using e-consent reported cost, technology issues, and difficulty training staff as barriers to e-consent adoption. Traditional consenting methods (e.g., face-to-face, phone, and mail) continued to be used at biobanks reporting use of e-consent. The survey results suggest strong interest in e-consent among U.S. biobanks, and a need to consider a range of implementation issues, including user preferences and receptivity; institutional and technical support; integration with clinical data networks; electronic signature capture; and what type of e-consent to implement. Biobanks will need evidence-based guidance for purposes of addressing these issues, so that e-consent processes enhance efficiency, as well as contributor receptivity, understanding, and trust.

[1]  T. Delvaux,et al.  Ebola in Africa: beyond epidemics, reproductive health in crisis , 2014, The Lancet.

[2]  Jeffrey C Murray,et al.  Active choice but not too active: Public perspectives on biobank consent models , 2011, Genetics in Medicine.

[3]  Catherine A McCarty,et al.  Study newsletters, community and ethics advisory boards, and focus group discussions provide ongoing feedback for a large biobank , 2011, American journal of medical genetics. Part A.

[4]  F. Lawrenz,et al.  An empirical examination of the management of return of individual research results and incidental findings in genomic biobanks , 2012, Genetics in Medicine.

[5]  D. Winickoff,et al.  The charitable trust as a model for genomic biobanks. , 2003, The New England journal of medicine.

[6]  Amy K. Yarbrough,et al.  Technology Acceptance among Physicians , 2007, Medical care research and review : MCRR.

[7]  Jill M. Pulley,et al.  Attitudes and perceptions of patients towards methods of establishing a DNA biobank , 2008, Cell and Tissue Banking.

[8]  R. Holden.  Social and personal normative influences on healthcare professionals to use information technology: towards a more robust social ergonomics , 2012, Theoretical issues in ergonomics science.

[9]  Shahram Ahmadi Nasab Emran.  The four-principle formulation of common morality is at the core of bioethics mediation method , 2015, Medicine, health care, and philosophy.

[10]  S. Brink.  Making Informed Consent Work for All , 2006 .

[11]  B. McNamara,et al.  Reconsidering the Value of Consent in Biobank Research , 2011, Bioethics.

[12]  Anand K. Gramopadhye,et al.  An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting , 2013, Int. J. Medical Informatics.

[13]  L. Nisticò,et al.  Research understanding, attitude and awareness towards biobanking: a survey among Italian twin participants to a genetic epidemiological study , 2009, BMC medical ethics.

[14]  C. Compton,et al.  Biobankonomics: developing a sustainable business model approach for the formation of a human tissue biobank. , 2011, Journal of the National Cancer Institute. Monographs.

[15]  M. Boccia,et al.  The effect of format modifications and reading comprehension on recall of informed consent information by low-income parents: a comparison of print, video, and computer-based presentations. , 2004, Patient education and counseling.

[16]  Robert C. Green,et al.  Managing incidental findings and research results in genomic research involving biobanks and archived data sets , 2012, Genetics in Medicine.

[17]  M. Guyer,et al.  Charting a course for genomic medicine from base pairs to bedside , 2011, Nature.

[18]  E. Kodish,et al.  Laws that conflict with the ethics of medicine: What Should Doctors Do? , 2014, The Hastings Center report.

[19]  K. Ormond,et al.  The Views of Participants in DNA Biobanks , 2009 .

[20]  Fan-Yun Pai,et al.  Applying the Technology Acceptance Model to the introduction of healthcare information systems , 2011 .

[21]  L. Parker.  The Future of Incidental Findings: Should They Be Viewed as Benefits? , 2008, The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics.

[22]  Wendy A. Wolf,et al.  Assessing the understanding of biobank participants , 2009, American journal of medical genetics. Part A.

[23]  Wouter Duyck,et al.  Assessing Hospital Physicians' Acceptance of Clinical Information Systems: A Review of the Relevant Literature , 2013 .

[24]  Vincenzo Canzonieri,et al.  An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank , 2013, BMC medical ethics.

[25]  Laura Pritchard-Jones,et al.  Ageism and Autonomy in Health Care: Explorations Through a Relational Lens , 2017, Health Care Analysis.

[26]  Farid E Ahmed,et al.  Biobanking perspective on challenges in sample handling, collection, processing, storage, analysis and retrieval for genomics, transcriptomics and proteomics data , 2011 .

[27]  S. Cummings,et al.  Interactive Informed Consent: Randomized Comparison with Paper Consents , 2013, PloS one.

[28]  Michael P Caligiuri,et al.  Reformed consent: adapting to new media and research participant preferences. , 2009, IRB.

[29]  Aziz Sheikh,et al.  Organizational issues in the implementation and adoption of health information technology innovations: An interpretative review , 2013, Int. J. Medical Informatics.

[30]  G. Henderson,et al.  Neglected ethical issues in biobank management: Results from a U.S. study , 2013, Life Sciences, Society and Policy.

[31]  A. Sutin,et al.  Abandoning the dead donor rule? A national survey of public views on death and organ donation , 2014, Journal of Medical Ethics.

[32]  V. Dranseika,et al.  Child’s assent in research: Age threshold or personalisation? , 2014, BMC medical ethics.

[33]  D. Jeste,et al.  Comparison of two enhanced consent procedures for patients with mild Alzheimer disease or mild cognitive impairment. , 2007, The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry.

[34]  D. Jeste,et al.  Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. , 2002, The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry.

[35]  G. Henderson,et al.  Characterizing biobank organizations in the U.S.: results from a national survey , 2013, Genome Medicine.

[36]  Joseph M. Plasek,et al.  A rural community's involvement in the design and usability testing of a computer‐based informed consent process for the personalized medicine research project , 2014, American journal of medical genetics. Part A.

[37]  H. Llewellyn-Thomas,et al.  Presenting clinical trial information: a comparison of methods. , 1995, Patient education and counseling.

[38]  P. Myles,et al.  Improving communication when seeking informed consent: a randomised controlled study of a computer‐based method for providing information to prospective clinical trial participants , 2010, The Medical journal of Australia.

[39]  M. White,et al.  Developing ethical awareness in global health: four cases for medical educators. , 2014, Developing world bioethics.

[40]  M. Barr.  ‘I'm not Really Read up on Genetics’: Biobanks and the Social Context of Informed Consent , 2006 .

[41]  G. Geller,et al.  Public perspectives on informed consent for biobanking. , 2009, American journal of public health.

[42]  Laura M. Pfeifer,et al.  Using computer agents to explain medical documents to patients with low health literacy. , 2009, Patient education and counseling.

[43]  Adam A. Nishimura,et al.  Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials , 2013, BMC Medical Ethics.

[44]  B. Rapkin,et al.  Improving informed consent: a comparison of four consent tools. , 2003, IRB.

[45]  L. Ross,et al.  Empirical data about women's attitudes towards a hypothetical pediatric biobank , 2008, American journal of medical genetics. Part A.

[46]  K. Hoeyer,et al.  Motivating Donors to Genetic Research? Anthropological Reasons to Rethink the Role of Informed Consent , 2006, Medicine, health care, and philosophy.