Developing model biobanking consent language: what matters to prospective participants?

Developing model biobanking consent language: what matters to prospective participants?
Research Article
Laura M. Beskow, Catherine M. Hammack-Aviran, Kathleen M. Brelsford
BMC Medical Research Methodology, 15 May 2020; 20(119)
Open Access
Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to participate. At the same time, advances in large-scale genomic research have expanded both the opportunities and the risks for participants, families, and communities. To advance the use of effective consent materials that reflect this landscape, we used empirical data to develop model consent language, as well as brief questions to assist people in thinking about their own values relative to participation.
We conducted in-person interviews to gather preliminary input on these materials from a diverse sample (n = 32) of the general population in Nashville, Tennessee. We asked them to highlight information they found especially reassuring or concerning, their hypothetical willingness to participate, and their opinions about the values questions.
Consent information most often highlighted as reassuring included the purpose of the biobank, the existence and composition of a multidisciplinary oversight committee, the importance of participants’ privacy and efforts to protect it, and controlled access to a scientific database. Information most often highlighted as concerning included the deposition of data in a publicly accessible database, the risk of unintended access to data, the potential for non-research use of data, and use of medical record information in general. Seventy-five percent of participants indicated initial willingness to participate in the hypothetical biobank; this decreased to 66% as participants more closely considered the information over the course of the interview. A large majority rated the values questions as helpful.
These results are consistent with other research on public perspectives on biobanking and genomic cohort studies, suggesting that our model language effectively captures commonly expressed reasons for and against participation. Our study enriches this literature by connecting specific consent form disclosures with qualitative data regarding what participants found especially reassuring or concerning and why. Interventions that facilitate individuals’ closer engagement with consent information may result in participation decisions more closely aligned with their values.

Assessing the stability of biobank donor preferences regarding sample use: evidence supporting the value of dynamic consent

Assessing the stability of biobank donor preferences regarding sample use: evidence supporting the value of dynamic consent
Joel E. Pacyna, Jennifer B. McCormick, Janet E. Olson, Erin M. Winkler, Josh T. Bublitz, Matthew A. Hathcock & Richard R. Sharp
European Journal of Human Genetics, 23 April 2020
Dynamic consent has been proposed as a strategy for addressing the limitations of traditional, broad consent for biobank participation. Although the argument for dynamic consent has been made on theoretical grounds, empirical studies evaluating the potential utility of dynamic consent are needed to enhance deliberations about the merits of dynamic consent. Few studies have assessed such considerations as whether donor preferences may change over time or if participants would use a dynamic consent mechanism to modify preferences when they change. We administered a 66-item survey to participants in a large DNA biobank. The survey sought to gauge the stability of donor preferences specified at the time of biobank enrollment, specifically the stability of donors’ preference regarding posthumous availability of biospecimens to next-of-kin. We received 1164 completed surveys for a response rate of 72%. Forty percent of respondents indicated a preference regarding sample availability on the survey (T2) that was inconsistent with the preference they had expressed when they enrolled in the biobank (T1). Most (94%) individuals with inconsistent preferences regarding sample availability had initially restricted sample availability at T1 but were comfortable with broader availability when asked at the time of the survey (T2). Our findings demonstrate that preferences regarding sample use expressed at the time of enrollment in a DNA biobank may not be reliable indicators of donor preferences over time. These findings lend empirical support to the case for a dynamic consent model in which biobank participants are approached over time to clarify their views regarding sample use.

From Subjective To Objective Informed Consent In Healthcare : Biobanks In Focus [CONFERENCE PAPER]

From Subjective To Objective Informed Consent In Healthcare : Biobanks In Focus [CONFERENCE PAPER]
Syeda Amna Sohail, Faiza Allah Bukhsh
Alice & Eve 2020: Celebration of Women in Computer Science – University of Twente, 24 January 2020 – 24 January 2020; Enschede, Netherlands
Healthcare data has long been handled as per the national\local legislative and organizational prerequisites of the healthcare providers across the EU. This inculcates that the healthcare providers goals/objectives substantially dictated the data handling paths of the patients. Where the former could be starkly different from that of the patients/data subjects. Recently, healthcare stakeholders, for patients optimal value care, embedded the idea of Informed Consent (IC) at the onset of data collection. To transform the former, subjective way of data handling by healthcare providers into an objective pan European data handling procedure, the EU introduced General Data Protection Regulation, GDPR. Post GDPR, the EU legitimized patients IC as an integral part at the onset of patients information value care. Now IC, entails patients explicit, well informed , specific, free choice for his/her healthcare data collection and processing, demonstrated in an easily accessible and understandable manner with patients having the right of erasure at any point of data processing (GDPR, article 7). This poses limitations, specifically against scientific research, when applied in biobanks and bio-repositories. Limitations range from Biobanks data collection to data anonymization or/and pseudonymization to the data storage and sharing. In each phase of data handling, the issues and their respective solutions are discussed. Solution lies in defining the public/vital and legitimate interests and in incorporating the broad-open ended informed consent. This is vital for better health outcomes of the patients and the society at large. Regulatory and legislative authorities at the EU and national level must unite to resolve these issues.

Relationships of health information orientation and cancer history on preferences for consent and control over biospecimens in a biobank: A race‐stratified analysis

Relationships of health information orientation and cancer history on preferences for consent and control over biospecimens in a biobank: A race‐stratified analysis
Soo Jung Hong, Bettina Drake, Melody Goodman, Kimberly A. Kaphingst
Journal of Genetic Counselling, 28 January 2020
In this study, we investigated how patients’ self‐reported health information efficacy, relationship with health providers, and cancer history are associated with their preferences for informed consent and need for control over biobank biospecimens. We recruited 358 women aged 40 and older (56% African American; 44% European American) and analyzed the data using multivariable regression models. Results show that African American participants’ health information efficacy was significantly and negatively associated with their need for control over biospecimens and preference for a study‐specific model. European American participants’ dependency on doctors was a significant and negative predictor of their preference for a study‐specific model. Several significant interaction effects, which varied across races, were found with regard to health information efficacy, personal cancer history, need for control, and preference for a study‐specific model. The study findings suggest it is important to consider health information efficacy, relationship with providers, and need for control when developing large diverse biobanks.

Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic

Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic
Stephanie E. Soares, Nicholas R. Anderson, Leslie J. Solis, Javier E. López
Biopreservation and Biobanking, 26 December 2019
Informed consent for research biospecimen donations is traditionally obtained through a face-to-face interaction with research staff and by signing an Institutional Review Board (IRB)-approved printed form. Electronic signatures (eSign) are routinely used in the electronic medical record (EMR) for the consenting of clinical services after patients review printed documentation. Our goal was to develop an electronic self-consenting workflow that mimicked clinical services. Specifically, we tested a research consent process for the biobanking of remnant clinical samples that relies solely on clinical resources in a busy outpatient practice.
Materials and Methods
The Biorepositories Core Resource (BCR) unit initiated a new enterprise-wide biobanking infrastructure for consenting patients, termed Biospecimen Use for Research-Related Investigations and Translational Objectives (BURRITO). BURRITO is modeled after an established clinical process called Terms and Conditions of Service (TACOS). The TACOS requires patients to annually review printed documentation and self-consent electronically for clinical services. BURRITO also requires patients to review printed documentation and self-consent with eSign to opt-in for remnant biospecimen banking, but patients must complete this process only once. We captured eSign for consents directly into the EMR without research staff.
Patients reviewed the IRB-approved documents and self-consented during their cardiology clinic visit. At checkout, their participation preferences were electronically documented by clinic staff. During a 6-month period, 123 patients agreed to donate. After a review of process, a second 3-month period identified 202 patients agreeing to donate. BURRITO did not require face-to-face interactions with research staff, used a “no-paper” eSign for consent, and created discrete fields in the clinical EMR of the patient’s preference.
BURRITO electronically documents informed consent using an EMR functionality and the least amount of clinical and research resources. Our results show promise for developing institutionally adopted processes, which could leverage existing clinical workflows for universal research consenting and scalability.

Jordanians’ Perspectives On Open Consent In Biomedical Research

Jordanians’ Perspectives On Open Consent In Biomedical Research
Original Research
Nasr Alrabadi, Hanin Makhlouf, Omar F Khabour, Karem H Alzoubi
Risk Management and Healthcare Policy, 2 December 2019; 2019(12) pp 265—273
The informed consent process is an integral step in biomedical research. However, the emergence of biobanks and the need for open consent (also called “broad” or “blanket” consent) create challenges to this process.
Aims and methodology
A survey was used to examine Jordanians’ perspectives on open consent and reuse of stored samples in future research.
The majority of participants had positive perceptions of informed consent and its importance. In addition, they appreciated the challenges that are associated with multiple uses of their biospecimens. About 55% agreed to provide open consent for reuse of their donated biospecimens. Participants (75–80%) also agreed that issues such as the possibility of sharing samples with international research centers, storage duration, and use of biospecimens after their death should be clarified as part of open consent. The inconvenience of the re-contact process, trust in the research team, and the importance of biobanks were all associated with participants’ willingness to provide open consent (P<0.05). On the other hand, privacy and confidentiality, doubt about future use of samples, unknown storage period, and the possibility of cross-border sample sharing were significantly associated with participants’ reluctance to provide open consent.
The majority of Jordanians accept the idea of open consent. Clarification of issues such as international sample sharing, duration of storage, domains of intended research, confidentiality, and privacy can provide more support for the use of open consent.


Dynamic Consent: An Evaluation and Reporting Framework

Dynamic Consent: An Evaluation and Reporting Framework
Research Article
Megan Prictor, Megan A. Lewis, Ainsley J. Newson, Matilda Haas, Sachiko Baba, Hannah Kim, Minori Kokado, Jusaku Minari, Fruzsina Molnár-Gábor, Beverley Yamamoto, Jane Kaye, Harriet J. A. Teare
Journal of Empirical Research of Human Research Ethics, 15 November 2019
Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher–participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.


Broad consent for biobanks is best – provided it is also deep

Broad consent for biobanks is best – provided it is also deep
Rasmus Bjerregaard Mikkelsen, Mickey Gjerris, Gunhild Waldemar, Peter Sandøe
BMC Medical Ethics, 15 October 2019; volume 20(71) 
Open Access
As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent.
Main text
In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication.
We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.

Biobanks in the Era of Genomic Data

Biobanks in the Era of Genomic Data
Juliann Savatt, Cassandra J. Pisieczko, Yanfei Zhang, Ming Ta Michael Lee, W. Andrew Faucett, Janet L. Williams
Current Genetic Medicine Reports, 30 August 2019 7(3) pp 153-161
Purpose of Review
Biobank research brings together participants, their samples and data, and researchers to provide a productive and efficient resource that advances discovery, prevention, diagnosis, and treatment. This mini-review addresses the importance of governance issues regarding consent, privacy and confidentiality, data sharing, and return of results in biobanks that utilize genomic sequencing data.
Recent Findings
With the availability of genomic sequencing data, there is renewed attention to the value of biobank research. Governance components of consent, data sharing, privacy protections, and disclosure of research results vary widely among biobanks currently established. There is no consensus standard of best practice for managing genomic data regardless of the biobank infrastructure.
Understanding the various biobank research program components will aid genetics providers and other healthcare providers as they interact with biobank researchers and participants. Governance structures for biobanks will need to be informed by the engagement of participants, researchers, and regulatory agencies. Education concerning the importance of biobank research, transparency of governance structure, and the relationship of genomic data to the improvement of individual health is critical to support continued biobank research.

Researchers’ Perspectives on Informed Consent and Ethical Review of Biobank Research in South Africa: A Cross-Sectional Study

Researchers’ Perspectives on Informed Consent and Ethical Review of Biobank Research in South Africa: A Cross-Sectional Study
Research Article 
Erisa Mwaka, Lyn Horn
Journal of Empirical Research on Human Research Ethics, 5 August 2019  
There is limited literature on the opinions and perspectives of researchers on the ethical issues in biobank research in South Africa. This study aimed to explore researchers’ perspectives on informed consent and ethical review of biobank research in South Africa. An online survey was conducted among researchers and scientists at Stellenbosch University and the University of Kwazulu-Natal. The majority of researchers opined that broad consent is appropriate for biobank research. However, there was no consensus on the necessity for re-consent. Researchers were also in agreement that issues concerning informed consent and future use of samples require thorough discussions during the ethical review process. Overall, the attitude of researchers on informed consent and ethical review of biobank research was positive and ethically informed.