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
Abstract
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.
Month: May 2020
Approaches for assessing decision-making capacity in older adults a scoping review protocol
Approaches for assessing decision-making capacity in older adults a scoping review protocol
Systematic Review Protocols
Ruth Usher, Tadhg Stapleton
JBI Evidence Synthesis, April 2020; 18(4) pp 832-840
Open Access
Abstract
Objective
This review will identify and map existing evidence on current approaches to determining decision-making capacity in older adults. It will provide a summary of available evidence and policies and identify gaps in research.
Introduction
Assessment of decision-making capacity is emerging as an important issue in society and healthcare. It is considered an ethically challenging area of clinical practice, and issues with implementation have been identified internationally. With the aging population increasing globally, approaches to assess and support decision-making are becoming more pertinent.
Inclusion criteria
This scoping review will consider studies on assessment approaches and procedures that are used to evaluate the decision-making capacity of older adults, aged 60 years and over. It will include those with age-related cognitive impairment, dementia, and neurodegenerative conditions. Quantitative, qualitative, and mixed-methods studies along with gray literature, including expert opinions, policies reports, and practice guides, will be included.
Methods
The JBI scoping review methodological framework will be used. The review will also be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist for scoping reviews. The following major healthcare databases will be searched: MEDLINE, PsycINFO, Embase, CINAHL, Cochrane Databases, Web of Science, and Scopus. The search will cover studies published in English from January 2000 to the present date. Titles and abstracts will be screened against inclusion criteria. Data will be extracted using a form developed for this review. A stakeholder consultation meeting will be held to provide feedback on the findings.
Ageism in Consent? In a decision-making capable geriatric orthopaedic trauma patient population, does increased age impact who physicians consent for surgical fixation?
Ageism in Consent? In a decision-making capable geriatric orthopaedic trauma patient population, does increased age impact who physicians consent for surgical fixation?
Madeline M McGovern, Michael F McTague, Marilyn Heng
Jefferson Digital Commons, January 2020
Open Access
Abstract
Introduction
Persistent misconceptions of frailty and dementia in geriatric patients impact physician-patient communication and leave patients vulnerable to disempowerment. Our study examines the consenting process in an orthogeriatric trauma patient population to determine if there is a relationship between increased age at presentation and utilization of health care proxies (HCPs) for surgical procedure consent.
Methods
We retrospectively reviewed medical records of patients aged 65 and older admitted for an operative fracture between 2013 and 2016. Patients were considered decision-making capable if there was absence of history of cognitive impairment prior to surgical consent and if the patients screened negative in a pre-surgical Confusion Assessment Method (CAM) and Mini-Cog Assessment. Data was analyzed via chi-squared and t-test analysis in SPSS.
Results
510 patients were included, and 276 (54.1%) patients were deemed capable of consent. 27 (9.8%) decision-making capable patients had HCPs consent for surgery. 20 of the 27 (74.1%) were 80 years of age or older and 7 patients between 70 and 79 had HCP consent. (p=0.07). HCP consent was significant for age (p<0.001), income level (p=0.03), and HCP physically present at consult (p<0.001). Additionally, language other than English was found to be a significant predictor of HCP consent (p=0.035).
Conclusion
It is concerning that cognitively intact geriatric orthopaedic trauma patients are not always consented for their own surgical procedures. Factors including age, income, and language contribute to increased risk of HCP consent. Increased physician vigilance and adoption of institutional consenting guidelines can reinforce appropriate respect of geriatric patients’ consenting capacity.
Editor’s note: The Jefferson Digital Commons is a service of Thomas Jefferson University’s Center for Teaching and Learning (CTL). The Commons is a showcase for Jefferson books and journals, peer-reviewed scholarly publications, unique historical collections from the University archives, and teaching tools.
Reflecting on three creative approaches to informed consent with children under six
Reflecting on three creative approaches to informed consent with children under six
Lorna Arnott, Loreain Martinez, Kate Wall, Caralyn Blaisdell, Ioanna Palaiologou
British Educational Research Journal, 10 March 2020
Abstract
In an era where children’s rights are paramount, there are still few practical examples to guide us when seeking informed consent from children. This paper therefore makes a significant contribution to the field by examining three practical approaches to negotiating informed consent with young children under 6 years old. We draw on researcher field notes, images and observations from four research projects that employed creative methods for seeking informed consent from young children. We take a reflexive approach, considering how successful the three techniques have been in facilitating young children’s decision making around research participation. Our findings suggest that innovative approaches to informed consent create spaces for children to engage in dialogue and questioning about the research project. However, in order for the approaches to be meaningful they need to be pedagogically-appropriate to the maturity and capabilities of the children. We also demonstrate that irrespective of the approach devised, researchers have a responsibility to ensure consent is continuously negotiated throughout the project through reflexive questioning.
Children’s ability to consent to medical management in South Africa
Children’s ability to consent to medical management in South Africa
J van Heerden, R Delport, M Kruger
South African Journal of Child Health, 23 April 2020; 14(1) pp 25-29
Open Access
Abstract
Background
The South African Children’s Act No. 38 of 2005 requires paediatric medical consent from 12 years of age
Objective
To determine children’s ability to provide informed consent for medical treatment.
Methods
Assessment used hypothetical treatment storyboards and structured interviews for assessment of 100 children (aged 10 -17 years), and 25 adult controls, using a tandardized scoring tool to test understanding, ability to deliberate treatment choices, and provide rational reasons. Statistical analysis involved multivariate analyses of variance (MANOVAs) and analysis of variance (ANOVA).
Results
The female:male ratios for children and adults were 1:0.92 and 1:0.98, respectively. Children ≥12 years were competent with regard to treatment choices (p<0.001), while 10-year-olds could deliberate reasonable outcomes, similar to adults (p<0.001). However, only children 12 years and older could provide rational reasons, where abstract concepts were not involved, whereas children who were ≥14 years old were able to provide rational reasons involving abstract concepts. The actual understanding of choices, compared with adults, was only observed in children older than 14 years (p<0.001). Gender was not a statistically significant denominator.
Conclusion
Children of 12 years and older are competent to make medical decisions, but the understanding of medical treatment choices under the age of 14 years is not clear.
A Survey of Current Practices of Informed Consent by Pediatric Anesthesiologists
A Survey of Current Practices of Informed Consent by Pediatric Anesthesiologists
Short Report
Allison M Fernandez, Scott C Watkins, David J Clendenin, Erik B Smith, Jenny E Dolan, Ernest Amankwah, Ali Jalali, Luis Ahumada, Anh Thy H Nguyen, Mohamed Rehman, Richard A Elliott
Pediatric Anesthesia, 22 April 2020
Abstract
Informed consent is fundamental to the ethical practice of medicine and carries important legal implications. Of particular relevance to pediatric anesthesia is the Food and Drug Administration’s Drug Safety Communication (DSC), which highlights potential yet theoretical adverse effects on brain development of repeated or prolonged anesthesia administration to children younger than 3 years of age.
Risk disclosure and informed consent: practice caveats in the post‐Montgomery era
Risk disclosure and informed consent: practice caveats in the post‐Montgomery era
Original Article
Danny WH Lee, Paul BS Lai
Surgical Practice, 1 April 2020
Abstract
The UK Supreme Court decision in Montgomery v Lanarkshire Health Board has overturned the use of the “accepted practice test” (Bolam) in deciding breach of duty cases related to risk disclosure and informed consent. Following Montgomery, a doctor is under a legal duty to take reasonable care to ensure his patient is aware of any material risks involved in the recommended treatment, and of any reasonable alternative or variant treatments. Based on Montgomery and a number of relevant published cases, this article highlighted some practice caveats for surgeons to take note of when they participate in the consent process with the following headings: the objective and subjective elements of the legal test of materiality of risks; postoperative risks, follow‐up and management; timing and adequacy of risk disclosure; withholding information and therapeutic exception; and the incorporation of Montgomery into local professional code and case law. In order to minimize legal risks, surgeons are also encouraged to keep abreast of the medico‐legal development in this area, to reflect on their own practices, and to take proactive steps to enhance their interactions with patients.
Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration
Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration
Grace Gartel, Heather Scuderi, Christine Servay
Ochsner Journal, March 2020; 20(1) pp 76–80
Open Access
Abstract
Background
The Common Rule, which governs federally funded clinical research involving human subjects, formally defines the requirements for institutional review board (IRB) membership, functions and operations, and review of research, as well as the requirements for obtaining informed consent from research participants. The revisions to the Common Rule effective in January 2019 changed some content requirements for informed consent forms.
Methods
This article summarizes the history of informed consent requirements, the changes made to the requirements by the revision to the Common Rule, and the ways in which IRBs and research staff work together to develop informed consent forms that comply with the regulations and provide all the information potential research subjects need to decide whether to participate in a study.
Results
Clinical research coordinators, under their investigators’ supervision, are responsible for ensuring that research consent forms comply with the requirements of the federal regulations and the institution. Many IRBs have provided education regarding these new requirements, as well as consent templates that contain all the required elements. To ensure that the Common Rule’s requirements are met, the IRB reviews each study submission, including the consent form. The IRB panel makes revisions to the consent forms as needed and returns the approved consent form to the investigator and clinical research coordinator.
Conclusion
Research coordinators play an essential role in developing consent forms and providing the required review information to the IRB. In turn, through optimizing and standardizing consent forms and ensuring that all requirements of the Common Rule are followed, IRBs ensure that the rights of participants are protected and upheld.
Editor’s note: The Ochsner Journal is a peer-reviewed quarterly medical journal.
Revised Common Rule Changes to the Consent Process and Consent Form
Revised Common Rule Changes to the Consent Process and Consent Form
Leah L LeCompte, Sylvia J Young
Ochsner Journal, March 2020; 20(1) pp 62-75
Open Access
Abstract
Background
The Federal Policy for the Protection of Human Subjects—the Common Rule—was revised in 2017 to reduce administrative burdens for low-risk research while enhancing protections for human subjects enrolled in greater-than-minimal-risk trials. These enhanced protections involve changes to the consent process.
Methods
We review the general requirements applicable to the consent process, as well as the additional elements of consent mandated by the revisions to the Common Rule. The regulations apply to federally funded studies and are optional for non–federally funded studies.
Results
Two new general requirements for the consent process, one basic required element for the consent form, and three optional additional elements for the consent form were added in an effort to improve potential subjects’ understanding of research studies and to facilitate the exchange of information between the research staff and potential subjects. Important information about the study should be extracted into a concise key information section to help potential subjects make informed decisions regarding participation.
Conclusion
The revisions to the Common Rule are intended to enhance human subject protection by providing more information in an understandable form during the consent process. The new consent elements aim to increase transparency and help improve clarity.
Understanding Broad Consent
Understanding Broad Consent
John W Maloy, Pat F Bass III
Ochsner Journal, March 2020; 20(1) pp 81–86
Open Access
Abstract
Background
The 2018 revisions to the Common Rule that were effective in January 2019 introduced a new category of informed consent: broad consent.
Methods
Investigators and institutional review board (IRB) members need to understand (1) what broad consent is, (2) the role of broad consent under the revised Common Rule, (3) how and when broad consent can be used, (4) exempt research categories that relate to broad consent, and (5) the scope of limited IRB review as it relates to broad consent.
Results
Under the prior regulations, researchers had two consent options: obtain study-specific informed consent or request the IRB to waive the requirement to obtain informed consent. The revision to the Common Rule introduced the third option of broad consent, but its applicability is limited. Broad consent can only be used to obtain an individual’s consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. The regulatory authority for broad consent is at 45 CFR §46.116(d). None of the required elements of broad consent can be omitted or altered because each element is considered essential. Broad consent shares many of the requirements for study-specific informed consent, but several elements are unique: a description of the types of secondary research that may be conducted; statements describing the private information or biospecimens that might be used in research, whether sharing of the information or biospecimens might occur, and the types of institutions or researchers that might conduct research with the information or biospecimens; information on how long the information or biospecimens may be stored, maintained, and used; a statement that subjects will or will not be informed of the details of any subsequent research; a statement that research results will or will not be disclosed to subjects; and contact information for obtaining answers to questions about the subjects’ rights regarding storage and use of information or biospecimens and whom to contact regarding research-related harm.
Conclusion
Broad consent provides flexibility that did not exist prior to the revision, giving researchers the option to obtain broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. With an understanding of the regulations, an investigator can plan how best to organize his or her research plan and decide whether to obtain study-specific informed consent, to apply for a waiver of consent, or to obtain broad consent.
Center for Informed Consent Integrity 