Big Health Data Research and Group Harm: The Scope of IRB Review

Big Health Data Research and Group Harm: The Scope of IRB Review
Megan Doerr, Sara Meeder
Ethics & Human Research, 8 July 2022; 44(4) pp 34-38
Open Access
Abstract
Much of precision medicine is driven by big health data research—the analysis of massive datasets representing the complex web of genetic, behavioral, environmental, and other factors that impact human well-being. There are some who point to the Common Rule, the regulation governing federally funded human subjects research, as a regulatory panacea for all types of big health data research. But how well does the Common Rule fit the regulatory needs of this type of research? This article suggests that harms that may arise from artificial intelligence and machine-learning technologies used in big health data research—and the increased likelihood that this research will affect public policy—mean it is time to consider whether the current human research regulations prohibit comprehensive, ethical review of big health data research that may result in group harm.

Biobanking and consenting to research: a qualitative thematic analysis of young people’s perspectives

Biobanking and consenting to research: a qualitative thematic analysis of young people’s perspectives
Fabian van der Velden, Lily Gills, Jasmin Broadey, Louise Hayes, Eve Roberts, Jack Courtney, Joanne Ball, Marieke Emonts, Emma Lim
BMJ Archives of Disease in Childhood, 17 August 2022
Abstract
Aims
Biobanking biological samples and consenting patients are common practice in paediatric infectious diseases research. We aimed to gain insight into young people’s knowledge, views and perspectives around current practices of biobanking and consent, in order to improve consent procedures.
Methods
We designed a structured electronic survey aimed at children and young people (CYP), 11-21 years of age, collecting demographic data, and views on biobanking and consent using four scenarios: 1) prospective consent, 2) deferred consent, 3) reconsent and assent age, and 4) animal studies. The survey was disseminated via Young Person’s Advisory Group North England (YPAGne) and other YPAGs social media channels and to the secondary schools of participating young people in this project. Data were analysed utilising a qualitative thematic approach by three independent data reviewers and common themes identified. Triangulation of data by a 4th reviewer occurred independently. Data were collected in two time waves. The second wave ensured data saturation.
Results
102 CYP completed the survey. All were ≥11 years old, the majority between 16-18 years (63.7%, n=65), female (66.7%, n=68), and from North East England and Cumbria (82.4%, n=84). 73 had no prior knowledge of biobanking (72.3%). Prospective consent acceptability for biobanking was high (91.2%, n=93), with main themes being ‘altruism’ and ‘potential benefits outweigh individual risks’. Main themes against were ‘increased risk of complications’ and ‘needle phobia’. Deferred consent acceptability was lower (84.3%, n= 86), common themes were: ‘altruism’, ‘body integrity’, and ‘sample frugality’. Participants state that prospective consent is preferable, but not always appropriate given the clinical situation. Communication is key and it is important to state why deferred consent is needed, and participation can still be declined. Those opposing deferred consent state it violated their integrity and takes away their control over their own body. Reconsent once children reach the age of informed assent was preferred by 76.5% of CYP (n=78), the majority stating an age >14 years as appropriate. 79.2% would want to be informed if their biobanked sample is used in future research (n=80). Just over half agrees with samples being used for animal testing (54.5%, n=55), which goes up to 80.2% (n=81) if explained as the last necessary step prior to human testing for medical research.
Conclusion
Acceptability of prospective and deferred consent for biobanking is high among CYP, with ‘altruism’, ‘frugality’ and ‘body integrity’ as important themes. Justification and clear communication are paramount and assent should be obtained from any CYP with capacity. CYP should be part of the consenting procedure, not just their parent/legal guardian.

Biobanks in the low-and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements—a qualitative study involving biobank managers

Biobanks in the low-and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements—a qualitative study involving biobank managers
Research
Ahmed Samir Abdelhafiz, Mamoun Ahram, Maha Emad Ibrahim, Alya Elgamri, Ehsan Gamel, Rania Labib, Henry Silverman
BMC Medical Ethics volume, 14 August 2022; 23(83)
Open Access
Abstract
Background
Biobanks have recently been established in several low-and middle-income countries (LMICs) in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks.
Methods
In-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt (6), Jordan (1), and Sudan (1). Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45–75 min. After verbal consent, interviews were recorded and then transcribed. The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process.
Results
Biobank managers discussed the main challenges in establishing their biobanks. These included the staff’s lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders.
Conclusion
Managers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust.

Biological sample donation and informed consent for neurobiobanking: Evidence from a community survey in Ghana and Nigeria

Biological sample donation and informed consent for neurobiobanking: Evidence from a community survey in Ghana and Nigeria
Research Article
Arti Singh, Oyedunni Arulogun, Joshua Akinyemi, Michelle Nichols, Benedict Calys-Tagoe, Babatunde Ojebuyi, Carolyn Jenkins, Reginald Obiako, Albert Akpalu, Fred Sarfo, Kolawole Wahab, Adeniyi Sunday, Lukman F. Owolabi, Muyiwa Adigun, Ibukun Afolami, Olorunyomi Olorunsogbon, Mayowa Ogunronbi, Ezinne Sylvia Melikam, Ruth Laryea, Shadrack Asibey, Wisdom Oguike, Lois Melikam, Abdullateef Sule, Musibau A. Titiloye, Isah Suleiman Yahaya, Abiodun Bello, Rajesh N. Kalaria,Ayodele Jegede,  Mayowa Owolabi, Bruce Ovbiagele, Rufus Akinyemi
PLOS One, 11 August 2022
Open Access
Abstract
Introduction
Genomic research and neurobiobanking are expanding globally. Empirical evidence on the level of awareness and willingness to donate/share biological samples towards the expansion of neurobiobanking in sub-Saharan Africa is lacking.
Aims
To ascertain the awareness, perspectives and predictors regarding biological sample donation, sharing and informed consent preferences among community members in Ghana and Nigeria.
Methods
A questionnaire cross-sectional survey was conducted among randomly selected community members from seven communities in Ghana and Nigeria.
Results
Of the 1015 respondents with mean age 39.3 years (SD 19.5), about a third had heard of blood donation (37.2%, M: 42.4%, F: 32.0%, p = 0.001) and a quarter were aware of blood sample storage for research (24.5%; M: 29.7%, F: 19.4%, p = 0.151). Two out of ten were willing to donate brain after death (18.8%, M: 22.6%, F: 15.0%, p<0.001). Main reasons for unwillingness to donate brain were; to go back to God complete (46.6%) and lack of knowledge related to brain donation (32.7%). Only a third of the participants were aware of informed consent (31.7%; M: 35.9%, F: 27.5%, p<0.001). Predictors of positive attitude towards biobanking and informed consent were being married, tertiary level education, student status, and belonging to select ethnic groups.
Conclusion
There is a greater need for research attention in the area of brain banking and informed consent. Improved context-sensitive public education on neurobiobanking and informed consent, in line with the sociocultural diversities, is recommended within the African sub region.

Perspectives from a Predominantly African American Community about Biobank Research and a Biobank Consent Form

Perspectives from a Predominantly African American Community about Biobank Research and a Biobank Consent Form
Laura K. Sedig, E. Hill De Loney, Sarah B. Bailey, Kayte Spector-Bagdady, Bianca Ghita, Lydia Koh Krienke, Raymond Hutchinson
Ethics & Human Research, 8 July 2022; 44(4) pp 26-33
Abstract
Minority populations have been underrepresented in clinical trials, as well as in research biobanks that are created to conduct research with participants’ biospecimens and related medical and research data. Biobank research raises issues about informed consent and privacy and the confidentiality of participants’ personal data. Our study involved three focus groups of 10 adults each that were conducted in a medically underserved, predominantly African American community to elucidate questions and concerns regarding an institutional biobank. Transcripts from the discussion were qualitatively analyzed. Three main themes that arose from the focus groups included the importance of trust, the importance of the community in research, and suggestions to improve trust. The concerns identified in this study provide a starting point for future research to help research institutions become more trustworthy to the communities they serve.

Valid informed consent and decision-making capacity in clinical trials

Valid informed consent and decision-making capacity in clinical trials
Discussion
Vittoria Sorice, Louise Burton, Amy Neal, Jodie Bradder
Nursing Times, 1 August 2022; 118(8)
Abstract
There are ethical and legal requirements involved in the consent process for research involving human participants. The Mental Capacity Act 2005 introduced a framework outlining how choices should be made by, and on behalf of, people lacking decision-making capacity. This ensures vulnerable groups are protected from being enrolled into clinical studies without their informed consent, and gives people access to studies that are of benefit to themselves and the field of clinical research.

Promoting the Values for Surrogate Decision-making

Promoting the Values for Surrogate Decision-making
Viewpoint
David Wendler
JAMA, 23 June 2022; 328(3) pp 243-244
Excerpt
The process of making medical decisions used to be straightforward. Clinicians selected the treatment course they determined would best promote the patient’s interests. More recently, in response to increased emphasis on individual autonomy, it is the patient, in consultation with their clinicians and loved ones, who makes medical decisions. This approach respects patients who are able to make their own treatment decisions. However, it poses a challenge for the many adult patients who are unable to understand the information relevant to the decision in question, reason in light of this information and their own values, make a voluntary decision on this basis, or communicate their decision…

Inclusion of older adults and reporting of consent processes in randomized controlled trials in the emergency department: A scoping review

Inclusion of older adults and reporting of consent processes in randomized controlled trials in the emergency department: A scoping review
Lauren T Southerland, Katherine K. Benson, Austin J. Schoeffler, Margaret A. Lashutka, Soo Borson, Jason J. Bischof
Journal of the American College of Emergency Physicians Open, May 2022
Open Access
Abstract
Objective
Conducting research in the emergency department (ED) is often complicated by patients’ acute and chronic illnesses, which can adversely affect cognition and subsequently capacity to consent for research, especially in older adults. Validated screening tools to assess capacity to consent for research exist, but neither the frequency of use nor which ones are used for ED research are known.
Methods
We conducted a scoping review using standard review techniques. Inclusion criteria included (1) randomized controlled trials (RCTs) from publication years 2014–2019 that (2) enrolled participants only in the ED, (3) included patients aged 65+ years, and (4) were fully published in English. Articles were sourced from Embase and screened using Covidence.
Results
From 3130 search results, 269 studies passed title/abstract and full text screening. Average of the mean or median ages was 55.7 years (SD 14.2). The mean number of study participants was 311.9 [range 8–10,807 participants]. A few (n = 13, 4.8%) waived or had exception from informed consent. Of the 256 studies requiring consent, a fourth (26.5%, n = 68) specifically excluded patients due to impaired capacity to consent. Only 11 (4.3%) documented a formal capacity screening tool and only 13 (5.1%) reported consent by legally authorized representative (LAR).
Conclusions
Most RCTs enrolling older adults in EDs did not report assessment of capacity to consent or use of LARs. This snapshot of informed consent procedures is potentially concerning and suggests that either research consent processes for older patients and/or reporting of consent processes require improvement.

Developmental Stages and Patient Assent for Research Studies or Medical Treatment

Developmental Stages and Patient Assent for Research Studies or Medical Treatment
Rachel Y. Moo
American Academy of Pediatrics Journal Blogs, 17 August 2022
Excerpt
    As a pediatrician and a clinical researcher, I am well aware of the requirements of when we need to obtain parental consent, and when a child needs to assent, meaning the child needs to agree.

In general, we talk about child assent for clinical studies, but there are times when medical treatment and enrollment in a clinical study are one and the same. For instance, most children with cancer are automatically enrolled in a clinical study, because we are still learning the best way to treat many of these cancers. And many children with cancer are alive today because of those before them who entered into these studies.

But what does it mean to get assent from a child?

This week, Pediatrics is early releasing a Pediatrics Perspectives by Gianna McMillan, a parent and bioethicist at Loyola Marymount University, entitled “The Parent’s Dilemma: Pediatric Assent in Research”.

Dr. McMillan helps us understand that assent means different things at different developmental stages. At some stages, the parent should make the decision, with or without the child’s input (again, depending on the child’s developmental stage). As the child becomes more developmentally mature, it may become appropriate for the child to make the decision, with parental agreement…

The Parent’s Dilemma: Pediatric Assent in Research

The Parent’s Dilemma: Pediatric Assent in Research
Gianna McMillan
Pediatrics Perspectives, 17 August 2022
Excerpt
Parents and their children rarely understand what it means “to consent” to participate in pediatric clinical research. This became clear during my 15 years as a patient advocate, when I facilitated hundreds of conversations about the implications of aggressive treatment of the very young and the existential crises faced by parents who made life-or death decisions for their children. In the United States, most children with cancer enter a clinical trial,1 and although parents understand enough of the scientific information to deliberate on the pros and cons of research, it is harder to grasp the subtleties of “consenting for” experimental studies, “giving permission to” the investigators, or “gaining assent from” the child. This lack of clarity leaves parents confused about the ethical weight and propriety of their decisions or unaware of any ethical significance at all…