Informed Consent: A Monthly Review

October 2019

This digest aggregates and distills key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation

David R. Curry
President & CEO
GE2P2 Global Foundation

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_October 2019

Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear

Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear
Jeffrey Peppercorn, Eric Campbell , Steve Isakoff, Nora K. Horick, Julia Rabin, Katharine Quain, Lecia V. Sequist, Aditya Bardia, Deborah Collyar, Fay Hlubocky, Debra Mathews
The Oncologist, 6 September 2019
Oncology research increasingly involves biospecimen collection and data sharing. Ethical challenges emerge when researchers seek to use archived biospecimens for purposes that were not well defined in the original informed consent document (ICD). We sought to inform ongoing policy debates by assessing patient views on these issues.
Materials and Methods
We administered a cross‐sectional self‐administered survey to patients with cancer at an academic medical center. Survey questions addressed attitudes toward cancer research, willingness to donate biospecimens, expectations regarding use of biospecimens, and preferences regarding specific ethical dilemmas.
Among 240 participants (response rate 69%), virtually all (94%) indicated willingness to donate tissue for research. Most participants (86%) expected that donated tissue would be used for any research deemed scientifically important, and virtually all (94%) expected that the privacy of their health information would be protected. Broad use of stored biospecimens and data sharing with other researchers increased willingness to donate tissue. For three scenarios in which specific consent for proposed biobank research was unclear within the ICD, a majority of patient’s favored allowing the research to proceed: 76% to study a different cancer, 88% to study both inherited (germline) and tumor specific (somatic) mutations, and 70% to permit data sharing. A substantial minority believed that research using stored biospecimens should only proceed with specific consent.
When debates arise over appropriate use of archived biospecimens, the interests of the research participants in seeing productive use of their blood or tissue should be considered, in addition to addressing concerns about potential risks and lack of specific consent.
Implications for Practice
This survey evaluated views of patients with cancer regarding the permissible use of stored biospecimens from cancer trials when modern scientific methods are not well described in the original informed consent document. The vast majority of patients support translational research and expect that any biospecimens they donate will be used to advance knowledge. When researchers, policy makers, and those charged with research oversight debate use of stored biospecimens, it is important to recognize that research participants have an interest in productive use of their blood, tissue, or data, in addition to considerations of risks and the adequacy of documented consent.

Editor’s note: The Oncologist is the official journal of the Society for Translational Oncology.            

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.

Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition

Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition
Research Article
Jane Paik Kim, Katie Ryan, Laura Weiss Roberts
Journal of Empirical Research on Human Research Ethics, 22 July 2019; 14(4)
In this study, participants with a self-reported history of depression, diabetes, or no illness underwent a simulated informed consent process for a hypothetical genetic study related to depression or diabetes. Participants completed a survey assessing their perceived understanding of the research process, perceptions of its risks and benefits, their satisfaction with the informed consent process, and their readiness to make a hypothetical enrollment decision. All participants indicated strong readiness to make an enrollment decision regarding the research characterized in the simulation. Participants reported understanding the consent process relatively well and being generally satisfied with it. Greater concerns were expressed regarding psychosocial risks than biological risks for genetic studies on mental disorders. Our study documented positive attitudes toward volunteering for research that involved the collection of genetic data.

Overvaluing individual consent ignores risks to tribal participants

Overvaluing individual consent ignores risks to tribal participants
Krystal S. Tsosie, Joseph M. Yracheta, Donna Dickenson
Nature Reviews Genetics, 15 July 2019;  20 pp 497–498 
Genomic studies often rely on individual-based consent approaches for tribal members residing outside of their communities. This consent model fails to acknowledge the risks to small groups such as tribes, which can implicate the community as a whole…

What Qualitative Researchers Must Do When Ethical Assurances Disintegrate? Recognise Internal Confidentiality, Establish Process Consent, Reference Groups, Referrals for Participants and a Safety Plan [Conference Paper]

What Qualitative Researchers Must Do When Ethical Assurances Disintegrate? Recognise Internal Confidentiality, Establish Process Consent, Reference Groups, Referrals for Participants and a Safety Plan [Conference Paper]
Martin Tolich
World Conference on Qualitative Research, 17 September 2019
Informed consent and confidentiality are the two mainstays of qualitative research ethics, yet they have a propensity to disintegrate in an emergent, iterative research design. This chapter examines how to approach this uncharted territory by having researchers take full responsibility for ethical considerations by using more robust forms of consent like process consent; recognising the dual faces of confidentiality, distinguishing external confidentiality from internal confidentiality. Other responsibilities in post ethics review environment include recognising and addressing big ethical moments. At times, participants and researchers ethical protections disintegrate too. When participants are at risk, furnish referrals (i.e. suicide watch phone numbers). When researchers are at risk work off a safety plan. Additionally, given this unpredictability, researchers should create a standing reference group to assist answering the fourth question above: what to do when the project raises ethical questions not foreseen in formal ethics review or by the researcher.

HealthLit4Kids Animation: inclusive and informed participants [Conference Extract]

HealthLit4Kids Animation: inclusive and informed participants [Conference Extract]
eCite Digital Repository
C Mainsbridge, R Nash, S Elmer, K Patterson, V Cruickshank, A McDonald, E Burke, R Dick
Engagement Transforms 2019 (ET19), 6 September 2019, Hobart, Tasmania
HealthLit4Kids is an education program designed for use in schools. Teachers invite children to participate in classroom-based health literacy development activities. The learning culminates with the development of an Artefact (creative piece accompanied with a description). Consent must be obtained from a parent or guardian and the child prior to uploading the HealthLit4Kids Artefact to the Open Education Resource and prior to the inclusion of each Artefact in research and evaluation. English is an additional language for 30% of the families at 2 of the 5 schools currently engaged with HealthLit4Kids, and limited literacy made it difficult to engage with “traditional” information sheets and informed consent processes. In response to these identified needs, the researchers developed a short, animated resource to support an informed consent process: 1. HealthLit4Kids Information Video 2. Parent/Child Information and Consent Video 3. Parent Term 1 Focus Group Information and Consent Video 4. Parent Term 3 Focus Group Information and Consent Video

The Effect of an Educational and Interactive Informed Consent Process on Patients with Cervical Spondylotic Myelopathy Caused by Ossification of the Posterior Longitudinal Ligament

The Effect of an Educational and Interactive Informed Consent Process on Patients with Cervical Spondylotic Myelopathy Caused by Ossification of the Posterior Longitudinal Ligament
Young-Seok Lee, Dae-Chul Cho, Joo-Kyung Sung, Inbo Han, Chi-Heon Kim, Ji-Yoon Kim, Kyoung-Tae Kim
Spine, 6 September 2019
Open Access
In this study, an educational and interactive informed consent (EIC) program was proposed for patients with OPLL-CSM to improve their comprehension level during the informed consent process.
Summary of Background Data
Cervical spondylotic myelopathy caused by ossification of the posterior longitudinal ligament (OPLL-CSM) is a slow progressive disease, and it is difficult for patients to understand the disease. Few studies have evaluated very specific programs to improve the informed consent process for these patients.
This prospective study evaluated patients with OPLL-CSM who either underwent the proposed EIC process (n=63) or the standard consent process (n = 124). The standard consent process only included a physician-patient interview. During the EIC process, information was provided regarding OPLL-CSM through information booklets, a video, verbal information, and initial and second physician-patient interviews. After the second physician-patient interview, the patient was requested to answer 14 medical questions to assess their knowledge about OPLL-CSM. The proposed EIC process took approximately 90 minutes. They were asked to report the most useful educational method and the most effective method of reinforcing verbal communication.
The mean questionnaire scores were higher in the EIC group than in the control group (p < 0.001). Video was selected by 50/63 patients (79.4%) as the most useful EIC process method, and the most effective method of reinforcing verbal communication was video (n = 61; 96.8%). Patients in the EIC group reported having higher satisfaction with surgery (p = 0.024) than did those in the control group.
The proposed EIC process was shown to result in good patient comprehension and recall regarding OPLL-CSM. Using a video was the most informative and effective reinforcement of verbal communication. The enhanced educational group had better knowledge and improved satisfaction following surgery. The EIC process might help physicians educate and counsel patients regarding OPLL-CSM and its treatment.

Editor’s note: Spine is an international, peer-reviewed, bi-weekly periodical which describes itself as the leading subspecialty journal for the treatment of spinal disorders

A video decision aid improves informed decision-making in patients with advanced cancer considering palliative radiation therapy

A video decision aid improves informed decision-making in patients with advanced cancer considering palliative radiation therapy
Brief Report
Kavita V. Dharmarajan, Chasity B. Walters, Tomer T. Levin,  Carol Ann Milazzo, Christopher Monether,  Robin Rawlins-Duell,  Roma Tickoo,  Daniel E. Spratt, Shona Lovie, Gina Giannantoni-Ibelli, Beryl McCormick
Journal of Pain and Symptom Management, 28 August 2019
Advanced cancer patients have unrecognized gaps in their understanding about palliative radiation therapy (PRT).
To build a video decision aid for hospitalized patients with advanced cancer referred for PRT and prospectively test its efficacy in reducing decisional uncertainty, improving knowledge, increasing treatment readiness and readiness for palliative care consultation, and its acceptability among patients.
Forty patients with advanced cancer hospitalized at Memorial Sloan Kettering Cancer Center watched a video decision aid about PRT and palliative care. Patients’ conceptual and logistical knowledge of PRT, decisional uncertainty, treatment readiness, and readiness for palliative care consultation were assessed before and after watching the video with a 6-item knowledge survey, the decisional uncertainty subscale of the Decisional Conflict Scale, and Likert instruments to assess readiness to accept radiation treatment and/or palliative care consultation, respectively. A post-video survey assessed the video’s acceptability among patients.
After watching the video, decisional uncertainty was reduced (28.3 vs. 21.7, p=0.02); knowledge of PRT improved (60.4 vs. 88.3, p<0.001); and PRT readiness increased (2.0 vs. 1.3, p=0.04). Readiness for palliative care consultation was unchanged (p=0.58). Patients felt very comfortable (70%) watching the video and would highly recommend it (75%) to others.
Among hospitalized patients with advanced cancer, a video decision aid reduced decisional uncertainty, improved knowledge of PRT, increased readiness for PRT, and was well-received by patient viewers.

Characteristics of patients having telemedicine versus in-person informed consent visits before abortion in Utah

Characteristics of patients having telemedicine versus in-person informed consent visits before abortion in Utah
Sara Daniel, Sarah Raifman, Shelly Kaller, Daniel Grossman
Contraception, 4 September 2019
This study aimed to evaluate demographic and service delivery differences between patients using telemedicine relative to an in-person visit to satisfy Utah’s state-mandated informed consent visit, which must occur at least 72 h before the abortion.
Study design
We conducted a retrospective cohort study with data from Planned Parenthood Association of Utah (PPAU), which included all informed consent and abortion encounters from January 1, 2015 – March 31, 2018. We evaluated the following for each encounter by informed consent type (telemedicine vs. in-person): demographics, distance to a PPAU facility, length of time between informed consent and abortion visits, and gestational age at time of abortion.
Of the 9175 informed consent visits, 91% were in-person (n=8395) and 9% were via telemedicine (n=780), which ranged from 5% in 2015 to 16% in 2018. Compared to in-person patients, telemedicine patients were slightly older (27 vs. 25 median years, p<.001), more likely to live out of state (47% vs. 4%, p<.001) and further away from PPAU clinics offering informed consent visits (104 miles vs. 10 median miles, p<.001). Among those who received abortion care at PPAU (6233), telemedicine informed consent patients were more likely to have medication abortions (adjusted odds ratio 1.68, 95% confidence interval 1.28–2.19) compared to in-person informed consent patients.
PPAU’s telemedicine option for completing the abortion informed consent visit appears to be of particular interest to patients who live further from clinics, including out of state, as it could help reduce travel burdens imposed by Utah’s mandatory delay law.
Telemedicine provision of state-mandated informed consent is feasible and could be used in other states where similar mandatory delays before abortion are required and where telemedicine is allowed.