Informed Consent: A Monthly Review

April 2020

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 Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_April 2020

Parental consent undermines the right to health of adolescents

Parental consent undermines the right to health of adolescents
UNAIDS, 16 March 2020
Open Access
Many countries have laws or policies that prevent adolescents from accessing essential health services without the consent of a parent or guardian. The original intention may have been to protect minors, but these stipulations often have the opposite effect and increase the risk of HIV and other health problems among adolescents.

A large proportion of countries across all regions restrict access to HIV testing and treatment for adolescents. In 2019, for instance, adolescents younger than 18 years needed explicit parental consent in 105 of 142 countries in order to take an HIV test. In 86 of 138 reporting countries, they needed such consent to access HIV treatment and care. These kinds of laws and policies also may complicate or hinder adolescent access to pre-exposure prophylaxis (PrEP), a highly effective prevention tool.

Research in sub-Saharan Africa shows that in countries where the age of consent is 15 years or lower, adolescents are 74% more likely to have been tested for HIV in the past 12 months compared with countries where the age of consent is 16 years or higher—with girls especially benefiting from the easier access.

Country-level details on which countries have consent laws can be viewed on the UNAIDS Laws and Policies Analytics web page.

NIH-funded effort may help people with intellectual disability participate in clinical studies

NIH-funded effort may help people with intellectual disability participate in clinical studies
Media Advisory
National Institues of Health, 24 February 2020
Open Access
The NIH Toolbox Cognitive Battery — an assessment of cognitive functioning for adults and children participating in neuroscience research —can be adapted to people with intellectual disabilities by modifying some test components and making accommodations for the test-takers’ disabilities, according to researchers funded by the National Institutes of Health. The adaptations ensure that the battery can be used to assess the cognitive ability of people with intellectual disabilities who have a mental age of 5 years and above, providing objective measures that could be used in a wide variety of studies.

The research team, led by David Hessl, Ph.D., of the University of California Davis Medical Center, published their findings in Neurology. The work was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and National Center for Advancing Translational Sciences, as well as the Administration for Community Living.

The battery is administered on a computer tablet and measures memory, vocabulary, reading and executive functioning, which includes skills such as the ability to shift from one thought to another, pay attention and control impulses. The researchers adapted the battery by reducing the complexity of the instructions and including developmentally appropriate starting points. They also developed a structured manual to guide test administrators.

The researchers validated the battery and its modifications by assessing 242 people ages 6 through 25 with fragile X syndrome, Down syndrome or other disabilities. They found that the battery produced reliable and valid results for those with a mental age of 5 years and above. The authors called for additional research to adapt the battery to people with lower mental ages and to older adults with intellectual disability who may be experiencing cognitive decline or dementia.

Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D

Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D
WHO, 2020
Open Access
…What are the requirements for informed consent in emergencies?

Individual informed consent is a fundamental ethical requirement for research. Prospective research participants must be able to weigh the risks and benefits of participation. This can be particularly challenging in a public health emergency because of uncertain risks and the perception that any research-related intervention must be ‘better than nothing’. Consequently, researchers and review bodies have an obligation to ensure that research activities do not proceed unless there is a reasonable scientific basis to believe that the study intervention is likely to be safe and efficacious and that risks to participants have been minimized to the extent reasonably possible.

Cultural and linguistic differences, as well as confusions about the dual role of the clinician/researcher, may be heightened for research conducted in this context, and so processes for obtaining informed consent, including the wording of documents and methods of obtaining and recording consent, should be developed in consultation with local communities. Finally, researchers should inform potential participants about the circumstances under which their data or samples might be shared…

From the Lab Bench to the Battlefield: Novel Vaccine Technologies and Informed Consent [BOOK CHAPTER]

From the Lab Bench to the Battlefield: Novel Vaccine Technologies and Informed Consent [BOOK CHAPTER]
Paul Eagan, Sheena M. Eagan
Ethics of Medical Innovation, Experimentation, and Enhancement in Military and Humanitarian Contexts
Springer, 18 March 2020; pp 69-85
Vaccines are a commonly used medical countermeasure against many infectious diseases and represent one of the tools used by militaries to maintain a healthy fighting force. Vaccines also constitute an essential intervention during humanitarian missions where contagious disease outbreaks can be the primary cause of the crisis or a by-product of social upheaval and natural disaster. Though many infectious diseases are recurrent problems and vaccines exist to address the threat, recent outbreaks of H1N1, Ebola, and Zika have brought to the forefront the inherent inadequacies of traditional vaccine development. New technologies such as nucleic acid-based therapies provide some hope for a more rapid and robust response capability. The potential acceleration of the vaccine development pipeline carries both opportunities and potential pitfalls. The use of immune enhancement technologies, experimental immunization protocols or unproven vaccines in military personnel or vulnerable populations during times of crisis brings to the forefront ethical issues concerning the adequacy of informed consent, human experimentation, and free choice. An overview of novel vaccine technologies is followed by an analysis of the ethical issues surrounding informed consent and human experimentation in vulnerable military and civilian populations.

The role of institutional review boards, and hospital pharmacists as members, in the informed consent process in clinical research: a retrospective observational study

The role of institutional review boards, and hospital pharmacists as members, in the informed consent process in clinical research: a retrospective observational study
E Villamañán, C Sobrino, M Freire, JN Inmaculada, SR Luis, L Patricia, C Lara, E Fernández De Uzquiano, A Herrero, M Moreno
European Journal of Hospital Pharmacy, 24 March 2020; 27(suppl 1:6ER-023)
Open Access
Background and importance
It is the responsibility of institutional review boards (IRBs) and hospital pharmacists, as members of these boards, to review a research proposal and ensure that adequate informed consent procedures are implemented in an ethical way, promoting participant autonomy and protecting them from potential harm. In this context, informed consent forms (ICFs) have become increasingly complex and difficult for patients to understand.
Aim and objectives
To analyse non-approval of clinical research by IRBs, related to deficiencies found in the ICFs. Secondary outcomes were type of objections in terms of readability, length, description of study purpose, design, expected benefits and foreseeable risks. Other ethical and legal aspects, such as voluntary agreement to participate, right to withdraw, biological sample management and access to personal data were also analysed
Material and methods
This was a retrospective observational study of the clinical studies evaluated by the IRB in a tertiary hospital. We evaluated the IRB resolutions of all clinical studies over 4 years, including interventional studies (clinical trials) and non-interventional research assessed by the IRB where a hospital pharmacist was a member of the board. The committee’s decisions on approval were registered in the minutes of the meetings. The pharmacists reviewed the minutes, evaluating the final opinion of the committee (approval/non-approval of the study) in the first review.
A total of 91 sets of minutes, corresponding to the IRB meetings over 4 years, were analysed. In these meetings, 1858 clinical trials were evaluated (1057 clinical trials and 801 non-interventional studies). Of these, 1558 required informed consent for participation (83.9%, 95% CI 82.1–85.5) and 987 were not approved at first review due to deficiencies detected in the ICF (63.3%, 95% CI 60.9–65.7). The main reasons for non-approval were unreadability (11.7%), inadequate information given about access to personal data rights (9.2%), biological sample management (7.8%) and expected benefits (7.6%).
Conclusion and relevance
There was a high proportion of deficiencies in the ICFs for clinical research. They were an important reason for non-approval of protocols evaluated by IRBs. Taken together, there are three fundamental weaknesses in ICFs where IRBs in hospitals play a key role: improving their readability, adapting them to regulations concerning data protection or biological sample management, and avoiding misleading information concerning enrolment.

Ethics (Informed Consent and Conflicts of Interest) [BOOK CHAPTER]

Ethics (Informed Consent and Conflicts of Interest) [BOOK CHAPTER]
Kara K. Rossfeld, Jordan M. Cloyd, Elizabeth Palmer, Timothy M. Pawlik
Clinical Trials
Springer, 11 March 2020; pp 17-31
The aim of clinical trials is to obtain generalizable knowledge that can be used to advance healthcare. The ethical issues in clinical trials arise when human subjects, who may not directly benefit from the research, are faced with the risk of being exploited or harmed. Additional ethical challenges pertain to informed consent of subjects and conflicts of interest of physician-investigators. The current ethical standards for research are based on guidelines and laws which were a necessary response to historical abuses of participants in the name of science. In this chapter, a framework for evaluating clinical research for ethical deficits is discussed, as are challenges in upholding ethical principles, including in obtaining informed consent from research participants as well as in navigating conflicts of interest.

Animation-supported consent for urgent angiography and angioplasty: a service improvement initiative

Animation-supported consent for urgent angiography and angioplasty: a service improvement initiative
Original Research
David S Wald, Oliver Casey-Gillman, Katrina Comer, Josephine Sarah Mansell, Howie Teo, Kyriacos Mouyis, Matthew Kelham, Fiona Chan, Selda Ahmet, Max Sayers, Vincent McCaughan, Nito Polenio
Heart, 10 March 2020
Open Access
Patient understanding of angiography and angioplasty is often incomplete at the time of consent. Language barriers and time constraints are significant obstacles, particularly in the urgent setting. We introduced digital animations to support consent and assessed the effect on patient understanding.
Multi-language animations explaining angiography and angioplasty ( were introduced at nine district hospitals for patients with acute coronary syndrome before urgent transfer to a cardiac centre for their procedure. Reported understanding of the reason for transfer, the procedure, its benefits and risks in 100 consecutive patients were recorded before introduction of the animations into practice (no animation group) and in 100 consecutive patients after their introduction (animation group). Patient understanding in the two groups was compared.
Following introduction, 83/100 patients reported they had watched the animation before inter-hospital transfer (3 declined and 14 were overlooked). The proportions of patients who understood the reason for transfer, the procedure, its benefits and risks in the no animation group were 58%, 38%, 25% and 7% and in the animation group, 85%, 81%, 73% and 61%, respectively. The relative improvement (ratio of proportions) was 1.5 (95% CI 1.2 to 1.8), 2.1 (1.6 to 2.8), 2.9 (2.0 to 4.2) and 8.7 (4.2 to 18.1), respectively (p<0.001 for all comparisons).
Use of animations explaining angiography and angioplasty is feasible before urgent inter-hospital transfer and was associated with substantial improvement in reported understanding of the procedure, its risks and its benefits. The approach is not limited to cardiology and has the potential to be applied to all specialties in medicine.

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.

Capacity to Consent to Research Participation in Adults with Metastatic Cancer: Comparisons of Brain Metastasis, Non-CNS Metastasis, and Healthy Controls

Capacity to Consent to Research Participation in Adults with Metastatic Cancer: Comparisons of Brain Metastasis, Non-CNS Metastasis, and Healthy Controls
Kyler Mulhauser, Dario A Marotta, Adam Gerstenecker, Gabrielle Wilhelm, Terina Myers, Meredith Gammon, David E Vance, Burt Nabors, John Fiveash, Kristen Triebel
Neuro-Oncology Practice, 9 March 2020
To evaluate the ability of persons with metastatic cancer to provide informed consent to research participation, we used a structured vignette-based interview to measure four consenting standards across three participant groups.
Participants included 61 persons diagnosed with brain metastasis, 41 persons diagnosed with non-CNS metastasis, and 17 cognitively intact healthy controls. All groups were evaluated using the Capacity to Consent to Research Instrument (CCRI), a performance-based measure of research consent capacity. The ability to provide informed consent to participate in research was evaluated across four consent standards: expressing choice, appreciation, reasoning, and understanding. Capacity performance ratings (intact, mild/moderate impairment, severe impairment) were identified based on control group performance.
Results revealed that the brain metastasis group performed significantly lower than healthy controls on the consent standard of understanding, while both metastatic cancer groups performed below controls on the consent standard of reasoning. Both metastatic cancer groups performed similar to controls on the standards of appreciation and expressing choice. Approximately 60% of the brain metastasis group, 54% of the non-CNS metastasis group, and 18% of healthy controls showed impaired research consent capacity.
Our findings, using a performance-based assessment, are consistent with other research indicating that the research consent process may be overly cumbersome and confusing. This, in turn, may lead to research consent impairment not only in patient groups but also in some healthy adults with intact cognitive ability.