Informed Consent: A Monthly Review

December 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_December 2019

United Republic of Tanzania lowers age of consent for HIV testing

United Republic of Tanzania lowers age of consent for HIV testing
29 November 2019
Press Release
The United Republic of Tanzania has approved a change to the law that lowers the age of consent for HIV testing from 18 years to 15 years. The amendment to legislation also makes self-testing for HIV legal, also from the age of 15 years.

“These amendments will significantly accelerate our intention to meet the 90–90–90 goals, which aim at ending the AIDS epidemic by 2030,” said Ummy Mwalimu, Minister of Health, Community Development, Gender, Elderly and Children. The ministry was instrumental in tabling the amendments to the legislation.

The 90–90–90 targets are ambitious treatment targets to help end the AIDS epidemic. They aim to ensure that, by 2020, 90% of all people living with HIV will know their HIV status, 90% of all people who know their HIV status will be on antiretroviral therapy and 90% of all people on antiretroviral therapy will be virally suppressed.

The changes to the law will contribute to improved access to HIV testing for adults aged 15 years and over.

At the end of 2018, the progress on the 90–90–90 targets in the United Republic of Tanzania was 78–92–87. In 2018, there were 72 000 new HIV infections in the country. While this is a 13% reduction from 2010, it is below the 28% reduction across eastern and southern Africa.

“I congratulate the Government of the United Republic of Tanzania on its leadership and high-level political commitment to the AIDS response. UNAIDS will continue to work hand-in-hand with all our partners to ensure that access to HIV testing and treatment continues to expand,” said Leo Zekeng, UNAIDS Country Director in the United Republic of Tanzania.

Guidelines for ethical research on sexual exploitation involving children

Guidelines for ethical research on sexual exploitation involving children
ECPAT – ECPAT is the only child right’s organisation that is solely focusing on ending the sexual exploitation of children (
29 November 2019
Press Release
…The Guidelines for Ethical Research on Sexual Exploitation involving Children offer a framework for ethical research design in this area. They guide the reader through four steps in research design and implementation and set up a series of ‘ethical tasks’ that should be undertaken in your research project…
Doing research involving children in the context of sexual exploitation raises a range of ethical questions and dilemmas. Some of these are similar for any research with human participants or vulnerable groups; but others are very specific to children affected by sexual exploitation (see ‘Ethics of Research on Sexual Exploitation Involving Children’ for a review of the literature). This document provides guidance for negotiating these ethical questions for a range of people engaged in field research (from lead researchers to data collectors)…
 Informed Consent
…Even though not always legally required, with research involving children, it is also ethically appropriate to also obtain ‘assent ’from child participants. Obtaining ‘assent’ means to formally get permission from the child that they want to participate (not to just assume they do because a parent/caregiver gave consent). Children have the right to participate, but they also have the right to choose whether to express or not express those views6 This “means that the child must not be manipulated or subjected to undue influence or pressure…”

Abstract 391: Variation in Time to Notification After Enrollment in Trials Conducted Under Exception From Informed Consent for Emergency Research [POSTER PRESENTATION]

Abstract 391: Variation in Time to Notification After Enrollment in Trials Conducted Under Exception From Informed Consent for Emergency Research [POSTER PRESENTATION]
Graham Nichol, Rui Zhuang, Tom P Aufderheide, Eileen Bulger, Clifton W Callaway, Jim Christenson, Mohamud R Daya, Ahamed H Idris, Peter Kudenchuk, Laurie J Morrison, Martin A Schreiber, George Sopko, Jeremy Sugarman, Christian Vaillancourt, Henry E Wang, Myron Weisfeldt, Susanne May
Circulation, 11 November 2019; 140(supplement 2)
Open Access
Research in an emergency setting is challenging because the window of opportunity to treat may be short, and preclude time to obtain informed consent from the patient or their representative. Such research can be conducted under exception from informed consent (EFIC) if specific criteria are met. In the United States, this includes notification of an enrolled subject or their representative as soon as feasible after enrollment so that they have autonomy to opt out from ongoing study participation. To date, there is limited empiric information about time to notification (TTN).
To describe variation in TTN among sites participating in randomized trials conducted under exception from informed consent for emergency research.
Notification strategies were determined at each site prior to initiation of subject enrollment, and approved by a local institutional review board or equivalent. TTN was summarized overall, as well as stratified by site and clinical outcome among patients enrolled in multiple trials conducted by the Resuscitation Outcomes Consortium (ROC).
Included were 34,868 patients enrolled in four trials. Of these, 33,805 had with out-of-hospital cardiac arrest; and 1,063 had life-threatening traumatic injury. TTN varied (Table).
There is large variation in TTN in trials conducted under EFIC for emergency research. Early notification is difficult; delayed notification may reduce the autonomy of patients or their representative.

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation
Research Article
Rajesh Ranjan, Nidhi B. Agarwal, Prem Kapur, Amit Marwah, Rizwana Parveen
Asia Pacific Journal of Public Health, 3 November 2019
Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical trials. Majority (54%) were unaware about any informed consent document. None of them were aware of their right of profession competence, privacy and integrity, transparency, nonexploitation, and nonusage of their biological samples. Effective implementation of principles of informed consenting is largely lacking among contract research organizations in Delhi, India. This could potentially cause risk to the participants.

20 Development of an application for digital capture of informed consent in research [POSTER]

20 Development of an application for digital capture of informed consent in research [POSTER]
Azariah Kusi-Yeboah, Dan Ward, Ross Murray, Daiana Bassi, Sue Conner, Yun Fu, Dean Mohamedally, Gemma Molyneux, Graham Roberts, Neil Sebire
Archives of Disease in Childhood, 22 November 2019; 104(supplement 4)
Clinical trials and research studies are vital for treatment innovations. In order to give informed consent, participants are provided with information sheets that describe the study in detail. The current system is paper based and documents must be retained and archived. The aim of this project was to create a system to digitalise the process.
As part of a joint collaboration between GOSH and UCL computer science (CS) through the industry exchange network programme, we developed a mobile application for digital capture and management of consent. The application was based on a standard 3-tier (presentation, logic and data), software architecture pattern. The presentation tier consists of mobile and web applications. The mobile app was developed in Ionic4, while the web app makes use of Bootstrap to create fully responsive web pages. The logic tier, which contains the application’s functional business logic, was written in Node.js and consists of the RESTful APIs the mobile and web app use to access data. The data tier comprises of a MySQL database.
A web application was developed to create study documentation that can be viewed and completed on a mobile app. The system allows for the management of study documents to ensure version control. User profiles for staff can be created to control access to studies, therefore only staff with permission can access documentation and consent participants to a research study. The application allows information sheets to be sent to by email to participants, and for signatures to be taken digitally. All completed paperwork can be stored on a cloud database.
A proof of principle system for capturing consent electronically has been developed. This system could be further enhanced to provide a screen reader function and could incorporate animations or films to enhance the description of research studies to children.

Editor’s note: GOSH refers to the Great Ormond Street Hospital and UCL to the University College London.

Privacy Nudges: An Alternative Regulatory Mechanism to Informed Consent for Online Data Protection Behaviour

Privacy Nudges: An Alternative Regulatory Mechanism to Informed Consent for Online Data Protection Behaviour
Sheng Yin Soh
European Data Protection Law Review, 1 October 2019; 65
The informed consent paradigm of data protection law in the EU has failed to foster privacy-protective behaviour online, due to findings from behavioural science such as bounded rationality and asymmetric information. Hence, this article proposes a soft partnership approach through the use of “privacy nudges” as an alternative regulatory tool to informed consent to nudge users towards more optimal privacy protection decisions. This article also discussed the potential benefits of privacy nudges, some of the main critiques of nudging and future direction for improvement.

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.


Informed Consent in Clinical Trials for Persons with Dementia

Informed Consent in Clinical Trials for Persons with Dementia
Joan G Carpenter
Innovation in Aging, 8 November 2019; 3(Supplement 1)
Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.


What is needed to obtain informed consent and monitor capacity for a successful study involving People with Mild Dementia? Our experience in a multi-centre study

What is needed to obtain informed consent and monitor capacity for a successful study involving People with Mild Dementia? Our experience in a multi-centre study
Jennifer NW Lim, Rosa Almeida, Vjera Holthoff-Detto, Geke DS Ludden, Tina Smith, Kristina Niedderer
International Mind Conference, 19-20 September 2019; Dresden Germany
Open Access
Strategies on informed consent process and capacity monitoring for mild dementia research are at developing state. We reflected on our experience and found that the successful collection of informed consent and full participation of PwD required the involvement of familiar healthcare professionals/care workers/staff at the recruitment and data collection stages and this needs to occur in an active support environment. Time is another important factor affecting the success of the study.