Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing

Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing
NIH – Office of Science Policy/Office of Extramural Research, May 2022; pp 1-7
Introduction
…The following resource… outlines suggested points to consider when addressing data and biospecimen storage and sharing for future use in consent language and provides supplemental sample language that could be modified as needed when developing informed consent documents. Of note, the sample language provided below is designed to be incorporated into a primary research consent document. The use of the sample language by itself does not address federal, state, local, tribal, or international requirements that may apply to the primary research. Furthermore, this resource is designed for research consent documents; it does not address the storage and sharing of data and biospecimens initially collected for clinical purposes. Use of the information provided in this resource, including sample language, is completely voluntary.

Emergency use of unproven clinical interventions outside clinical trials: ethical considerations

Emergency use of unproven clinical interventions outside clinical trials: ethical considerations
Technical Document
World Health Organisation, 12 April 2022
Open Access
Introduction
Outbreaks and other events that may become public health emergencies frequently face a lack of  safe and effective therapeutic or preventive interventions, such as drugs specific to the pathogen or condition. WHO and its partners therefore established the “WHO R&D blueprint” in 2016 to stimulate research into diseases or conditions that pose the greatest public health risks because of their epidemic potential or for which there are no or insufficient countermeasures (31). In response to the ethical duty to conduct research during public health emergencies (17), rapid, rigorous, simple clinical trials or other types of research (32, 33) are essential to establish the safety and efficacy of unproven interventions – including “off label” interventions (9) – and to discard those that are unsafe or ineffective to avoid their use in health systems. When a PHEIC is declared, “it is critical that the global research effort is rapid, robust, conducted at scale and coordinated across multiple countries” (33)…

Screenshot 2022-06-02 at 1.02.49 PM

Ethical Research in Fragile and Conflict Affected Contexts: Guidelines for Reviewers

Ethical Research in Fragile and Conflict Affected Contexts: Guidelines for Reviewers
Guidelines
UKRI Research and Innovation, 16 November 2021
Open Access
Rationale
Ethical considerations arise in all research. They are, however, amplified in fragile and conflict-affected contexts. The power imbalances between local and international researchers are increased and the risk of harm is augmented. The research takes place in a context where appropriate safeguards are often reduced and the probabilities of unethical research are magnified. Existing explorations of ethics and ethical review processes often focus primarily on the front end of the data cycle. Yet, we know that harm can occur at any stage in the research cycle. Ethical research in fragile and conflict-affected contexts therefore requires that researchers and funders reflect even more critically and systematically on every step of the research process – from defining the research agenda and selecting researchers through to data collection, analysis and dissemination and communication of findings. These UKRI and UNICEF reviewer guidelines provide a unique tool for reviewers to assure themselves, as reviewers and/or funders, that research projects funded will give systematic and on going consideration to the ethics of research in fragile and conflict-affected contexts. The tool provides seven criteria for consideration and a checklist for reviewers to use systematically to support their review process…

Editor’s note: UK Research and Innovation provides research and innovation funding, funded through the science budget of the Department for Business, Energy and Industrial Strategy.

Protecting Privacy and Consent Online

Protecting Privacy and Consent Online
News
Barnaby Lewis
International Standards Organisation, 23 June 2020
Excerpt
For everyone concerned about online privacy, ISO/IEC 29184 has just been published…
Devices such as these collect and process your personal data. That might include geographical and biometric data, or the frequency and timing of interactions with the device. That’s legitimate, and useful for those who want to be able to get an objective insight into, say, their sleeping habits. But it also provides lucrative opportunities to companies who use such data to market their products and services, often without our informed consent… The new standard, developed jointly by ISO and the IEC’s committee on information security, cybersecurity and privacy protection1), provides details on the implementation of privacy principles from ISO/IEC 29100. Specifically, it addresses consent and choice (Principle 1), and openness, transparency and notice… In addition to providing clearer information about what kind of PII is being collected and how it is being used, ISO/IEC 29184 will help people to better understand just what they’re signing up to when they use connected services and, importantly, how to withdraw their consent…

Parental consent undermines the right to health of adolescents

Parental consent undermines the right to health of adolescents
Update
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
What
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
Excerpt
…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…

United Republic of Tanzania lowers age of consent for HIV testing

United Republic of Tanzania lowers age of consent for HIV testing
UNAIDS
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 (ecpat.org)
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…
Excerpt
Introduction
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…”