We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Call for input on the right to access and take part in scientific progress
Issued by Special Rapporteur in the field of cultural rights, UNHCHR
Deadline: 13 November 2023
Purpose: To inform the upcoming report of the Special Rapporteur to the Human Rights Council to be presented in March 2024
Key questions and types of input/comments sought via the questionnaire (Word):
English | Français | Español
[Excerpt]
…Participation in science
- How is the right of every person to participate in scientific progress and in decisions concerning its direction understood and implemented? What are the challenges? How are lack of representativeness of marginalized groups and inequalities in participation addressed?
- How is ‘citizen science’ (ordinary people doing science) understood in your country? Is it considered important, and what measures have been put in place to support it, particularly in terms of access to information and data, and participation in decision-making? What are the challenges? Please provide an example.
- To what extent are indigenous sciences and alternative sciences acknowledged, supported and included in policy decision-making? How is the conversation ensured between science and other kinds of knowledge?What are the limits to the right of every person to take part in scientific progress and in decisions concerning its direction and for which purposes? Please provide examples if any.
Request for Information (RFI): Inviting Comments and Suggestions on Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) Including Electronic Health Records, for National Institutes of Health (NIH) Supported Biomedical and Behavioral Research
U.S. National Institutes of Health on 09/28/2023.
Responses must be received by December 14, 2023
Background
Researchers are increasingly using data collected in real-world settings to augment traditional research studies, as well as develop more effective treatments and interventions for patients. These “real-world data (RWD)”, defined by the U.S. Food and Drug Administration, are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. While these data hold tremendous promise for biomedical and behavioral research, they can be collected from a variety of sources through multiple mechanisms, creating challenges for researchers and questions for those whose data are being shared.
Importantly, NIH is committed to ensuring participant privacy and autonomy are protected in all NIH-supported research. As NIH establishes health-related research data platforms that include access to RWD, NIH continues to prioritize maximizing data access while upholding participant preferences regarding the collection and use of their data…
Information Requested
NIH is requesting public comment on the use of RWD for NIH-supported biomedical and behavioral research, including opportunities for leveraging the benefits of RWD and strategies for its responsible use. NIH also seeks to better understand community perspectives on the potential value and constraints—including scientific, administrative, legal, business, and bioethical—for the increased use of RWD in biomedical and behavioral research.
Center for Informed Consent Integrity 