Meta consent: a flexible and autonomous way of obtaining informed consent for secondary research

BMJ ◽  
2015 ◽  
Vol 350 (may07 31) ◽  
pp. h2146-h2146 ◽  
Author(s):  
T. Ploug ◽  
S. Holm
Keyword(s):  
Informed Consent ◽  
Secondary Research ◽  
Meta Consent

Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data

2021 ◽  
pp. 019394592110292
Author(s):  
Elizabeth E. Umberfield ◽  
Sharon L. R. Kardia ◽  
Yun Jiang ◽  
Andrea K. Thomer ◽  
Marcelline R. Harris
Keyword(s):  
Informed Consent ◽  
Scoping Review ◽  
Real World ◽  
Genetic Information ◽  
Final Analysis ◽  
Health Data ◽  
Federal Regulations ◽  
Secondary Research ◽  
Domain Experts ◽  
Key Issues

Nurse scientists are increasingly interested in conducting secondary research using real world collections of biospecimens and health data. The purposes of this scoping review are to (a) identify federal regulations and norms that bear authority or give guidance over reuse of residual clinical biospecimens and health data, (b) summarize domain experts’ interpretations of permissions of such reuse, and (c) summarize key issues for interpreting regulations and norms. Final analysis included 25 manuscripts and 23 regulations and norms. This review illustrates contextual complexity for reusing residual clinical biospecimens and health data, and explores issues such as privacy, confidentiality, and deriving genetic information from biospecimens. Inconsistencies make it difficult to interpret, which regulations or norms apply, or if applicable regulations or norms are congruent. Tools are necessary to support consistent, expert-informed consent processes and downstream reuse of residual clinical biospecimens and health data by nurse scientists.

scholarly journals The biobank consent debate: why ‘meta-consent’ is still the solution!

2019 ◽  
Vol 45 (5) ◽  
pp. 295-297 ◽  
Author(s):  
Thomas Ploug ◽  
Soren Holm
Keyword(s):  
Informed Consent ◽  
Medical Ethics ◽  
Recent Article ◽  
Broad Consent ◽  
Autonomous Choice ◽  
Biobank Research ◽  
Meta Consent

In a recent article in the Journal of Medical Ethics, Neil Manson sets out to show that the meta-consent model of informed consent is not the solution to perennial debate on the ethics of biobank participation. In this response, we shall argue that (i) Manson’s considerations on the costs of a meta-consent model are incomplete and therefore misleading; (ii) his view that a model of broad consent passes a threshold of moral acceptability rests on an analogy that misconstrues how biobank research is actually conducted and (iii) a model of meta-consent is more in tune with the nature of biobank research and enables autonomous choice.

scholarly journals Informed Consent in the Big Data Age: The Need for Normative Updates

2020 ◽  
Vol 20 (2) ◽  
pp. 115-131
Author(s):  
Ekaterina A. Koval ◽  
◽  
Marina D. Martynova ◽  
Natalya V. Zhadunova ◽  
◽  
...  
Keyword(s):  
Big Data ◽  
Informed Consent ◽  
The Novel ◽  
Use Of Data ◽  
Dynamic Consent ◽  
New Models ◽  
Complete Rejection ◽  
Catch 22 ◽  
The Individual ◽  
Meta Consent

Big data is changing the usual practices of obtaining informed consent. Traditional informed consent models stop working because they don’t take into account the speed, volume, and variety of collected and processed data. In the traditional model it is extremely difficult to identify all possible uses for the information received from users, and obtaining secondary consent is difficult or simply impossible in a situation where data is depersonalized. As a re­sult, a person signing an informed consent gets into the situation described by J. Heller in the novel «Catch-22»: absurd rules aimed at taking care of the individual lead to the op­posite results. To avoid falling into catch-22, it is necessary to create new models of in­formed consent (the model of broad (full) consent, the model of dynamic consent, the mar­ket model, the model of postponed consent, the model of meta consent, the model of multi-level consent, the democratic model of consent), which can more effectively protect per­sonal autonomy, confidentiality, privacy and serve as a guarantor of trust in the subjects of collecting, processing, and using big data. Although the new models of informed consent are not without drawbacks, a complete rejection of this procedure entails a violation of the pre­cautionary principle and increases the likelihood of harm to the data subject. At the same time, following the precautionary principle should take into account the relationship be­tween the individual and the General good and not hinder the development of different spheres of public life in the condition of big data accumulation. The creation of rules governing the receipt of informed consent and the use of data should be based on an analysis of existing practices and take into account a measure of openness and trust, which are determined by both personal and socio-cultural characteristics.

Abstract A04: Preferences for models of informed consent for secondary research uses of biospecimens among diverse women

2014 ◽  
Author(s):  
Katherine Brown ◽  
Bettina F. Drake ◽  
Sarah Gehlert ◽  
Leslie Wolf ◽  
James DuBois ◽  
...  
Keyword(s):  
Informed Consent ◽  
Secondary Research

Informed Consent for Secondary Research under the New NIH Data Sharing Policy

2021 ◽  
Vol 49 (3) ◽  
pp. 489-494
Author(s):  
Mark A. Rothstein
Keyword(s):  
Informed Consent ◽  
Data Management ◽  
Data Sharing ◽  
Grant Application ◽  
Secondary Research

AbstractThe new NIH data sharing policy, effective January 2023, requires researchers to submit a data management and data sharing plan in their grant application. Expanded data sharing, encouraged by NIH to facilitate secondary research, will require informed consent documents to explain data sharing plans, limitations, and procedures.

scholarly journals The biobank consent debate: Why ‘meta-consent’ is not the solution?

2018 ◽  
Vol 45 (5) ◽  
pp. 291-294 ◽  
Author(s):  
Neil C Manson
Keyword(s):  
Informed Consent ◽  
Central Element ◽  
Consent Process ◽  
Practical Reasons ◽  
Broad Consent ◽  
Ethical Considerations ◽  
Ethical Argument ◽  
The Past ◽  
Different Types ◽  
Meta Consent

Over the past couple of decades, there has been an ongoing, often fierce, debate about the ethics of biobank participation. One central element of that debate has concerned the nature of informed consent, must specific reconsent be gained for each new use, or user, or is broad consent ethically adequate? Recently, Thomas Ploug and Søren Holm have developed an alternative to both specific and broad consent: what they call a meta-consent framework. On a meta-consent framework, participants can choose the type of consent framework they require, for different kinds of use, different types of user and so on. Meta-consent involves a distinctive kind of design of the consent process. Here it is argued, first, that although a meta-consent framework does not wrong participants, Ploug and Holm understate the likely costs and burdens of such a framework, so there are good practical reasons not to offer it. Second, although Ploug and Holm allude to some ethical considerations that might seem to ground an ethical argument for providing meta-consent, they do not offer any sound argument, and it does not wrong participants in any way to fail to offer them the opportunity to design their own consent process.

Tools and Resources: Web Sites of Interest

2001 ◽  
Vol 6 (2) ◽  
pp. 6-8
Author(s):  
Christopher R. Brigham
Keyword(s):  
Informed Consent ◽  
Physical Examination ◽  
Functional Status ◽  
Web Sites ◽  
Satisfaction Survey ◽  
High Quality ◽  
Diagnostic Studies ◽  
Physician Relationship ◽  
Complete History

Abstract The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Fifth Edition, explains that independent medical evaluations (IMEs) are not the same as impairment evaluations, and the evaluation must be designed to provide the data to answer the questions asked by the requesting client. This article continues discussions from the September/October issue of The Guides Newsletter and examines what occurs after the examinee arrives in the physician's office. First are orientation and obtaining informed consent, and the examinee must understand that there is no patient–physician relationship and the physician will not provide treatment bur rather will send a report to the client who requested the IME. Many physicians ask the examinee to complete a questionnaire and a series of pain inventories before the interview. Typical elements of a complete history are shown in a table. An equally detailed physical examination follows a meticulous history, and standardized forms for reporting these findings are useful. Pain and functional status inventories may supplement the evaluation, and the examining physician examines radiographic and diagnostic studies. The physician informs the interviewee when the evaluation is complete and, without discussing the findings, asks the examinee to complete a satisfaction survey and reviews the latter to identify and rectify any issues before the examinee leaves. A future article will discuss high-quality IME reports.

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