Broad Consent for Future Research: International Perspectives

Abstract

In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect it will have on research and whether it adequately protects the interests of research participants. There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation.

Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study

“…Finally, although there are serious risks connected to the use of health data, such as loss of data and misuse, these risks are different in kind and arguably less severe than risks of clinical research [12]. Accordingly, in the conceptual ethical debate about alternative consent models for data-or biospecimen-based research, broad consent to unspecified future research is suggested as an alternative to specific consent [12,15]. The main issues highlighted as problematic in this debate so far regard the problem of consenting to research that is as of yet unknown.…”

“…The GDPR biobank debate does not touch upon possible alternative forms of consent, though. In biobank research today, broad consent is the standard and widely accepted model of consent [15]. Attitudes towards data sharing for health research have been studied in the US as well as in Europe and some meta-studies have attempted to summarize the results [22,[34][35][36][37].…”

“…Likewise, meta-consent implements tiered consent on an online platform, including options to ask for study specific consent or to opt for broad consent. [12][13][14][15]. The General Data Protection Regulation (GDPR), which was introduced in the EU in 2018, constitutes an important part of existing governance frameworks.…”

Ethical Considerations for Artificial Intelligence in Medical Imaging: Data Collection, Development, and Evaluation

“…Obtaining explicit informed consent from every data subject for each specific reuse of deidentified data would be costly. Some have therefore argued that patients should be asked to provide broad consent to the use of their deidentified data for future secondary research projects (12). More radically, some argue that after deidentification there is no owner of the data and that consent thus should be replaced by an enhanced duty of care to ensure data use is appropriate (13).…”

Legal and Ethical Challenges of International Direct-to-Participant Genomic Research: Conclusions and Recommendations

“…Broad consent (i.e., a single consent for future, unspecific uses of data for scientific research) 75 is another important area where the GDPR defers heavily to EU or Member State law. Recital 33 allows Member Nations to permit broader, less specific consent than would generally be allowed by Article 9.…”