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This multipart review provides an overview of innovative approaches to improving and expanding the informed consent process for researchers and participants, along with short essays covering specific areas of innovation.
The Changing Face of Informed Consent
Christine Grady, R.N., Ph.D.
In the classic interaction in which informed consent is obtained for research, an investigator presents the potential participant with information regarding a new therapeutic, diagnostic, or prophylactic intervention and then asks the participant to read and sign a detailed written consent document. This traditional prototype is becoming outdated. Informed consent, which is ethically essential in most clinical research, respects persons’ rights to decide whether participation in the research is compatible with their interests, including their interests in protection from exploitation and harm.1,2 In the process of informed consent, participants are given an opportunity to understand relevant information about research participation and to make a voluntary choice.3 Required by ethical guidelines and regulations unless explicitly waived by institutional review boards,4–7 informed consent is thus a means of protecting the rights and welfare of participants while they contribute to the advancement of knowledge.
Over the past 50 years, the informed consent process has become increasingly regulated and standardized, while the challenges remain persistent and hard to overcome.8 Consent forms are increasingly long and complicated, obscuring important details, and are often designed to serve the interests of institutions and sponsors. Data show that participants often have a limited understanding of study information even when they have signed a consent form.8 Technological advances driving changes in research methods and information practices have influenced how we think about informed consent for research, which raises the possibility of new approaches to informed consent and innovative options for obtaining it.
Changing Research Methods
Unprecedented opportunities to answer important clinical research questions are available through the analysis of massive amounts of data (“big” data) in commercial, health care, research, and government databases, in social media and mobile devices, and in growing collections of biologic specimens and clinical and genomic data. Data are amassed quickly and easily, sometimes through passive technologies such as location-based mobile devices, through registries, or through systems of electronic health records or data and biospecimens collected for other purposes. Innovative studies...