Ethics Oversight of Participant Led Medical Research: Problems and Prospects
|
If you are the presenter of this abstract (or if you cite this abstract in a talk or on a poster), please show the QR code in your slide or poster (QR code contains this URL). |
Abstract
Background
Participant-led health research (PLR) has emerged as a significant phenomenon, with the results of such research appearing in leading medical journals. PLR differs from standard research in that the research project is typically initiated or conducted by participants rather than by investigators attached to official research institutions. PLR promises multiple benefits, including research into topics marginalized by the scientific establishment, and speedier publication of results, including negative results. Moreover, it empowers and involves individuals within the enterprise of scientific research. However, like all research involving human subjects, PLR is subject to ethical and scientific standards of appraisal. In standard research, such appraisal is conducted by institutional review boards (IRBs). The question that arises is how appropriate ethical scrutiny may be secured in PLR and whether this demands employing IRB review.
Objective
The paper argues that the form of ethical oversight appropriate to a form of research should be tailored to its distinctive nature. In particular, it seeks to formulate standards of ethical oversight that are adapted to how PLR may saliently differ from standard research, and appropriate mechanisms for implementing those standards.
Methods
The primary method to be adopted is a form of reflective moral reasoning keyed to the salient differences between PLR and standard research with regard to the types of ethical concern that they raise. A related focus of investigation will be a comparison of the effectiveness of IRBs with novel mechanisms of ethical oversight; in particular, a key question will be whether we can realistically conceive of less formal, more flexible replications of the sort of ethical oversight provided by IRBs. One alternative model of ethical oversight that will be discussed is the idea of crowd-sourcing ethics review.
Results
The paper generates results at two levels. The first concerns the general obligation of ethical oversight that applies to PLR. In view of the comparison with standard research, it will be proposed that the appropriate form of ethical oversight of PLR projects depends on which of three categories they fall into. In the first category, which satisfies what I call the ‘institution-plus’ criterion, standard IRB review is mandatory. For forms of PLR that do not satisfy this criterion, the appropriate form of ethical oversight depends on whether or not the research involves a more than minimal risk. If it does not, no formal ethics review is required. If it does, some kind of formal review is required, but it need not be by an IRB. The second level at which the paper generates results is to consider alternative forms of ethical review for this second category of cases, in particular, how a form of ‘crowdsourcing’ ethics review might be appropriately implemented.
Conclusions
The novel form of research represented by PLR requires us to re-think best practice standards and mechanisms of ethical oversight, to ensure that we can derive the promised benefits of such research without unduly compromising the relevant ethical considerations bearing on research with human subjects.
Participant-led health research (PLR) has emerged as a significant phenomenon, with the results of such research appearing in leading medical journals. PLR differs from standard research in that the research project is typically initiated or conducted by participants rather than by investigators attached to official research institutions. PLR promises multiple benefits, including research into topics marginalized by the scientific establishment, and speedier publication of results, including negative results. Moreover, it empowers and involves individuals within the enterprise of scientific research. However, like all research involving human subjects, PLR is subject to ethical and scientific standards of appraisal. In standard research, such appraisal is conducted by institutional review boards (IRBs). The question that arises is how appropriate ethical scrutiny may be secured in PLR and whether this demands employing IRB review.
Objective
The paper argues that the form of ethical oversight appropriate to a form of research should be tailored to its distinctive nature. In particular, it seeks to formulate standards of ethical oversight that are adapted to how PLR may saliently differ from standard research, and appropriate mechanisms for implementing those standards.
Methods
The primary method to be adopted is a form of reflective moral reasoning keyed to the salient differences between PLR and standard research with regard to the types of ethical concern that they raise. A related focus of investigation will be a comparison of the effectiveness of IRBs with novel mechanisms of ethical oversight; in particular, a key question will be whether we can realistically conceive of less formal, more flexible replications of the sort of ethical oversight provided by IRBs. One alternative model of ethical oversight that will be discussed is the idea of crowd-sourcing ethics review.
Results
The paper generates results at two levels. The first concerns the general obligation of ethical oversight that applies to PLR. In view of the comparison with standard research, it will be proposed that the appropriate form of ethical oversight of PLR projects depends on which of three categories they fall into. In the first category, which satisfies what I call the ‘institution-plus’ criterion, standard IRB review is mandatory. For forms of PLR that do not satisfy this criterion, the appropriate form of ethical oversight depends on whether or not the research involves a more than minimal risk. If it does not, no formal ethics review is required. If it does, some kind of formal review is required, but it need not be by an IRB. The second level at which the paper generates results is to consider alternative forms of ethical review for this second category of cases, in particular, how a form of ‘crowdsourcing’ ethics review might be appropriately implemented.
Conclusions
The novel form of research represented by PLR requires us to re-think best practice standards and mechanisms of ethical oversight, to ensure that we can derive the promised benefits of such research without unduly compromising the relevant ethical considerations bearing on research with human subjects.
Medicine 2.0® is happy to support and promote other conferences and workshops in this area. Contact us to produce, disseminate and promote your conference or workshop under this label and in this event series. In addition, we are always looking for hosts of future World Congresses. Medicine 2.0® is a registered trademark of JMIR Publications Inc., the leading academic ehealth publisher.
This work is licensed under a Creative Commons Attribution 3.0 License.