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Wellcome Trust and Medical Research Council
Framework on the feedback of individual health related findings in research
Summary
During a study involving human participants, researchers may make a finding that is relevant
to an individual’s health. Potential ‘health related findings’ (HRFs) include both incidental
findings and pertinent findings that relate to the aims of the study.
In the absence of general UK-wide guidelines for researchers and clear ethical consensus
on how HRFs should be handled, the Wellcome Trust and Medical Research Council have
developed this Framework to support researchers’ decisions about individual feedback. This
Framework is intended to help researchers design and implement a proportionate approach
to HRFs that protects research participants. This Framework will be kept under review and
updated as necessary.
This Framework sets out points to consider in deciding whether individual feedback is
appropriate for the study; determining what information should be included in the consent
process; and in designing feedback mechanisms where feedback is to be provided. The
Framework is designed to apply to all types of research involving human participants,
wherever the research is conducted. This Framework is relevant to researchers establishing
new studies or reconsenting participants in existing studies.
A. Introduction
1. During a study involving human participants, researchers may make a finding that is
relevant to an individual’s health. Potential ‘health related findings’ (HRFs) include
incidental findings – “a finding that has potential health or reproductive importance, which
is discovered in the course of conducting research, but is beyond the aims of the study”1
– and pertinent findings that relate to the aims of the study. In the context of this
guidance we consider health-related findings to include only those findings with potential
clinical relevance. HRFs may result from many types of research involving human
participants, such as imaging and genetic studies and studies involving physiological
measurements or assays. Depending on the type of tests involved, HRFs will vary in
both their nature and the frequency with which they arise.
2. Since potential HRFs are identified from research data, rather than from data or samples
gathered for specific clinical evaluation, further clinical and analytical verification may be
required to assess their significance. In addition, expertise beyond that of the research
team may be required in the assessment and reporting back of an incidental finding.
Complex issues such as these mean that the most appropriate way to manage HRFs in
research is currently a topic of intense debate.
3. In developing this Framework we have considered a wide range of ethical and legal
principles that relate to this issue, including autonomy; beneficence and nonmaleficence; and duty of care. One of the key ethical considerations is how to balance
the potential benefit to the participant, by enabling them to seek medical intervention or
change their behaviour in relation to a known condition, with the potential harms created
by this knowledge, for example the stress caused and implications for the purchase of
insurance. Some principles are beginning to emerge from these deliberations in the
1
Wolf et al J Law Med Ethics (2008) 36: 219
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international research community, for example that findings should only be reported back
where they are clinically significant and the condition is serious and treatable.
4. In the absence of general UK-wide guidelines for researchers and clear ethical
consensus on how health related findings should be handled, the Wellcome Trust and
Medical Research Council have developed this Framework to support researchers’
decisions about individual feedback. This Framework is intended to help researchers
design and implement a proportionate approach to HRFs that protects research
participants. This Framework will be kept under review and updated as necessary.
5. The development of this Framework has been informed by wider project, including: a
literature review focused on the legal and ethical issues;2 a review of existing policies
and practice; an analysis of the costs and timescales associated with feedback in
genetics and imaging studies; and research on public attitudes towards the feedback of
HRFs.3
B. What do we expect of researchers?
6. This Framework sets out points to consider in deciding whether individual feedback is
appropriate for the study; determining what information should be included in the consent
process; and in designing feedback mechanisms where feedback is to be provided. The
Framework is designed to apply to all types of research involving human participants,
wherever the research is conducted. This Framework is relevant to researchers
establishing new studies or reconsenting participants in existing studies.
7. There is not yet consensus on how health related findings should be handled. However,
internationally there appears to be a movement towards individual feedback, for example
the Canadian Tri-Council Policy Statement, which applies to all research in institutes that
receive public funding, mandates the disclosure to the participant of “any material
incidental findings discovered in the course of research”.4
8. Therefore, as a minimum requirement, we expect researchers to carefully consider
issues around HRFs when establishing a study or reconsenting participants. In
particular, researchers must:
 consider whether or not individual feedback will be provided as part of the
study and be able to demonstrate the reasoning behind their approach to
funders, the Research Ethics Committee and the research participants
(Section C)
 include information on individual feedback in the consent process whether or
not feedback will be provided (Section D)
 in cases where feedback is to be provided, consider the decision making
Framework and mechanism of feedback (Section E)
2
http://www.wellcome.ac.uk/stellent/groups/corporatesite/@msh_peda/documents/web_document/wtx058032.pdf
http://www.wellcome.ac.uk/About-us/Publications/Reports/Public-engagement/WTVM055197.htm
4
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
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C. Points to consider in developing an approach to individual feedback
Researchers must consider issues around HRFs at study set up, or when reconsenting
participants, to decide whether it is appropriate to feed back health related findings to
individuals. In making this decision, points to consider include:
i What is the likely nature of health related findings?
The type of HRFs that may be identified will depend on the nature of the study. Researchers
should consider: the probability of identifying HRFs; the potential severity of HRFs; the
nature of the test and the chance of false positives; and whether potential HRFs are likely to
be actionable, that is whether there are available and accessible strategies for treatment or
prevention. Researchers should use this information to help them consider the relative
benefits and harms of providing feedback to participants in the context of that study.
ii What is considered good practice in the field of the study?
In the UK, practices around health related findings vary widely between disciplines and
institutions. However, sector-specific guidance is beginning to emerge, for example the
Royal College of Radiologists have produced recommendations for the management of
incidental findings in research imaging.5
iii Do the researchers have a responsibility to feedback?
Researchers should consider their responsibilities and those of others involved in the study
with respect to feedback. For example, a clinician’s legal duty of care may put them in a
different position regarding feedback than a researcher who is not a medical doctor.
iv What is the nature of the relationship between the participant and researchers?
The relationship between the researcher and participant is important as it may affect a
number of factors including the researcher’s legal duties, for example in a doctor-patient
relationship; practical aspects of feedback; and participants’ expectations. Where
researchers are secondary users of data or samples obtained by another, it is important that
they understand the policies and practice of the original data or sample holder.
In research involving vulnerable populations such as adults lacking capacity or children,
researchers should give special consideration about how participants and/or their
representatives would make decisions about and respond appropriately to feedback.
v How long is likely to pass between recruitment or last contact and feedback?
Research on public attitudes towards HRFs found that generally there is a strong preference
for feedback. However, the passage of time between when a participant was recruited to a
study and when they would receive feedback had some impact on this preference for
feedback. While some felt feedback should still be provided after any length of time, others
considered that they would not want to be contacted about a potential finding if years had
passed since they last had contact with researchers. There is no consensus about how to
handle the issue posed by the potential gap between recruitment and making a potential
finding. The US National Heart Blood and Lung Institute’s guidance on incidental findings
approaches this by recommending that “a researcher’s obligation to return individual
research results to a study participant should not ordinarily extend beyond study funding.”6
5
https://www.rcr.ac.uk/docs/radiology/pdf/BFCR(11)8_Ethics.pdf
Fabsitz et al (2010) Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants.
Circulation: Cardiovascular Genetics 3:574-580
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In developing an approach to individual feedback, researchers should consider when in the
course of a study HRFs may be identified and when they will have contact with the research
participant.
vi What are the practical implications for the study?
There are practical issues that must be taken into account in developing an approach to
individual feedback.
Where studies are reconsenting participants, researchers should consider the nature of the
original consent. The approach to feedback in the original consent may influence the
development of new approaches to feedback because of its important impact on participants’
expectations. However, the nature of the original consent cannot be relied upon as the main
argument underpinning the development of a new approach feedback.
Researchers should consider how logistical issues might affect the ability to provide
feedback. For example, will researchers have up-to-date records of participants in order to
deliver feedback through an appropriate route? There will often be resource implications
associated with the robust reporting of individual findings. Researchers should consider the
potential resource burden of the approach that they plan to adopt to ensure that this is
sustainable and does not compromise the aims of the study. Research on public attitudes
towards HRFs showed that a majority of participants agreed that due to the potential benefits
to society, large scale studies should still go ahead even when they cannot provide feedback
due to logistical or cost reasons.
D. Points to consider in the consent process
The consent process is important to manage participants’ expectations about individual
feedback. There is a growing consensus that the consent process should include information
on whether or not participants would receive feedback about health related findings, to
enable them to make an informed decision about taking part. For example, the US
Presidential Commission for the Study of Bioethical Issues has recommended that
researchers “make individuals aware that incidental findings are likely to be discovered in the
course of whole genome sequencing” and convey information on genetic findings in the
consent process.7
Researchers should be prepared to explain to participants why they adopted a particular
approach to feedback.
In studies where feedback may be provided, the following points should be considered in
deciding what information to provide to participants:
i Do participants have a choice whether or not to receive feedback?
Some research participants may not want information on a potential finding fed back to
them. It is therefore important for research participants to understand whether and how the
conditions of the study allow the “right not to know” to be fulfilled.
ii What is the scope of feedback that a participant could receive?
In order to make an informed choice about feedback it is important that potential participants
understand the types of findings that could be fed back to them. For example, important
information might include the likelihood of a relevant finding being made and the types or
categories of conditions where feedback would be considered, for example where a finding
indicates a condition that is serious but actionable.
7
http://bioethics.gov/cms/sites/default/files/PrivacyProgress508.pdf
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iii What information do participant’s need about how feedback will be delivered
and the support they will receive?
Researchers should consider providing accessible information on how feedback would be
delivered if the situation arises and the support that would be available to a participant to
follow up and seek the additional help they need.
E. Points to consider in designing feedback mechanisms
Mechanisms for feedback
In studies where feedback will be provided, it is important that the mechanisms for providing
feedback are considered at the outset rather than at a point when this becomes necessary.
An appropriate chain of responsibilities must be in place and researchers should consider
how to provide appropriate support to participants receiving feedback. The following points
should be taken into account in designing the feedback mechanism:
i Who is likely to identify potential findings?
Researchers should consider the relevant skills, expertise and seniority of the individual who
may first come across a potential finding. It should be clear should be how and when this
individual will make a decision about whether the finding needs to be considered further. It
may be necessary for the finding to be referred to someone with specialist expertise for
consideration and arrangements to access necessary expertise should be considered as the
protocol is developed.
ii Does the finding need to be verified?
Following initial identification of a finding, further analysis may be needed to verify the
finding, for example the repetition of tests on an independent sample. It may be necessary to
involve the participant before analytical validity can be assured, for example where they
need to provide a new sample or be present for a test. Researchers should consider how
any analytical verification will be achieved and how to appropriately involve the patient in this
process, where necessary.
iii What criteria will be used to judge if it is appropriate to feed back in an
individual case and who will make this decision?
In each case of a finding being made it will be important to consider the balance of the
potential benefits and harms to the research participant in order to decide whether the
finding is fed back. A range of factors will be important in this decision including the personal
circumstances of the participant, such as age, and information about the relevant condition.
While there is no definitive view on how the characteristics of a condition determine whether
it should be fed back, there is an emerging consensus that findings should only be reported
back where they are clinically significant and the condition is serious and actionable. For
example, for a range of genetic variants Berg et al. considered the potential impact of the
condition and whether the finding was “medically actionable” to establish a model for
defining an appropriate response.8
In developing a mechanism for feedback, researchers should consider the criteria that will be
used to decide whether it is appropriate to provide feedback in a given case and which
person or group of people will be responsible for making this decision.
8
Berg et al (2011) Deploying whole genome sequencing in clinical practice and public health: Meeting the challenge one bin at
a time. Genetics in Medicine 13(6): 499-504.
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iv Who will feed back to the participant and how and when will feedback be
delivered?
Researchers should consider who would provide feedback to the participant, ensuring that
they have the necessary expertise. It is also important to consider how the feedback would
be delivered, for example in a face to face meeting or over the telephone, and how the
feedback would be delivered in a timescale that is appropriate to the finding identified.
Researchers should consider how to ensure that participants have access to appropriate
support to understand and be able to implement the choices or actions that need to be taken
following feedback, for example referral to a specialist.