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Please note:
The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.
Consent
[NS 1.7 - 1.12, 15.4 - 15.8, 16.9 - 16.14 and Commentary. 'Consent' is also discussed in other relevant sections of the Commentary.]
Trust
Consent is widely believed to affirm the autonomous decision-making rights of prospective research participants, and their capacity to protect their own interests. However, this belief can also be seen as simplistic, for it can seem to ignore the wrongness even of asking people to consent to some proposals (for example, to becoming enslaved). [Footnote 21] In biomedical research, for example, many research participants who are also patients trust their physician, who is also the researcher, to guide them through this decision-making process. [Footnote 22]
A 'Subject Interview Study' conducted by the United States Advisory Committee on Human Radiation Experiments found, not surprisingly, that many factors influenced patients' decisions to participate. [Footnote 23] What is striking about this research, and other studies, [Footnote 24] is the profound trust that participants placed in researchers and the research enterprise. However, while it is no doubt true, as E.D. Pellegrino has suggested, that trust is essential to all human relationships [Footnote 25] and that this is a critical aspect of the relationship under discussion, trust does not necessarily protect the vulnerable party to a relationship from being harmed. [Footnote 26] Taking advantage of participants' vulnerabilities is a serious abuse of trust and HRECs must safeguard research participants against this.
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Forms of consent
Consent to participation in research should normally be provided by participants themselves. However, there may be circumstances where other forms of consent are acceptable.
- Deferred consent is where the subject is entered into a research study and consent is gained from surrogates after a specified period of time for continuation of the subject's inclusion in the trial. This form gained popularity in the research community in the 1980s but was abandoned by the US Department of Health and Human Services on legal advice in 1993.
- Prospective informed consent represents an attempt to canvass support in advance from a population considered at risk of developing a serious illness. This approach suffers from all the weaknesses associated with advance directives, and is rarely applicable to the conditions relevant to emergency research, such as sudden cardiac arrest or motor vehicle trauma.
- Surrogate consent (ideally a substituted judgement made by a person responsible for health care decision-making for a particular patient under the relevant legislation) has been questioned, but remains the standard for autonomous health care decisions in incompetent patients. This form of consent remains relevant in all but the most emergency situations, and offers some reassurance that the requirements described above have been considered.
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Consent and inducement
Inducement involves the offer of excessive and inappropriate reward in order to obtain compliance from potential research participants. Examples of inducements may include payment for research participation, offers of subject credits to students, or promises of leniency to prisoners.
Inducements compromise the ability of the potential participant to make a free choice. However, exactly what constitutes excessive or inappropriate reward can be difficult for an HREC to determine. Monetary compensation appropriate for volunteers of a medium socioeconomic group (or for a member of an HREC), could well constitute an inducement for volunteers of a lower socioeconomic group. Economic disadvantage and/or low self-esteem may be found among certain dependent groups. Both these factors make exploitation by way of inducement far more likely. But equally, people in dependent relationships should not be exploited by denying them due reward for taking part in research projects.
Payment may induce the participation of those who are most vulnerable, leading to exploitation of the poor as research participants for the primary benefit of the rich. Indeed, there is some evidence to support this view. [Footnote 27] However, at the same time, a certain level of payment may constitute fair recognition of the contribution that participants make to research. In assessing whether a payment constitutes an inducement, as opposed to appropriate recompense, HRECs need to evaluate each research proposal within its specific context. Committees will need to weigh the risks associated with participation, the relative freedom of potential participants to refuse to take part uninfluenced by an offer of payment, and the degree of the participant population's vulnerability to exploitative offers.
Further reference should be made to the Research Ethics Collection, ' Prisoners, research involving ', page E121, for a more detailed discussion of these issues, and to the Research Law Collection, ' Consent ', page L13, for a discussion of legal issues.
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Consent, refusal and withdrawal
Withdrawal of consent to further participation needs to be distinguished from removal of all data related to the participant who withdraws. In some cases, where all data about the participant are identifiable, withdrawal of consent can be accompanied by withdrawal or destruction of data relating to that participant. In other cases it may be practically impossible to withdraw information specific to a particular participant, or it may be that the research would be undermined were such withdrawal to take place.
It is important to distinguish between 'identifiable', 'potentially identifiable' and 'de-identified' data. If data are identifiable, they will be possible to track that data belonging to a particular individual and, in some situations, remove them from the collected research data. If data are de-identified, it cannot be identified and tracked. That is, all identifiers have been removed from the data and it is therefore impossible to retrieve or expunge information related to a particular individual. 'Potentially identifiable' data, though not immediately identifiable, may be re-identified via the code used to replace participant identifiers, such as the name of the participant concerned. Therefore, it may be possible to retrieve and expunge potentially identifiable data when a participant withdraws consent.
However, it may be difficult or time-consuming for the researcher to retrieve a sample. An HREC must also consider whether the validity of the study could be affected by withdrawing such a sample.
If it is initially intended that a sample or data not be withdrawn after a particular stage in the research process, then this should be made clear on any information sheet or consent form given to potential participants. A researcher should also be asked to justify the rationale for this requirement.
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Handbook TOC
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Abbreviations
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Commentary on the National Statement
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A Research Ethics Collection
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A Research Law Collection
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Bibliography
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Appendices
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