Impaired decision-making capacity adults with research-

Background: Proper decision making capacity, adequate disclosure and voluntary decisions are basic constituents of informed consent which is required in surgical procedures, any interventions, any tissue collection, or any research involving the human participants. Time has gone by assembling or regulating effective laws for research involving persons with impaired decision making capacity. Still, question arises, is it ethical to enroll an incompetent person who is not physically or mentally fit to make a decision in risky research or interventional trials? If it is, how the informed consent and ethical measures can be taken? Method: Extensive literature review was done in Google scholar, PubMed and national or institutional websites with the corresponding keywords to summarize the cases of impaired decision making and regulation of informed consent and ethical measures in those cases.

Impaired decision-making capacity adults with research

Impaired decision-making capacity adults with research

Google Scholar 9. Crit Care Med. Table 2 Quantitative Vinyl panties from study information Impaired decision-making capacity adults with research Full size table. Reprints and Permissions. Recommendations for research practice To improve comprehension and uncertainty for decision-mmaking those involved in research with adults lacking capacity, there is a need for accuracy in the use of terms for consultees and legal representatives by researchers in study documents. Considerable variation was found in the written information sheets provided to proxies. For subjects with fluctuating decision making capacity or those with decreasing capacity to give consent, a re-consenting process with surrogate consent may be necessary. We also thank the members of Impairee Public and Patient Involvement group who kindly support the project.

Sissy univision. Background

All Rights Reserved. Like Us on Social Media. Conclusions Our study suggests that enrollment by surrogate authorization into stroke genetic Impaired decision-making capacity adults with research is often not approved by IRBs, and even when allowed is frequently not used. Researchers may consider the following questions to assess Picking things up while pregnant. PIs should seek counsel with Research Integrity staff on how to proceed. When participants lack the capacity to give consent, investigators may obtain permission from the legally authorized representative of a subject as described below. LARs who make research decisions on the basis of substituted judgment should be guided by their knowledge of the beliefs, views, and preferences of the subject. This consultation would enable the IRB to gather additional information and perspectives in carrying out its review and oversight responsibilities. Surrogates should be informed of the risks, benefits, and alternatives to the research when they are providing permission for an individual to participate. The PI is responsible for developing a monitoring plan which follows the guidelines outlines Impaired decision-making capacity adults with research for impaired decision making research participants.

Metrics details.

  • Psychiatric disorders e.
  • Apply to Medical School.

Metrics details. Research involving adults who lack the capacity to provide informed consent can be challenging. In England and Wales there are legal provisions for consulting with others who know the person with impaired capacity. Information about the study is usually provided to the proxy; however, little information is available to proxies about their role, or the appropriate legal and ethical basis for their decision, to help inform their decision-making.

The aim of this study was to analyse the written information that is provided to consultees and legal representatives. Studies including adults lacking capacity to consent which utilised consultees or legal representatives were identified using the UK Clinical Trials Gateway database. Information sheets and other study documents provided to proxies were obtained, and relevant content was extracted.

Considerable variation was found in the written information sheets provided to proxies. Particular discrepancies were found in information provided to those acting as consultees or legal representatives in a professional, as opposed to a personal, capacity. Incorrect uses of terminology were frequently found, and a small number of studies inaccurately interpreted the law. Future recommendations include ensuring proxies are provided with adequate and accurate information which complies with the legal frameworks.

Further research is needed to explore the information and decision-making needs of those acting as consultees and legal representatives. Informed consent is fundamental to ethically conducted medical research [ 1 ], but obtaining valid consent can be particularly challenging in specific practice contexts [ 2 ].

Individuals may be unable to provide consent for themselves due to an impairing medical condition that strikes suddenly like a stroke or causes a gradual loss of capacity such as dementia or due to profound learning disabilities. Any indication that the person would not have wished to participate must be respected [ 5 ]. Responsibility for deciding whether to include a person lacking capacity lies ultimately with the researcher [ 5 ]. The legal representative must be given the opportunity to understand the objectives, risks, and inconveniences of the trial, and then provides informed consent on behalf of the person who lacks capacity [ 6 ].

The term proxy is used in this paper to include both consultees and legal representatives acting in either a personal or professional capacity.

Written information about the study is tailored for proxies, usually in the form of an amended version of the information provided to participants themselves. Proxy versions of participant information sheets PISs and consent or declaration forms are not standardised, and there is minimal guidance available for researchers when drafting documents for studies involving adults lacking capacity, although templates are available [ 9 ].

There is no guidance for proxies about how their decision should be made or what to do if they are unable to determine what the person would have wanted.

Decision-making may be challenging for proxies. Preferences regarding future participation in research are rarely discussed and, for individuals who have never held relevant views and preferences, they will be impossible to determine. Proxies are acutely aware of the moral difference between deciding for oneself and deciding for others. They report that decisions about research participation are burdensome [ 10 ], and they experience varying degrees of comfort and confidence in proxy decision-making.

Many studies have empirically evaluated the readability and content of PISs and consent forms [ 11 , 12 , 13 , 14 , 15 ] and assessed participant comprehension [ 16 ]. However, no studies have examined written information provided to proxies. Documents can be considered as socially situated products which are produced, consumed, and used in organised settings, and understanding how they function is important [ 17 ]. Content analysis has been used in a range of academic disciplines, including social and healthcare sciences, and has been applied to a variety of data and to various depths of interpretation, using both qualitative and quantitative methodology [ 19 ].

The correct legal basis was determined by reference to the legislation governing research involving adults lacking capacity in England and Wales, the MCA [ 5 ], and CTR [ 6 ]. The UKCTG is primarily intended for patients to find relevant clinical trials to participate in, and so the database uses condition-specific search terms, in addition to filters such as trial status.

Studies which involved emergency research, and therefore a consent waiver, were excluded. A search strategy was designed to include trials conducted in different decisional contexts through classifying the circumstances under which proxy involvement is required, either as part of a progressive process, following a sudden or acute event, or to reflect long-term circumstances.

This necessitated a pragmatic search strategy which identified condition-specific search terms as required by the UKCTG that would capture trials across these three areas. It is recognised that a lack of capacity cannot be established by reference to a condition [ 5 ], and only some individuals living with these conditions will experience any cognitive impairment or impaired capacity specific to the particular enrolment decision.

Search terms to identify eligible studies were divided between three groups of decisional contexts:. All types of research designs were included. A sample of 30 studies was randomly selected from the list of eligible studies, stratified by the three groups of decisional context. In content analysis, there are no established criteria for the number of sampling units or objects to study; the sample size is based on the informational needs and the ability to answer the research question with confidence [ 20 ].

The sample size estimation for this analysis was derived from a similar study examining consent forms for clinical genetic content [ 15 ]. Studies were only eligible if study documents were available. Sampling continued until the target sample was reached. The sampling unit for inclusion was the study; the unit of analysis was the documents provided to proxies to provide information to help inform their decision-making for each study. Studies were allocated a unique reference number and anonymised to remove any identifiable information.

Study documents were reviewed and analysed for content relating to the role of the proxy and the decision about research participation, and the area of interest data extracted. The respective numbers and types of documents were recorded by individual study and per group progressive loss of capacity, acute loss of capacity, no prior capacity. Content analysis can take many forms [ 17 , 19 ].

This study was conducted using a pragmatic content analysis approach [ 17 ], incorporating both quantitative and qualitative analyses. Content areas, defined as parts of the text that address a specific topic, were identified and extracted.

Content was divided into that which informed the proxy as to why they had been approached, the basis for their decisions, how the proxy might approach making a decision, practical instructions to be followed, and information about withdrawal from the study.

The meaning unit or coding or content unit was defined as words, sentences, or paragraphs containing aspects related to each other through their content and context [ 19 ]. The documents were reviewed in order to ensure familiarity with the text, and the content areas from the study documents were extracted and entered into qualitative data analysis software NVivo The data were coded iteratively by one researcher VS , with discussion with the research team to increase the stability and reliability of the coding process.

Sample data extracts were regularly reviewed by the group to ensure consistency of coding. There are no universally adopted concepts for the headings used in content analysis [ 20 ]; however, themes were the broader overall concepts, and the categories were the smaller sub-themes that brought together a number of related meaning units.

Given the nature of data contained in these types of documents, a manifest analysis which stays closer to the original meaning and context was considered to be appropriate.

A summary of themes and categories was tabulated, with illustrative meaning units presented. The themes and categories were quantified to allow a greater representation of information [ 20 ]. There were no refusals. Content relating to why the proxy was being approached was found in all 42 study documents. One study advised the professional representative to ensure that there were no other known factors e. Only one non-CTIMP study directly stated that the responsibility to decide whether the participant should be entered into the research lies ultimately with the researcher ID The MCA has provisions for Advance Decisions to Refuse Treatment ADRT which relate to refusal rather than a positive request, and it refers to medical treatment decisions rather than those about research [ 5 ].

Assent is not a recognised term in legislation governing research involving adults in England and Wales, although it is a legally recognised term in paediatric research, and is used informally by some research professionals when referring to the involvement of adults who lack capacity to consent. Not all studies included the option of a professional acting as proxy, and it was not clear whether the person could take part in the study if no personal proxy was able or willing to be involved.

In spite of the shared legal basis of personal and professional proxies, some studies appeared to differentiate between them. This extended to consent forms for two clinical trials that both visually and in terms of content differed significantly from standard consent forms used in research, where the appearance was consistent with a letter and did not contain individual statements or boxes to be initialled, and no counter signature was required from the person obtaining consent ID 09, ID Unlike the personal legal representative consent forms, they did not include similar statements about providing consent for access to medical notes by the research sponsor or other representatives ID 09, ID 23 or consent to obtain a blood sample for analysis for the study and retention for future related studies ID For one study there was no information sheet for professional legal representatives, and in place of a consent form there was a small section to be completed on the baseline case report form ID One information sheet for professional legal representatives listed the inclusion and exclusion criteria as well as details about the dose of the medicinal product being investigated, its preparation and administration, and trial unblinding procedures, whereas the equivalent for a personal legal representative did not ID Some study documents conflicted with the regulatory frameworks through inaccurate interpretation of the legislation.

The CTR do not specify which family members or friends, or in what hierarchical order, the researcher should approach to act as legal representative [ 6 ]. Another instance included the requirement that mental capacity assessment be undertaken on all potential participants, during which specific details needed to be recalled by the person a care home resident prior to being deemed to have capacity to provide informed consent for the study ID The MCA clearly states that a person must be assumed to have capacity unless it is established that they lack capacity; this is a key principle of the Act s1 2 [ 5 ].

This study examined study documents provided to consultees and legal representatives who are involved in decisions about research participation on behalf of an adult who lacks capacity to consent. The database search in this study also confirmed findings from other studies that only very small numbers of studies include people who lack capacity [ 3 , 26 , 27 ].

All included studies could recruit participants both with and without capacity and had study documents for the participant themselves if appropriate these documents were not included in the study documents analysed. The length of information sheets varied considerably.

Information sheets for professionals acting as proxy median number of words were shorter than those for personal proxies words and for professionals and personal proxies jointly words. All studies had received Research Ethics Committee REC approval, and either they were currently recruiting participants or recruitment had been completed. Despite this, issues with incorrect terminology were common. This suggests that issues identified in a study which was conducted shortly after the introduction of the MCA, where the legal requirements for research involving incapacitated adults were not being consistently or correctly interpreted by researchers and RECs [ 29 ], are largely unchanged in the decade since.

This lack of clarity may contribute to the confusion and lack of understanding about the legislation by health and social care professionals [ 30 ], leading to the exclusion from research of those who lack capacity [ 4 ]. The discrepancy between the legislatory requirements and the research practice as a result of inaccurate interpretation of the law is also significant, as it may affect the identification and involvement of the correct proxy in the decision-making process and interfere with the appropriate legal and ethical basis for that decision.

Information sheets varied considerably in the content relating to how the proxy should make a decision, with 21 studies not providing any such information across a total of 29 documents. Four of the information sheets did not provide information about withdrawing the person from participating, and a further two provided it to the personal proxy only and not the professional acting as proxy ID 19, ID The few documents which advised that the patient should be involved in the decision were from studies being conducted with older people living in care homes.

The role of the professional representative was distinguished from that of the personal proxy in several of the studies, both in the amount and content of the information provided to them and in how their consent or advice was sought and documented. These may be intractable questions due to the nature of the requirements of the current legislation. There appeared to be a disconnect between the conceptualisation of advance decisions under the MCA and the wording used in the documents, which was based on the HRA template information sheet [ 9 ].

This was seen both in terms of differences in scope, as the MCA provisions relate specifically to ADRTs only [ 5 ], and because the negative orientation towards treatment options under the MCA means that an ADRT would be relevant only to studies involving the treatment that was being refused and not refusal of research in general.

Only one study ID 02 mentioned the role of a Lasting Power of Attorney LPA for health and welfare or a Court of Protection-appointed Deputyship who would be involved in decisions about care and treatment on behalf of a person with impaired capacity. However, the role of an LPA or Deputy in decisions about research remains unclear [ 35 ]. To the best of our knowledge, no previous studies have examined the information provided to proxies who are involved in decision-making about research participation by adults lacking capacity.

Studies involving different populations and study designs were included in order to represent a range of contexts in which proxy decision-making occurs. The searches were conducted using one database which is not necessarily intended for searches of this nature; therefore, the search for eligible studies is by no means considered exhaustive.

Studies could only be included where the documents were publicly available or where the investigators were willing to share the documents, and therefore selection bias may have been introduced. There were no refusals to provide study documents. Very small numbers of CTIMPs were found, and none of the included studies was sponsored or conducted by pharmaceutical companies.

Author manuscript; available in PMC Jan 5. DHHS Request for information and comments on research that involves adult individuals with impaired decision-making capacity. Patients who learn they are terminally ill, often experience an initial short-lived period of emotional shock and denial which impairs their capacity to provide consent. Survey instruments were coded to ensure nonduplication of data. Some investigators waited for sufficient stroke recovery to obtain informed consent. Where assent is a reasonable requirement, mere failure to object may not be construed as assent. The following additional safeguards may be useful to investigators designing and carrying out studies involving subjects with consent capacity impairments and to IRB members as they evaluate research proposals.

Impaired decision-making capacity adults with research

Impaired decision-making capacity adults with research

Impaired decision-making capacity adults with research

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Some individuals may be incompetent but not have a legal guardian. PIs should seek counsel with Research Integrity staff on how to proceed. Individuals with impaired capacity to consent may be especially vulnerable to therapeutic misconception. Investigators must ensure participants and their families or caretakers are aware of the experimental nature of the research, including the uncertainty of benefits.

For some research involving individuals with impaired decision-making capacity, additional safeguards may be advisable. For example, researchers and the IRB may consider using. The University IRB includes members who are familiar with decision-making capacity impairments and will seek the expertise of qualified consultants when additional expertise is warranted.

The IRB may seek the advice of University Counsel to determine the applicability of state laws that might affect the participation of legally incompetent persons in research. Research Integrity. About Us. Human Research. Research Misconduct. Investigators planning research in which adults with impaired decision-making capacity will be enrolled must provide the IRB with a scientific reason for involving this population in the research, plan for assessing capacity to consent, plan for obtaining surrogate consent as appropriate , plan to obtain subject assent or description of why subject assent is not feasible , and description of the procedures that are designed to minimize risks to participants.

Justification for Including Individuals with Impaired Decision-Making Capacity in Research Individuals with impaired decision-making capacity may be enrolled in research only when their participation in the study is justified, capacity to consent is assessed and documented, and provisions for surrogate permission are in place for participants who are incompetent. Assessing Capacity to Consent to Participation in Research The capacity to consent of individuals with impaired decision-making capacity may be unknown.

Fluctuating or Diminishing Capacity to Consent For conditions in which decision-making capacity may fluctuate, PIs must include mechanisms to monitor the capacity of individual participants on an ongoing basis. Researchers may consider the following questions to assess understanding: We are inviting you to be in a research study. Do you have to be in the study? What will happen if you agree to take part in this study?

What will happen if you decide not to be in the study? What other care is available to you if you decide not to be in the study? How might this study help you? How might this study cause you harm? What should you do if you agree to be in the study but want to stop later? Adjudicated Incompetence Persons formally adjudged incompetent have a court-appointed guardian. Vulnerability to Therapeutic Misconception Individuals with impaired capacity to consent may be especially vulnerable to therapeutic misconception.

Additional Safeguards For some research involving individuals with impaired decision-making capacity, additional safeguards may be advisable. For example, researchers and the IRB may consider using independent assessment of capacity to consent; use of standardized instruments to assess capacity to consent; independent clinician, monitors, or participant advocates during the consent process; special techniques to deliver information to prospective and enrolled participants e.

Risks associated with genomic research are not well documented, and beliefs regarding these risks vary greatly. Nevertheless, some IRBs may judge the risk, even when minimal, to be too great to allow surrogate enrollment.

In SWISS, the risk associated with participating is that of sending a letter inviting siblings to participate and of giving a double-coded blood sample for genome-wide scan and linkage analysis. Researchers in many other brain disorders also find that use of surrogate decision-makers in research is not straightforward ethically or practically. The two other mechanisms, research advance directives and awaiting return of decision-making ability, are unfortunately not feasible alternatives.

Some investigators waited for sufficient stroke recovery to obtain informed consent. In general, the term consent bias is applied to the negative effect on external validity attributable to individuals declining to participate in research.

Consent bias in clinical trials research has been well recognized. When the determinants of severity are some of the very factors sought in the studies or on the same causal pathways, there is potential for significant confounding and at worst may completely obscure important associations. Our survey addresses the issue of enrolling individuals with impaired decision-making capability in the context of a single multisite study at 2 time points.

The large number of sites and the high response rates are strengths. Our study does not seek explanations for current IRB and investigator practices. Nonetheless, at least in practice, many IRBs appear to treat genetic research as carrying considerable risks to participants by prohibiting surrogate authorization. Currently, there are few viable strategies for enrolling decisionally-impaired adults in genetic studies, even when their enrollment may be necessary for scientific validity.

Enrollment by surrogate authorization is one such strategy that is frequently allowed in other types of research. We find that use of surrogate authorization is frequently not permitted or is underutilized in genomic research.

This situation has implications for scientific validity of genomic research on many brain disorders of public health significance. The authors thank David Wendler for comments on a previous draft. Drs Chen and Worrall had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

National Center for Biotechnology Information , U. Author manuscript; available in PMC Jan 5. Donna T. Meschia , MD, Thomas G. Brott , MD, Robert D. Brown , MD, Bradford B. Author information Copyright and License information Disclaimer. Mayo Clinic, Rochester, Minn. Correspondence to Bradford B. E-mail ude. Copyright notice.

The publisher's final edited version of this article is available at Stroke. See other articles in PMC that cite the published article.

Abstract Background and Purpose In stroke and other brain disorders, severely affected phenotypes often impair decision-making capacity. Conclusions Our study suggests that enrollment by surrogate authorization into stroke genetic research is often not approved by IRBs, and even when allowed is frequently not used.

Keywords: research ethics, genetic research, informed consent, proxy, third-party consent. Open in a separate window. Discussion In ischemic stroke, severe outcomes cause decisional impairment and severity may have genetic determinants.

Summary Currently, there are few viable strategies for enrolling decisionally-impaired adults in genetic studies, even when their enrollment may be necessary for scientific validity. Acknowledgments The authors thank David Wendler for comments on a previous draft. Footnotes Disclosures Drs Chen and Worrall had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

References 1. Impact of restricting enrollment in stroke genetics research to adults able to provide informed consent. Thromb Res. IL1RN intron 2 polymorphism caused by variable number tandem repeats is associated with 1-year outcome in patients with ischaemic stroke. J Neurol Neurosurg Psychiatry. DHHS Code of federal regulations ; Science and society: Children and incompetent adults in genetic research: Consent and safeguards.

Nat Rev Genet. DHHS Request for information and comments on research that involves adult individuals with impaired decision-making capacity. Federal Register. BMC Med Genet. The impact of privacy protections on recruitment in a multicenter stroke genetics study. A survey of the SWISS researchers on the impact of sibling privacy protections on pedigree recruitment.

Glutathione s-transferase P1 and T1 gene polymorphisms predict longitudinal course and age at onset of Alzheimer disease. Am J Geriatr Psychiatry. Apolipoprotein e4 allele presence and functional outcome after severe traumatic brain injury. J Neurotrauma. The met allele of the BDNF Val66Met polymorphism predicts poor outcome among survivors of aneurysmal subarachnoid hemorrhage. The effect on risk estimates of excluding cases from a case-control study of ischemic stroke. What makes clinical research ethical?

Wendler D. Informed consent, exploitation and whether it is possible to conduct human subjects research without either one. The burden of complex genetics in brain disorders. Arch Gen Psychiatry.

Background: Proper decision making capacity, adequate disclosure and voluntary decisions are basic constituents of informed consent which is required in surgical procedures, any interventions, any tissue collection, or any research involving the human participants. Time has gone by assembling or regulating effective laws for research involving persons with impaired decision making capacity. Still, question arises, is it ethical to enroll an incompetent person who is not physically or mentally fit to make a decision in risky research or interventional trials?

If it is, how the informed consent and ethical measures can be taken? Method: Extensive literature review was done in Google scholar, PubMed and national or institutional websites with the corresponding keywords to summarize the cases of impaired decision making and regulation of informed consent and ethical measures in those cases. If a person has factual understanding, implies a certain level of rational belief, knows to manipulate information to arrive at a choice and remains stable on the choice, is known to be capacitated in decision making.

Although a definite line between decisional capacity and incapacity is still in question, many assessment tools are available to conclude it. But, these conditions should not prevent anyone from understanding, choosing, or accepting any intervention as sometimes they may have some preserved abilities too. As per accepted ethics, respect for persons incorporates at least two ethical convictions.

First, the individual should be treated as an autonomous agent and second, the person with diminished autonomy is entitled to protection. But surrogacy should be reviewed by the institutional review board IRB. Multimedia consent process, advanced consent directives, rational consent waiver and many other processes are practiced in case of ethical research involving decisional incapacitate persons which are discussed in the paper.

Conclusion: It should be clarified by the IRB whether involvement of impaired subjects has beneficial scientific aim or not. Capacity assessment system should be in an organized and systemic way. Threshold for capacity and recognition of persons able to conduct this process should be fixed.

Role of surrogacy and involvement of IRB to align it in a proper manner is always a matter of concern. Consideration of risk management, subjects autonomy and assent-dissent issues should be clarified in research.

This license permits use, distribution and reproduction in any medium, provided the original work is properly cited, is not changed in any way, and is not used for commercial purposes. Skip to main content Skip to main navigation menu Skip to site footer. Abstract Background: Proper decision making capacity, adequate disclosure and voluntary decisions are basic constituents of informed consent which is required in surgical procedures, any interventions, any tissue collection, or any research involving the human participants.

Downloads Download data is not yet available. How to Cite. Biswas, T. Bangladesh Journal of Bioethics , 7 1 , Vol 7 No 1 Current Issue. Information For Readers For Authors.

Impaired decision-making capacity adults with research