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The Conduct of Canadian Researchers and Institutional Review Boards regarding Substituted Consent for Research Author(s): Gina Bravo, Marie-France Dubois and Mariane Pâquet Source: IRB: Ethics and Human Research, Vol. 26, No. 1 (Jan. - Feb., 2004), pp. 1-8 Published by: The Hastings Center Stable URL: http://www.jstor.org/stable/3563580 . Accessed: 15/06/2014 12:19 Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at . http://www.jstor.org/page/info/about/policies/terms.jsp . JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact [email protected]. . The Hastings Center is collaborating with JSTOR to digitize, preserve and extend access to IRB: Ethics and Human Research. http://www.jstor.org This content downloaded from 185.44.78.156 on Sun, 15 Jun 2014 12:19:45 PM All use subject to JSTOR Terms and Conditions

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Page 1: The Conduct of Canadian Researchers and Institutional Review Boards regarding Substituted Consent for Research

The Conduct of Canadian Researchers and Institutional Review Boards regarding SubstitutedConsent for ResearchAuthor(s): Gina Bravo, Marie-France Dubois and Mariane PâquetSource: IRB: Ethics and Human Research, Vol. 26, No. 1 (Jan. - Feb., 2004), pp. 1-8Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563580 .

Accessed: 15/06/2014 12:19

Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at .http://www.jstor.org/page/info/about/policies/terms.jsp

.JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range ofcontent in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new formsof scholarship. For more information about JSTOR, please contact [email protected].

.

The Hastings Center is collaborating with JSTOR to digitize, preserve and extend access to IRB: Ethics andHuman Research.

http://www.jstor.org

This content downloaded from 185.44.78.156 on Sun, 15 Jun 2014 12:19:45 PMAll use subject to JSTOR Terms and Conditions

Page 2: The Conduct of Canadian Researchers and Institutional Review Boards regarding Substituted Consent for Research

IR A I

ii,

The Conduct of Canadian Researchers and Institutional Review Boards Regarding Substituted Consent for Research

by Gina Bravo, Marie-France Dubois, and Mariane

P^quet 1

IN THE FIELD:

When a Research Subject Calls with a Complaint, What Will the Institutional Review Board Do?

by Kathleen J. Motil, Janet Allen, and Addison

Taylor 9

The Certificate of Confidentiality Application

by Leslie E. Wolf, Jola Zandecki, and Bernard Lo 1 4

IN MEMORIAM:

Louis Cesare Lasagna

by Robert Levine 1 9

ANUARY-FEBRU-A-RY 20,04 ?-* VLU~t;Z?6?iNUMisn I?.

The Conduct of Canadian Researchers and Institutional Review Boards Regarding Substituted Consent for Research

BY GINA BRAVO, MARIE-FRANCE DUBOIS, AND MARIANE PAQUET

As the population ages world- wide, a growing number of individuals suffer from dis-

eases that impair their decision- making capacity.' Over the years, researchers around the world have intensified their efforts to identify the causes of these diseases, devel- op effective treatments to slow their progression, and further our understanding of their impact on affected individuals and their fami- lies.-

At the same time, there has been increasing recognition of the ethical dilemma that arises in conducting research on diseases that alter deci- sionmaking capacity.3 All research involving human subjects should be conducted in accordance with three cardinal ethical principles: justice, beneficence, and respect for persons.4 Respect for persons entails securing free and informed consent from potential research participants before their enrollment in a study. This requirement poses special challenges to investigators conducting dementia research on diseases that impair decisional capacity, such as advanced demen- tia. Subjects in the early stages of the disease may retain sufficient

decisionmaking capacity to give informed consent for some studies. However, the irreversible and pro- gressive nature of the illness ulti- mately robs its victims of the abili- ty to fully appreciate the conse- quences of their involvement in

research.5 Due to this distinguish- ing characteristic, decisionally-com- promised subjects are viewed as a group particularly vulnerable to exploitation whose rights and wel- fare call for special legal protec- tion.6

Recognizing the need to pro- duce knowledge that may lead to improved care for future incapaci- tated patients, many jurisdictions authorize the enrollment of sub- jects unable to consent themselves provided certain precautions are fulfilled. These often include the obligation to obtain the approval of an Institutional Review Board (IRB), the consent of the subjects' legal representatives, and the sub- jects' assent. Although a matter of some debate, these legal provisions are viewed by many commentators as a socially acceptable compro- mise between proceeding without any consent and foregoing all research on diseases that impair decisionmaking capacity.

In order to protect vulnerable individuals, these special provisions must be known and respected by

Gina Bravo, Marie-France Dubois, and Mariane Piquet, "The Conduct of Canadian Researchers and Institutional Review Boards Regarding Substituted Consent for Research," IRB: Ethics & Human Research 26, No. 1 (oo004): 1-8.

A PUBLICATION OF

THE HASTINGS CENTER

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Page 3: The Conduct of Canadian Researchers and Institutional Review Boards regarding Substituted Consent for Research

all concerned, including researchers and IRB members. Recently, we conducted a postal survey in these two populations to assess their knowledge of the legislation that governs the process of consent for research on mentally incapacitated older adults.7 The survey was con- ducted in Quebec, Canada, where the law (Appendix A) prohibits enrolling such subjects in most experiments if they are not legally represented. Only emergency research is exempt from the obliga- tion to obtain prior consent from the legal representative.

The study revealed a lack of knowledge in both groups, perhaps because the legislators failed to define the term experiment. As a result, there has been considerable debate surrounding the type of research to which the law applies.8 Interestingly, two-thirds of the respondents unaware of the law wrongly thought that a caring fami- ly member who was not legally appointed could provide a substitut- ed consent for research on behalf of a mentally incapacitated relative, as is the case for consent to health care9 and emergency research. As part of the survey, we also asked the respondents who they thought should consent to research on behalf of an incapacitated person.'o Opinions varied with the degree of risk involved in the study. In the absence of risk, over 70% of the researchers and IRB members felt that the surrogate decisionmaker did not have to be legally appointed.

These findings suggest that researchers may be enrolling cogni- tively impaired subjects with the consent of someone who is not legally authorized to make a substi- tuted decision. Moreover, the con- duct of researchers may be sanc- tioned by their IRB, which provided prior approval of the research pro- tocol. To our knowledge, no pub- lished study has examined the con- duct of researchers and IRB mem- bers with respect to proxy consent.

Figure 1 Flow chart summarizing the conduct of researchers with prospective subjects

who are unable to consent.

Researchers who participated in the survey n = 98

Researchers targeting older adults unable to consent n = 63 (64.3%)

Conduct of researchers with potential subjects unable to consent n = 59 (4 did not answer)

Exclude them Check their Solicit the immediately legal status consent of

n = 2 (3.4%) n = 35 (59.3%) traditional proxies n = 22 (37.3%)

( Conduct of researchers with potential subjects not legally represented

Exclude them Solicit the n = 13 (37.1%) consent of

traditional proxies n = 22 (62.9%)

This article reports data from the third component of our survey that was designed specifically to shed some light on this issue. We also report data on related issues, such as respondents' views of the conse- quences and scope of current legisla- tion governing substituted consent.

Survey of Researcher and IRB Conduct Involving Proxy Consent: Methods

a Study Participants The survey has been described in

detail elsewhere." To summarize, we first designed, pretested and mailed a postal questionnaire to all researchers in aging from Quebec identified from the latest version of the Provincial Directory of Public Researchers (n = 16o). With the objective of maximizing the response rate, we followed Dillman's suggestions on how to design an attractive questionnaire, the ideal number of repeated mailings, and the content of each mailing." Potential respondents received a first copy of the questionnaire with a

JANUARY-FEBRUARY 2004

U IRB: ETHICS & HUMAN RESEARCH

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personal covering letter that stated the objective of the survey and underscored the importance of their participation. The first mailing also contained a self-addressed and stamped return envelope, a letter of support signed by three well-known researchers from the fields of aging, mental health and ethics, and a postcard to be returned separately from the questionnaire. The post- card served to identify those who had returned the questionnaire while maintaining the anonymity of their responses. Two weeks later, a reminder postcard was mailed to all non-respondents. Lastly, two months after the first mailing, indi- viduals who had not yet returned their questionnaire received a replacement copy and a new person- alized letter. Ninety-eight researchers returned the questionnaire. Excluding ineligible researchers (n = 16), the response rate was 68.1%.

Second, we identified the 37 IRBs designated by the provincial Minister of Health and Social Services to review research protocols involving persons unable to consent for themselves. All these IRBs are affiliated with a university or health care institution. IRB chairpersons were contacted personally by phone to inform them of the study and solicit their participation as well as that of their members. One chair- person refused to participate. The others received a personalized intro- ductory letter, a one-page question- naire for them to fill out personally and the relevant number of a second questionnaire for distribution to the ethics committee members. Two months later, chairpersons and indi- vidual IRB members received a sec- ond letter reiterating the importance of their participation. Twenty-four chairpersons (64.9%) and 136 IRB members (34.6%) returned their respective questionnaires.

U The Questionnaires

The data reported in this article

Figure 2 Flow chart summarizing IRBs' position in regard to substituted consent

IRB chairpersons who returned the one-page questionnaire n = 24

IRBs reviewing research proposals involving older adults unable to consent n = 21

Accept, under certain circumstances, that older adults unable to consent participate in research

n= 19

Accept, under certain circumstances, that older adults unable

to consent and not legally represented participate in research n = 12

Only in the context In other situations of emergency research n = 8

n=4

( If the research involves ... * )

No serious risk No serious risk Some risks but but or also

some personal personal benefit for personal benefits benefits for the subject but greater than the subject benefits for others the risks

n=8 n=4 n=l

* More than one answer could be given

originate from three different ques- tionnaires investigating researchers' and IRBs' behavior regarding proxy consent. In the case of researchers, this was achieved through a series of questions regarding how they secure consent from incapacitated older adults for studies with minimal risk

(Appendix B). The questions designed to assess ethics committees' willingness to approve research pro- posals involving such individuals were addressed specifically to the IRB chairpersons. These questions were constructed using the same model as those addressed to the

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Table 1. Researchers' and IRB members' opinions regarding the legislation that governs proxy consent for research

Researchers IRB members n - 98 n - 136

Is the current legislation an impediment to the advancement of knowledge? Yes 76 (80.9%) 97 (71.3%)

No 18 (19.1%) 39 (28.7%) Missing 4 0

Does the current legislation deprive decisionally-incapacitated older adults of the benefits of research participation? Yes 70 (76.1%) 95 (70.9%)

No 22 (23.9%) 39 (29.1%) Missing 6 2

Does the law apply to all research projects? Yes 29 (30.9%) 60 (44.8%) No 23 (24.5%) 27 (20.2%)

Don't know 42 (44.7%) 47 (35.1%) Missing 4 2

In your opinion, what constitutes an

experiment on human subjects? * An intervention involving risk for the subject 7 (11.1 %) 10 (11 .0%) N Any intervention, irrespective of the risk involved 30 (476%) 42 (46.1 %)

I Any study, whatever type 26 (41.3%) 37 (40.7%) * Missing 35 47

researchers (Appendix B). Four other questions were includ-

ed in the questionnaires distributed to the researchers and the individual members of the IRBs. The first asked respondents whether they thought forbidding research on

incompetent individuals who are not legally represented constitutes an impediment to the advancement of knowledge; the second whether this prohibition deprives these indi- viduals of the benefits of research

participation. The two last ques- tions, one closed- and one open- ended, invited respondents to describe the type of research they believe falls under the legislation governing substituted consent.

The study protocol was approved by the Ethics Review Board of the Sherbrooke University Geriatric Institute.

How Researchers and IRBs Obtain Proxy Consent: Results

igure 1 gives an overview of the conduct of researchers regarding

proxy consent. Sixty-four percent of the respondents answered that some of their research projects target older adults unable to consent for themselves. In the vast majority of cases, a member of the research team solicits the consent of the

prospective subjects and judges whether they are able to consent, often after consulting with a health

professional aware of the subject's mental condition (data not shown). When encountering an incapacitated older adult, 3.4% exclude him/her immediately, 59.3% investigate the legal status of the prospective sub- ject, and 37.3% solicit the consent of a proxy who may not have been formally appointed as the subject's

legal guardian. Among those who

investigate the legal status of a

potential subject, 37.1% will exclude a subject who is not legally represented, while the others will solicit the consent of a traditional surrogate decisionmaker. Overall, 74.6% of researchers do not comply with the law in effect in Quebec by recruiting decisionally incapacitated older adults on the basis of a con- sent given by someone who may not have the legal authority to do so.

Figure 2 summarizes the IRB

chairpersons' responses to the ques- tions designed to assess their degree of permissibility towards substituted consent. Of the twenty-one IRBs that have reviewed proposals involv- ing decisionally incapacitated older adults, two responded that such protocols would be rejected. Of the nineteen IRBs open to the recruit-

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ment of older adults unable to con- sent, twelve accept that these individ- uals do not have a legal guardian, at least under certain circumstances. In one-third of the cases, these circum- stances are restricted to emergency research. In the other two-thirds, all would approve a study that involved no serious risk for the prospective subject and could benefit him/her personally; one in two would sup- port a study with no serious risk or benefit for the subject but that could benefit others; and one would approve a study involving some risks to the participants, provided the ben- efits for the subjects outweigh the risks.

Responses to the four questions submitted to both researchers and individual IRB members are shown in Table 1. In the opinion of the majority, the obligation to exclude incapacitated adults who are not legally represented impedes the advancement of knowledge, in addi- tion to depriving these individuals of the benefits of being a research sub- ject. One in five respondents believed that the legislation governing substi- tuted consent does not apply to all types of research. Forty-five percent of researchers and 3 5% of IRB members admitted that they simply didn't know.

Three common themes emerged from the content analysis of the researchers' and IRB members' defi- nition of what constitutes an experi- ment. In both groups, 11% defined an experiment as an intervention involving some risks to the subject's health. For example, one researcher wrote: "an experiment is an inter- vention that involves an aggressive physical or mental procedure (pain, risk of infection, discomfort)." Half alluded to an intervention in their definition, but without mentioning risk. Two examples are: "Process that requires a person to submit to specific conditions related to treat- ment or care which his/her condition does not necessarily require" and

"Any intervention in regard to a per- son which has the potential to modi- fy physical and/or psychological functions with the aim of developing scientific knowledge in a specific field." Another 40% of respondents believed that the term experiment encompasses all types of research, whether or not an intervention is present, and whether or not risks are involved. The following definition proposed by a member of an IRB illustrates this view: "Any research project in which a person partici- pates or is observed in order to test a hypothesis."

Non-Compliance with Legal Requirements: Possible Explanations and Discussion of Implications

Improving the patient's condition is the sole aim of clinical care. In

contrast, research is conducted to produce knowledge that may lead to improved care for future patients. As in many jurisdictions, Quebec authorizes a close relative or friend to consent to health care required by an incapable patient when a legal guardian has not yet been appointed.13 Turning to families for assistance with health care deci- siomaking is a common practice among medical practitioners. It is also widely accepted by the general population. Surveys have repeatedly shown that most people would trust their families to make medical deci- sions on their behalf when the need arises.14 Despite potential conflicts of interest's and strong empirical evi- dence of significant discrepancies between patients' treatment prefer- ences and proxies' perception of those preferences,'6" the family con- tinues to be viewed as the most con- cerned for the welfare of a decision- ally-compromised patient.

Recognizing the distinctions between health care and research, some jurisdictions'7 chose to limit authority for research decisionmak- ing to the legal guardian when the

prospective subject is unable to decide him/herself. Stricter regula- tions are justified by the need to pro- tect vulnerable individuals from the risk of being exploited in the name of science. But they must be respect- ed. The data reported in this article show that this is not the case, at least in the province of Quebec. Three out of four researchers on aging admit- ted soliciting the consent of a tradi- tional proxy, half without first deter- mining whether the potential subject has a legal representative. Moreover, a number of IRBs approve non- emergency research involving incom- petent older adults without legal rep- resentation.

Different hypotheses could explain the conduct of researchers and ethics committees. First is their lack of knowledge of the legisla- tion.'8 Investigators and IRB mem- bers should be familiar with the laws that apply in their jurisdictions. Educational efforts to enhance awareness of legal aspects of research consent are still in an embryonic state.'9 Second is the ambiguity of the law itself, which does not specify the type of research to which it applies. As a result, the interpretation of the law varies with- in the group of researchers as well as among ethics committee members (Table i). Thus researchers conduct- ing intervention trials without risk to the subjects' health may proceed with the consent of traditional prox- ies simply because they think the law does not apply in that case. IRB members may approve such proto- cols for the same reason. Given the ambiguity of the law, researchers and IRB members should not be criti- cized for not complying with the leg- islation governing surrogate consent for research.

A third explanation lies in the belief that the current legislation is inadequate, for several reasons. Most would agree that cognitively impaired subjects deserve special legal protection. But complete exclu-

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sion of all those without legal repre- sentation may deprive them of the health benefits of research participa- tion,20 a view shared by the majori- ty of respondents in our survey (Table 1). These benefits may include access to a promising treat- ment, enhanced medical attention, or increased social and emotional support." Many people and fami- lies also take comfort and find hope in being able to help increase

knowledge about currently incur- able conditions such as Alzheimer's disease.

In addition to discriminating against non-legally represented incompetent individuals, the obliga- tion to exclude them makes ade- quate recruitment difficult, skews the population being studied, and limits the generalizability of the results." Despite widespread profes- sional and public endorsement of advance planning, few people have

appointed an agent to make deci- sions on their behalf in the event of incapacity.23 Those who have are known to differ from the general population, particularly with respect to their socioeconomic status. Limiting enrollment to cognitively impaired subjects who are legally represented could thus lead to unrepresentative samples. These considerations may have motivated a majority of researchers and IRB members to respond that the cur- rent legislation inhibits scientific

progress (Table 1). Given the mod- est impact of interventions designed to promote advance planning for health care and research,24 the num- ber of legally represented older adults is unlikely to increase signifi- cantly in the near future.

The picture we have presented of the conduct of researchers and ethics committees reflects a widely endorsed practice that involves obtaining informed consent from a proxy for the subject, whether or not this person has been legally des- ignated as a guardian, along with the subject's assent.2s Our finding

that the Quebec legislation is often violated does not imply that impaired older adults in this province are exposed to greater risks since the questions put to the researchers were restricted to studies with minimal risk. Furthermore, to our knowledge there is no empirical evidence that legal guardians afford better protection to cognitively impaired adults than caring family members without legal authority. To allow the latter to consent on behalf of relatives with diminished mental capacity would move research deci- sionmaking from the courtroom to the common practice of clinical decisionmaking.26 In the clinical setting, when patients are incompe- tent and lack a formally appointed surrogate, physicians turn to the patient's family for insight into treatment preferences. Patients who do not have the ability to make complex decisions may still have

decisionmaking capacity to choose a trusted surrogate.

As pointed out by some authors,27 it makes little sense to allow a proxy to withdraw or with- hold artificial nutrition or hydration but not to consent to blood drawing for research purposes, a brain autopsy, or medication trial for dementia. Many people likely share these views. In a recent telephone survey,28 88% of interviewees sup- ported allowing their family to make research decisions for them in the absence of prior specifications on their part. Moreover, 80% stated that their families could enroll them in research that offers a potential for medical benefit even when their advance directives opposed research participation. Strong support for allowing traditional proxies to con- sent to research that involves little risk was also observed in our sur- vey.29 These results attest to the confidence older adults place in their close relatives to make deci- sions on their behalf, whether legal- ly appointed or not. Of course, changes to the current legislation

should be accompanied by educa- tional efforts designed to enhance researchers' and IRB members' awareness of the rules governing substituted consent for research.

Acknowledgment The study was supported by an

unrestricted grant from the Alzheimer Society of Canada. The first author holds a National Researcher's Award from the Fonds de la recherche en sante du Quebec.

N Gina Bravo, PhD, is Professor and Chair, Department of Community Health Sciences, Faculty of Medicine, University of Sherbrooke; Marie-France Dubois, PhD, is Adjunct Professor, Department of Community Health Sciences, Faculty of Medicine, University of Sherbrooke; Mariane

Paiquet, MSc, is Research Coordinator, Research Centre on Aging, Sherbrooke University Geriatric Institute.

References

i. Canadian Study of Health and Aging Working Group. The Canadian Study of Health and Aging: Study methods and preva- lence of dementia. Canadian Medical Association Journal 1994;150:899-913; Fichter MM, Meller I, Schroppel H, et al. Dementia and cognitive impairment in the oldest old in the community: Prevalence and comorbidity. British Journal of Psychiatry 1995;i66: 6z1-629; United States General Accounting Office. Alzheimer's disease: Estimates of prevalence in the United States. Washington, DC, 1998; Lobo A, Launer LJ, Fratiglioni L, et al. Prevalence of dementia and major subtypes in Europe: A collabora- tive study of population-based cohorts.

Neurology 2ooo;54:S4-9. z. Post SG, Whitehouse PJ. Emerging

antidementia drugs: A preliminary ethical view. Journal of the American Geriatrics Society 1998;46:784-787; Woodward B.

Challenges to human subject protections in US medical research. JAMA 1999;z82:1947- 1952.

3. Keyserling EW, Glass KC, Kogan S, et al. Proposed guidelines for the participation of persons with dementia as research sub- jects. Perspectives in Biology & Medicine 1995;38:319-362; Brodaty H, Dresser R, Eisner M, et al. Consensus Statement. Alzheimer's disease international and interna- tional working group for harmonization of dementia drug guidelines for research involv- ing human subjects with dementia. Alzheimer Disease and Associated Disorders 1999;13: 71-79; Cohen CA, Whitehouse PJ, Post SG, et al. Ethical issues in Alzheimer Disease: The experience of a National Alzheimer Society task force. Alzheimer Disease and Associated

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Disorders 1999;13:66-70. 4. Medical Research Council of Canada,

Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri- Council Policy Statement. Ethical Conduct for Research Involving Humans. Ottawa, Ontario: Public Works and Government Services Canada, 1998; AGS Ethics and Research Committee. The responsible conduct of research. Journal of the American Geriatrics Society zooo;49:1120-1122.

5. Sachs GA. Advance consent for demen- tia research. Alzheimer Disease and Associated Disorders 1994;8(Suppl. 4):19-27; Sachs GA, Stocking CB, Stern R, et al. Ethical aspects of dementia research: Informed con- sent and proxy consent. Clinical Research 1994;42:403-412.

6. Sachs GA, Cassel CK. Biomedical research involving older human subjects. Law, Medicine & Health Care 1990;18:234-243; Sachs GA, Rhymes J, Cassel CK. Biomedical and behavioral research in nursing homes: Guidelines for ethical investigations. Journal of the American Geriatrics Society 1993;41: 771-777.

7. Bravo G, Paquet M, Dubois ME Knowledge of the legislation governing proxy consent to treatment and research. Journal of Medical Ethics 2003;29:44-50.

8. At a symposium held in June 200ooz and organized by the authors, lawyer Marie Josee Longtin, Director General, Legislative Affairs, Quebec Ministry of Justice, stated that the term experiment encompasses all types of research, medical as well as psychosocial. Proceedings of the symposium entitled "Consent to research on incompetent persons: Can we reconcile ethical, legal and scientific issues?" (translation from French), ISBN 2- 921470-41-1, page 8.

9. Civil Code of Quebec, 1994, article 15: "Where it is ascertained that a person of full

age is incapable of giving his consent to care

required by his state of health, consent is given by his mandatary, tutor or curator. If the

person of full age is not so represented, con- sent is given by his spouse, [...], a close rela- tive or a person who shows a special interest in the person of full age."

io. Bravo G, Paquet M, Dubois ME Opinions regarding who should consent to research on behalf of an older adult suffering from dementia. Dementia: The International Journal of Social Research and Practice zoo3; 2:49-65.

11. See ref. 7 and lo, Bravo et al. 200oo3. 12. Dillman DS. Mail and internet surveys:

The tailored design method. New York: John Wiley & Sons, zooo2000.

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1996;44:185-188; Hopp FP. Preferences for

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17. For example: Alberta, Manitoba and Prince Edward Island in Canada, nine states in the United States (Hougham GW, Stocking CB, Legner J, et al. Census of U.S. state laws governing research on cognitively impaired subjects. Poster presented at the AGS zooz Annual Scientific Meeting, Washington DC, May 2ooz), and France (Code de la Sante Publique).

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tific integrity and the responsible conduct of research. Academic Medicine 1993;68:871- 875; McKneally MF, Singer PA. Bioethics for clinicians: 25. Teaching bioethics in the clini- cal setting. Canadian Medical Association Journal zool;164:1163-1167.

zo. See ref. 6, Sachs & Cassel 1990; ref. 3, Brodaty et al. 1999; Brody BA. The ethics of biomedical research. An international perspec- tive. Oxford: Oxford University Press, 1998.

21. Connell CM, Shaw BA, Holmes SB, et al. Caregivers' attitudes toward their family members' participation in Alzheimer disease research: Implications for recruitment and retention. Alzheimer Disease and Associated Disorders 2001zool;15:137-145.

zz. See ref. 6, Sachs et al. 1993, as well as Bravo G, Charpentier M, Dubois MF, et al. Article 21 of the Civil Code of Quebec: Implications for research in gerontology (in French). Canadian Journal on Aging 00zooo;19:1-17.

23. Menikoff JA, Sachs GA, Siegler M. Beyond advance directives - health care surro- gate laws. NEJM 1992;327:1165-1169; Berghman RL. Ethics of end-of-life decisions in cases of dementia: View of the Royal Dutch Medical Association with some critical com- ments. Alzheimer Disease and Associated

Disorders 1999;13:91-95. Steinhauser KE, Christakis NA, Clipp EC, et al. Factors con- sidered important at the end of life by patients, family, physicians and other care providers. JAMA zooo2000;284:2476-2482; Douglas R, Brown H. Patients' attitudes toward advance directives. Journal of Nursing Scholarship oo200z;34:61-65.

24. Hare J, Nelson C. Will outpatients complete living wills? A comparison of two interventions. Journal of General Internal Medicine 1991;6:41-46; Reilly BM, Wagner M, Ross J, et al. Promoting completion of health care proxies following hospitalization: A randomized controlled trial in a community hospital. Archives of Internal Medicine

1995;155:202-z22zo6; See also ref. 14, Sachs

et al. 1992 and ref. 23, Douglas & Brown 2002.

25. See ref. 3, Brodaty et al. 1999; Capron AM. Ethical and human-rights issues in research on mental disorders that may affect decision-making capacity. NEJM 1999;340:1430-1434; Karlawish JHT, Hougham GW, Stocking CB, et al. What is the quality of the reporting of research ethics in publications of nursing home research? Journal of the American Geriatrics Society 1999;47:76-81; Coppolino M, Ackerson L. Do surrogate decision makers provide accu- rate consent for intensive care research? Chest 20oo1;119:603-612.

z6. Karlawish JHT, Sachs GA. Research on the cognitively impaired: Lessons and warnings from the emergency research debate. Journal of the American Geriatrics Society 1997;45:474-481.

27. See ref. 5, Sachs 1994 and ref. 14, High 1994.

28. Wendler D, Martinez R, Fairclough D, et al. Views of potential subjects toward pro- posed regulations for clinical research with adults unable to consent. American Journal of Psychiatry zooz;159:585-591.

29. See ref. io, Bravo et al. 2003.

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Page 9: The Conduct of Canadian Researchers and Institutional Review Boards regarding Substituted Consent for Research

APPENDIX A

Article 21 of the Civil Code of Quebec

[...] a person of full age who is incapable of giving con- sent may not be submitted to an experiment if the experi- ment involves serious risk to his health or, where he under- stands the nature and consequences of the experiment, if he objects.

Moreover, a person of full age who is incapable of giving consent may be submitted to an experiment only if, [...], it has the potential to produce results capable of conferring benefit to other persons in the same age category or having the same disease or handicap. Such an experiment must be part of a research project approved and monitored by an ethics committee. The competent ethics committees are formed by the Minister of Health and Social Services or designated by that Minister among existing research ethics committees; [...].

Consent to experimentation may be given, [...], in the case of a person of full age incapable of giving consent, by the mandatary, tutor or curator. Where a person of full age suddenly becomes incapable of consent and the experiment, insofar as it must be undertaken promptly after the appear- ance of the condition giving rise to it, does not permit, for lack of time, the designation of a legal representative, con- sent may be given by the person authorized to consent to any care the person requires; [...]

APPENDIX B

Questions addressed to the researchers:

1. Are older adults who are unable to consent for them- selves sometimes targeted by your research projects?

O No, never - Go to question 4. O Yes

2. What do you do when a prospective subject has been judged unable to consent for him/herself to research involv- ing no serious risks for his/her health?

O I exclude him/her --

Go to question 4. O I immediately ask a significant other (spouse, close

relative, etc.) to provide substituted consent -- Go to question 4.

O I check the prospective subject's legal status.

3. What do you do when a prospective subject who is unable to consent for him/herself to research involving no serious risks is not legally represented?

O I exclude him/her.

O I ask a significant other to provide substituted consent.

Questions addressed to the IRB chairpersons:

i. Are older adults who are unable to consent for them- selves sometimes targeted by research protocols submitted for approval to the Review Board you chair?

O No, never - Please return the questionnaire in the enclosed envelope.

O Yes

2. Does your Review Board accept, under certain cir- cumstances, that older adults who are unable to consent for themselves participate in research?

O No, never 4 Please return the questionnaire in the enclosed envelope.

O Yes

3. Does your Review Board accept, under certain circum- stances, that older adults who are unable to consent for themselves and are not legally represented participate in research?

O No, never - Please return the questionnaire in the enclosed envelope.

O Yes

4. Under what circumstances does your Review Board allow a close relative of an incompetent older adult who is not legally represented, to decide on his/her behalf whether or not to participate in a research project? (Check all cir- cumstances that apply.)

El If the research does not involve any serious risk for the prospective subject's health and could benefit him/her personally.

O If the research does not involve any serious risk for the prospective subject's health and will not benefit him/her personally but could benefit others.

O If the research involves some risks for the prospective subject's health but also potential benefits that are greater than the risks.

O If... Please specify:

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