Principles of Research Principles of Research Ethics: consent, risk and Ethics: consent, risk and

justicejustice

Lisa Schwartz, PhDLisa Schwartz, PhD

Arnold Johnson Chair in Health Care Arnold Johnson Chair in Health Care EthicsEthics

McMaster UniversityMcMaster University

OutlineOutline

►HistoryHistory

►PrinciplesPrinciples

►A challenging balanceA challenging balance

►Practical considerationsPractical considerations

A history for concernA history for concern

►Nuremberg & JapanNuremberg & Japan

►TuskegeeTuskegee

►US prison experimentsUS prison experiments

►HeLa cell lineHeLa cell line

Christine BorlandChristine Borland Cet etre-la, Cet etre-la, c’est a toi de le creer! Vous devez c’est a toi de le creer! Vous devez

la creer!la creer! 19971997

Ongoing concernsOngoing concerns

►Disturbing stories about paediatric post-Disturbing stories about paediatric post-mortem collection of organs mortem collection of organs

► The routine use in research The routine use in research without consentwithout consent of of Patient recordsPatient records Guthrie CardsGuthrie Cards Prenatal screening samplesPrenatal screening samples Tissue collected for treatmentTissue collected for treatment

The responseThe response► Nuremberg code Nuremberg code

http://www.med.nus.edu.sg/phar/sgcpp/nuremburg.htmhttp://www.med.nus.edu.sg/phar/sgcpp/nuremburg.htm

► Declaration of Helsinki Declaration of Helsinki www.wma.netwww.wma.net ► CIOMS Statement CIOMS Statement http://www.cioms.ch/http://www.cioms.ch/

► Tri-Council Policy Statement (Canada)Tri-Council Policy Statement (Canada)► National Committee on Ethics in Human Research National Committee on Ethics in Human Research

(Canada) (Canada) http://ncehr-cnerh.org/http://ncehr-cnerh.org/

► Belmont Report (US)Belmont Report (US)► Office of Human Research Protection (US) Office of Human Research Protection (US)

http://ohrp.osophs.dhhs.gov/index.htmlhttp://ohrp.osophs.dhhs.gov/index.html

► MRC guidelines MRC guidelines ((http://www.mrc.ac.uk/ethicshttp://www.mrc.ac.uk/ethics UK)UK)

► British Sociological Society (UK)British Sociological Society (UK)► Nuffield Reports (UK) Nuffield Reports (UK) http://www.nuffieldbioethics.org/home/index.asphttp://www.nuffieldbioethics.org/home/index.asp

► Research Ethics BoardsResearch Ethics Boards

ProblemsProblems

►They need to be interpreted They need to be interpreted

►Variability of applicationVariability of application

PrinciplesPrinciples

Respect for human dignityRespect for human dignity

Beneficence / Non-Beneficence / Non-MaleficenceMaleficence

UtilityUtility

JusticeJustice

Respect for human dignityRespect for human dignity

► Respect for autonomyRespect for autonomy

► Informed ConsentInformed Consent

►HonestyHonesty

► Respect for privacy Respect for privacy

► Fair recruitment proceduresFair recruitment procedures

► Follow upFollow up

► Collaborative researchCollaborative research

Tallon D, Chard J, Dieppe P. Consumer Tallon D, Chard J, Dieppe P. Consumer involvement in research is essential. involvement in research is essential.

BMJBMJ 2000; 2000;320320:380-380:380-380

►“…“…consumer involvement will greatly consumer involvement will greatly enhance the overall relevance of clinical enhance the overall relevance of clinical research. It will ensure that the most fruitful research. It will ensure that the most fruitful research questions are addressed and the research questions are addressed and the most appropriate outcome measures used, most appropriate outcome measures used, thus maximising the potential for the results thus maximising the potential for the results to be relevant and beneficial to research to be relevant and beneficial to research consumers. Furthermore, it should lead to a consumers. Furthermore, it should lead to a more efficient use of research resources.”more efficient use of research resources.”

Ends, means, subjects and Ends, means, subjects and objectsobjects

There is a danger of reducing There is a danger of reducing

research subjects research subjects

to research objectsto research objects

Edward WestonEdward Weston Nude Nude 19361936 © Center for Creative Photography, Arizona Board of Regents Scan courtesy of © Center for Creative Photography, Arizona Board of Regents Scan courtesy of

Masters of PhotographyMasters of Photography

Edward Weston Edward Weston Shells Shells 1927 1927 © Center for Creative Photography, Arizona Board of Regents Scan courtesy of © Center for Creative Photography, Arizona Board of Regents Scan courtesy of

Masters of PhotographyMasters of Photography

Ends, means, subjects and Ends, means, subjects and objectsobjects

►Be aware of the humanity in each Be aware of the humanity in each personperson

►Treat persons as ends in Treat persons as ends in themselves and never solely as themselves and never solely as means to endsmeans to ends

►Includes honesty, consentIncludes honesty, consent

Beneficence / Non-Beneficence / Non-MaleficenceMaleficence

► IntentionsIntentions

►OutcomesOutcomes

►Balance the good of many with the Balance the good of many with the good of fewgood of few

M.H. Pappworth in 1967M.H. Pappworth in 1967

►““No physician is justified in placing No physician is justified in placing science or the public welfare first science or the public welfare first and his obligation to the individual, and his obligation to the individual, who is his patient or subject, who is his patient or subject, second. No doctor, however great second. No doctor, however great his capacity or original his ideas, his capacity or original his ideas, has the right to choose martyrs for has the right to choose martyrs for science or for the general good.”science or for the general good.”

►Pappworth M.H. Human Guinea Pigs; Boston: Pappworth M.H. Human Guinea Pigs; Boston: Beacon Press, 1967; pg. 27Beacon Press, 1967; pg. 27

UtilityUtility

►Make best use of scarce resourcesMake best use of scarce resources

►Research participants are a valuable Research participants are a valuable

resource not to be exploitedresource not to be exploited

►Ensure value of the research questionEnsure value of the research question

►Ensure quality of methodEnsure quality of method

JusticeJustice

►Fairness as equityFairness as equity

►Equal access to benefitsEqual access to benefits

►Equal share of burdensEqual share of burdens

►Deprived populationsDeprived populations

►Global researchGlobal research

A challenging balanceA challenging balance

Justice, risk and consentJustice, risk and consent

Risk Risk Edwards SJ et al Research Ethics Committees and Edwards SJ et al Research Ethics Committees and

paternalism, paternalism, Jrl of Medical EthicsJrl of Medical Ethics 2004;30:88-91 2004;30:88-91 ► Research entails riskResearch entails risk► Should we permit high risk research? (e.g. Should we permit high risk research? (e.g.

Gelsinger, Roche)Gelsinger, Roche)► Respect for persons + BeneficenceRespect for persons + Beneficence

==Paternalism or Disclosure of RiskPaternalism or Disclosure of Risk

► But the risks associated with research are But the risks associated with research are mostly unknown and ...mostly unknown and ...

US US Hearings on Human Hearings on Human Experimentation, Experimentation, 19731973

►““Those who have borne the brunt Those who have borne the brunt of research – whether it is drugs or of research – whether it is drugs or even experimental surgery – have even experimental surgery – have been the more disadvantaged been the more disadvantaged people within our society; have people within our society; have been the institutionalised, the poor, been the institutionalised, the poor, and minority members.”and minority members.”

►Sen. T Kennedy, prt 3, 7.3.1973, p. 841Sen. T Kennedy, prt 3, 7.3.1973, p. 841

Acceptable levels of risk?Acceptable levels of risk?

► Baltimore Lead in Children studyBaltimore Lead in Children study

► Relative to context and interpretationRelative to context and interpretation

►May imply that risky research is tolerable May imply that risky research is tolerable among populations who live with high levels of among populations who live with high levels of risk in their day to day existencerisk in their day to day existence

► Spriggs M Canaries in the mines: children, risk, non-Spriggs M Canaries in the mines: children, risk, non-therapeutic research and justice, therapeutic research and justice,

Jrl of Medical Ethics 2004;30:176-181.Jrl of Medical Ethics 2004;30:176-181.

A modest proposal by M A modest proposal by M SpriggsSpriggs

► ‘‘My proposal is that researchers and My proposal is that researchers and reviewers should be expected to reviewers should be expected to contemplate and sign a statement that contemplate and sign a statement that says: ‘‘I would not hesitate to submit says: ‘‘I would not hesitate to submit myself, or members of my own family, myself, or members of my own family, or anybody for whom I have any or anybody for whom I have any respect or affection, if in respect or affection, if in circumstances identical to those of the circumstances identical to those of the intended subjects’’’.intended subjects’’’.

►Based on Papworth quoteBased on Papworth quote

Justice, Risk and REBsJustice, Risk and REBs

►Safe mechanismsSafe mechanisms e.g. REBs, Monitoring, Audite.g. REBs, Monitoring, Audit

►Equal distribution of risks, harms Equal distribution of risks, harms and benefits of researchand benefits of research

Practical Practical considerationsconsiderations

Justice and the measurement Justice and the measurement of benefit and burden in of benefit and burden in

researchresearch

Considerations that might affect theConsiderations that might affect theappropriateness of involvement of appropriateness of involvement of

some communities in researchsome communities in research (Beyrer (Beyrer

& Kass 2002)& Kass 2002) ►VulnerabilityVulnerability►PovertyPoverty►Human rights violationsHuman rights violations►DiscriminationDiscrimination►Poor access to resourcesPoor access to resources►EducationEducation►CoercionCoercion►Lack of trustLack of trust

Research findings that could Research findings that could increase risk of violationsincrease risk of violations

► In some instances, the findings rather In some instances, the findings rather than the procedures of studies, could than the procedures of studies, could lead to harmlead to harm

►Findings could be used to stigmatiseFindings could be used to stigmatise

►e.g. the status of refugees can be e.g. the status of refugees can be compromised by research compromised by research

4 theoretical considerations4 theoretical considerations

1.1. Information sharing for consentInformation sharing for consent

2.2. VoluntarinessVoluntariness

3.3. TrustTrust

4.4. PrivacyPrivacy

Justice Justice from Beyrer C, Kass NE Human rights, from Beyrer C, Kass NE Human rights, politics, & reviews of research ethics. politics, & reviews of research ethics. LancetLancet 2002 Jul 2002 Jul

20;360(9328):246-51.20;360(9328):246-51. ► In research ethics, the principle of distributive justice In research ethics, the principle of distributive justice

forbids research risks and burdens being borne forbids research risks and burdens being borne disproportionately by vulnerable groups within societydisproportionately by vulnerable groups within society; ; similarly, the more privileged in society cannot similarly, the more privileged in society cannot disproportionately reap research benefitsdisproportionately reap research benefits

► Just research may be impossible to achieve in settings Just research may be impossible to achieve in settings where equality, fairness, and the distribution of social good where equality, fairness, and the distribution of social good and harm are routinely abrogatedand harm are routinely abrogated

► Where permission is granted by the very people who are Where permission is granted by the very people who are oppressing the potential participants, researchers must be oppressing the potential participants, researchers must be aware of potential misuse of findings. Conversely, there aware of potential misuse of findings. Conversely, there may be instances in which participation would be in the may be instances in which participation would be in the best interests of the minority group, but government best interests of the minority group, but government officials deny accessofficials deny access

Vulnerable populations Vulnerable populations (Beyrer & Kass (Beyrer & Kass

2002)2002)

► Typically, the justification for including a Typically, the justification for including a vulnerable group in research is when a problem vulnerable group in research is when a problem disproportionately affects that groupdisproportionately affects that group

► Conversely, forbidding research in regions with Conversely, forbidding research in regions with limited human rights could deny research benefits limited human rights could deny research benefits to those with the most pressing health or social to those with the most pressing health or social needs. needs.

►Macrolevel concerns about justice become Macrolevel concerns about justice become involved if global research consistently ignores the involved if global research consistently ignores the health problems of poor communitieshealth problems of poor communities

Share in benefits Share in benefits (Beyrer & Kass 2002) (Beyrer & Kass 2002)

► If a community is to bear the risk of research, If a community is to bear the risk of research,

it must also reap future benefitsit must also reap future benefits

► Institutional review boards should ask Institutional review boards should ask

investigators about the implementation plan investigators about the implementation plan

for their research, steps to ensure the chances for their research, steps to ensure the chances

that the intervention will be available to local that the intervention will be available to local

groups, and how serious any discussions with groups, and how serious any discussions with

governments, aid agencies, or both have beengovernments, aid agencies, or both have been

After the trial is over After the trial is over (Beyrer & Kass (Beyrer & Kass 2002) 2002)

► What responsibilities are owed to the What responsibilities are owed to the

research community?research community?

► Encourage access to the benefits from Encourage access to the benefits from

findingsfindings

► Train researchers and care providers in the Train researchers and care providers in the

communitycommunity

► Ensure privacy of participants and Ensure privacy of participants and

researchersresearchers

Ethics Review Ethics Review (Beyrer & Kass 2002) (Beyrer & Kass 2002)

►The review board must assess whether The review board must assess whether studies have an adequate balance of studies have an adequate balance of benefits to risks, whether consent benefits to risks, whether consent procedures are adequate, and whether procedures are adequate, and whether any groups of participants are any groups of participants are improperly targeted or denied benefits improperly targeted or denied benefits as a result of the study. as a result of the study.

Beneficence and JusticeBeneficence and Justice

Research Ethics BoardsResearch Ethics Boards

►The REB is your friendThe REB is your friend

►Element of peer reviewElement of peer review

►Protects participantsProtects participants

►Protects researchersProtects researchers

ReferencesReferences► Beauchamp T L, Childress J F, 1994 The principles of biomedical ethics, Beauchamp T L, Childress J F, 1994 The principles of biomedical ethics,

4th edn. Oxford University Press4th edn. Oxford University Press► Beyrer C, Kass NE Human rights, politics, & reviews of research ethics. Beyrer C, Kass NE Human rights, politics, & reviews of research ethics.

LancetLancet 2002 Jul 20;360(9328):246-51. 2002 Jul 20;360(9328):246-51. ► Centre for Disease Control and Prevention Centre for Disease Control and Prevention

http://www.cdc.gov/nchstp/od/tuskegee/time.htm#tophttp://www.cdc.gov/nchstp/od/tuskegee/time.htm#top► CIOMS International Guidelines for Biomedical Research Involving Human CIOMS International Guidelines for Biomedical Research Involving Human

Subjects Subjects http://www.cioms.ch/frame_guidelines_sept_2002.htmhttp://www.cioms.ch/frame_guidelines_sept_2002.htm ► Health Care Consent Act Ontario, 1996Health Care Consent Act Ontario, 1996 ► Hornblum, Allen M 1998 Acres of Skin. Routledge, NYHornblum, Allen M 1998 Acres of Skin. Routledge, NY► MRC guidelines for good clinical practice in clinical trials 1998. MRC guidelines for good clinical practice in clinical trials 1998.

http://www.mrc.ac.uk/ethicshttp://www.mrc.ac.uk/ethics► Pappworth M H 1990 "Human Guinea Pigs"- a history. British Medical Pappworth M H 1990 "Human Guinea Pigs"- a history. British Medical

Journal 301:1456-1460 Journal 301:1456-1460 ► Pappworth M H 1967 Human Guinea Pigs. Beacon Press, BostonPappworth M H 1967 Human Guinea Pigs. Beacon Press, Boston► Tri-Council Policy Statement Tri-Council Policy Statement

http://www.nserc.ca/programs/ethics/english/index.htmhttp://www.nserc.ca/programs/ethics/english/index.htm ► Uris L, 1992 QB VII Harper Collins LondonUris L, 1992 QB VII Harper Collins London