Principles of Research Ethics: consent, risk and justice Lisa Schwartz, PhD Arnold Johnson Chair in Health Care Ethics McMaster University

Outline History Principles A challenging balance Practical considerations

History

Principles

A challenging balance

Practical considerations

A history for concern Nuremberg & Japan Tuskegee US prison experiments HeLa cell line

Nuremberg & Japan

Tuskegee

US prison experiments

HeLa cell line

Christine Borland Cet etre-la, c’est a toi de le creer! Vous devez la creer! 1997

Ongoing concerns Disturbing stories about paediatric post-mortem collection of organs The routine use in research without consent of Patient records Guthrie Cards Prenatal screening samples Tissue collected for treatment

Disturbing stories about paediatric post-mortem collection of organs

The routine use in research without consent of

Patient records

Guthrie Cards

Prenatal screening samples

Tissue collected for treatment

The response Nuremberg code http://www.med.nus.edu.sg/phar/sgcpp/nuremburg.htm Declaration of Helsinki www.wma.net CIOMS Statement http://www.cioms.ch/ Tri-Council Policy Statement (Canada) National Committee on Ethics in Human Research (Canada) http://ncehr-cnerh.org/ Belmont Report (US) Office of Human Research Protection (US) http://ohrp.osophs.dhhs.gov/index.html MRC guidelines ( http://www.mrc.ac.uk/ethics UK) British Sociological Society (UK) Nuffield Reports (UK) http://www.nuffieldbioethics.org/home/index.asp Research Ethics Boards

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

Declaration of Helsinki www.wma.net

CIOMS Statement http://www.cioms.ch/

Tri-Council Policy Statement (Canada)

National Committee on Ethics in Human Research (Canada) http://ncehr-cnerh.org/

Belmont Report (US)

Office of Human Research Protection (US) http://ohrp.osophs.dhhs.gov/index.html

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

British Sociological Society (UK)

Nuffield Reports (UK) http://www.nuffieldbioethics.org/home/index.asp

Research Ethics Boards

Problems They need to be interpreted Variability of application

They need to be interpreted

Variability of application

Principles Respect for human dignity Beneficence / Non-Maleficence Utility Justice

Respect for human dignity Respect for autonomy Informed Consent Honesty Respect for privacy Fair recruitment procedures Follow up Collaborative research

Respect for autonomy

Informed Consent

Honesty

Respect for privacy

Fair recruitment procedures

Follow up

Collaborative research

Tallon D, Chard J, Dieppe P. Consumer involvement in research is essential. BMJ 2000; 320 :380-380 “… consumer involvement will greatly enhance the overall relevance of clinical research. It will ensure that the most fruitful research questions are addressed and the most appropriate outcome measures used, thus maximising the potential for the results to be relevant and beneficial to research consumers. Furthermore, it should lead to a more efficient use of research resources.”

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

Ends, means, subjects and objects There is a danger of reducing research subjects to research objects

There is a danger of reducing research subjects

to research objects

Edward Weston Nude 1936 © Center for Creative Photography, Arizona Board of Regents Scan courtesy of Masters of Photography

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

Ends, means, subjects and objects Be aware of the humanity in each person Treat persons as ends in themselves and never solely as means to ends Includes honesty, consent

Be aware of the humanity in each person

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

Includes honesty, consent

Beneficence / Non-Maleficence Intentions Outcomes Balance the good of many with the good of few

Intentions

Outcomes

Balance the good of many with the good of few

M.H. Pappworth in 1967 “ No physician is justified in placing science or the public welfare first and his obligation to the individual, who is his patient or subject, second. No doctor, however great his capacity or original his ideas, has the right to choose martyrs for science or for the general good.” Pappworth M.H. Human Guinea Pigs; Boston: Beacon Press, 1967; pg. 27

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

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

Utility Make best use of scarce resources Research participants are a valuable resource not to be exploited Ensure value of the research question Ensure quality of method

Make best use of scarce resources

Research participants are a valuable resource not to be exploited

Ensure value of the research question

Ensure quality of method

Justice Fairness as equity Equal access to benefits Equal share of burdens Deprived populations Global research

Fairness as equity

Equal access to benefits

Equal share of burdens

Deprived populations

Global research

A challenging balance Justice, risk and consent

Risk Edwards SJ et al Research Ethics Committees and paternalism, Jrl of Medical Ethics 2004;30:88-91 Research entails risk Should we permit high risk research? (e.g. Gelsinger, Roche) Respect for persons + Beneficence = Paternalism or Disclosure of Risk But the risks associated with research are mostly unknown and ...

Research entails risk

Should we permit high risk research? (e.g. Gelsinger, Roche)

Respect for persons + Beneficence

=

Paternalism or Disclosure of Risk

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

US Hearings on Human Experimentation, 1973 “ Those who have borne the brunt of research – whether it is drugs or even experimental surgery – have been the more disadvantaged people within our society; have been the institutionalised, the poor, and minority members.” Sen. T Kennedy, prt 3, 7.3.1973, p. 841

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

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

Acceptable levels of risk? Baltimore Lead in Children study Relative to context and interpretation May imply that risky research is tolerable among populations who live with high levels of risk in their day to day existence Spriggs M Canaries in the mines: children, risk, non-therapeutic research and justice, Jrl of Medical Ethics 2004;30:176-181.

Baltimore Lead in Children study

Relative to context and interpretation

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

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

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

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

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

Based on Papworth quote

Justice, Risk and REBs Safe mechanisms e.g. REBs, Monitoring, Audit Equal distribution of risks, harms and benefits of research

Safe mechanisms

e.g. REBs, Monitoring, Audit

Equal distribution of risks, harms and benefits of research

Practical considerations Justice and the measurement of benefit and burden in research

Considerations that might affect the appropriateness of involvement of some communities in research (Beyrer & Kass 2002) Vulnerability Poverty Human rights violations Discrimination Poor access to resources Education Coercion Lack of trust

Vulnerability

Poverty

Human rights violations

Discrimination

Poor access to resources

Education

Coercion

Lack of trust

Research findings that could increase risk of violations In some instances, the findings rather than the procedures of studies, could lead to harm Findings could be used to stigmatise e.g. the status of refugees can be compromised by research

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

Findings could be used to stigmatise

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

4 theoretical considerations Information sharing for consent Voluntariness Trust Privacy

Information sharing for consent

Voluntariness

Trust

Privacy

Justice from Beyrer C, Kass NE Human rights, politics, & reviews of research ethics. Lancet 2002 Jul 20;360(9328):246-51. In research ethics, the principle of distributive justice forbids research risks and burdens being borne disproportionately by vulnerable groups within society ; similarly, the more privileged in society cannot disproportionately reap research benefits Just research may be impossible to achieve in settings where equality, fairness, and the distribution of social good and harm are routinely abrogated Where permission is granted by the very people who are oppressing the potential participants, researchers must be aware of potential misuse of findings. Conversely, there may be instances in which participation would be in the best interests of the minority group, but government officials deny access

In research ethics, the principle of distributive justice forbids research risks and burdens being borne disproportionately by vulnerable groups within society ; similarly, the more privileged in society cannot disproportionately reap research benefits

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

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

Vulnerable populations (Beyrer & Kass 2002) Typically, the justification for including a vulnerable group in research is when a problem disproportionately affects that group Conversely, forbidding research in regions with limited human rights could deny research benefits to those with the most pressing health or social needs. Macrolevel concerns about justice become involved if global research consistently ignores the health problems of poor communities

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

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

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

Share in benefits (Beyrer & Kass 2002) If a community is to bear the risk of research, it must also reap future benefits Institutional review boards should ask investigators about the implementation plan for their research, steps to ensure the chances that the intervention will be available to local groups, and how serious any discussions with governments, aid agencies, or both have been

If a community is to bear the risk of research, it must also reap future benefits

Institutional review boards should ask investigators about the implementation plan for their research, steps to ensure the chances that the intervention will be available to local groups, and how serious any discussions with governments, aid agencies, or both have been

After the trial is over (Beyrer & Kass 2002) What responsibilities are owed to the research community? Encourage access to the benefits from findings Train researchers and care providers in the community Ensure privacy of participants and researchers

What responsibilities are owed to the research community?

Encourage access to the benefits from findings

Train researchers and care providers in the community

Ensure privacy of participants and researchers

Ethics Review (Beyrer & Kass 2002) The review board must assess whether studies have an adequate balance of benefits to risks, whether consent procedures are adequate, and whether any groups of participants are improperly targeted or denied benefits as a result of the study. Beneficence and Justice

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

Beneficence and Justice

Research Ethics Boards The REB is your friend Element of peer review Protects participants Protects researchers

The REB is your friend

Element of peer review

Protects participants

Protects researchers

References Beauchamp T L, Childress J F, 1994 The principles of biomedical ethics, 4th edn. Oxford University Press Beyrer C, Kass NE Human rights, politics, & reviews of research ethics. Lancet 2002 Jul 20;360(9328):246-51. Centre for Disease Control and Prevention http://www.cdc.gov/nchstp/od/tuskegee/time.htm#top CIOMS International Guidelines for Biomedical Research Involving Human Subjects http://www.cioms.ch/frame_guidelines_sept_2002.htm Health Care Consent Act Ontario, 1996 Hornblum, Allen M 1998 Acres of Skin. Routledge, NY MRC guidelines for good clinical practice in clinical trials 1998. http://www.mrc.ac.uk/ethics Pappworth M H 1990 "Human Guinea Pigs"- a history. British Medical Journal 301:1456-1460 Pappworth M H 1967 Human Guinea Pigs. Beacon Press, Boston Tri-Council Policy Statement http://www.nserc.ca/programs/ethics/english/index.htm Uris L, 1992 QB VII Harper Collins London

Beauchamp T L, Childress J F, 1994 The principles of biomedical ethics, 4th edn. Oxford University Press

Beyrer C, Kass NE Human rights, politics, & reviews of research ethics. Lancet 2002 Jul 20;360(9328):246-51.

Centre for Disease Control and Prevention http://www.cdc.gov/nchstp/od/tuskegee/time.htm#top

CIOMS International Guidelines for Biomedical Research Involving Human Subjects http://www.cioms.ch/frame_guidelines_sept_2002.htm

Health Care Consent Act Ontario, 1996

Hornblum, Allen M 1998 Acres of Skin. Routledge, NY

MRC guidelines for good clinical practice in clinical trials 1998. http://www.mrc.ac.uk/ethics

Pappworth M H 1990 "Human Guinea Pigs"- a history. British Medical Journal 301:1456-1460

Pappworth M H 1967 Human Guinea Pigs. Beacon Press, Boston

Tri-Council Policy Statement http://www.nserc.ca/programs/ethics/english/index.htm

Uris L, 1992 QB VII Harper Collins London