Research ethics HRH Research Forum Dr Muna I Abdel Aziz MBBS, MD, MPH, PhD, CCST, FFPH Session developed 10 March 2012.

Research ethics

HRH Research ForumDr Muna I Abdel Aziz

MBBS, MD, MPH, PhD, CCST, FFPH

Session developed 10 March 2012

Sources• Henry Silverman, MD, MA, University of Maryland School of Medicine.

Presentations to Research ethics course, Khartoum College of Technology, Feb 2012.

• Abdur Rab M, Afzal M, Abou-Zeid A, Silverman H. Ethical Practices for Health Research in the Eastern Mediterranean Region of the World Health Organization: A Retrospective Data Analysis. Ethical Practices for research. 2008; 3(5): e2094

• G Serour. Islam and the four principles. Principles of health care ethics 1994: 75-91

• Sleem H, Abdelhai RAA, Al-Abdallat I, etal. Development of an Accessible Self-Assessment Tool for Research Ethics Committees in Developing Countries. Journal of Empirical Research on Human Research Ethics 2010: 85–96.

• Further reading: FMoH. Research ethics for TECs, 2010. FMoH Research methods manual, updated 2012.

Session objectives

• Learn something new in this session• Do something differently after this session

• At the end, please write for yourself:– One thing I learnt new:– One thing from today I will do:

Contents

• Ethical principles

• Overview of ethics in research

• Ethical issues in Planning and review

• Ethical issues in implementing research

• Ethical issues in disseminating research

• Discussion

Personal introduction to the topic

• “... if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society? ”

• We are all bound by our own values as to what is right and wrong.

• Yet people differ... And our deeply held values differ.• Conflicts arise when values are challenged. • Check yourself when you are most angry and you will find that

one of your deeply held values is violated.• Because we differ and because we need to be reminded, there

is a need for this talk and there is a need for research ethics committees.

Ethics

• The word ‘ethics’ derives from the Greek, ethos, which means custom or character.

• Ethics is contrasted with morality, which frequently relates to how you were raised and what values you learned from parents, religion, culture, and other influences.

• Ethics is the systematic study of values by which a determination of what is the right and wrong thing to do is made.

• Ethics is also different from law and regulation, both of which mandate a certain way of acting.

Ethical principles

• Beneficence

• Non- maleficence

• Justice

• Autonomy: – The right to make a decision and – Respect of persons

Declaration of Helsinki

• In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. It was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today.

• Issues addressed in the Declaration of Helsinki include: – Research protocols should be reviewed by an independent

committee prior to initiation – Informed consent from research participants is necessary – Research should be conducted by medically/scientifically

qualified individuals – Risks should not exceed benefits

US National Research Act

• 1974 • The National Research Act created the

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

• The Commission drafted the Belmont Report, a foundational document in for the ethics of human subjects research in the United States.

The Belmont Report

• The Belmont Report articulates 3 core ethical principles:

• Autonomy/Respect for persons

• Beneficence/ non-Maleficence

• Justice

•Favorable risk-benefit ratio•Use best possible research design to minimize harm•Use qualified investigators

Informed consent

Confidentiality

Fairness in distribution of risks and benefits

Fairness in selection of human subjects

What makes clinical research ethical

• Scientific Validity• Favorable Risk-Benefit Ratio• Independent Review• Social and Scientific Values• Community Perspective• Fair Subject Selection• Informed Consent• Respect for Enrolled Subjects

Contents






• Discussion

Why Research Ethics and TECs?

• Enhance Global Health– Protect human welfare– Minimize harms– Ensure Justice– Protect human rights

• Obtain External Funding• Publish International Journals

• REC/TEC/IRB is the research technical and ethical committee or institutional review board

Ethics in research in developing countries

• The national budget devoted to research is small (much less than 1%).

• UNESCO has set the level for R&D expenditure to be 1.5% of GNP in Newly Industrialized Countries.

• No prior exposure to research ethics in 28% to 62% researches submitted to EMRO

• Ethical challenges used to be in clinical trials... Now we have genetics research / stored tissues / biobanks

Planning and TEC review

• Need for the research• Design and conduct (technical validity, study

limitations)• Community consultation• Selection of participants (equity, vulnerability) • Risks and benefits• Safety of subjects• Privacy and confidentiality• Informed consent• Researcher responsibility vs TEC responsibilities

Implementing research

• Follow protocol• Protocol violations/deviations• Adverse events and safety monitoring• Withdrawal of subjects• Informed consent and continued consent• Drop-outs

Disseminating research

• Review of final report by TEC• The intention behind dissemination• Disseminate to Decision makers• Publish and contribute to body of evidence• Disseminate to Participants• Disseminate to Communities

Contents






• Discussion

Planning and TEC review

• Need for the research• Design and conduct (technical validity, limitations)• Community consultation• Selection of participants (vulnerability) • Risks and benefits• Safety of subjects• Privacy and confidentiality• Informed consent• Researcher responsibility vs TEC responsibilities

Technical validity and study limitations

Case studies

• Research not needed /old x

• Biased research or poorly designed research x

• Well written section on limitations of the study ie what this study will NOT do.

Critical appraisal of the proposed research

Consider the following• Methods will result in valid results with respect to– Bias– Confounding– Chance– True effects

• Importance of results (statistical, clinical, association versus causation)

• Limitations of the study• Generalisability to other settings

Informed Consent

ELEMENTS OF INFORMED CONSENT

24

Disclosure

voluntarinesscapacity

Principles of consent

Essential elements for consent

Additional elements for consent

• Statement that there may be risks that are unforeseeable

• Withdrawal criteria• Additional costs to subjects• Consequences of subject’s withdrawal• Statement that subjects will be told of new

findings• Approximate number of subjects in study

Documenting consent

• Approved by the REC.• Signed by the subject or representative.• A copy must be given to the person signing

the form.

Privacy and confidentiality

• Information governance• Access to Personal information• Keeping records (how long, how secure)• Anonymity• Disclosure

Vunerability

• Children• Illiterate• Poor/disadvantaged/disenfranchised• Prisoners• Physically disabled• Mentally disabled• Outsourcing of clinical trials to developing

countries

Contents






• Discussion

Implementing research

• Follow protocol • Protocol violations/deviations• Adverse events and safety monitoring• Withdrawal of subjects• Informed consent and continued consent• Drop-outs

Must ensure

• Consent is a continuous process, not a one‐time event

• Runs research as per protocol (no significant changes) – resubmit for ethical review

• Maintains principles ( eg limit inadvertent/ unplanned harm)

• Research Checkpoints: continue, resubmit for ethical review, or terminate... Check again...

Contents






• Discussion

Disseminating research

• Review of final report by TEC• The intention behind dissemination• Disseminate to Decision makers• Publish and contribute to body of evidence• Disseminate to Participants• Disseminate to Communities

Disseminate...

• Disseminate – acknowledge all scientific contributions• First author, second author etc rights• Declare limitations• Declare conflicts of interest and funding• Primary dissemination: Participants as promised, decision

makers who need to know• Academic literature is secondary. But it is good for

documentation and wider prolonged dissemination.• Media / community dissemination is good for community

advocacy and awareness about risks and benefits. Justifies their continued participation in research

Contents






• Discussion

Now a question for you... If we have time...

• What are the ethical issues in health systems research or HRH research?

Check the principles:– Beneficence– Non- maleficence– Justice– Autonomy:

• The right to make a decision and • Respect of persons

Session objectives

• Learn something new in this session• Do something differently after this session

• Please write for yourself:

–One thing I learnt new:

–One thing from today I will do:

Personal Summary...

One thing I learnt new:• There are frameworks to help think about ethics. The principles

are a good starting point. It is good to get other people’s perspectives (i.e. to check against their values as well as my own) even before taking a proposal for TEC committee review.

One thing from today I will do:• Ethical issues are not just about consent. I will think about

information governance, confidentiality and record keeping. Technical validity is important. I will write up a comprehensive section on study limitations from the perspective of a critical appraisal.

Research ethics

HRH Research ForumDr Muna I Abdel Aziz

MBBS, MD, MPH, PhD, CCST, FFPH

Session developed 10 March 2012

Research ethics HRH Research Forum Dr Muna I Abdel Aziz MBBS, MD, MPH, PhD, CCST, FFPH Session developed 10 March 2012.

Documents

human research ethics

research ethics committees

health research

research ethics course

research ethical issues

biomedical research

research participants

necessary research