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Protecting human subjects in research Pawel Stefanoff.

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Presentation on theme: "Protecting human subjects in research Pawel Stefanoff."— Presentation transcript:

1 Protecting human subjects in research Pawel Stefanoff

2 Key issues Historical perspective Guiding principles Guidance for protocol preparation Informed consent Ethical committee review Conducting the study Reporting the study

3 Ethical guidance for research: Milestones Nuremberg code –War crimes tribunal at Nuremberg (1947) Universal declaration of human rights –United Nations General Assembly (1948) Declaration of Helsinki (1964) –World Medical Association International technical guidelines –Council for International Organisations of Medical Sciences (CIOMS) World health Organization WHO

4 The Tuskegee syphilis study (1/2) Cohort study conducted in the first part of the 20th century Patients recruited with syphilis and followed up for decades to study the natural history Tuskegee, Macon County, AL, USA

5 The Tuskegee syphilis study (2/2) Issues –No treatment given –No information –No consent Dramatic consequences Epilogue –President Clintons apology (1997) to survivors Spinal taps Burial stipends

6 Basic ethical principles Autonomy –Respect for the person who is a study subject Justice –Burdens and benefits should be equally distributed Beneficence –Do good Non-maleficence – Do no harm

7 Research vs. non-research Research –Produces results that are generalizable Non-research –Programme evaluation –Surveillance –Emergency operations (e.g., outbreak investigation)

8 Ensuring the protection of human subjects in epidemiology All projects –Minimize risks Ensure confidentiality –Maximize benefits –Obtain informed consent Research projects –The same general principles apply –Ethical committee clearance required in addition

9 Exercise 1: Is this research? ?A case-control study of tick-borne encephalitis risk factors ?A telephone survey collecting information on attitudes towards vaccination ?An evaluation of a surveillance system for aseptic meningitis

10 Criteria that a research protocol must meet Useful research question Scientifically sound approach Appropriate procedures Planned analysis Vulnerable populations protected Low risks, maximum benefits Good tools Informed consent

11 Only good studies are ethical!

12 Example of vulnerable populations Pregnant women Adolescents Children Elderly Refugees Prisoners Those who can't give consent (unconscious) Persons with mental or behavioural disorders

13 Research in vulnerable populations Must not be studied if unnecessary –Do not study a new drug among prisoners May be studied if the research question is of direct relevance to the population –Harm reduction strategies might be relevant to prisoners among which illicit drug use is common –Provide evidence that the vulnerable population will not be exploited

14 Low risks and maximum benefits (1): Study participants Risks and benefits for the participants Weight them honestly –Do not under-estimate risks –Do not over-estimate benefits

15 Low risks and maximum benefits (2): Study population and other populations Benefit / harm for communities from which the participants are drawn Benefit / harm for communities beyond the research population

16 Maximize the welfare of participants Counsel participants Protect privacy and psycho-social needs Deal with adverse reactions

17 Exercise 2: Minimizing risks, maximizing benefits You would like to conduct a study on the factors associated with anemia among adolescent girls You propose to conduct a survey, to collect blood samples and to identify the factors that are associated with being anemic List two critical steps you would take to: –Minimize harm –Maximize benefits

18 Informed consent Ban undue inducements to participate Ensure free participation Make provision for: –Those who cant read / sign –Those who cant give personal consent

19 How does a person give an informed consent? Information received Information understood Decision made without: –Coercion –Undue influence / inducement, –Intimidation

20 The consent form (1/5) Attached to protocol Lay language Complete /adequate Clear mention of research Rationale for the study Details of what is asked from participants Duration of the research

21 The consent form (2/5) Nature, sequence and frequency of procedures Nature and likelihood of anticipated discomfort or adverse effects –Physical risks –Psychological and social risks –Clarifications What has been done to minimize risks Action to be taken if they occur Outlines the possible benefits, if any

22 The consent form (3/5) Outline of the procedure to protect confidentiality Mention if confidentiality is not possible Mention that: –Participation is voluntary –Refusal to participate (or discontinue participation) involves no penalty / loss Description of alternatives to participation

23 The consent form (4/5) Nature of any compensation /reimbursement –Time –Travel –Person-days lost from work Plans for feedback to participants if any Contact information

24 The consent form (5/5) Provision for subjects incapable of reading and signing Provision for participants incapable of giving personal consent

25 Referring to the biological specimens in the consent form (1/2) Nature, number and volume Procedures to be used –Routine or experimental –Invasive or not Use to which specimens will be put –For the study –In the longer term (e.g., left over)

26 Referring to the biological specimens in the consent form (2/2) Will results will be returned to subjects? How will the leftovers be handled? Will there be genetic/genomic testing?

27 Confidentiality of data Do not collect identifiers on data collection instruments –Use study codes Do not enter identifiers in electronic data files

28 Identifiers logs Contain identifying information Collected on paper Separated from the data collection instruments after field verifications Kept under lock and key Destroyed after data analysis

29 Line listing and identifier log Electronic data file –Not confidential, can be analyzed Separate identifier log –Confidential, cannot be analyzed, kept on paper

30 Confidentiality of specimens Clinical specimens for investigations (e.g., outbreaks) –Identifier may be on the specimen –Results given back to patient/ provider Research specimen –Study code on the specimen –Results given back or not, as relevant

31 Ethical committees Basic responsibilities Composition Terms of reference Review procedures WHO guidelines available – thics.htm

32 Responsibilities of the ethical committee Safeguarding the dignity, rights, safety, and well-being of research participants Consider principles of justice Review ethics of proposed studies

33 Composition of ethics committees Multidisciplinary / multi-sectoral 5-7 to members External chairperson Member secretary –Operates routine business Members from diverse origins Adequate age, gender and community representation

34 Initial approval and follow up Review of proposed research –Before its initiation Regular evaluation of ongoing studies –All that received a positive decision

35 Ethical committee review Presentation of protocol Discussions / questions (quorum) Clear decision –Clearance –Conditional clearance –Deferral –Refusal Documentation of all processes –Checklist / standard operating procedures

36 Exemption from ethical review Teaching Educational tests Research on existing data Programme evaluation Consumer satisfaction survey for food

37 Conducting the research according to the protocol Follow protocol Ensure protection of human subjects as part of the field work quality assurance –Train field workers –Standardize field work procedures –Supervise –Check forms and reports

38 Actually collecting informed consent Present the study Offer participation Collect consent if the patient agrees Leave a copy of the signed document

39 Data analysis Do not analyze files containing identifiers Make sure that the analysis would not disclose personal information –E.g., surveillance reports identifying cases in a small community

40 Exercise 3: Ethical review needed? ?A case-control study of tick-borne encephalitis risk factors ?A telephone survey collecting information on attitudes towards vaccination ?An evaluation of a surveillance system for aseptic meningitis

41 Elements to mention in the final report Risks and benefits to participants Measures taken to protect human subjects Clearance obtained (or exemption)

42 Take home messages Follow principles of autonomy, justice, beneficence and non-maleficence Use a checklist to prepare your protocol Conduct the study according to protocol Only well planned, valid studies are ethical! Apply country rules, but act according to universal ethical principles

43 Useful resources

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