Ethical Considerations In Human Subject Studies

Ewnetu Firdawek

Outline

• The foundation for Ethical Principles and rules• Existing Ethical Guidelines• Ethical Principles and Rules• Informed Decision Making• Ethical approval procedures

Foundation and Existing Guidelines

• The general conduct of biomedical studies is guided by internationally recognized principles of human rights, including the international ethical guidelines.

• The main source of guidance on the ethical conduct of clinical research have been – Nuremburg code– Declaration of Helsinki– Belmont Report– International Ethical Guideline for Biomedical research

involving Human Subjects– Operational Guidelines for Ethics Committees that

review Biomedical Research– National Guidelines

Ethical Considerations

• In broader sense Research projects are reviewed for three broad categories of Ethical subjects– Respect for Persons– Beneficence– Justice

Respect for Persons

• Participation in the research should be completely voluntary and based on informed consent

• Privacy should be protected by ensuring confidentiality while data collection in individuals

• Respect to the community means respecting its values and having its approval for the research

Respect for Persons…

• Respect for person addresses two main ethical considerations– Autonomy and– Protection of persons with diminished or impaired

autonomy

• An autonomous person is that who is capable of deliberation about personal goals and of acting under the direction of such deliberations.

• Every person is not capable to self-decide.

Respect for Persons…

• Persons who are considered incapable are diminished autonomy are

– Children due to lack of maturity– Mental disability– Circumstances that severely restrict liberty e.g. prisoners– decreased capacity of self-decision

• The extent of protection afforded depends on the risk of harm and the likelihood of benefit.

• Respect for person also demands voluntary participation and Confidentiality.

• Voluntary Participation:– An agreement to participate in research constitutes a

valid consent only if voluntarily given. – This requires free of coercion and undue influence. – Coercion occurs when an overt threat of harm is

intentionally presented by one person to another to obtain compliance.

– On the contrary, undue influence occurs through an offer excessive, unwarranted, inappropriate or improper reward to obtain compliance.

• Confidentiality: – The need to respect the response of the research

participant providing the information that is not to be disseminated is obviously clear.

– The investigator must establish secured safeguards of the confidentiality of research data, by using codes.

– Disclosure may result in substantial costs for participants, researchers and society.

– The use of information for any purpose other than that to which participants consented is an unethical to the dignity of the participants.

Beneficence

• When research involves experimentation on human subjects, every effort should be made to maximize the benefits to the subjects(beneficence) and the subjects should suffer no harm(non-maleficence)

• Beneficence

– Participants are treated in an ethical manner not only by respecting their decisions, but also protecting them from harm and making efforts to secure their well-being.

– Two general rules have been formulated as complementary expressions of beneficence:

a) Do not harm, and

b) Maximize possible benefits and minimize possible harms.

– Beneficence has two components: benefits and risks

• Benefits could have different components– Beneficiaries: Research Participants, Community,

Country– Forms of benefits: Monetary, Health care,

capacity building–Magnitude of Benefits: compensation– Duration of benefit: Short (only for the study

period) and long (extends beyond the study period)term

Justice

• Participation in the research should correlate with expected benefits

• No population group should carry an undue burden of research for the benefit of another group

• Justice:– The underlined principle of justice is to treat each person in

accordance with what is morally right and proper, i.e., fairness in distribution.

– This is to say that there must be equitable distribution of both the burdens and benefits of participation in research.

Informed Decision Making

• The participant should be given clear information on the research prior to giving consent for participation, and hence the need for informed consent.

• The roles of Informed Consent are:– To respect individual rights– To establish participatory research

• Types of informed consent–Written: written consent has to be obtained for

epidemiological research as much as possible. But for clinical research, written consent is a must.

– Verbal: verbal consent may be opted in communities where people are reluctant to put their signature on official document for epidemiological research. This, however, cannot be an excuse for clinical studies.

Individual informed consent is obtained from a competent individual who – Has received the necessary information– Has adequately understood the information– Has arrived at a decision without having been

subject to coercion, undue influence, inducement or intimidation

• The prospective research participant may have a number of serious concerns including–Why the research is being done–Why to take part in the study–What to be asked–What to be provided– Advantages of being a participant– Disadvantages of being a participant– Confidentiality– Possibility of withdrawal

• Hence the researcher needs to address the concerns of the participants by providing information's regarding– Aims and Methods of the research– Expected duration of participation– Benefits to the participant and the society– Any risk or discomfort as of participation– Extent of maintaining confidentiality– Free medical services for research related injury– Any compensation– Freedom of withdrawal

• Investigators Obligation– adequately communicate to the participants– Provide opportunity to participants to ask if any– Avoid the possibility of unjustified deception– seek consent after due understanding – obtain a signed consent as an evidence– Renew the informed consent if any changes on

procedure

• Reading Assignment – Informed consent in special circumstances– The process of informed consent– Informed consent form–World medical association declaration of helsinki

ethical principles for medical research involving human subjects

– International ethical guidelines for biomedical research involving human subjects

Thank you