Research EthicsBY: NONSO DERRICK ONWUDINJOFOR: PRESTON HEALTHCARE CONSULTING LTD.DATE: 9 T H DECEMBER 2016

Outline guide History of Research Ethics The Nuremburg Code The Belmont Report Principles of the Belmont Report Questionable Ethical Conduct in Nigeria NHREC Tips for Conducting Ethical Research Conclusion

History of Research Ethics

Concentration Camp Experiments

The Nuremburg Code The Nuremberg Code was established in 1948, stating that "The voluntary consent of the human subject is absolutely essential”.

Tuskegee Syphilis Study (1932-1972) Declaration of Helsinki. In 1964 The Belmont Report

The Belmont Report The Report was issued on 30 September 1978. It summarizes ethical principles and guidelines for research involving human subjects.

Cornerstone and most widely accepted standard for Ethical Research standards locally and internationally.

The Principles of the Belmont Report

Respect for Persons Individuals should be treated as autonomous agents. Persons with diminished autonomy are entitled to protection Informed consent Subjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them

The consent process must include three elements: information, comprehension, and voluntariness.

Respect for Persons Informed consent Information: People must be given enough information in order to make a knowledgeable decision whether they want to participate or not.

Information usually includes; Purpose of the research Study methods Time required to participate Potential Risks and/ or Benefits

Respect for Persons (cont’d) Informed consent Comprehension; Ensure people comprehend the information you give to them Information must be presented in a way for people to understand it. This includes special classes of people, under 18, impaired mental capacities, terminally ill.

Special classes may need the permission of a third person to protect them from possible harm.

Respect for Persons (cont’d) Informed consent Voluntariness; People must willingly give consent or permission to participate in the study. People must not feel coerced or pressured to participate.

Beneficence Human subjects should not be harmed Research should maximize possible benefits and minimize possible harms. Assessment of risks and benefits The nature and scope of risks and benefits must be assessed in a systematic manner

Justice The benefits and risks of research must be distributed fairly.

Selection of subjects There must be fair procedures and outcomes in the selection of research subjects

Questionable Ethical Conduct in Nigeria

The AZT (Zidovudine) trials in African and other developing countries

The Pfizer Trovan study in Nigeria

National Health Research and Ethics Committee of Nigeria

The National Health Research Ethics Committee (NHREC) is the apex body responsible for the provision of and ensuring adherence to guidelines that govern ethical research practice in order to ensure the protection of human research participants in Nigeria.

To whom does the code cover? Therapeutic procedures – interventions administered with the intent of providing direct benefit to the research participant

Non-therapeutic procedures – interventions that are not administered with therapeutic intent and are only intended to answer the scientific question of the study

Exemptions Studies that are designed to evaluate or assess quality of services, programs and procedures and formulate guidelines leading to their improvement are exempt. Such studies may involve the collection and analysis of some data.

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (1) Research on regular and special education instructional strategies, or (2) Research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods.

Tips in conducting Ethical Research

1. Require staff to sign a pledge of confidentiality.

2. Train staff on appropriate use of data and ethical concerns.

3. Use the information collected only for the intended purpose of the study.

4. Avoid undue intrusion. Do not collect data that has already been collected.

5. Do not harass or repeatedly ask the members of the sample to respond. Encouragement participation in a positive, non-threatening way.

Tips in conducting Ethical Research (cont’d)

6. Be honest with the potential respondents regarding all aspects of the project.

7. Consider the sensitivity of the information during collection.

8. Be clear and concise in the introduction so that respondents are fully informed.

9. Be aware of cultural and social differences relating to the topic of the project and wording of questions.

10. Obtain consent of a parent or guardian before collecting information from minors.

Conclusion War crimes of Nazi Scientists inspired the scientific community to set guidelines for ethical research practices.

Just because you have a research question does not mean your research is ethical.

Always ensure ethical standards are fully observed.