Research ethics

1. Research
Ethics
BY: NONSO DERRICK ONWUDINJO
FOR: PRESTON HEALTHCARE CONSULTING LTD.
DATE: 9TH DECEMBER 2016

2. 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

3. History of Research Ethics

4. Concentration Camp Experiments

5. 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

6. 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.

7. The Principles of the Belmont Report

8. 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.

9. 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

10. 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.

11. 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.

12. 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

13. 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

14. Questionable Ethical Conduct in Nigeria
The AZT (Zidovudine) trials in African and other
developing countries
The Pfizer Trovan study in Nigeria

15. 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.

16. 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

17. 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.

18. 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.

19. 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.

20. 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.