What is Research Ethics? Historical Background Need for Training 12/20/2015 Research Ethics. Ghaiath 1.

What is Research Ethics? Historical Background

Need for Training

04/21/23Research Ethics. Ghaiath 1

Ethics and bioethics Research Ethics Historical background on the

development of international guidelines and codes

Conclusion

The expressive level (unanalyzed expressions or feeling that, by themselves, don’t provide reasons or justification)

The pre-reflective level (justification via law, religious tenets, social values, codes of ethics, etc.; accepted uncritically)

The reflective level (reasoned ethical argument/defence based on ethical principles, rules, virtues, values to which we consciously subscribe; justification provided)

Thomas J and Waluchow W, 1998

explicit critical reflection on moral beliefs, practices and problems

philosophical study of morality

This is at the reflective level…

(contrast with “descriptive ethics”)

GhaiathEthics of Pt. Safety, July 08. 5

Bioethics is about the study of ethical issues arising along health care or research, and the associated decision-making process to resolve them.

GhaiathEthics of Pt. Safety, July 08. 6

 When there is conflict of moral values, beliefs, and objectives e.g. between the health care providers and the patients.

When there is conflict of commitments and responsibilities: e.g. saving patients' lives vs. using the available resources "rationally"

When there is the concern that our patients rights/values are not respected.

When the issue in focus is related to justice in allocating the available resources

Finally, when we, as care providers feel that we are not sure what we should do.

GhaiathEthics of Pt. Safety, July 08. 7

The three questions are: How to take an ethically acceptable

decision to the issue in focus? Why did we take this decision? (i.e. why

we chose this ethical option and not another?)

How to implement the decision we have taken?

04/21/23Research Ethics. Ghaiath 8

•The study of ethical issues raised by public health interventions

It is the field of ethics that systematically analyze the ethical and legal questions raised by rresearch involving human subjects.

Its main focus is to ensure that the study participants are protected and, ultimately,

that clinical research is conducted in a way that serves the needs of such participants and of society as a whole.

It works when and only when it is applied before the research is conducted

04/21/23Research Ethics. Ghaiath 9

Born in Scandal… The Evolution of Research Ethics

04/21/23Research Ethics. Ghaiath 10

James Lind “scurvy study in sailors - Salisbury Edward Jenner cowpox vaccine test 1897 Guiseppe Sanarelli yellow fever test

1900 Walter Reed established several [first ever] “safeguards”

1. Self-experimentation

2. Only adults would be enrolled in research

3. Written informed consent

4. Reimbursement (inducement)

Pre-World War II Research standards left up to the

discretion of the individual researcher World War II Experiments conducted on inmates of Nazi

concentration camps 1945-1949 - Trials in Nuremberg,

Germany– physicians convicted of crimes against humanity

Nuremberg Code (1947)

As a result of WWII Nazi experiments First international code in research ethics Voluntary consent absolutely essential

(restricting research with infants, children, developmentally challenged, etc.)

Risk/Benefit Analysis essential to ethics review

Scientific Soundness is important to ethics review

The first provision of the code requires that “the voluntary informed consent of the human subject is absolutely essential.” The code provides other details implied by such a requirement:

capacity to consent freedom from coercion comprehension of the risks and benefits

involvedThe code on the web: http://ohsr.od.nih.gov/nuremberg.php3

04/21/23Research Ethics. Ghaiath 15

Experiment should be designed and based on: The results of animal experimentation Knowledge of natural history of disease The anticipated results will justify the

performance of the experiment Avoidance of all unnecessary physical or mental

suffering and injury

× No experiment should be conduct where: There is a prior reason to believe that death

or disabling injury will occur Exception: experimenting physicians also

serve as subject Degree of risk to be taken should never

exceed that determined by the humanitarian importance of the problem

Proper arrangements made to protect the subjects against the possibilities of:

Injury Disability DeathExperiment to be conducted by highest qualified

persons Highest degree of skill and care required

through all stages of the experiment

o During the course of the experiment the human subjects should be at liberty:

To bring the experiment to an end Scientist in charge should be prepared to:

Terminate the experiment at any stage if he/she has probable cause to believe that continuation of the experiment is likely to result in injury, disability or death

The World Medical Association created the Declaration of Helsinki in 1964 & amended in: Tokyo (1975), Venice (1983), Hong Kong (1989), South Africa (1996), Edinburgh (2000), Washington (2002), and Tokyo (2004)

“The well-being of the subject should take precedence over the interests of science and society”

Consent should be in writing Use caution if participant is in

dependent relationship with researcher

Limited use of placebo Greater access to benefit

04/21/23Research Ethics. Ghaiath 20

Respect for Persons – people are not a means to an end; researchers have duty to protect life, health, privacy and dignity of research participants

Standard of care must be best available, even for control group

Proxy consent and assent for vulnerable populations

In 1972, the public became aware of the Tuskegee study, which took place in the southern United States from 1932 to 1972.

In 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established.

In 1978, the commission submitted its report titled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.

Those principles—respect for persons, beneficence and justice—are accepted as the 3 fundamental principles for the ethical conduct of research involving human participants.

04/21/23Research Ethics. Ghaiath 24

US National Commission for the Protection of Human

Subjects of Biomedical and Behavioural Research wrote

The Belmont Report in response to the Tuskegee and

Willowbrook Controversies.

This Led the US Department of Health and Human

Services (and others) to adopt Federal Regulations

regarding Research Ethics:

The Common Rule or US 45 CFR 46, last revised in

2001

Informed consent Research in developing countries Protection of vulnerable

populations Distribution of the burdens and

benefits Role of ethics committees

04/21/23Research Ethics. Ghaiath 26

First code to consider less developed communities Individual informed consent Appropriate inducements Special populations Privacy and confidentiality Independent ethics committee review

In collaborative research: Responsive to health needs of host country Agree in advance that products will be made reasonably

available afterward

Formed bu US,Japan and Europe Its goal is to standardize the process

by which new drugs are developed, tested and brought to market.

The ICH guidelines require review by an ethics committee and informed consent of participants.

04/21/23Research Ethics. Ghaiath 28

Kano trovan clinical trials in 1996, on pediatric age group, during the worst ever meningococcal meningitis.

Lack of proper Governmental authorization and informed consent during the studies publicized in 2000, by Washington Post.

Court trial and release of investigation panel reports stalled in Nigeria.

Suit for 5.8 billion USD moved to the USA and report leaked there too.

Settlement out of court being discussed.

“Research Scandals” led to the development of guidelines

Guidelines alone can not stop the violations of ethical conduct of research

It happened everywhere, and nobody is immune… including Sudan

Please bear that in mind when studying Research Ethics

www.nursingtimes.net http://ohsr.od.nih.gov/nuremberg.php3

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