Research Ethics: Principles, Practices, and Policies, Slides of Reasoning

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Welcome to IRB Tutorial!

This tutorial will help you and your research team to learn more

about the development of codes and principles of research

ethics, the informed consent process, selection and recruitment of

research participants, protection of confidentiality of subjects,

and regulation of research.

You will also learn the basics of submitting research protocols

and what will be expected of you, as a researcher, after you have

obtained initial AUCA IRB approval.

This tutorial is certainly not exhaustive, and the AUCA IRB

promotes further education of researchers regarding the

principles of research ethics.

Online Tutorial Structure

The Online Tutorial consists of two sections:

 Section 1: Compliance

 Section 2: Research Ethics

Both sections (Section 1 and Section 2) are required readings.

The required EXAM following Section 1 and Section 2 must be completed to receive certificate of completion of Online Tutorial.

Section 1: Compliance

Basic moral standards and rules

Throughout the history some individual researchers have valued the acquisition of scientific knowledge more highly than the protection of human subjects’ rights and well-being. Significant harm to and death of subjects has occurred when scientists failed to adhere to basic moral standards/rules such as:

 Concern for the well-being of others  Respect for the autonomy of others  Trustworthiness & honesty  Willing compliance with the law (with the exception of civil disobedience)  Basic justice; being fair  Refusing to take unfair advantage  Benevolence: doing good  Preventing harm

AUCA expects its faculty and student researchers who use human participants in research to:

 adhere to established personal (societal) ethical practices;

 follow professional ethical principles established by their respective disciplines;

 ensure full compliance with AUCA IRB policies and procedures which address protection of human participants.

Failure to comply with ethical principles while using human participants for research may result in a serious offence and penalty including suspension of IRB approval or disciplinary action depending on severity of non-compliance. All acts of non-compliance will be reviewed on a case by case basis the AUCA IRB and may involve representatives from top administration.

Tuskegee Syphilis Study

 In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks.

 The study initially involved 600 black men - 399 with syphilis, 201 who did not have the disease.The study was conducted without the benefit of patients' informed consent. Researchers told the men they were being treated for "bad blood," a local term used to describe several ailments, including syphilis, anemia, and fatigue.

 The men were never given adequate treatment for their disease. Even when penicillin became the drug of choice for syphilis in 1947, researchers did not offer it to the subjects. Although originally projected to last 6 months, the study actually went on for 40 years. In July 1972, an Associated Press story about the Tuskegee Study caused a public outcry that led the Assistant Secretary for Health and Scientific Affairs to appoint an Ad Hoc Advisory Panel to review the study.

 The panel found that the men had agreed freely to be examined and treated. However, there was no evidence that researchers had informed them of the study or its real purpose. In fact, the men had been misled and had not been given all the facts required to provide informed consent.

Radiation Experiments

 From 1944 to 1974, the government sponsored thousands of radiation experiments.

 These studies were conducted to advance biomedical, national defense, or space exploration science.

 Some of these experiments involved prisoners and military personnel, at times unknowingly.

 If consent was obtained, it was found that the documents were difficult to comprehend and sometimes misleading.

 At times, consent documents overemphasized the benefits of the research and overstated the therapeutic potential.

 These consent documents often did not properly discuss the potential risks involved with participation, in particular psycho-social risks and financial costs that could be incurred.

Nuremburg Code

 In 1946, 23 leading members of the German medical hierarchy involved with the Nazi experiments were indicted for their participation. In August 1947, all were found guilty. Sixteen were imprisoned and seven were sentenced to death for conducting “crimes against humanity.” During this verdict, the judges included a section called “Permissible Medical Experiments”, which became known as the Nuremberg Code.

 The Nuremberg Code mandated protections for human subjects in medical and non-clinical experiments. The code established basic principles that must be observed in order to satisfy moral, ethical and legal concepts.

Nuremburg Code Basic Principles

 Voluntary (informed) consent is essential

 Experiment to yield fruitful results for society, and not random or unnecessary

 Research to be based upon animal experimentation or knowledge of the disease or problem to ensure that the results justify the undertaking of the experiment

 Experiment conducted so as to avoid unnecessary physical and mental suffering and injury

 Experiment not conducted if possibility that death or disabling injury will occur

 Degree of risk not to exceed the humanitarian importance of the problem to be solved

 Proper preparations and facilities to protect the subject from remote possibility of injury, disability, or death

 Conducted only by scientifically qualified persons using highest degree of skill and care

 Subject at liberty to withdraw from the experiment at any time

 Scientist in charge must be prepared to terminate the experiment at any stage if continuation likely to result in injury, disability, or death to the subject

Belmont Report

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The Belmont Report sets forth three basic ethical principles for the conduct of human subjects research:

 Respect for persons involves recognition of the personal dignity and autonomy (right to choose) of individuals, and special protection of those persons with diminished autonomy. This principle requires obtaining informed consent from all potential research subjects (or their legally authorized representatives).

 Beneficence requires that researchers protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Research-related risks must be reasonable in light of expected benefits.

 Justice requires that the benefits and burdens of research be distributed fairly.

Belmont Report Link: http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/

Respect for Persons

There are two basic moral requirements underlining this principle:

 To acknowledge autonomy (i.e., freedom to deliberate and make considered choices) of research participants  To protect those with diminished autonomy. For example, immature children, geriatric/senile individuals, persons with diminished capacity from illness or mental disability, and persons with conditions that severely affect individual liberty (e.g., prisoners)

 The extent of protection afforded to those with diminished autonomy depends on the risk of harm and likelihood of benefit of being involved with the research. In certain circumstances, extensive protection or exclusion is required. While other circumstances warrant only the assurance that involvement with the research is undertaken willingly, and that they are aware of possible adverse consequences.

 One application of this principle is the consent process. Subjects must be given ample time to consider all of the information of a study they need before consenting to participate without pressure. Participants are free to withdraw participation at any time without penalty.

Glossary

 Risk : A combination of the probability of experiencing a harm and the severity of the envisioned harm  Benefit : Something of positive value related to health or welfare of the subject  The nature and scope of risks and benefits:  Psychological  Physical  Legal  Social  Economic  Dignity

Justice

 Researchers and IRBs must ensure that the risks and benefits of research are distributed fairly.

 They must determine whether certain social classes or groups of people are not unjustly targeted for research, for example, because of ease of recruitment.

 The Belmont Report states that, “ An injustice occurs when some benefits to which a person is entitled is denied without good reason or when some burden is imposed unduly. ”