Researching a Bioethical Question

Mohamed AbdulmongyMBBCh Candidate

Egypt

• Are these studies ethical?

• How do we know?

Ethics of clinical research• The goal of clinical research is to generate useful knowledge about human health and illness, and ways to prevent, diagnose and treat diseases.• The goal is not benefit to the individuals who participate (although there is sometimes benefit).• People are the means to developing useful knowledge; and are thus at risk of exploitation.

Ethics of clinical research

• Promote benefits to society and futurePatients.

• Protect and respectrights and welfare ofParticipants.

• Types of Bioethical Issues.• Types of Bioethical Research Methodologies.• Special Considerations in Bioethical Research.

• Examples of Important Bioethical Research:Historical Research Methodology Conceptual Analysis Cross-Cultural Analysis Empirical Research Policy Analysis

• During the past 35 years, there has been a significant increase in interest in bioethical questions.

• Common questions include the following:

Is it ethical to pay children up to $1,400 to participate in clinical research on a new antiasthma drug?Does payment for participation in clinical research lead to having more socio-economically vulnerable subjects?Does payment for participation in clinical research lead to worse informed consent?Is it appropriate to conduct research on a stored biological sample without the patient’s informed consent?Should international clinical research studies offer all participants the best therapy available anywhere in the world? Or is it sufficient to provide subjects in an international clinical research study only the local standard of care?

TYPES OF BIOETHICAL ISSUES

TYPES OF BIOETHICAL RESEARCHMETHODOLOGIES

• Historical Research Methodology • Conceptual Analysis • Cross-Cultural Analysis • Empirical Research • Policy Analysis

1) Historical Research Methodology• One of the most interesting uses of

historical research on bioethical questions is related to informed consent.

that the first reported legal case in the English language involving informed consent was Slater vs. Baker & Stapleton in 1767.

A patient sued two surgeons for rebreaking a partially healed leg fracture in an effort to improve its alignment.

Relying on the statement of physicians, the court ruled that it is “the usage and law of surgeons” to obtain the patient’s consent before performing an operation.

The court held that the two practitioners had violated the well known and accepted rules of consent.

• In the late 19th century, significant efforts were made to identify the etiology of yellow fever.

• Example, In 1897, the Italian researcher Guiseppe Sanarelli claimed he identified the yellow fever bacillus and, using this bacillus, had produced yellow fever in several patients.

• William Osier condemned these experiments, saying “to deliberately inject a poison of known high degree of virulency into human beings, unless you obtain that man’s concent, is not ridiculous, it is criminal.”

• When Walter Reed conducted his experiments on the etiology of yellow fever, he developed a written “contract” with the subjects that outlined “the risks of participation in the study as well as the benefits.

• Meticulous historical research using the traditional methods of historians- examining published articles and government documents, reading correspondence, journals, and notebooks, etc.- reveals that the informed consent for clinical care and research is not a recent, post-WorldWar II phenomenon.

• So, historical research into informed consent has made several important contributions.

• Another interesting example of the value of historical research for bioethical questions relates to the debate over euthanasia and physician-assisted suicide.

• The standard view is that advances in technology create interest in desire for euthanasia and physician-assisted suicide.

• Start the debate by ancient Greece then in the United States and Britain in the latter third of the 19th century.

• The situations changes ?

• So, the historical research can help answer some important bioethical questions, including:

- What bioethical concerns are caused by advances in medical technology and what are inherent in medicine? - How have these bioethical issues been addressed and resolved previously?

2) Conceptual Analysis• conceptual analysis has been essential to advancing bioethics and clinical

research.• The first example, is the development of the justification for randomized

controlled trials (RCTs). RCTs are deemed justifiable when physicians have no reason to believe that one

therapy is better than a second therapy and that there is no other therapy better than both. This was termed equipoise.

“If a clinician knows, or has good reason to believe, that a new therapy (A) is better than another therapy (B) he cannot participate in comparative trials of therapy A versus therapy B. Ethically, the clinician is obligated to give therapy A”

• A second example of the importance of conceptual analysis may be found in the issue of coercion, undue inducement, and exploitation. These are critical concepts for research ethics.

• Coerced consent is involuntary and therefore not valid. Consent rendered in response to undue inducements also is thought to be invalid.

• A third example of helpful conceptual analysis is a clarification about the physician-patient relationship.

3) Cross-Cultural Analysis• One of the more important cross-cultural studies in bioethics related to how

different cultures in the United States approach explicit discussions of death. • many years, there has been pressure for physicians to be more frank in disclosing a

patient’s terminal status; • data showed that the vast majority of Americans wanted to be told when they

were dying. However, there was growing experience that at least some people from other cultures did not desire such frankness about death and dying.

• But surveyed Mexican Americans and Korean Americans about their preferences regarding end-of-life decision making.

• They found significant differences between these groups and the dominant white population in the United States :

o only 47% of Korean Americans o and 65% of Mexican Americans o 87% of Anglo-Americans

4) Empirical Research• Beginning in the mid- to late-1980s, there was increasing

understanding that many bioethical questions required rigorous empirical research.

• This research is important for many reasons. Many ethical norms invoke a “reasonable person” standard; for example,

what information would a reasonable person want for informed consent?

Do research participants really want to know whether their researcher has consulting contracts with the drug company sponsoring the study?

Do videos improve the quality of understanding in informed consent?

• First, there are descriptive studies. The first area in which such studies occurred and became methodologically rigorous was end-of-life care.

• A major issue in end-of-life care related to proxy decision making. When patients become incompetent and cannot make decisions about medical interventions.

• A second type of research involves elucidating predictors of an outcome such as a decision or behavior.

• In such research, a certain outcome is described and univariate and multivariate analyses indicate whether certain factors are significantly associated with the outcome.

• This has been done effectively in the area of conflicts of interest.• There has been extensive discussion and debate about this point.• Many defenders of physicians have argued that receiving money for medical services does

not affect their medical judgment.• An important series of studies demonstrated that there is a link between physician

investment in medical facilities and a higher use of the services provided by those facilities.• One of the most important studies was conducted by Hillman et al., who compared the

frequency and costs of diagnostic radiologic imagining between physicians who have diagnostic radiologic facilities in their offices and physicians who refer patients to radiologists for diagnostic imaging. The results ?

Physicians who self-referred that is, utilized radiologic services in their offices performed diagnostic imaging 4 to 4.5 times more often than physicians who referred patients to outside radiologists.

• There are many studies of conflict of interest among clinical researchers. • Probably the most important is a study by Stelfox and colleagues. In the

mid-1990s,• it was controversial whether the use of calcium channel antagonists as

antihypertensive medications was safe.• Stelfox and colleagues assessed whether financial ties to drug

companies that manufactured calcium channel antagonists influenced researchers’ judgments.

5) Policy Analysis• Policy analysis can take a variety of forms, but one that has been useful in

relationship to bioethical issues is akin to meta-analysis.• It is the collection, summary, and analysis of data on a potential policy choice.• An example in which this has been done relates to cost savings from use of

hospice care.• It has been commonly argued that spending for dying patients is extremely high

and that use of a hospice can produce substantial cost savings.• the analysis suggests that during the last year of life, hospice use is associated

with a saving of 10% in total costs.

SPECIAL CONSIDERATIONS INBIOETHICAL RESEARCH

• First, few clinical researchers have any training or experience in the methods of historical research, such as using original sources and archival material.

Collaboration with people who have expertise in these areas can provide a way of obtaining the skills.

• Second, The more precise the concepts, the better the empirical research. if one wanted to do research on voluntariness in informed consent, then it is

important to understand what is essential to voluntariness not feeling pressure from the researcher, being able to refuse enrollment, and being able to withdraw.

• Third, creating validating outcome measures. To overcome bias. • Finally, a problem that is common in bioethical empirical research is small

numbers and low power. Many studies have been conducted at single institutions with small numbers of participants.

Reference :

• Principles and Practice of Clinical Research - Gallin, John .

• IPPCR Course by NIH Clinical Center .