Protection of Human Subjects, Fraud and Misconduct

Question 1

Unethical behaviors

Answer 1

1) Actions or conducts that violate a subject’s rights, safety, and well-being
2) Is not illegal and frequently falls in a gray area, where a person has to distinguish between right and wrong.

Question 2

Bioethics

Answer 2

the study of ethical issues resulting from advances in biology and medicine. It concerns law, politics, science and religion

Question 3

Ethical Codes

Answer 3

the rules that govern how ethics are to be implemented

Question 4

Fraud

Answer 4

1) Deception practiced deliberated in order to secure unfair or unlawful gain
2) can also be described as an intentional perversion of truth for the purpose of inducing another to part with something valuable, or to surrender a legal right. Fraud is deliberate deception, deceit, or trickery. Fraud is illegal and criminal offense.

Differences of opinion or honest errors occurring in research settings should not be automatically labeled as fraud. When suspected behavior of this nature is identified, gain understanding and garner thorough evidence before flagging someone’s choices as “fraud”.

Question 5

Suspected Fraud

Answer 5

When identifying incidents, all communications, both within your organization and within regulatory agencies must refer to such incidents as ‘suspected’ fraud until proven otherwise - serious legal implications are at play otherwise.

Examples of fraud:

• the deliberate reporting of false, fabricated, or misleading data,
• the withholding of reportable data,
• omission or commission of data,
• fabricating data,
• falsifying data, or
• committing plagiarism

Question 6

Misconduct

Answer 6

1) Deviation from duty by a professional or a transgression of an established agreed upon rule. Misconduct happens unconsciously.
2) Seen as unacceptable behavior, but it is not a criminal offense.

Question 7

Fraud and Misconduct

Answer 7

1) Can happen at any stage of the clinical research process

2) The main difference between fraud and misconduct is the level of consciousness of the agent.

Question 8

Therapeutic misconception

Answer 8

1) both physicians and patients have a psychological tendency to minimize tensions; neither wants to recognize the important ethical conflicts that may exist between clinical care and research.

2) often manifests as the false and often implicit belief that the primary aim of research is to benefit the patient
- although patients often do benefit from their involvement in research, nearly all clinical research includes procedures that carry risks to subjects that are not compensated for by the corresponding benefits. By definition, research protocols are designed to answer scientific questions, not to optimize the medical care of the patient

Proper training for Investigators and their research team and timely detailed information sessions for the patient before signing the informed consent form are required before any trial related activities occur. These will ensure that both parties are clear on the primary aims of research versus clinical care.

Question 9

Clinical Equipoise

Answer 9

1) No conflict between the ethics of clinical care (treating the patient) and those of research (collecting data)

In randomized clinical trials, the treatment cannot be chosen by the Investigator or the subject. Under clinical equipoise, there appears no conflict between the ethics of clinical care and those of research as the treatments are being judged as equally effective and safe for the Subject. This is not always the case in real life, like in placebo-controlled trials, etc., which causes ethical concerns and tensions.

Question 10

Ethics

Answer 10

Involves moral decision making processes and distinguishes right from wrong, good from bad, and acceptable from unacceptable behaviors

Question 11

Biologics Control Act

Answer 11

Passed in 1902 by Congress after patients suffered injuries from the diphtheria vaccine which was contaminated with tetanus.

The new law required licensing of biologics establishments, inspections of vaccine manufacturers, and pre-market approval of vaccines and other related products.

Question 12

Declaration of Helsinki

Answer 12

Adopted by the World Medical Association, provides the most significant ethical adaptation of human rights and safety while balancing the progress of science and the conduct of clinical trials for public good.

• In a MA state school, they performed radiation tests on mentally impaired boys from 1946-1953. The boys believed they were participating in a science club and were not informed that they were being exposed to radiation.
• Thalidomide was sold in the late 1950s and 1960s to pregnant women as an antiemetic to combat morning sickness and other symptoms. It was available as a prescription in around 50 countries (not in the US). This was later found to be toxic in fetal development as a shortening of limbs.

By requiring informed consent, the Declaration turned the focus of research from the investigators perspective to the patient’s rights.

Question 13

The Belmont Report

Answer 13

The report resulted in better protection of the rights of trial participants, greater respect for an individual’s autonomy, and attention to beneficence and justice when humans were involved in research. It discussed informed consent, the assessment of risk and benefit and the selection of subjects.

Question 14

Nuremberg Code

Answer 14

• hailed as a landmark document in medical and research ethics. It’s a set of research ethics principles involving human subjects and came as a result of the Nuremberg Trials at the end of WWII.
• the Nuremberg Code emphasized for the first time the principles of Informed Consent but was not supported in law