Groups of participants you could be aware of investigating and which can be considered as vulnerable
Prisoners, children and pregnant women.
What is an emergency waiver?
Situations which can be considered of informed content.
What are the 3 principles essential to the ethical conduct of research with humans according to the Belmond Report?
Respect for persons
Beneficience
Justice
What is the IRB which is referred to in the Belmond Report’s purpose of “justice”?
Shorting for Institutional Review Board: an oversight of research ethics and compliance.
What is the purpose of Risk-Benefit analysis mentioned in the Belmond Reports point of Beneficence?
The primary understanding of the analysis which is done to minimize harm and maximize the benefits.
What is Nuremburg Code?
The first international code of research ethics (1947). The Nuremberg Code became the first international standard for the conduct of research and introduced the modern era of protection for human research subjects.
What does the principle of “Respect for Persons” according to the Belmond Report mean?
“To respect autonomy is to give weight to the autonomous person’s considered opinions and choices while refraining from obstructing his or her actions…” -Belmont Report
- Individuals should be treated as autonomous agents.
- Persons with diminished autonomy are entitled to additional protections.
The Belmont principle of respect for persons is primarily applied by requiring that all human subjects research participants provide voluntary informed consent to participate in research
What does the principle of “Beneficence” according to the Belmond Report mean?
“The term beneficence is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation” - Belmont Report
- Do no harm.
- Maximize possible benefits and minimize possible harms.
What does the principle of “Justice” according to the Belmond Report mean?
Justice requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research.
What are the criteria that Federal Departments and Agencies have to evaluate when conducting or supporting a human subjects research according to the HHS regulations?
- Risks to the subjects
- Adequacy of protection against these risks
- Potential benefits of the research to the subjects and others
- Importance of the knowledge gained or to be gained
What is the HHS?
U.S. Department of Health and Human Services
What are the 3 fundamental aspects of informed consent?
- Voluntariness
- Comprehension
- Disclosure
What are the conditions that allow to waive or alter some or all of the required elements of informed consent?
“The research involves no more than minimal risk to the subjects
The waiver or alteration will not adversely affect the rights and welfare of the subjects
The research could not practicably be carried out without the waiver or alteration
Whenever appropriate, the subjects will be provided with additional pertinent information after participation”
What are the categories of risks that participants in a research may encounter?
Physical
Psychological
Social
Legal
Economic
What is Therapeutic Misconception?
“Therapeutic misconception is the tendency for research participants to: “… downplay or ignore the risks posed to their own well-being by participation … [due to] the participants’ deeply held and nearly unshakeable conviction that every aspect of their participation in research has been designed for their own individual benefit”. ”
What is the difference between equitable and equal treatment?
“To treat “equitably” means to treat fairly. To treat “equally” means to treat in exactly the same way.
Research should strive for equitable distribution of the risks and potential benefits of the research.”
What are the requirements for consent form when using placebo in research?
“Informed consent process must disclose sufficient information to ensure that potential research participants:
Understand what placebos are
Understand the likelihood that they will receive a placebo
Are able to provide their fully informed consent that they are willing to receive a placebo”
What is minimal risk?
Minimal risk is defined in the Common Rule to be “that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
How do investigators collect consent from participants with diminished autonomy?
An individual’s capacity to consent to a particular study should be assessed based on:
- The individual’s level of capacity, and
- The complexity and risks of the study, i.e., the capacity needed for an individual to be able to understand the study well enough to consent to participate
The HHS regulations require that legally authorized representatives provide voluntary informed consent for individuals with the diminished capacity to participate in research.
What are undue inducements?
Undue inducements are inducements that are unduly influential and inappropriate.
Undue inducements are troublesome because:
- offers that are too attractive may blind prospective subjects to the risks or impair their ability to exercise proper judgment; and
- they may prompt subjects to lie or conceal information that, if known, would disqualify them from enrolling — or continuing — as participants in a research project.
The level and kind of compensation must take into consideration the vulnerabilities of the research population to minimize the possibility of undue inducement.
What should investigators consider before using incomplete disclosure or deception?
Incomplete disclosure and deception may be useful for some research goals, but researchers may use them only after thorough consideration of:
- Whether the scientific goals of the research can be achieved by methods that do not involve incomplete disclosure or deception
- Whether participants would consider the information withheld during the informed consent process important to their decision to participate in the study
- Whether it is possible to inform participants that they will only learn about all the goals of the research after the research study is over
How does the Belmont Report distinguish between individual and social justice in the selection of subjects?
- Individual justice requires that investigators “should not offer potentially beneficial research only to some patients who are in their favor or select only ‘undesirable’ persons for risky research.”
- Social justice “requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons.”
- When research leads to the development of new treatments, procedures, or devices, justice demands that the research should involve persons from groups who are likely to benefit from subsequent applications of the research.
