What are the three essential principals of the Belmont Report?
- Respect for persons
- Beneficence
- Justice
These three basic principles serve as the foundation of the current HHS regulations and guidelines for the ethical conduct of human subjects research supported by HHS.
What are the basic ideas of the respect of people?
- Individuals should be treated as autonomous agents
- Persons with diminished autonomy are entitled to additional protections
What are the challenges of the respect of persons principle
- Making sure that potential participants comprehend the risks and potential benefits of participating in research
- Avoiding influencing potential participants’ decisions either through explicit or implied threats (coercion) or through excessive compensation (undue influence)
What are the general rules of beneficience?
- Do no harm
- Maximize possible benefits and minimize possible harms
what is the challenge in the beneficience principle?
how to determine when potential benefits outweigh considerations of risks and vice versa.
What is the challenge of applying the Belmont principle of justice?
how to decide which criteria should be used to ensure that harms and benefits of research are equitably distributed to individuals and populations.
What is the HHS?
U.S. Department of Health and Human Services, a federal agency that protects the health of Americans
What are the subparts of the HHS regulations?
Subpart A – Basic HHS Policy for Protection of Human Research Subjects
Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Subpart D – Additional Protections for Children Involved as Subjects in Research
Subpart E – Registration of Institutional Review Boards
What is the correct Protection for Psychological risks (e.g. Anxiety)
Friend or spouse can stay with participant during study procedures
What doe Subpart A in HHS describes?
the required protections for all human subjects
What does an investigator obtains from a human subject according to Subpart A?
- Data through intervention or interaction with the individual, or 2. Identifiable private information.
how does Subpart A described research?
a systematic investigation designed to develop or contribute to generalizable knowledge.
What are the three fundamental aspects of informed consent?
- Voluntariness
- Comprehension
- Disclosure
What is informed consent?
- on-going process rather than a level of legal protection for an institution.
- designed to inform research subjects about the purpose, risks, potential benefits and alternatives to the research that allows people to make a decision about whether or not to participate based on their own goals and values.
When should we collect informed consent?
At enrollment and throughout the study.
What other methods than the consent form can we use to enhance participants’ comprehension?
- Oral presentations – an opportunity to discuss the information and ask questions
- Additional educational materials about research in general and/or the specific procedures that will be used in the study
- Video presentations that familiarize potential participants with the procedures that will be used in the study*
What is the withdrawal effect?
People who were exposed to fewer emotional posts (of either valence)
In what language should be the consent form process delivered?
In one that the participant can understand – both language and reading level
When is it allowed for the IRB to waive requirement?
- “The only record linking the participant to the research would be the [informed] consent document Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern
- The research presents no more than minimal risk to the participants and involves no procedures for which written consent is normally required outside of the research context”
What should an individual’s capacity to consent be based on?
- The individual’s level of capacity,
- The complexity and risks of the study
What are the specific requirements to informed consent for prisioners?
- Any possible advantages accruing to the prisoner through his or her participation in the research,are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired 2. dequate assurance exists that parole boards will not take into account a prisoner’s participation in the research
What participant must do when there is a pratical application of respect for pesons?
- Give their consent freely and voluntarily
- Have the decisional capacity to understand the information presented to them
- Be provided complete information about the study in order to make an informed decision
What is risk?
The probability that a certain harm will occur.
What is the main categories of the risk encounters by researchers?
Physical, Psychological, Social, Legal, Economic
