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Belmont Report

Terms in this set (117)

What was the charge of the commission?
1. Identifying the ethical principles to guide all research involving human subjects
2. Developing guidelines for the conduct of ethical research involving human subjects
What are the two basic ideas in principle of respect for persons?
1. Individuals should be treated as autonomous agents.
Prospective research participants must be given the information they need to determine whether or not they want to participate in research. There should be no pressure to participate and ample time to decide. Respect for persons demands that participants enter into the research voluntarily and with adequate information. This is called informed consent, and will be covered in detail in other sections of this training.
A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study.
2. Persons with diminished autonomy are entitled to additional protections.
Special provisions may need to be made when an individual's comprehension is severely limited or when a class of research participants is considered incapable of informed decision making (e.g. children, people with severe developmental disorders, or individuals suffering from dementias). Even for these persons, however, respect for persons requires giving them the opportunity to choose, to the extent they are able, whether or not they wish to participate in research activities. In some cases, respect for persons may require seeking the permission of other parties, such as a parent or legal guardian.
What are the challenges in applying the Belmont principle of respect for persons?
* 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 is the challenge inherent in applying the Belmont principle of beneficence?
It is how to determine when potential benefits outweigh considerations of risks and vice versa.
What is Subpart A, also called?
"The Common Rule", describes the required protections for all human subjects.
How does subpart A define human subject?
Subpart A defines a human subject as "a living individual about whom an investigator...conducting research obtains:
"OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. Note that if the individuals who provide coded information or specimens collaborate on other activities related to the conduct of this research with the investigators who receive such information or specimens, then OHRP would consider such additional activities to constitute involvement in the conduct of the research. Examples of such additional activities include, but are not limited to: (1) the study, interpretation, or analysis of the data resulting from the coded information or specimens; and (2) authorship of presentations or manuscripts related to the research."

1. Data through intervention or interaction with the individual, or
2. Identifiable private information."
How does subpart A define research?
Subpart A defines research as "a systematic investigation...designed to develop or contribute to generalizable knowledge."

This definition includes:

* Research development
* Testing
* Evaluation
What are considered vulnerable populations?
Subparts B, C and D define the specific categories of research in which pregnant women, human fetuses and neonates, prisoners, or children respectively may be involved. The subparts describe additional requirements for informed consent, and may specify additional responsibilities for the Institutional Review Board (IRB) when reviewing research involving these populations, and list the requirements for research that need additional levels of review and approval.
What are the criteria to evaluate application for research in supporting human subjects?
The HHS regulations (45 CFR 46.120) require that Federal Departments and Agencies that conduct or support human subjects research must evaluate all applications for research using the following criteria:

* 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 should each institution have to engage in NIH funded human subject research?
Each institution that is engaged in NIH-funded human subjects research must:
* Obtain or hold a current Federalwide Assurance (FWA), assuring that an institution will comply with HHS regulatory requirements for the protection of human subjects (this is obtained from the HHS Office for Human Subjects Protections (OHRP)); and
* Certify to NIH that grant applications and contract proposals describing research involving human subjects has been reviewed and approved by an Institutional Review Board (IRB) designated in the FWA, and will be subject to continuing review by an IRB.
What is an IRB?
IRBs are committees that consist of 5 or more members with varying expertise and diversity that are responsible for reviewing and approving human subjects research activities on behalf of institutions
What are the principles of respect?
The principle of respect for persons can be broken down into two basic ideas:
1. Individuals should be treated as autonomous agents
"An individual capable of deliberation about personal goals and of acting under the direction of such deliberation."
2. Persons with diminished autonomy are entitled to additional protections
How can IRB waive or alter some or all of the required elements of an informed consent?
The HHS regulations (45 CFR 46.116(c)) allow institutional review boards (IRBs) to waive or alter some or all of the required elements of informed consent
A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study.
if all of the following conditions are met:
1. "The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; (iv) possible changes in methods or levels of payments for benefits or services under those programs, and
2. The research could not practicably be carried out without the waiver or alteration."
How should an individual's consent be assessed?
An individual's capacity to consent to a particular study should be assessed based on:
"An individual capable of deliberation about personal goals and of acting under the direction of such deliberation."

1. The individual's level of capacity, and
2. 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
What does HHS require with studies involving pregnant women?
The HHS regulations require:
* Preclinical studies be completed prior to the involvement of pregnant women
* A consideration of risks and potential benefits for the fetus and pregnant woman
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