BELMONT REPORT -ME EXAM WITH COMPLETE SOLUTIONS 100%
VERIFIED!!! ALREADY GRADED A+
What was the charge of the commission? - (ANSWER)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? - (ANSWER)1. Individuals should be
treated as autonomous agents.
2. Persons with diminished autonomy are entitled to additional protections.
What are the challenges in applying the Belmont principle of respect for persons? - (ANSWER)* 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? - (ANSWER)It is how to
determine when potential benefits outweigh considerations of risks and vice versa.
What is Subpart A, also called? - (ANSWER)"The Common Rule", describes the required protections for
all human subjects.
How does subpart A define human subject? - (ANSWER)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." 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."
,BELMONT REPORT -ME EXAM WITH COMPLETE SOLUTIONS 100%
VERIFIED!!! ALREADY GRADED A+
How does subpart A define research? - (ANSWER)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? - (ANSWER)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? - (ANSWER)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? - (ANSWER)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
, BELMONT REPORT -ME EXAM WITH COMPLETE SOLUTIONS 100%
VERIFIED!!! ALREADY GRADED A+
* 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? - (ANSWER)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? - (ANSWER)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? - (ANSWER)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? - (ANSWER)An individual's capacity to consent to a
particular study should be assessed based on:
VERIFIED!!! ALREADY GRADED A+
What was the charge of the commission? - (ANSWER)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? - (ANSWER)1. Individuals should be
treated as autonomous agents.
2. Persons with diminished autonomy are entitled to additional protections.
What are the challenges in applying the Belmont principle of respect for persons? - (ANSWER)* 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? - (ANSWER)It is how to
determine when potential benefits outweigh considerations of risks and vice versa.
What is Subpart A, also called? - (ANSWER)"The Common Rule", describes the required protections for
all human subjects.
How does subpart A define human subject? - (ANSWER)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." 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."
,BELMONT REPORT -ME EXAM WITH COMPLETE SOLUTIONS 100%
VERIFIED!!! ALREADY GRADED A+
How does subpart A define research? - (ANSWER)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? - (ANSWER)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? - (ANSWER)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? - (ANSWER)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
, BELMONT REPORT -ME EXAM WITH COMPLETE SOLUTIONS 100%
VERIFIED!!! ALREADY GRADED A+
* 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? - (ANSWER)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? - (ANSWER)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? - (ANSWER)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? - (ANSWER)An individual's capacity to consent to a
particular study should be assessed based on:
