PHRP Quizzes Flashcards
How do human subjects research benefit society?
It contributes to advances in technology and healthcare
“A living individual about whom an investigator conducting research obtains information through intervention or interaction with the individual” defines what?
human subject
If investigators collect identifiable private information about research subjects or their identifiable biospecimens, the research may be considered:
human subjects research
“A systematic investigation designed to develop or contribute to generalizable knowledge, including research development, testing, and evaluation” defines what?
research
Information or records used for criminal justice investigative purposes are generally considered:
not to be human subjects research
Tissue or data not obtained directly from the patient or their records is not considered human subjects research as long as:
the information is anonymous
If participants are used to provide information about a topic unrelated to themselves, such as evaluating a product, is the study considered human subjects research?
no
Federal policy dictates that human subjects research must include a variety of races, ethnicities, genders, ages and:
disability status
To contribute to advances in healthcare and social programs, the design of a research study should consider:
whether the treatment affects different subpopulations differently
Which of the following is considered human subjects research?
- Collecting blood from participants
- Conducting a survey over the phone
- Administering medicine to participants
- Conducting an in-person focus group
The purpose of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was to:
identify ethical principles for conducting research involving humans
The Belmont Report principle of “Respect for persons” states that individuals should be treated as:
autonomous agents
If a participant has diminished comprehension or is unable to make an informed decision, what should the study provide for that person?
additional protections
Beneficence involves treating people in an ethical manner by respecting their decisions, protecting them from harm, and making efforts to:
protect a person’s well-being
During the planning of a research study, researchers should design ways to:
maximize the benefits and reduce the risks of harm
What is never morally justified in human subjects research?
brutal or inhumane treatment
Debriefing participants after the research is over can help protect participants from which type of harm?
psychological harm
Vulnerable subjects are individuals who have difficulty providing voluntary consent, lack decision-making capacity, or:
are at risk for exploitation
When is it important to include vulnerable subjects in research?
when the research can provide advances in treatment for that population
Which of the following measures does NOT help researchers protect participants from physical harm?
Provide counseling after research sessions
The Common Rule, based on 45 CFR 46 provides as the regulatory foundation for which of the following federal agencies?
1Department of Education
2Central Intelligence Agency
3Department of Transportation
4Department of Health and Human Services
Which of the following provides protections for children involved in research supported by or conducted by the Department of Health and Human Services?
Subpart D
How often should each IRB renew its registration?
Every 3 years
Which of the following is not a Common Rule federal agency or department?
Federal Bureau of Investigation
YES:
1Department of Transportation
2Department of Housing and Urban Development
3Department of Education
What is an Institutional Authorization Agreement (IAA)?
A Method to Use for Single IRB Review
The Common Rule outlines core provisions. Which one of the following is not a provision of the Common Rule?
The choice of clinical trial participants
Which of the following provides protections for human fetuses?
Subpart B
Which of the following is true as it relates to department heads of organizations operating under the Common Rule?
Department Heads retain final judgement as to whether a particular activity it conducts or supports is covered by the Common Rule
What government agency issues Federal Wide Assurance?
OHRP
Which of the following research is permitted when prisoners are involved?
- Research to determine the possible causes, effects, or processes of incarceration and criminal behavior.
- Research to determine to determine conditions affecting prisoners as a class.
- Research to study prisons as institutional structures.
What institutions in the United States must abide by the Common Rule?
All institutions receiving U.S. Government funding for their research activities
The term “Common Rule” refers to:
45 CFR 46 Subpart A
The Common Rule can best be described by which phrase below?
1Respect for persons, beneficence, and justice
2Regulatory rules of ethics for human subjects protection
3Guidance for biomedical and behavioral research involving human subjects
4Baseline standard of ethics for government-funded research using human subjects
True or False? The FWA is legally binding.
True
Institutions that have signed an FWA and started a research study prior to Sept. 21, 2019:
- Can switch their study to follow the revised Rule
- Can continue their study with the original Rule
True or False? For a research project that started after Sept. 21, 2019, you can choose to follow the original Rule.
False
The purpose of the 2018 Common Rule revisions was to:
1Strengthen protections for study participants
2Decrease administrative workloads for researchers
3Add flexibility for the modern research environment
True or False? Under the revised Rule, certain public health surveillance activities are NOT considered research.
True
True or False? Under the revised Rule, all research must be reviewed by an IRB at least once per year.
False
How many times has the Rule been revised?
One
At a minimum, the IRB must be comprised of 5 members.
True
Which of the following provides the regulatory language for the IRB?
Common Rule
Which of the following is not an outcome associated with a full IRB review?
Referral
What are the outcomes associated with a full IRB review?
1Tabled
2Approved
3Disapproved
CHECK
The IRB ensures the research investigator(s) follow institutional policies and procedures related to research.
True
Under an exempt review, which of the following would occur if the protection of the confidential information of the research subject is warranted?
1Self Determination
2Limited Review (correct?)
3Full Review (wrong)
4Private Review
Which of the following might be present within an organization with an expansive research portfolio?
Human Research and Protection Program
At a minimum, which of the following must be part of an IRB?
1A scientist
2A non-scientist
3An individual not associated with the organization
Which of the following types of research could fall under HHS regulations exemptions?
1Educational Exemptions
2Public Benefit/Service Program Research
3Benign Behavioral Intervention
Under the Common Rule, an IRB must ensure certain written procedures are in place. Which of the below choices is NOT correct?
Investigators must report how many researchers are involved
Research studies that do not clearly show there is adequate protection of human research subjects will often lead to which of the following?
Disapproval
