Term
| What is course designed for? |
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Definition
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Term
| Why was this course designed? |
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Definition
| to fulfill the "Required Education in the Protection of Human Research Subjects". |
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Term
| Goals and Principles of Human Subjects Protection? |
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Definition
| The relationship between investigators and human subjects is critical and should be based on honesty, trust, and respect. |
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Term
| What are the HHS Regulations? |
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Definition
Health and Human Services Regulations: The ethical principles for research involving human subjects described in the Belmont Report. It's part of the Code of Federal Regulations, specifically, 45 CFR 46 (title 45- public welfare, part 46). There's a bunch of subparts.
Everything from the Belmont report is included in this. |
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Term
| Subpart A of Basic HHS Policy for Protection of Human Research Subjects |
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Definition
| "The Common Rule"- required protections for all human subjects. |
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Term
| What does Subpart A define a human subjects as? |
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Definition
"a living individual about whom an investigator conducting research obtains:
1. Data through intervention or interaction with the individual, or
2. identifiable private information |
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Term
| What does Subpart A define research as? |
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Definition
"a systematic investigation designed to develop or contribute to generalizable knowledge."
This definition includes:
-research development
-testing
-evaluation |
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Term
| Case Study: An investigator is using human hearts in order to study factors leading to heart failure. One group of control hearts are taken from cadavers, while a set of diseased hearts will be taken from individuals about to receive a heart transplant. |
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Definition
| The healthy hearts from cadavers do not constitute human subjects because they're from dead people. The diseased hearts from donors make it human subjects research. |
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Term
| What individuals need additional protections under the Belmont principle of respect for persons states? |
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Definition
Individuals with "diminished autonomy"- an individual with restricted capability of deliberation about personal goals and of limited ability to act under the direction of their deliberations.
Subparts B, C, and D describe additional protections.
B- pregnant women, human fetuses, and neonates in research
C- biomed and behavioral research involving prisoners
D- children
These subparts talk about the additional requirements for informed consent.
OTHER VULNERABLE POPS: mentally disabled, economically and/or educationally disadvantaged. The regulations with these guys don't specify what additional protections are necessary, but they do ask investigators to include additional safeguards, since these people are more likely to be vulnerable to coercion or undue influence" |
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Term
Case study: treatment and prevention research in adolescents
A study proposes to examine the effectiveness of a medical treatment and prevention program for adolescents in a location where the legal age for consent to such treatment is 12. The adolescents involved range from ages 12 to 17.
Do subparts b, c, or d require that participants in this study receive additional protections? |
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Definition
| No. The regulatory definition of children depends both on local laws and on the specific treatments and procedures that'll be involved in the study. Since the area allows consent at 12, they're not considered children under the HHS regs and can do informed consent. Therefore, no additional protections of subpart D are required. |
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Term
| What kind of human subjects research may be exempt from HHS regs? |
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Definition
They have to be exempt by the IRB, not themselves.
-classroom stuff
-anonymous school standardized tests
-observing public figures
-using previously collected information that is public record, or is collected preserving anonymity
-involving public benefit or service
-taste tests |
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Term
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Definition
(1939-1945) Nazis injected people with gasoline, live viruses, immersed people in ice water, forced people to ingest poisons, and immersed them in ice water.
The defendants had:
-corrupted the ethics of medical and scientific professions
-repeatedly and deliberately violated the rights of the subjects
Condemned as crimes against humanity. 16 of the 23 doctors are found guilty and imprisoned. 7 were sentenced to death. |
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Term
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Definition
| (aka Permissible Medical Experiments)- first international code of research ethics. |
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Term
| The Syphilis Study at Tuskegee |
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Definition
Involved 600 black men, 400 with syphilis, and 200 without. Recruited w/o informed consent.--> led to believe that spinal taps and other procedures were "special treatment". When it was discovered that penicillin cured syphilis, they weren't treated with penicillin, so that the study could continue.
Outcomes:
1. National Research Act of 1974
2. Basic HHS Policy for Protection of Human Research Subjects
3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
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Term
| Identify the 3 principles of ethical human subjects research identified in the Belmont Report. |
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Definition
1. respect for persons
2. beneficence
3. justice |
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Term
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Definition
| influencing an individual's decision about whether or not to do something by using explicit or implied threats. |
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Term
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Definition
one of the 3 principles of ethical human subjects research identified in the Belmont Report:
-individuals should be treated as autonomous agents
-persons with diminished autonomy are entitled to additional protections
CHALLENGES:
-making sure that participants comprehend the risks and potential benefits of participating in research
-avoiding influencing potential either through explicit or implied threats (coercion) or through excessive compensation (undue influence) |
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Term
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Definition
Two rules:
1. Do no harm
2. Maximize possible benefits and minimize possible harms
CHALLENGE: how to determine when potential benefits outweigh considerations of risks and vice versa |
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Term
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Definition
Requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research. Justice may arise in decisions about inclusion and exclusion criteria for participation in research. Are groups considered for inclusion simply because of their availability, their compromised position, or their vulnerability, rather than for reasons directly related to the problem being studied.
CHALLENGE: how to decide which criteria should be used to ensure that harms and benefits of research are equitably distributed to individuals and populations. |
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Term
| Requirements for Federal Support of Human Subjects Research |
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Definition
Federally conducted 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 |
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Term
| Equivalent Protections for International Research |
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Definition
| HHS says that HHS regulations for research should be honored domestically AND internationally. Since it applies to both domestic and international stuff, there's no need for them to pass any additional codes or policies. |
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Term
| Requirements for Engagement in Human Subjects Research |
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Definition
Must:
-obtain or hold a Federalwide Assurance (FWA). This assures that researchers will comply with HHS regulations and protect human subjects.
-certify to NIH that grants and contracts with human subjects have been reviewed and approved by an IRB (Institutional Review Board) designated in the FWA. This also means that it will be reviewed continuously by an IRB. |
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