Can prisoners participate in research studies?
Research involving prisoners may proceed only after receipt of the OHRP authorization letter
. If OHRP determines that the proposed research does not involve one of the permissible categories, it will state in the letter to the institution that such research involving prisoners cannot proceed.
Can prisoners be used in research studies?
California law prohibits all biomedical research on prisoners
(Section 3502).
Why are prisoners excluded from research?
The strongest factors prompting researchers to exclude prisoners were the
perceived difficulties/costs of recruiting and involving them
, with over half (59%) citing this.
Is it ethical to do research on prisoners?
Application of a risk-benefit analysis may determine that, because the risks are very low and important knowledge or benefits may accrue for prisoners as a class,
the research may be considered ethically acceptable
.
Should prisoners be allowed to participate in clinical trials?
Correctional facilities have experienced many COVID-19 outbreaks and are structurally unsuited to social distancing (among other precautions). And so, the researchers argue, like other people at high risk of catching the disease,
prisoners should be allowed to participate in clinical trials.
Can prisoners be exempt from IRB review?
Yes, so long as the appropriately constituted IRB reviews the research and makes the appropriate findings regarding the waiver or alteration of informed consent requirements, research involving prisoners may be approved with a waiver or alteration of informed consent.
Why do prisoners participate in research?
Such a lack of treatment options also has implications for the ethics of prison-based research. If the available care is indeed so poor, some prisoners may feel that
in order to receive care they have no other choice but to participate in research.
Are prisoners vulnerable in research?
Within medical research and healthcare
certain groups are offered special protections and services because they are considered “vulnerable”
(Ruof, 411). Vulnerable populations include but are not limited to prisoners, women who are pregnant, children, and minorities.
Are prisoners a vulnerable population for research?
Prisoners, individuals involuntarily confined or detained in a penal institution, as a population are considered vulnerable
because the constraints of incarceration may affect an individual’s ability to give voluntary, informed consent.
Which example of research with prisoners would be allowable?
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history
. Examining age at first arrest is the correct answer.
Can prisoners make a voluntary decision about participating in a clinical trial?
The NIH explains: “Because
prisoners may not be free to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research
, the regulations require additional safeguards for the protection of prisoners in research. These safeguards are found in 45 CFR 46, Subpart C.
Why can prisoners not give consent?
Notes. [note 1] Some experts believe that incarcerated persons can never give true informed consent because
they live in an environment in which they have little or no freedom to make an informed decision
.
Why should prisoners not be tested on?
In Conclusion, No
Overall, we see that it would not make scientific sense to replace many of the animal studies with human experiments.
Prisoners do not come with lifetime medical histories, their genetics cannot be manipulated, and frankly, there just aren’t enough of them
.
When reviewing federally supported research involving prisoners an IRB must have?
IRB review must include
a prisoner or prisoner representative
(45 CFR 46.304(b) and if the study is reviewed by a full board, the convened meeting must also meet a membership requirement concerning the number of IRB members not associated with a prison/jail involved in the research (45 CFR 46.304(a).
What additional regulations must an IRB consider when reviewing research involving prisoners?
For research involving prisoners as subjects, the IRB must meet the special composition requirements of
45 CFR 46.304
for all types of review of the protocol, including initial review, continuing review, review of protocol amendments, and review of reports of unanticipated problems involving risks to subjects.
Who is protected 45 CFR 46?
In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for
human subjects in research carried out or supported by most federal departments and agencies
.
Can prisoners be experimented on?
According to the Common Rule (45 CFR 46),
prisoners may only be included in human subjects research when the research involves no more than a minimal risk of harm
.
Should death row inmates be used for medical testing?
The medical testing on prisoners is not a punishment to them in the first place
. It is a way that our government gives those death-penalized prisoners a chance to pay back the society. Medical experiments on prisoners are not cruel or unusual.
What did the National Research Act of 1974 do?
In 1974, the National Research Act was signed into law,
creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
. The group identified basic principles of research conduct and suggested ways to ensure those principles were followed.
Who are considered vulnerable populations in research?
There are some groups who have been identified by the federal regulations as “vulnerable populations”:
pregnant women and fetuses, minors, prisoners, persons with diminished mental capacity, and those who are educationally or economically disadvantaged
.
Which of the following studies need IRB approval?
Which of the following studies need IRB approval?
Studies collecting data about living individuals
. If a study intends to collect data or information about the living individual, an IRB review and approval must be obtained.
Which type of IRB review does not require?
“Exempt” human subjects research
is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
Which of the following studies would need IRB approval?
Which of the following studies need IRB approval?
Studies collecting data about living individuals
. Per federal regulations, which of the following elements must be included in an informed consent document? All foreseeable risks and discomforts.
What is blatant coercion?
1
glaringly conspicuous or obvious
.
What is IEC in clinical research?
IRBs can also be called
independent ethics committees
(IECs). An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants.
Can a prisoner attend the birth of his child?
If a prisoner is eligible for release on temporary licence, this could include instances of attending the birth of their child
. Where the prisoner is not assessed as suitable for temporary release, attendance at the birth will not be possible.
Is it ethical for prisoners to participate in clinical trials for medical research?
The recent report by the Institute of Medicine would create a national system of oversight and a public database to track studies. The institute’s report also recommended that
prisoners not be allowed to participate in Phase I and II studies when safety has not been established
.
Is using prisoners to manufacture goods an ethical business practice?
There are several ethical concerns with prison labor
. Prisoners are paid pennies per hour, often work in unsafe conditions, and are forced to produce low-quality and dangerous products.
What is the importance of studying the ethical standard in correctional system?
Which of the following meets the regulatory definition of prisoner quizlet?
Which of the following meets the regulatory definition of prisoner?
Individuals detained in treatment centers as a condition of parole
. Which of the following is a reason that prisoners need special protection? Prisoners have limited free choice because their autonomy is restricted.
What are the needs of the prisoners?
(1) Every prisoner shall be provided by the administration at the usual hours with
food of nutritional value adequate for health and strength, of wholesome quality and well prepared and served
. (2) Drinking water shall be available to every prisoner whenever he needs it.
At what point he and his study team must submit COI disclosures to comply with the PHS regulation?
Which example of research with prisoners would be allowable?
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history
. Examining age at first arrest is the correct answer.
Is it ethical for prisoners to participate in clinical trials for medical research?
The recent report by the Institute of Medicine would create a national system of oversight and a public database to track studies. The institute’s report also recommended that
prisoners not be allowed to participate in Phase I and II studies when safety has not been established
.
When reviewing federally supported research involving prisoners an IRB must have?
IRB review must include
a prisoner or prisoner representative
(45 CFR 46.304(b) and if the study is reviewed by a full board, the convened meeting must also meet a membership requirement concerning the number of IRB members not associated with a prison/jail involved in the research (45 CFR 46.304(a).
What additional regulations must an IRB consider when reviewing research involving prisoners?
For research involving prisoners as subjects, the IRB must meet the special composition requirements of
45 CFR 46.304
for all types of review of the protocol, including initial review, continuing review, review of protocol amendments, and review of reports of unanticipated problems involving risks to subjects.
