Can prisoners be compensated for research? “Researchers are not to provide compensation or other rewards to an inmate for his/her participation in research, unless special permission is granted by the RRC (Research Review Committee).” Compensation decisions are made on a case-by-case basis.
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
.
Can prisoners participate in clinical trials?
Unless additional safeguards are implemented and constantly monitored, prisoners will continue to be at risk of being coerced into participating as research subjects
. However, with proper procedures and due diligence, prisoners’ choices about research participation can be informed, deliberate and voluntary.
Why are prisoners not allowed to participate in clinical trials?
But prisoners have also been excluded from the trials
out of concern that they might be coerced into participating or exploited if they do
. Now, some researchers argue that including prisoners in studies could offer outsize health benefits.
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.
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.
What is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners?
This decision:
Is wrong
because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners. Research conducted in prisons is not exempt under 46.104 if the subject population only includes prisoners.
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.
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
.
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.
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
.
Which of the following is a reason that prisoners need special protection?
Which of the following is a reason that prisoners need special protection?
Prisoners have limited free choice because their autonomy is restricted
.
What institutions in the United States must abide by the Common Rule?
The Revised Common Rule, at 45 CFR 46.114 (b) (cooperative research), requires all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency rely upon approval by a single IRB for the portion of the research that is conducted in the …
Which of the following is included in the Nuremberg Code?
The ten points became known as the Code, which includes such principles as
informed consent and absence of coercion; properly formulated scientific experimentation; and beneficence towards experiment participants
.
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.
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.
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.
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.
How long is an investigator required to keep consent?
DHHS regulations (45 CFR 46.115) require that an IRB keep approved sample consent forms for
at least three years
after the completion of the research. The investigator has the responsibility to retain the signed consent forms and to keep these forms confidential.
Which of the following sections of 45 CFR 46 is synonymous with the common rule?
Subpart A
, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration.
What do you mean by incarceration?
:
confinement in a jail or prison
: the act of imprisoning someone or the state of being imprisoned Despite the drop in crime in past decades, rates of arrest and incarceration in New York City have not gone down.—
Which of the following statements most accurately describes the requirement for the documentation of minors assent?
Which of the following statements most accurately describes the requirement for the documentation of minors’ assent to participate in research?
Documentation is required unless waived by an IRB.
What is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners?
This decision:
Is wrong
because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners. Research conducted in prisons is not exempt under 46.104 if the subject population only includes prisoners.
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).
