Informed Consent Form for Prisoners
Prisoners are referred to as vulnerable populations because it is tricky to determine whether their acceptance to a clinical study is voluntary. This is because prisoners are held in police custody for their crimes and thus the research organization must make sure the prisoners are not being coerced. Prisoners are easy targets and heave been exploited in the past by research institutes (Hornblum, 1997, 1998; Mitford, 1974). The IRB-HSR decide if prospective clinical trial with prisoners satisfy the conditions under 45 CFR 46, Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects.” Hence there are certain requirements that need to be mentioned in the Informed Consent form for prisoners. …show more content…
like attractive advantages should not be made available to the prisoner unless it is most essential, as these things hold more importance for a prisoner than his own well-being. There is a high chance he will voluntarily accept to the research study, without paying any heed to the risks and potential side effects of the study. Payment can be mentioned under ‘Payments’ section after discussion with prison police authorities.
Secondly, the prisoner is assured that any information or opinion he divulges during the proceedings of the trial study will not be revealed to the prison authorities. Also, his behavior and compliance during the study will not be revealed to the parole body and hence, will not affect his parole in any way. This is mentioned under ‘Confidentiality’ title of the IC form. A ‘Certificate of Confidentiality’ can also be attached to the IC form.
Under ‘Voluntary Participation’, it is mentioned again to reiterate the point that none of the prisoner’s information will be divulged to the parole staff or prison
Prisoners are referred to as vulnerable populations because it is tricky to determine whether their acceptance to a clinical study is voluntary. This is because prisoners are held in police custody for their crimes and thus the research organization must make sure the prisoners are not being coerced. Prisoners are easy targets and heave been exploited in the past by research institutes (Hornblum, 1997, 1998; Mitford, 1974). The IRB-HSR decide if prospective clinical trial with prisoners satisfy the conditions under 45 CFR 46, Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects.” Hence there are certain requirements that need to be mentioned in the Informed Consent form for prisoners. …show more content…
like attractive advantages should not be made available to the prisoner unless it is most essential, as these things hold more importance for a prisoner than his own well-being. There is a high chance he will voluntarily accept to the research study, without paying any heed to the risks and potential side effects of the study. Payment can be mentioned under ‘Payments’ section after discussion with prison police authorities.
Secondly, the prisoner is assured that any information or opinion he divulges during the proceedings of the trial study will not be revealed to the prison authorities. Also, his behavior and compliance during the study will not be revealed to the parole body and hence, will not affect his parole in any way. This is mentioned under ‘Confidentiality’ title of the IC form. A ‘Certificate of Confidentiality’ can also be attached to the IC form.
Under ‘Voluntary Participation’, it is mentioned again to reiterate the point that none of the prisoner’s information will be divulged to the parole staff or prison