Case 1: Migrants and Phase I Trials
Oscar Cabanerio is a 41-year-old immigrant living in the United States without any legal documentation. He is poor and needs cash to send to his family in Venezuela. SFBC International Inc. is a large contract research organization (CRO) testing drugs in human subjects for drug companies in Miami, Florida. Cabanerio agreed to be in a trial to test Oros Hydromorphone, made by Alza Corporation. The study paid each research subject $1,800. The subjects are instructed to swallow the tablets and not chew them, since chewing can cause overdosing. Adverse reactions include heart attack, allergic reaction, and even death. Informed consent for this study is usually very quick. The subjects are eager to earn money, …show more content…
Minimization of risk: In addition to determining that the risks are reasonable in relation to the anticipated benefits, the principle of beneficence requires that the risks in the research are the minimum required to achieve the research objective. To do this, researchers and IRBs should carefully consider alternative, less risky procedures or modifications to the procedures that reduce the magnitude or probability of the possible harm to subjects.
• Is there fair subject selection in these studies and why?
No, unfair, not equitable: Selection of subjects: the selection of research subjects needs to be scrutinized in order to determine whether some are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied" .
Based on the National Commission’s recommendations, additional protections for targeted vulnerable populations were added to 45 CFR 46 in the following years. These include: Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects …show more content…
• The risks to subjects should be minimized.
• The selection of subjects should be equitable.
• Informed consent will be sought.
• Informed consent will be documented.
• Where appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure safety of subjects.
• Where any of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect subjects.
• Providing consent in a language that is understandable to the subject or his/her legally authorized representative (LAR).
• Providing non-English speaking subjects a translated informed consent document that is accurate (as determined by the IRB).
• If a translator is used, providing a written translation of the consent document is still required. Some IRBs allow use of a short form translation of the IRB consent document.
• Giving the subject enough time to think about his/her participation in the research before giving
Oscar Cabanerio is a 41-year-old immigrant living in the United States without any legal documentation. He is poor and needs cash to send to his family in Venezuela. SFBC International Inc. is a large contract research organization (CRO) testing drugs in human subjects for drug companies in Miami, Florida. Cabanerio agreed to be in a trial to test Oros Hydromorphone, made by Alza Corporation. The study paid each research subject $1,800. The subjects are instructed to swallow the tablets and not chew them, since chewing can cause overdosing. Adverse reactions include heart attack, allergic reaction, and even death. Informed consent for this study is usually very quick. The subjects are eager to earn money, …show more content…
Minimization of risk: In addition to determining that the risks are reasonable in relation to the anticipated benefits, the principle of beneficence requires that the risks in the research are the minimum required to achieve the research objective. To do this, researchers and IRBs should carefully consider alternative, less risky procedures or modifications to the procedures that reduce the magnitude or probability of the possible harm to subjects.
• Is there fair subject selection in these studies and why?
No, unfair, not equitable: Selection of subjects: the selection of research subjects needs to be scrutinized in order to determine whether some are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied" .
Based on the National Commission’s recommendations, additional protections for targeted vulnerable populations were added to 45 CFR 46 in the following years. These include: Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects …show more content…
• The risks to subjects should be minimized.
• The selection of subjects should be equitable.
• Informed consent will be sought.
• Informed consent will be documented.
• Where appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure safety of subjects.
• Where any of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect subjects.
• Providing consent in a language that is understandable to the subject or his/her legally authorized representative (LAR).
• Providing non-English speaking subjects a translated informed consent document that is accurate (as determined by the IRB).
• If a translator is used, providing a written translation of the consent document is still required. Some IRBs allow use of a short form translation of the IRB consent document.
• Giving the subject enough time to think about his/her participation in the research before giving