Informed Consent

3145 WordsAug 30, 201213 Pages
Informed Consent 1 Running Head: HUMAN SUBJECTS Human Subject’s Comprehension of Informed Consent Informed Consent 2 Statement of the Problem A primary protection of the rights of clinical research subjects revolves around the concept respect for persons and the provision of informed consent (Belmont Report, 1979). Legal and ethical policies and guidelines enforce that research participants give informed consent prior to voluntary enrollment in a research study (Code of Federal Regulations,1999). However, the informed consent process presents some major challenges for study participants and…show more content…
Research institutions such as academic health centers and universities have the ultimate responsibility to ensure that clinical investigators adhere to this informed consent process. Unfortunately, there are no standard tools to assess the results of the consent process. This prevents the IRBs from monitoring progress and efficiency of the investigators and determining if other barriers exist that may cause lack of comprehension. Statement of Significance Conducting a study of the consent process at l will enable the GCRC compliance office, the Committee on Research Involving Human Subjects (CORIHS-IRB), and the NIH to better ascertain if participants are being informed as per government guidelines. If no problems are detected, then the questionnaire can be used periodically as a standard measure for monitoring. However, if the survey shows that issues need to be addressed, this study will pinpoint what areas need attention. Once the problem areas are revealed, educational interventions can be applied specifically to remedy each situation. At the present time, we are not sure how much the research participants understand therefore to insure patient safety and educate the research community it would be very beneficial to conduct the

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