We propose to analyze investigator protocols and their corresponding consent forms for research being conducted at federally-funded General Clinical Research Centers (GCRCs) at the 25 medical schools in the United States that receive the largest amount of NIH research funding to ascertain how investigators address ethical issues related to use of stored biological materials for DNA-based testing or plans for such storage for future testing. In particular, we will focus on issues of consent; disposal, use, and disposal of samples; confidentiality; and dissemination of research results. We have the following specific aims for this project:
Specific Aim 1 : To determine how investigators are addressing the ethical issues related to use of stored human biological materials for DNA-based testing or plans for such storage for future testing in their protocols and consent forms in comparison to published guidelines.
Specific Aim 2 : To identify novel and helpful approaches to addressing these ethical issues that could be adopted more widely.
Specific Aim 3 : To identify ethical issues that require more discussion and analysis in such protocols and consent forms.
Specific Aim 4 : To determine whether and to what degree the use of best or problematic practices varies by investigator or protocol characteristics. Our research will provide empirical information about how investigators address the ethical issues in this type of research, promote targeted educational efforts to strengthen protection of human participants, identify issues for further analysis, and encourage wider adoption of innovative and effective approaches to these concerns.
| Wolf, Leslie E; Bouley, Timothy A; McCulloch, Charles E (2010) Genetic research with stored biological materials: ethics and practice. IRB 32:7-18 |
