Are the tools AHRQ has developed applicable in nonclinical studies?
Yes, they should be directly applicable to a variety of disciplines. How can we test the competence of researchers in applying innovative techniques to assure informed consent? Dr. Dunn said she was unaware of any standard assessment tools. Dr. Solomon suggested that “direct observation is the gold standard.” Spot checks using taped conversations would be helpful. Consideration of Recommendations Harmonization Subcommittee. Dr. Bierer explained that many SACHRP members wanted to amend the recommendation made at the July meeting regarding the establishment of a subcommittee on harmonization. They felt the objectives had not been crisply stated and the rationale for the recommendation should be more explicit. Dr. Strauss read a proposed amended version: Recommendation. Harmonization of human subject protection issues will result in better allocation of resources that will serve to enhance human subject protection, facilitate research, and improve public health. SACHRP recommends establis
