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APPENDIX C 136 of the IRB apply to the IRB, whether operated by the VAMC, the affiliated university, or jointly. SOURCE OF STANDARDS These draft standards were compiled from regulations and other applicable policies that apply to research conducted at VA medical facilities and by VA employees. The principal sources were: ⢠VA regulations at 38 CFR 16-17; ⢠DHHS regulations at 45 CFR 46; ⢠FDA regulations at 21 CFR 50, 56, 312, and 812; ⢠VA policy as documented in Chapter 9 of the M-3 manual; ⢠FDA Information Sheets; ⢠International Conference on Harmonisation Good Clinical Practice Guideline; and ⢠OHRP Compliance Activities: Common Findings and Guidance. Accreditation standards may not necessarily match a specific regulation word- for-word. In general, if a regulation specifies an activity that must occur the standard reflects this fact, and focuses on measurable evidence that it occurred. Where allowed by a regulation, standards are flexible, for example, with respect to methods to be used to achieve a specified process or outcome. If a regulation has a specified intent, but does not specify how such intent shall be achieved, the required level of achievement, or other relevant details, standards were developed that are consistent with the expressed regulatory intent. Because these standards focus on VA research, they do not cover all regulations and policies pertaining to the conduct of international research, research involving children, fetuses, and prisoners, or genetic research. ORGANIZATION OF THE STANDARDS In this document unless otherwise specified, the term âstandardsâ encompasses the rationale, standards, requirements, and elements, inclusively. The standards are organized into the following six domains: 1. Institutional Responsibilities; 2. IRB Structure and Operation; 3. Consideration of Risks and Benefits; 4. Subject Recruitment and Selection; 5. Privacy and Confidentiality; and 6. Informed Consent. Each of the six domains of standards includes a statement of rationale. Following in hierarchical fashion, are standards, requirements, and elements that
APPENDIX C 137 detail the performance expectations of the VAMC HRPP. The standards are organized to indicate a chain of activity, from policy and procedure (suggesting intent), through results (documented demonstration that the intent is being met and the desired outcome achieved). Each standard may be composed of one or several requirements. Each requirement contains many specific elements that provide detail and dimension to the requirement. Standards pertain to the following areas: ⢠Policies and procedures; ⢠Implementation of required activities; ⢠Performance of activities to demonstrate the HRPP is achieving required results (quality assurance and improvement); and ⢠Required results. Standards identify the allowable sources of evidence, and methods for the evaluation of evidence, to determine whether or not a particular standard has been met. While many data sources may be listed for a requirement, they are generally listed as alternative sources. That is, a VAMC need not demonstrate compliance with a requirement in each and every data source listed; rather, it must demonstrate compliance in at least one data source (and not contradict the finding in others). Interviews are the exception and will be used only to clarify and confirm information from other sources. Data sources listed are intended to provide information about different aspects of performance (generally reflected in the different elements). For example, a requirement may include data sources such as policies and procedures, as well as IRB protocol files. In this instance, the surveyor will look for evidence that the HRPP has a policy or procedure governing an issue, and will look in a sample of protocol files to assess whether the policy has been implemented effectively. The accreditation survey will result in one of four outcomes, as documented in the draft Accreditation Outcome Table below. Depending on their performance, Human Research Protection Programs can achieve Full Accreditation, Conditional Accreditation, Probational Accreditation, or No Accreditation. Each accreditation outcome brings with it a set of actions by NCQA as well as VA offices. These actions include, for example, follow-up oversight by NCQA, VA Office of Research and Development requirements for, and restrictions on, starting new research or continuing research, and VA Office of Research Compliance and Assurance follow- up, remedial action, and training. Please note that NCQA can only address its own actions and policies related to each outcome.
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