VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

The IRB is authorized by VCOM to review and approve research to be conducted in any of the mentioned possible vulnerable populations. Federal regulations do not outline specific criteria to be applied by an IRB when a project will enroll adult mentally disabled persons, or adult economically or educationally disadvantaged persons, or handicapped persons. VCOM authorizes the IRB to review and make case-by case determinations on when a proposed population may constitute a vulnerable population. The IRB decision regarding a vulnerable population will take into account the specific mental illness diagnosis, handicap, educational and/or economic disadvantage, the specific recruitment setting, and the nature of the research study proposed when making this determination. Additionally, the IRB will include one or more members, or consult with outside experts who are knowledgeable about or experienced in working with such participants. There are also requirements that members of specific populations be permitted or encouraged to become human research subjects to ensure that specific populations are adequately represented in research and have access to potential benefits of such research. The IRB is required to ensure that it has adequate board representation or the input of appropriate external consultants to consider specific kinds of research • The methods of recruitment, selection and the inclusion/exclusion criteria should be considered by the IRB, as should informed consent, the confidentiality of data and the willingness of the subjects to volunteer. • Group characteristics such as economic, social, physical and environmental conditions should be considered to ensure that the research includes appropriate safeguards for the protection of vulnerable subjects. • Applicable state or local laws that bear on the decision-making abilities of potentially vulnerable populations. • Research studies involving potentially vulnerable subject groups should have adequate procedures in place for assessing and ensuring subjects’ capacity, understanding and informed consent or assent. In some cases, researchers should be expected to enhance understanding for potentially vulnerable subjects. • Whether or not additional safeguards are necessary to protect vulnerable subjects. Such safeguards could include IRB monitoring of the consent process or the creation of a waiting period between contact and enrollment to allow for family questions. For additional information and full definitions see SOP on Vulnerable Subjects in Research. involving these vulnerable populations in a satisfactory manner. Elements to consider in research involving vulnerable subjects: Information regarding noncompliance in human subjects studies may come to the attention of the IRB through several pathways. These include information contained in new applications, continuing reviews, adverse event reports, and reports from collaborators, employees, or subjects. The IRB Chair and/or an IRB Co-Chair(s) (IRB Leadership) shall review allegations of noncompliance. The Chair/Co-Chair(s) will make a determination as to whether the alleged practices appear to: • cause injury or any other unanticipated problems involving risks to subjects or others, or 18. RESEARCHER NONCOMPLIANCE & PROTOCOL VIOLATION 18.1. Noncompliance of Investigators

VCOM Institutional Review Board Policies and Procedures

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