Under the supervision of the Corporate Director-Emig Research Center manages the Systems comprehensive Human Research Protection Program (HRPP), including the WellSpan Health Institutional Review Board (WSH IRB). Promotes the protection of human research participants through the management of a system-wide program that fosters a culture of respect for human research participants, including timely and thorough review of research protocols, meaningful education of the research community and proactive monitoring of the conduct of human subjects research. Oversees the development and implementation of standard operating procedures (SOPs) and programs for the effective administration of the HRPP in compliance with relevant federal regulations, state laws, sponsor requirements and System policies and procedures. Responsible for continued accreditation by and compliance with the standards of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Provides technical support to the Institutional Review Board (IRB), investigators, and research support staff. Coordinates the receipt, distribution, review, correspondence and record-keeping of all IRB business using a web-based software program.
Duties and Responsibilities:
1 Oversees the HRPP compliance program to ensure that human subjects research is approved and conducted in accordance with appropriate federal regulations, state and local laws, guidance and institutional MAP policy.
2 Manages inquiries and responses regarding allegations of noncompliance by investigators and/or the IRB and reports of adverse events. Assists in identifying corrective actions to ensure the protections of human subjects compliance with institutional policy.
3 Serves as the lead contact for inquiries regarding inquiries from Department of Health and Human Services, Food and Drug Administration, National Institute of Health, National Cancer Institute and the Association for the Accreditation of Human Research Protection Programs, Inc. Ensures thorough and timely responses in collaboration with the Corporate Director Emig Research Center, Federal Wide Signatory Authority, and when necessary, Corporate Compliance and Risk Management.
4 Provides oversight and management of personnel and daily operations of the HRPP including the hiring and performance management of staff.
5 Ensures the periodic performance review of the IRB membership and composition in order to maintain a diverse, qualified, membership. Assists in recruiting prospective IRB members and make recommendations to the IRB Executive Committee.
6 Coordinates the receipt and IRB review of all proposed research using IRBNet, a web-based electronic IRB submission and review program.
7 Provides technical support to investigators and research support staff.
8 Reviews informed consent documents in final format to insure the document meets the Institutional standards and the Boards instructions for formatting. Affixes IRB approval stamp and publishes the document with the approval letter in IRBNet.
9 Finalizes the IRB meeting agendas, ensuring matters are dealt with in a timely manner. Prepares and distributes meeting materials in IRBNet. Monitors availability of Board members to insure meeting quorum, attends board meetings and takes detailed minutes.
10 Securely maintains all IRB records with restricted access as appropriate including agendas, minutes, policies, regulations, reference materials and individual protocol files. Ensures only authorized personnel have access to confidential data/records/information. Reports any security breach immediately.
Manager-Human Research Protections
11 Maintains IRBNet, the web-based management system, for tracking IRB protocols including new protocols, protocol/consent modifications, annual reviews/re-approvals, safety reports and adverse event documentation. Maintains the computer based tracking software and paper-based records for IRB submissions made prior to 10/2010.
12 Prepares reports of protocol status and other reports as requested by the IRB Executive Committee, System Administration or regulatory agencies.
13 Develops and maintains standard operating procedures for IRB business, processing and record keeping consistent with the WellSpan Manual of Administrative Policy (MAP), multiple Institutional policies and government regarding research regulations.
14 Immediately attends to all mail or calls regarding IRB business.
15 Development and administration of educational material in regards to research record keeping, research compliance, and Wellspan Health Policy and Procedures for Research, Federal Regulations for Research and Good Clinical Practices.
16 Keeps abreast of changing requirements of certification by organizations that assure the quality of WellSpans HRRP.