Education | Oversight | Accountability
HRP Associates can provide training sessions in all aspects of human research protections for IRB members, IRB staff, investigators, research staff, students and technicians. At OHRP, Dr. Cohen conducted educational programs at institutions throughout the country and organized many regional conferences.
In addition to specific training sessions in the area of human subject protections, HRP Associates can assist institutions in developing and conducting their education program in the broader area of responsible conduct of research. HRP Associates draws on a large network of associates with a wide range of expertise in human research protections to participate in training sessions.
Oversight
Oversight in human research protections is generally provided by an Institutional Review Board (IRB). HRP Associates can provide auditing services and consultation to IRBs to assist them in functioning effectively and in compliance with the regulations. Audit results provided by HRP Associates are strictly confidential.
In addition to identifying potential problems through the audit process, HRP Associates can provide ongoing consultation to correct those problems.
During Dr. Cohen’s long career in the human research protections field and his service at OHRP, he has audited and provided consultation to many institutions. During his tenure at OHRP, he was a frequent member on OHRP’s Quality Assurance Site Visit teams.
Accountability HRP Associates can assist institutions and investigators in providing accountability in two ways. First, HRP Associates can train investigators and the IRB on appropriate recordkeeping methods and, second, HRP Associates can assist institutions in becoming accredited. Adequate recordkeeping by investigators and IRBs is an essential step toward being “audit ready”. There are many bodies that audit the review and conduct of human subjects research – sponsors, state and federal regulatory agencies, institutions, and the IRB itself. Being “audit ready” means ensuring that the investigators and the IRB have all of the necessary records accessible, accurate, and complete. HRP Associates can be instrumental in meeting this goal, including directly training IRB staff on auditing techniques and recordkeeping methods for continued use at the local level. Accreditation of human research protection programs is becoming an important part of public accountability. There are currently two organizations providing accreditation of human research protection programs – AAHRPP and PHRP.
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