59MDWI44-104 — Human Research Participant And Animal Subject Protection, Quality Assurance/quality Improvement

59MDWI44-104 governs quality assurance and quality improvement support for post-approval monitoring of human and animal research at the 59 MDW.

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  • Publication number: 59MDWI44-104
  • Title: HUMAN RESEARCH PARTICIPANT AND ANIMAL SUBJECT PROTECTION, QUALITY ASSURANCE/QUALITY IMPROVEMENT
  • Date: 2022-07-15

View 59MDWI44-104 on armypubs.army.mil

It defines QA/QI components, post-approval monitoring activities, the PAM Monitor’s role, and relationships with the IRB and IACUC. It requires audits, site visits, protocol reviews, reporting, access to research records and staff, and continuing education.

Topics covered

  • Quality assurance and quality improvement
  • Post-approval monitoring
  • Research protocol audits and site visits
  • PAM Monitor access to documents, records and staff
  • IRB and IACUC relationships
  • Principal Investigator self-assessment
  • Research continuing education

Questions and answers

What does quality assurance assess?

Assessing strengths and weaknesses through internal and external self-assessments and/or program evaluations intended to gauge compliance and evaluate known or suspected problems. (paragraph 2)

What access does the PAM Monitor have during audits or site visits?

The PAM Monitor shall have access to all documents and information maintained by the investigator and/or applicable oversight committee (IRB, IACUC) as part of any For-Cause protocol audits/site visits or random protocol audits/site visits. (paragraph 2)

What must the PAM Monitor’s report include?

The report will list any identified violations or areas of research non-compliance or scientific misconduct and include the basis and background of the violations and/or areas of non-compliance. (paragraph 2)

Who may request monitoring of protocol procedures?

The 59 MDW IACUC Chair, Attending Veterinarian, or ACUP IO may request monitoring of protocol procedures at any time. (paragraph 3)

How are random protocol audits and site visits conducted?

Random protocol audits/site visits are scheduled and conducted by the PAM Monitor or may be requested by the principal investigator/research staff. (paragraph 3)

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