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Consultation for IRBs to develop QA/QI Activities. Quality Assurance/Quality Improvement (QA/QI) Consulting
At a glance
Consultations offered include
  • Human subjects research QA/QI expertise
  • Support for institution-based education and training
  • Institutional officials responsible for the oversight of human subjects clinical and translational research
  • Hospital institutional review boards or committees at Harvard-affiliated schools and institutions that don't offer QA/QI programs
  • Institutions that are participating in or preparing to participate in the Master IRB Reliance Agreement
Funding level
  • Free during pilot stage

The Harvard Catalyst quality assurance/quality improvement (QA/QI) subcommittee is composed of QA/QI regulatory experts from the Harvard academic, medical, and hospital communities. This group offers consultation to IRBs within the Harvard Catalyst community that lack QA/QI resources and/or necessary expertise. The consulting service aims to increase research compliance by providing education and training targeted to investigators, study teams, IRB members, and other members of the research community.

  1. What kind of consultation services are available?
    • Advising for HRPP members at institutions without a QA/QI infrastructure
      • Review and comment on draft audit reports which detail findings and corrective actions/best practice recommendations
      • Participation in local education/training initiatives targeted at the local research community and/or HRPP program staff
    • Offering mentor-mentee support for the following types of individuals:
      • Newly hired QA/QI administrator(s) who may require an overview about QA/QI programs/functions, structure, and daily operations; guidance in local program development, etc.
      • Experienced QA/QI administrator(s) who may require focused guidance and/or support in an area previously unfamiliar to them or out of scope of their existing QA/QI program/function
    • For investigators at institutions with an established QA/QI program/function, providing a referral to their home institution's QA/QI program or contact person
  2. What kind of consultations are not available?
    • Conducting not-for-cause audits
    • Conducting for-cause audits
    • Consulting or referrals for investigators whose home institutions lack an established QA/QI program/function
  3. What costs are associated with the consultation service?
    Consultations are provided free of charge to Harvard Catalyst institutional officials and institutional review boards during the pilot stage of the consult service.
  4. How do I request a consultation?
    To initiate a consultation, complete and submit the webform. After your request is submitted, it will be reviewed by the consult service and you will be contacted to arrange the details of the consultation. Be advised that consultation is provided on a first-come, first-served basis. We recommend that you submit your request for a consultation as early as possible.

QA/QI Consulting Service Form
To request a Harvard Catalyst QA/QI consultation, complete and submit this webform.

To learn more, visit the Regulatory Foundations, Ethics, and Law Program and the Quality Assurance/Quality Improvement (QA/QI) research resource.

Cite Us

Have you received a consultation from Harvard Catalyst? Remember to cite Harvard Catalyst in your publications and posters.