Remote Site Visit for AAHRPP Reaccreditation to Occur on July 27th and 28th
Please take note that the remote site visit for our AAHRPP (Association for the Accreditation of Human Research Protection Programs) Reaccreditation will occur on July 27th and 28th. The primary purpose of AAHRPP is to strengthen protections for research participants. Each accreditation advances that objective and helps build public trust and confidence in research. An independent, non-profit accrediting body, AAHRPP uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. Through accreditation, MetroHealth can demonstrate the overall excellence of its research program by providing the most comprehensive protections for research participants. MetroHealth has been accredited since 2007 and must undergo reaccreditation every five years. The reaccreditation process begins a year prior to expiration and includes application preparation, on-site evaluation and final council review.
Our site visit will be conducted remotely on Tuesday, July 28 through Wednesday, July 29. AAHRPP has randomly selected and will interview investigators, research staff, IRB members and other individuals involved in human subjects research. All interviewees have been confirmed and the agenda has been finalized. Please note that responses to inquiries received by IRB staff may be delayed as we are busy preparing for the site visit. We appreciate all you do to help strengthen our HRPP (human research protection program) and ensure the protection of subjects enrolled our research program.
MetroHealth IRB Information Regarding COVID-19
(29 April 2020)
The MetroHealth IRB is fully operational and we expect this to continue. IRB Staff have been mandated to work from home, so email is the best method of communication.
For IRB research, highest priority will be given to all inquiries, requests and modifications related to COVID-19. Given the current pandemic, please note the following:
Amendments:
- Any changes to your protocol or the conduct of your research procedures still require an amendment with the IRB with the exception of those made to prevent immediate hazards (see below). Please be sure to include COVID-19 in the title so that we can prioritize those amendments.
- All changes should be documented in your regulatory binder. Be sure to include details about communication with the funding agency, sponsor, or FDA as well as justifications for any changes made.
Changes to Prevent Immediate Hazard:
- Any changes in IRB-approved research must be reported to the IRB and may not be implemented prior to review and approval by the IRB except when necessary to eliminate apparent immediate hazards to the subject. This is permitted by both the Common Rule and FDA regulations.
- Examples of modifications or safety changes include, but are not limited to:
o Cancelling non-essential study visits
o Conducting phone visits in lieu of in-person visits
o Conducting safety screening (initiated by the Principal Investigator) prior to in-person visits occurring.
o Other changes as deemed appropriate to eliminate immediate hazards to subjects because of the risk of exposure to this highly communicable disease.
- Please make all reasonable efforts to report deviations according to IRB policy and submit required amendments to the IRB promptly.
MHS Relying on Another IRB:
- Please monitor any communications from the IRB of Record and ensure compliance with the IRB of Record’s policies and procedures.
- Email David Webb directly at dwebb2@metrohealth.org with single IRB questions as we cannot access our IRBReliance@metrohealth.org email.
* Please check the eIRB homepage for frequent updates.
