There have been some recent updates to the Human Research Protection Program (HRPP) to be in compliance with the 2018 (New) Common Rule that went into effect Monday January 21, 2019, as well as making needed adjustments to forms and processes in anticipation of our HRPP re-accreditation site visit by AAHRPP this spring.
- Changes to our HRPP resulting from the implementation of the 2018 (New) Common Rule
Two sets of Standard Operating Procedures (SOPs) are now available on our HRPP Website
- The Pre-2018 (Old) SOPs: follow these if the study in question was initially approved on or before January 20, 2019.
- The 2018 (New) SOPs: follow these if your study was initially approved on or after January 21, 2019. Notable changes, as previously reported to you, include new exemption categories, changes to continuing review requirements and new consent process and documentation requirements.
Review the Forms and Template section in IRBNet for changes to forms required for compliance with the 2018 (New) Common Rule.
Note that, in general, if you are submitting a package, you should be sure to complete the required documents from the IRBNet Forms and Templates Library, not from a previously saved version. There have been updates to existing forms, and there are new supplemental forms. If the document title doesn’t specify “NEW RULE”, the content didn’t change with the new regulation, and it is applicable to, and usable for, all studies, regardless of approval date.
- General Updates to the Forms and Templates Area of IRBNet
- We have developed New Submission Checklists for Exempt, Expedited & Full Board, and External IRB Applications. This will help you submit complete submissions for review, with less back and forth due to missing items.
- We have separated our Consent Waiver and HIPAA waiver submission forms, to provide a less complicated process than previously experienced with the combined form. Note that, for projects approved under the 2018 (New) Common Rule, you no longer have to request a consent waiver in your application to the IRB in order to obtain information or biospecimens for the purposes of screening, recruiting or determining eligibility of prospective subjects under certain circumstances [see the 2018 (New) SOPs for more detail]. To conduct such review and accessing PHI (e.g., in medical records), you will still need to obtain a partial HIPAA waiver.
- In response to AAHRPP’s review of our initial application for accreditation, we created a new document called “ICH-GCP PI Attestation”, to be completed and uploaded by MaineHealth PIs who are conducting industry-funded studies (and therefore using an external IRB for review). This attestation is required because many industry contracts and protocols require compliance with ICH-GCP, and this new form provides documentation that such PIs are aware of their responsibilities.
If you have questions about any information provided in this update, or would otherwise like to provide input regarding our HRPP, please feel free to do so by contacting the Office of Research Compliance at 207-661-4474, or send an email to MMCIRB@mmc.org.