In light of the current COVID-19 epidemic, the MaineHealth Office of Research Compliance would like to provide you with information on the requirement for IRB review of changes in research made in response to this situation.
The FDA regulations require that:
Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects. 21 CFR 56.108(a)(4).
The Common Rule requires that:
In order to fulfill the requirements of this policy each IRB shall… Establish and follow written procedures for… (iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. 45 CFR 46.108(a)(3)(iii)
Both the Common Rule and FDA regulations require that prospective IRB approval be granted for changes in research except where necessary to eliminate apparent immediate hazards to the human subjects.
Eliminating immediate hazards may include actions to reduce potential exposure to COVID-19, or to continue to provide medically necessary study care (including study drug) to participants who have been placed in isolation or quarantine because of suspected or known exposures. You may consider shipping study drug directly to research participants, and/or replacing in-person study visits with phone calls, home visits, or telemedicine. MaineHealth encourages sponsors and investigators to take such steps as necessary to eliminate apparent immediate additional risks to participants.
If a sponsor or investigator needs to make a change to research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made and then reported to the IRB of record.
If your study is under the purview of MaineHealth IRB, you must report the changes in research as soon as possible, as per MaineHealth IRB policy.
If your study in under the purview of a commercial IRB (WIRB, Advarra, Sterling, etc.), you must report the changes in research per that IRB’s policy.
If reporting to the MaineHealth IRB, you may submit a full protocol amendment, but the changes may also be communicated via memo, letter, or other document that explains the changes being made, and provides enough information for the IRB to assess the relative risks resulting from the changes. The amendment (or change in research) document must be submitted for review in IRBNet.
If you have any questions about changes in research to eliminate apparent immediate hazards to subjects, please contact the Office of Research Compliance by calling 207-661-4474, or writing to MMCIRB@mmc.org.
In an effort to make the external IRB submission process more expeditious, the MaineHealth Office of Research Compliance will implement a NEW submission process called the “Direct Submission Model” for Western/Copernicus IRB (WIRB) studies. The Direct Submission Model will allow researchers to submit to MaineHealth IRB complete submission packages in IRBNet containing both locally required documents as well as documents required by WIRB.
MaineHealth’s IRB will acknowledge this package, publish an ACKNOWLEDGEMENT letter and IRBNet will send an email alert to let the study team know it is ready. The researcher will then be able to easily submit that same package (with the addition of the acknowledgement letter) directly to WIRB in IRBNet. With the exception of key personnel and site changes and local reporting requirements, all future packages for that study would then be submitted directly to WIRB via IRBNet by the researchers.
This new Direct Submission Model will become effective Monday April 1, 2019. If you have any questions, please contact the IRB office at 207-661-4474.
The National Institutes of Health (NIH) updated its policy for issuing Certificates of Confidentiality (COCs) for NIH-funded and conducted research. Effective October 1, 2017, COCs are issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on or after December 13, 2016. The COC is issued as a term and condition of award. No physical certificate document is issued for the NIH-funded projects affected by this policy change. This policy change is a result of the 21stCentury Cures Act, section 2012, which requires all federally funded research in which identifiable, sensitive information is collected or used to be issued a Certificate. The Certificate protects the privacy of research participants enrolled in biomedical, behavioral, clinical or other research by prohibiting the disclosure of any information, documents or biospecimens containing identifiable, sensitive information in response to legal demands, such as a subpoena.
The following document contains is additional information to assist the MaineHealth research community in complying with the NIH policy change: CoC Notification
In an effort to streamline external IRB submissions, the MaineHealth Office of Research Compliance will implement a New Direct Submission Model for WIRB studies. The Direct Submission Model will allow researchers to submit to MaineHealth IRB complete submission package in IRBNet containing both locally required documents as well as documents required by WIRB.
MaineHealth’s IRB will acknowledge this package and publish an ACKNOWLEDGEMENT letter; the researcher would then submit that same package (which will include the acknowledgement letter) directly to WIRB in IRBNet. All future packages would be submitted directly to WIRB via IRBNet by the researchers moving forward with minor exception.
The Direct Submission Model will become effective Monday April 1, 2019. If you have any questions, please contact the IRB office at 207-661-4474.
Dr. Elizabeth Kipp Campbell will be joining Maine Medical Center as our new Director of Research Compliance on February 19th. Elizabeth brings a wealth of academic and regulatory experience to this position. After earning a PhD degree in Human Development and Family Studies from the Pennsylvania State University, Elizabeth undertook an NIH-funded post-doctoral fellowship in Developmental Disabilities at the University of Minnesota and subsequently served as the IRB Administrator at the Children’s Hospital and Clinics of Minnesota. Subsequently, she was recruited to Purdue University and served there as the Director of the Human Research Protection Program. Most recently and for the last 3 years, as she and her family have moved in the direction of the east coast, Elizabeth has been the Director of the Office of Human Research Ethics at the University of North Carolina at Chapel Hill where she oversaw the professional staff responsible for the support of six IRBs.
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.
On January 21, 2019, a very important update to the “Federal Policy for the Protection of Human Subjects” will go into effect. This revision to the regulations, also known as the “Common Rule”, has been adopted by most of the signatories on the original 1991policy. Note that the Food and Drug Administration is not a signatory on the original or New Common Rule.
How will the New Rule affect you as a researcher? First and foremost, the New Rule will only apply to new studies approved on or after 1/21/19. So, any of your studies that are either currently approved, or that will receive initial approval prior to 1/21/19, will stay covered under the requirements of the current Rule. Any of your studies approved on or after 1/21/19, will be subject to the new Rule. More New Common Rule Information
There are new reporting requirements for Unanticipated Problems. Serious Adverse Events (that meet the definition of an UP – Unanticipated Problem) must reported by submitting the “MMC-Progress Report, Study Completion, Reportable New Information Form” wizard in IRBNet within 5 business days.
If the Serious Adverse Event is, or results in, death, and (a) meets the definition of a UP, i.e., related to the study and unanticipated, and (b) either occurred at MMC, or occurred at another site resulting in study-wide change to the protocol or to the informed consent form, then it must be reported within 48 hours using the form referenced above.
Investigators must report UPs to the IRB within 10 business days of occurrence (or notification, if from outside MMC) using the form referenced above. If investigators are uncertain but believe that the event might represent a UP, a report should be submitted.