IRB - HUMAN SUBJECTS

• Biomedical Research (Refreshers are required every three years)

OR

• Social Behavioral Education Sciences (Refreshers are required every three years)

GCP - GOOD CLINICAL PRACTICE 

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
• GCP FDA Refresher (The refresher should be taken every 3 years subsequent to the completion of the course above)

OR

• Good Clinical Practice Course for Clinical Trials Involving Investigational Drugs (ICH / international focus)
• GCP ICH Refresher (The refresher should be taken every 3 years subsequent to the completion of the course above)

OR

• GCP – Social and Behavioral Research Best Practices for Clinical Research

*All UVM employees are issued a UVM NetID upon hire, but there are many UVMMC (non-UVM) research key personnel who do not have a UVM NetID. A UVM NetID can be issued to UVMMC personnel to access the InfoEd system. If you do not have a UVM NetID, complete and submit the Request for UVM Net ID form (DOC) to RPO in order to gain access.

Common Rule Delay 

As the January 19 Common Rule effective date was closing in on us, last evening at 4:52 pm, we receive notice from our regulators that an Interim Final Rule (IFR) was approved to delay both the effective date and general compliance date until July 19, 2018.  The IFR has not been published, but may be found on the Federal Register (opens in a new window) as unpublished until the scheduled publication date of January 22, 2018. 

The Council on Governmental Relations (COGR) released their initial thoughts on the delay. 

“An eleventh hour delay of both the effective and compliance dates, however well-intentioned, presents a challenge to institutions which have strived to comply with the revised final rule on January 19, 2018 as required by regulation prior to yesterday’s notice of a pending IFR. Continued uncertainty about the final effective and compliance date with the proposal of additional rulemaking will add to that challenge.”

We concur with COGR’s assessment on this last minute delay.  Yesterday, RPO staff were running to the finish line to meet the compliance date, now we are working diligently to “reverse” steps that we had already put into place to address, in particular, the change to the continuing review of non-exempt research.  Researchers conducting expedited-level protocols now must continue to submit continuing reviews to comply with the pre-2018 rule.  Researchers will continue to receive the standard continuing review notices.  However, if you are unclear as to whether you need to submit a continuing review or not, please contact our office at 656-5040.  The delay does provide us additional time to refine changes to exemption processes as well as develop additional educational materials about the changes.  

What this Means for Researchers 

This delay means that we are unable to roll out changes that conflict with the pre-2018 Common Rule.  The following changes do conflict with the pre-2018 rule and therefore, will not be implemented at this time:

• Continuing Review Changes
• Exemption Category

Changes Changes that do not conflict with the pre-2018 Common Rule and will be implemented:

• Informed Consent Changes
• Single IRB for NIH funded projects (compliance date January 25, 2018)
• Single IRB for all other cooperative research (2020)

Please see the Regulatory Changes (opens in a new window) web page for information specific to the Informed Consent changes.  If you have questions, please do not hesitate to contact your IRB Research Analyst for assistance.  Within the week, we will release a new and improved research manual and two new dictionaries, one specific to regulatory definitions and one specific to consent language.   We hope you find these new resources helpful.

We will continue to keep you posted as to this situation.

View PDF Version

Changes to Instructor Assurances as a Result of the New Common Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

The rule adds to and modifies existing Exemptions. This includes modifying previous Exemptions to allow use of identifiable information with limited IRB review (which is a new category of review that requires an IRB member); inclusion of benign behavioral interventions; and storage, maintenance and secondary use of identifiable private information and identifiable biospecimens where broad consent is obtained.

The changes to the Exemption categories, while trying to reduce overall burden, are significantly more complicated requiring related experience and training in making appropriate Exemption determinations. Therefore, we will be retiring the Instructor Assurance process.

Locally and nationally, the majority of classroom projects are not considered research by Federal definition and do not require IRB review. If the intention of the class project meets the following criteria, then the project would not meet the definition of research and would not require IRB submission.

• It is an activity designed as part of a course requirement for purposes of learning research methods and;
• The results and data will not be used for any presentation, conference, publication, thesis, dissertation, or report outside of the course for which it is assigned.

If the student’s required classroom project does not meet the criteria above, an IRB submission is necessary. There will no longer be an option for the Instructor to make Exemption determinations for their student’s class project. A student project felt to be research defined by Federal regulations will need to submitted to the IRB for review. See attached Student Class Guidance for your responsibilities as the Class Instructor in these instances.

This new requirement does not apply to the Spring 2018 semester classes currently in progress.  However, Investigators will need to look ahead at any Summer and Fall classes to ensure student class projects that are research are submitted to the RPO Office.

Additional information on class projects including examples of projects not requiring review can be found under Student Class Project Guidelines (DOCX).

View PDF Version

Common Rule Changes to the Consent Templates

Changes to the Common Rule, the primary rule regulating human subjects research, go into effect on January 19, 2018. A number of UVM IRB policies, procedures, and systems have been updated as a result of the changes to the rule.

Investigators will see a number of changes required under the new rule specific to the Consent Form:

“The informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”

Revised Common Rule: Federal Register Volume 82, Number 12 (issued, January 19, 2017)

• All medical and behavioral consent forms will now be required to include a concise summary of study activities, risks, and benefits presented to research participants, on page one of the consent document. The IRB will not require re-consent for previously enrolled subjects.
• To assist researchers in creating this new section a Plain Language Medical Dictionary has been added to the website to promote consent comprehension.
• Additional elements of informed consent (specific to biospecimens) are required to be included in consent forms – these are included in the Medical Consent Template (DOCX) and Repository Consent Template (DOCX) and are highlighted in BLUE.
• Please note that only studies approved or altered after January 19, 2018 will be governed by the new rule; the IRB will grandfather all existing approved consent forms under the pre-2018 rule.
• IRB applications submitted shortly before January 19, 2018 may not be reviewed in time to qualify under the current human subjects protection regulations. Applications undergoing the review process at the time of transition may be returned to the study team to update the informed consent elements.
• The Research Protections Office has provided Concise Examples for the Web (DOCX) on how to apply this new element.
• If you have further questions about how to apply the new "key information" requirement for a particular study, contact your IRB Research Analyst for advice.

View PDF Version

• Regulatory Definitions (DOCX)

• Self-Assessment of Protocol Procedures (DOC)
• Self-Assessment of Consent Procedures (DOCX)

• IRB Basics (PPT)
• Guidance on Revised Safety Reporting (PPT)
• Regulatory Binder: Set-up and Maintenance (PDF)