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 NetID form (DOC) to RPO in order to gain access.

EPIC Title Waiver Request

Behavioral or Social Science (CHRBSS) Committee Review (Full or Expedited)

Full or Expedited Review

To choose the appropriate forms to submit you must first determine if what you are proposing is solely qualitative research or a combination of both qualitative and quantitative research. Qualitative research is the gathering of data primarily through the methods of participant observation, face-to-face interviews, or open-ended surveys or questionnaires, often for the purpose of addressing questions pertaining to social and/or cultural issues. Quantitative research generates numerical data or information that can be converted into numbers.

• Important: Investigators should prepare full submissions well in advance in order to meet the deadline and allow enough time for review.
• Important: The Research Data Management and Security Plan form in the table below is now required to be submitted along with all new full and expedited level protocols as well as any protocols where the IRB requires a clearer plan for the protection of data.

New Behavioral or Social Science Committee Protocols

Protocol Materials	Notes
Qualitative Research Protocol (DOCX)	If the research is purely qualitative complete the Qualitative Research Protocol AND Research Data Management and Security Plan (with guidance sheet) 10/19/17
Human Research Protocol (DOCX)	If the research is qualitative and quantitative complete the Common Protocol Cover Form AND Human Research Protocol AND Research Data Management and Security Plan (with guidance sheet) OR the Data Repository Protocol 07/01/15
NEW: Research Data Management and Security Plan (DOCX) Research Data Management and Security Plan Guidance (DOCX)	The Research Data Management and Security Plan form is required to be submitted along with all new full and expedited level protocols as well as any protocols where the IRB requires a clearer plan for the protection of data. 10/23/17
Common Protocol Cover Form (DOCX)	If the research is qualitative and quantitative complete the Common Protocol Cover Form AND Human Research Protocol AND Research Data Management and Security Plan (with guidance sheet) OR the Data Repository Protocol 08/31/18
Data Repository Protocol (DOCX)	01/04/18
Initial Review of an Administrative Tool or Projects to be Developed (DOCX)	This form is used only as a compilation of research being conducted under a specific grant. It does not constitute a review of the risk/benefit ratio of protocols to be conducted under it. Those protocols (including informed consent documents) must be submitted for IRB review and approval separate from this request. 09/25/17
Operations Center Activities Supplement (DOC)	(if applicable) include in any of the applications above 06/27/11
Consent Form or Waiver Request	(if applicable) include in any of the applications above
Awarded Grant, Contract or Agreement with Sponsor, Collaborative Agreements with Other Institutions, Recruitment Materials, Any documents provided to the subject (e.g. questionnaires/diaries/educational materials), Verbal Consent Script, Information Sheet in lieu of Signed Consent	(if applicable) include in any of the applications above

 

Medical (CHRMS) Committee Review (Full or Expedited)

Full or Expedited Review

Typically, the same protocol materials are required for Full vs Expedited Review.  Additionally, you will note below that certain types of expedited protocols do not require the Common Protocol Cover form.

• Important: Investigators should prepare full submissions well in advance in order to meet the deadline and allow enough time for review.
• Important: For Expedited protocols that ONLY involve secondary data analysis of identifiable Protected Health Information (PHI) from health records/pathology slides/radiographic images (no subject intervention or follow-up), complete only the Health Records Review Protocol form and Research Data Management/Security Plan.
• Important: The Research Data Management and Security Plan form in the table below is now required to be submitted along with all new full and expedited level protocols as well as any protocols where the IRB requires a clearer plan for the protection of data.

New Medical Committee Review

Protocol Materials	Notes
Common Protocol Cover Form (DOCX)	General application for full or expedited level: Common Protocol Cover Form AND Human Research Protocol AND Research Data Management and Security Plan (with guidance sheet) OR the Data Repository Protocol 08/31/18
Human Research Protocol (DOCX)	(industry written is acceptable) To be included with the general application to the IRB as shown above. 07/01/15
NEW: Research Data Management and Security Plan (DOCX) Research Data Management and Security Plan Guidance (DOCX)	The Research Data Management and Security Plan form is required to be submitted along with all new full and expedited level protocols as well as any protocols where the IRB requires a clearer plan for the protection of data. 10/23/17
Blood Collection Protocol for Non-Clinical Laboratory Research (DOCX)	This form is to be used when the only procedure involving human subjects is blood collection.  If any other procedures are being included STOP and complete the Common Protocol Cover form. 01/23/18
Biological Specimens/Data Repository Protocol (DOCX)	This form is to be used when the only procedure involving human subjects is their specimens and/or data, and use of a repository.  01/04/18
Initial Review of an Administrative Tool or Projects to be Developed (DOCX)	This form is used only as a compilation of research being conducted under a specific grant. It does not constitute a review of the risk/benefit ratio of protocols to be conducted under it.  Those protocols (including informed consent documents) must be submitted for IRB review and approval separate from this request. 09/25/17
Health Records Review Protocol (DOCX)	This form is to be used when the only procedure involving human subjects is review of identifiable Protected Health Information (PHI) from a covered entity. 06/28/18
Operations Center Activities Supplement (DOC)	(if applicable) include in any of the applications above 06/27/11
Emergency Use of an Investigational Drug, Biologic, or Device (DOCX)	(if applicable) include in any of the applications above
Consent Form or Waiver Request	(if applicable) include in any of the applications above
Investigational Drug/Device Brochure, Awarded Grant, Contract or Agreement with Sponsor, Collaborative Agreements with Other Insitutitons, Recruitment Materials, Any documents provided to the subject (e.g. questionnaires/diaries/educational materials), Verbal Consent Script, Information Sheet in lieu of Signed Consent	(if applicable) include in any of the applications above

 

Waiver or Alteration of Consent and HIPAA

Submissions Not Requiring Committee Review (Exempt, Not Human Subjects, and Not Research)

Exempt Review

Exempt Review

Exempt Review Materials	Notes
Protocol Exemption Review and Determination (DOCX)	08/07/17
Information Sheet (DOCX)	Include if applicable in the application. To be used when protocols are minimal risk and meet the criteria for a waiver of documentation. 03/09/18

 

Determinations of Not Human Subjects

Not Human Subjects

Not Human Subjects Review Materials	Notes
Research Not Involving Human Subjects Review and Determination (DOCX)	01/29/18
Attestation Form for Decedent Research (DOCX)	If your research uses decedent UVMMC PHI, fill this form out and send to Lianne.Cleary@uvmhealth.org. 09/22/15

 

Determinations of Not Research (Quality Assurance and Improvement, Program/Curriculum Evaluation and Public Health Practice projects)

The projects are conducted to assess a process, program or system with the intent to improve that same process, program or system or primary intent to identify/control a health problem.  Many of these projects also may contain elements of research.  Information usually will be shared beyond those involved in or overseeing the program/process/system.  Intent to publish is an insufficient criterion alone for determining if a project is research.  There are other purposes for publishing descriptions of non-research activities, e.g., QI projects are often disseminated outside the institution for the purpose of sharing the process (the QA/QI methodology) not the health care outcomes or implications.

Not Research

Not Research Review Materials	Notes
NEW: Not Research Determination Self-Service Tool	(Self-Service Tool Located on the RPO Website) There will no longer be documentation of the determination with the IRB office. The tool provides an option for you to print the determination for your records. 05/18/18

 

Instructor Assurance for Student Research are no longer in use. The IRB makes all exemption determination.

Instructor assurances are no longer being used post common rule change 2018. See the Student Class Project Guidance (DOCX). 

 

Miscellaneous Templates (Agreements and Institutional Support Letter)

The Committee has developed multiple templates for use.  Please refer to our Consent Form Guidance (PDF) for additional guidance. The HIPAA and Research FAQs (DOCX) document is also available for reference.

NEW: We have provided a Plain Language Medical Dictionary for your use.

Consent forms will now require a concise summary of study activities, risks, and benefits presented to research participants in advance of the body of the consent document. The IRB will not require re-consent for already enrolled subjects.  Additional elements of informed consent are required to be included in consent forms – these are included in the UVM sample consent template document below and highlighted in BLUE.

• Examples of the new concise key information section (DOCX)

Consent and HIPAA Guidance

Initial Informed Consent	Notes
Assent for Children (DOCX)	For use when the assent is a separate document from the parental consent. (behavioral/social study) 01/19/18
Consent for Behavioral/Social Study (DOCX)	Please also refer to  Consent Form Guidance (PDF). 01/19/18
Debriefing Consent (DOC)	To be used to inform and obtain continued consent to use subject's data when deception was used.
NEW: Consent for Medical Study (DOCX)	Please also refer to Consent Form Guidance (PDF). 06/22/18
Information Sheet (DOCX)	To be used when protocols are minimal risk and meet the criteria for a waiver of documentation. 03/09/18
NEW: Documentation of Consent Process Template example 1 (DOCX) Documentation of Consent Process Template example 2 (DOC)	Good Clinical Practice (GCP) for medical research recommends that you have documentation of the consent process for each participant.  Either of these templates can be used for this purpose.  Please modify the templates to fit your protocol’s consent process. 07/26/18
NEW: Documentation of Consent using a Legally Authorized Representative (DOCX)	Documentation of the consent process for a legally authorized representative (LAR). 04/11/18
Short Form Consent Template (DOCX)	To be used for non-English speaking individuals.  Refer to the Research Manual for more info. - UVMMC Interpreter Tips (PDF) 01/01/16
Blood Collection Consent Template (DOCX)	To be used for blood collection protocols only. 01/19/18 The IRB has developed guidance Blood Draws in Non-Clinical Settings (PDF) for researchers who are collecting blood outside of the clinical area.
Repository Protocol Consent Template (DOCX)	To be used for specimen or data collection protocols with the intention of banking for future research. 01/19/18
NEW: Pregnant Partner Consent and Authorization Template (DOCX)	To be used as a pregnancy follow-up consent and release of information authorization. 06/22/18
Expanded Access Consent Template (DOC)	(Emergency) This would only be used when the investigational products are to be used for serious or life-threatening conditions when there is no satisfactory alternative. Contact the office for assistance in these situations.
Media Consent to Interview (DOC)	To be used anytime a subject is willing to share his/her experiences with the media in any format.  The IRB does not need to review, but it should be executed and kept with the subject's research file.

Consent and HIPAA Guidance Continued

HIPAA Forms and Guidance	Notes
UVM Medical Center Data Use Agreement (DOC)	("Limited Data Sets") If the research includes use of a limited data set from the hospital you must enter into this agreement with the hospital. If the research includes use of a limited data set from UVM Medical Center you must enter into the UVM Medical Center Data Use agreement with UVM Medical Center. If you wish to review records (not taking any protected health information) to design a research study or to assess the feasibility of conducting a study, you must complete the UVM Medical Center Reviews Preparatory to Research and forward to UVM Medical Center Risk Management for approval.
UVM Medical Center Reviews Preparatory to Research (DOCX)	If you wish to review records (not taking any protected health information) to design a research study or to assess the feasibility of conducting a study, you must complete this form and forward to UVM Medical Center Privacy Officer Dept for approval. If the research includes use of a limited data set from UVM Medical Center you must enter into the UVM Medical Center Data Use agreement with UVM Medical Center. If you wish to review records (not taking any protected health information) to design a research study or to assess the feasibility of conducting a study, you must complete the UVM Medical Center Reviews Preparatory to Research and forward to UVM Medical Center Risk Management for approval. 10/12/17

Consent and HIPAA Guidance Continued

Ongoing Consent	Notes
Continued Participation after Reaching Age of Majority (DOCX)	To be completed once a child subject has turned 18 years of age. This document was developed by the IRB, therefore an IRB approval stamp is not required.  However, if you wish to change the content (other than inserting the names and numbers) it requires an amendment prior to use.
Consent Addendum (DOC)	To be used anytime you have some additional information for subjects that may affect their willingness to continue participation

Amendment Review Materials

Change in Principal Investigator or Key Personnel

Continuing Review Materials

Every protocol (except exempt) must submit a progress report at least every 12 months. You will recieve a reminder notice beginning three months prior to expiration of approval.

Note: If you wish to close the protocol, you must complete the appropriate continuing review form below and submit for review and final closure. 

Maintaining Approval - Continuing Review

Continuing Review Forms	Notes
Standard Protocol - Request for Continuing Review Form (DOCX)	01/23/18
Operations Center Activities Supplement - Continuing Review (DOC)	(if applicable) 11/12/14
Blood Collection Protocol for Non-Clinical Laboratory Research - Continuing Review (DOCX)	10/12/17
Biological Specimens/Data Repository Protocol - Continuing Review (DOCX)	10/09/17
Administrative Tool - Continuing Review (DOCX)	08/07/17
Health Records Review - Continuing Review (DOCX)	10/09/17
Copy of last signed consent – subject name covered (if enrolling within the last year), Data Safety and Monitoring Report, Sponsor Monitoring Report	Include as applicable in the application

Safety and Protocol Deviation Review Materials

The IRB must review all unanticipated problems that potentially affect risk to subjects or others.

Maintaining Approval - Safety and Protocol Deviation Review

Safety and Protocol Deviation Review Materials	Notes
Unanticipated Problem or Noncompliance Potentially Involving Risk to Subjects or Others (DOC)	08/31/17
New Safety Information Not Affecting Risk to Subjects or Others (DOC)	08/07/17
Interim findings from sponsor potentially affecting risk, Copy of DSMB meetings/minutes, Corrective action plans when there are protocol deviations, For adverse events attach pertinent medical information with subject name obscured, UVM Medical Center Safe Report, FDA Medwatch Form, If HIPAA deviation, copy of correspondence to UVM Medical Center HIPAA Privacy Officer	Include if applicable

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)