RPOHuman Subjects ResearchRegulations → Regulatory Changes

 

Special Notice

Publication Date: 01/18/2018

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  The IFR has not been published, but may be found on the Federal Register (opens in a new window) as unpublished until the scheduled publication date of January 22, 2018.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)

The Regulatory Changes web page contains 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 and we will continue to keep you posted as to this situation.

 

Important Elements:

 

Continuing Review - Delayed July 19, 2018

Summary: No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.

Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

Continuing Review

Required Annual Update

While the 2018 change does not require continuing review, it does require that the investigator notify the IRB when the protocol is closed. The IRB has developed an annual update inquiry that will be sent to investigators to obtain that information. The system reminder will be sent prior to the last anniversary approval date for the study. The IRB must receive confirmation on an annual basis that the research is still ongoing and that no changes have been made to the research that would require the IRB to conduct continuing review of the research. PI’s are required to log into the InfoEd system and add a "Annual Update" submission to the protocol. An electronic-form will ask the PI if the protocol is to remain open or closed, have the PI review and update the key personnel roster and remind the PI to submit any protocol changes at this time.

The inquiry will also include an File Annual Protocol Review (DOCX) form developed to assist researchers to remain in compliance with federal regulations and local UVM policies. This can also be used yearly as an internal self-audit. Previously study closure was initiated through the continuing review process but since many protocols are no longer required to submit continuing reviews, the PI’s may close their study via the “Annual Update” in InfoEd.

Ongoing PI Responsibilities

Even when continuing review is not required for a project, the PI and study team must continue to submit the following items in real-time:

  • amendments for protocol changes

  • adverse events, noncompliance and unanticipated problems

  • DSMB and IDB reports

  • key personnel roster updates

  • protocol closure

  • notice when personal identifiers are removed from the data/biospecimens and all codes and keys are destroyed

Currently Approved Studies

Expedited → RPO staff have determined which protocols fit the criteria for no further continuing review, will administratively change the InfoEd status to “Approved – Cont. review no longer required” and will notify the investigator. Investigators will continue to receive annual update inquiries.

Full Board → At next continuing review, RPO staff will determine if any further continuing reviews will be necessary.

New Studies

For new studies approved via expedited review on or after January 19, 2018, the IRB staff/member will determine the need for continuing review and set the status to “Approved – Cont. review no longer required” as applicable.  Investigators will continue to receive annual update inquiries.

Justification for Ongoing Continuing Review

While the majority of expedited studies will not require continuing review, there may be reasons for maintaining the continuing review requirement such as:

  • The project is regulated by the Food & Drug Administration (FDA) or by another sponsor that requires continuing review

  • An amendment or incident report reveals new findings that require additional oversight

  • An administrative tool protocol has been received and the PI needs to develop and submit the human subjects protocol described in the grant application

  • The investigator has had previous serious non-compliance or a pattern of non-serious non-compliance. In these instances the investigator will be notified along with justification for the continuing review requirement.

 

 

Exemptions - Delayed July 19, 2018

Summary: New categories and clarification of existing categories.  Some exemptions may require limited IRB review (similar to an expedited review process).

Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

#1 – EDUCATIONAL EXEMPTION

A new ineligibility criterion will be added to this interaction/intervention exemption for research that involves possible "adverse effects" on student learning of the required education content and/or on the assessment of educators.

#2 - SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, AND OBSERVATION OF PUBLIC BEHAVIOR

The scope will be expanded to include the collection of sensitive and identifiable data.  However, the following is not allowed:

  • Interventions

  • The collection of biospecimens

  • Research with children (except for educational tests or some public observation)

*May require expedited (limited) review

#3 - BENIGN BEHAVIORAL INTERVENTION (NEW)

The 2018 Common Rule added this new exemption category because respect for persons is accomplished through the prospective subject’s forthcoming agreement to participate, the research activities pose little risk, and the use of this exemption for many social and behavioral studies will enable IRBs to devote more time and attention to studies involving greater risk or ethical challenges.

This new exemption permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement.  However, the following is not allowed:

  • Research with children

  • Deception, unless prior agreement obtained

  • Physiological data collection methods (e.g., EEG; wearable devices, such as FitBitTM; blood pressure monitors)

  • Linking to additional personally-identifiable data

*May require expedited (limited) review.

#4 - SECONDARY RESEARCH (IDENTIFIABLE PRIVATE INFORMATION/BIOSPECIMENS)

Secondary research is referring to the re-using identifiable information and identifiable biospecimens that are collected for some other “primary” or “initial” activity. The information or biospecimens that are covered by this exemption would generally be found by the investigator in some type of records (in the case of information) or some type of tissue repository (such as a hospital’s department for storing clinical pathology specimens).

The goal of this exemption is to facilitate secondary research using identifiable private information or identifiable biospecimens that have been or will be collected or generated for nonresearch purposes or from research studies other than the proposed research study.

The scope of this exemption will be expanded to allow:

  • Prospective data review

  • Maintenance of identifiers, if all study data is protected health information (PHI)

  • Research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities

*May require expedited (limited) review.

#5 - PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECTS)

A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.

#6 - TASTE/FOOD QUALITY EVALUATION & CONSUMER ACCEPTANCE

Unchanged.

#7 - STORAGE / MAINTENANCE OF IDENTIFIABLE DATA/BIOSPECIMENS OBTAINED WITH "BROAD CONSENT" (NEW)

This new exemption allows for the storage of data and/or biospecimens in a repository, with identifiers maintained, that were collected under an approved IRB protocol with "Broad Consent" for future secondary use research.

UVM will not implement Exemption #7 at this time.

OLD #7 – UNIVERSITY OF VERMONT NON-FEDERAL EXEMPTION

Research involving collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, where this information is personally identifiable or coded.

This category has been retired. New IRB forms have been developed for each category.

Self-determination of exemption will not be allowed at this time.  Instructors will no longer be able to make this determination per the Special Notice – Instructor Assurance dated January 16, 2018.

#8 - USE OF IDENTIFIABLE DATA/BIOSPECIMENS OBTAINED WITH "BROAD CONSENT" (NEW)

This new exemption allows for secondary research use/analysis of identifiable data/biospecimens that were collected under an approved IRB protocol with "Broad Consent".

UVM will not implement Exemption #8 at this time.

 

 

Informed Consent

Summary: 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)


Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

Informed Consent

  • 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 File Medical Consent Template (DOCX) and File 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 File 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.

 

 

Single IRB of Record - Delayed January 20, 2020

Summary: IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based).

Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

Single IRB of Record (sIRB)

UVM will not transition to this rule until the IRB has more experience with sIRB projects funded by the NIH.

January 20, 2020

 

 

Broad Consent - Not Implementing

Summary: In the revised Common Rule, Broad Consent is an (optional) alternative consent process for use only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research.

Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

Broad Consent

UVM is not transitioning to the broad consent plan as this change would require prospective consent for all leftover specimens from clinical care. This would have required the hospital to create systems to track the consent data on an institutional level.

 

 

Certificates of Confidentiality

Summary: Certificates of Confidentiality (CoCs) protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations.

Per Section 2012 of the 21st Century Cures Act, as of October 2017, NIH funded researchers are automatically issued a CoC through their award. The CoC issuance applies to all NIH funded projects approved as of December 13, 2016.

Other Department of Health and Human Services (HHS) agencies issue CoCs to researchers they fund. Researchers not funded by HHS can continue to apply to NIH or the FDA as appropriate to request a CoC for HHS-mission relevant research.

National Institutes of Health (NIH) Regulatory Changes
Important Elements  Transition Plan

Certificates of Confidentiality (CoC)

Existing Protocols with NIH funding

The NIH standards for requiring a CoC are slightly different than those used by our IRB. You need to confirm with your program officer whether a CoC has been applied. If there is a CoC, and you are still enrolling subjects, you must revise your consent to include the CoC language as found in Appendix M (opens in a new window) in our Human Subjects Research Manual under “Suggested Consent Language Describing the CoC Protections."

New Protocols with NIH funding

You need to include the CoC consent language into your consent to obtain initial approval. Find consent language in Appendix M (opens in a new window) in our Human Subjects Research Manual under “Suggested Consent Language Describing the CoC Protections.”

New Protocols with no NIH funding

NIH will continue to issue certificates for health-related research that is not federally funded, in which identifiable, sensitive information is collected or used by applying through the NIH via the Online Certificate of Confidentiality Application System (opens in a new window). Please refer to Appendix M (opens in a new window) in our Human Subjects Research Manual for additional guidance.

 

 

NIH Single IRB

Summary: The NIH issued a policy for multi-site research, effective January 25, 2018, which establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46.

UVM has contracted with Western IRB (WIRB) for IRB services in these cases.

National Institutes of Health (NIH) Regulatory Changes
Important Elements  Transition Plan

NIH Single IRB (sIRB)

Existing NIH Grants

Researchers that will be submitting competing NIH renewals after January 25, 2018 are required to use sIRB. UVM has a reliance agreement with Western IRB. Researchers will contact our representative at WIRB to develop a budget. Please see the Western IRB page (opens in a new window) for additional information.

New NIH Grants

UVM researchers who wish to submit a new multi-site NIH funded project, should contact our representative at WIRB to develop a budget for the trial.

 

 

Good Clinical Practice Training

Summary: In 2016, the NIH launched a multi-faceted effort to enhance its stewardship over clinical trials. The goal of this effort is to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. The NIH definition of a clinical trial was revised in 2014 in anticipation of these stewardship reforms to ensure a clear and responsive definition of a clinical trial.

The Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials (opens in a new window) was released on September 16, 2016 with an effective date of January 1, 2017.  The policy established the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

Effective July 1, 2017, all researchers were notified in Issue 48 (PDF) of the IRB Newsletter that UVM had decided to extend the GCP training requirement to all investigators and staff engaged in Human Subjects research at UVM and UVM Medical Center regardless of funding.

GCP training is available through the Collaborative Institutional Training Initiative (CITI) program (opens in a new window). Additional information regarding GCP training and access to CITI can be found on our CITI Program Training page.

National Institutes of Health (NIH) Regulatory Changes
Important Elements  Transition Plan

Good Clinical Practice Training for Researchers Conducting Clinical Trials

Existing Studies

NIH clinical trials researchers have received several notifications regarding this requirement over this past year.

Non-NIH clinical trials researchers were notified of this requirement in July 2017. The IRB will not add new key personnel additions to protocols until the GCP requirement is met.

New Studies

Key personnel listed on protocols that meet the definition of a clinical trial will not be added to the protocol until the required GCP training is complete.

 

Introduction

  • In December 2016, the United States enacted the 21st Century Cures Act (Cures).
  • On a similar timeline, in January 2017, the U.S. Department of Health and Human Services (HHS), along with 15 other federal departments and agencies, issued a final rule updating the Policy for the Protection of Human Subjects (also referred to as the “Common Rule”).

More About Cures

Enactment of Cures was the culmination of a bipartisan, multi-year effort by Congress to modernize the cycle of discovery, development, and delivery of innovative medical products.

Cures authorized resources for the National Institutes of Health (NIH) to support biomedical research through the funding of basic, translational, and clinical research.  Cures gave the NIH the tools and flexibility to alleviate administrative burdens that can hamper biomedical innovation, increase data sharing among NIH-supported researchers, authorize innovation prize competitions, support high-risk, high-reward research, increase funding opportunities for young investigators, improve privacy protections in research volunteers, and encourage the inclusion of diverse populations in clinical research.

In Sec. 2034. Reducing Administrative Burden for Researchers, the Secretary of HHS is required, within two years of enactment, to make revisions to harmonize existing regulatory policies and reduce administrative burden.

Additionally, Cures provided the Food and Drug Administration (FDA) with new authorities to modernize the regulation of medical products throughout the lifecycle of discovery, development and delivery.

 

More About the Common Rule

The Common Rule is the set of regulations governing the conduct of human subjects research conducted or sponsored by the federal departments and agencies that subscribe to the rule. UVM applies the Common Rule to all human subject research conducted at the two institutions.

The FDA has not signed onto the Common Rule changes and therefore FDA regulated studies are not currently subject to these Common Rule changes.  However, as mandated by the Cures Act, HHS and the FDA must work together to harmonize long-standing differences within the next three years.

We have created this web page to provide a snapshot of all the regulatory changes. As these deadlines approach, we encourage you to check this web page periodically for updates.