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Final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") were issued by the Department of Health and Human Services (HHS) on July 18, 2017.

       Important Update  

The revised common rule is in effect as of January 21, 2019!

Please contact the IRB Office with any questions at IRBOffice@tuftsmedicalcenter.org or 617-636-7512

Overview of the Main Changes

1. Improving the informed consent form (ICF) and process to increase subject understanding

The new regulations require a summary of the study and important information right at the beginning of the consent form to ensure that participants are provided with enough information that would help a reasonable person decide whether or not to participate.

View this presentation to learn about Final Rule Impact on Minimal Risk Research. 

2. Requiring that ICFs for certain federally funded clinical trials be posted on a public website

There is a new requirement to post a copy of an IRB-approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency to a federal website. 

View this presentation to learn about Final Rule Impact on Minimal Risk Research. 

3. Requiring single Institutional Review Board (sIRB) review for cooperative research for some studies

The use of a single IRB of record for multi-site studies that are conducting the same protocol will help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites. This rule goes in effect for all NIH funded research starting January 25, 2018 and all federally funded research starting January 20, 2020.

Requests for Tufts to serve as the single IRB of record or cede oversight to a single IRB of record will be reviewed on a case-by-case basis. The SMART IRB platform will be used as the preferred IRB Authorization Agreement.

4. Eliminating continuing review for certain minimal risk research

The following studies no longer require Continuing Review, but instead require an Administrative Annual Review:

  1. Studies that are NOT regulated by the FDA
    NOTE: The US Food and Drug Administration (FDA) regulates clinical studies conducted on drugs, biologics, devices, diagnostics, and in some cases dietary supplements and food additives. If you are unsure if the study is FDA-regulated, contact the study sponsor or the IRB Office.
    NOTE: Studies subject to FDA regulations require a Continuing Review.
  2. Studies that are NOT receiving / have never received federal funding
  3. Studies that have received federal funding, but were initially approved as a new study after 21 January 2019
    NOTE: If a study received federal funding and was initially approved as a new study before 21 January 2019, a Continuing Review is required.

 

  1. The study is eligible for expedited review under categories 1 through 7 of the OHRP Expedited Review Categories
    NOTE: It may be that the study was reviewed under more than one of these categories, in which case, it will still be eligible for Administrative Annual Review as long as those categories are 1 through 7.
  2. Research that has advanced to involve one or both of the following:
    1. Data analysis, including analysis of identifiable private information or identifiable biospecimens, and/or
    2. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care, and not specifically for research

What this means for your study:

  • If your study meets the above criteria, you will complete an Administrative Annual Review submission using the Form 5.
  • If your study is FDA-regulated, federally funded and initially approved as a new study before 21 January 2019, or does not meet the above Administrative Annual Review criteria, a Continuing Review submission is required.
  • Submit by the Continuing Review / Administrative Annual Review deadlines in order to avoid a lapse in IRB approval! Conducting research after IRB approval has expired constitutes non-compliance.
  • Reportable New Information and Amendments or Modifications to the approved research must be submitted to the IRB for review and approval regardless of whether Continuing Review or Administrative Annual Review applies.
  • If the Informed Consent Form(s) are still being used and contain an expiration date in the IRB validation stamp, submit an electronic ICF with your submission. The IRB will remove the expiration date from the IRB validation dates, and will no longer validate the ICF unless a revised ICF is being submitted.
  • The most recent IRB-approved ICF must be used to consent new subjects. If an amendment was submitted that included ICF revisions that require re-consent of previously enrolled subjects, the newly approved ICF must be used to re-consent subjects.
  • Although you will still need to obtain updated financial conflict of interest (COI) forms from the PI and research team at the time of Continuing Review / Administrative Annual Review, you will only submit COI forms when there has been a change in COI for existing research team members (or a yes response for any new research team members).
  • Funding and grant progress reports are no longer required for submission.
  • The Tufts MC Clinical Research Recruitment Website formis no longer required at the time of Continuing Review for Tufts MC studies that utilize an ICF.
5. Establishing new exempt categories of research based on level of risk posed to subjects

The federal regulations have revised and developed new exempt categories.

  • Benign behavioral interventions (Category 3)

“Benign behavioral interventions” are defined as “being brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing (46.104).”

  • New exemption categories 7 & 8 relate to Secondary Research Use of Identifiable Private Information or Identifiable Biospecimens (and Storage or Maintenance for such Secondary Research Use) for which Broad Consent is Required. A proposed plan for implementing broad consent will be required for the new exemption categories 7 & 8.
  • Exemption categories that were predicated on the need for some type of privacy safeguards will require that an IRB conduct a limited review to ensure adequate provisions are in place to protect the privacy of subjects and to maintain data confidentiality.

View this presentation to learn about Final Rule Impact on Minimal Risk Research. 

6. Adding conditions to some of the existing exempt categories
  • Educational research conducted in established educational settings (Category 1) should not adversely affect classroom instruction time or students’ performance.
  • Research involving the use of educational tests (Category 2) allows for collection of potentially sensitive or harmful identifiable information from adults if the IRB makes a determination that adequate provisions for protecting privacy and maintaining confidentiality are in place.
  • Secondary data (Category 4) is not restricted to information/specimens pre-existing at the time the investigator begins the research study.

In accordance with the Office for Human Research Protections (OHRP) recommendation, the IRB will continue to make the determination about whether research is exempt, not the Investigator.

7. Adopting the definition of “Clinical Trial” that includes behavioral health-related outcomes

The revised common rule adopts the NIH’s definition of clinical trial.

https://grants.nih.gov/policy/clinical-trials/definition.htm

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Important features that distinguish a clinical trial from a clinical study are whether there is prospective assignment of an intervention, a study design that evaluates the effect of the intervention on the participants, and a health-related biomedical or behavioral outcome.

If these features are present, the study is a clinical trial. NIH’s case studies illustrate how to apply these questions. Note that studies that involve secondary research with biological specimens or health information are not clinical trials.

In addition, four definitions have been changed in significant ways:

  1. “Legally authorized representative” now adds specific authorization to use institutional policy when there is no applicable law that addresses this issue.
  2. “Human subject” now references “information and biospecimens” (replacing “data”) and adds “obtaining, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens” as trigger events.
  3. “Research” has been expanded to list activities that are specifically deemed not to be research (for example, journalism, certain scholarly activities such as oral history, public health surveillance, criminal justice or criminal investigative activities, and activities in support of intelligence, homeland security, defense, or other national security missions).
  4. The definition of “vulnerable” has been updated to no longer include pregnant women, handicapped, or physically disabled individuals as examples of populations that are potentially vulnerable to coercion or undue influence. Instead, the Final Rule uses the term “individuals with impaired decision-making ability” to replace the term “mentally disabled persons.” The update also reflects that the vulnerability of the subjects in research studies should be considered a function of the possibility of coercion or undue influence. The IRB should also focus concern on vulnerability to coercion or undue influence in reference to the subjects’ ability to make informed decisions about participating in research.

Resources

CITI Program Final Rule Resources

HRP Consulting Group New Final Common Rule - Summary of Changes

Federal Policy for the Protection of Human Subjects

HHS Press Release about the Final Rule 

PRIM&R’s Revised Common Rule Information

NIH Notice of Revised NIH Definition of “Clinical Trial”

NIH Clinical Trial Requirements for Grants and Contracts

Resources to Clarify the Definition of Clinical Trial

NIH Case Studies

The simplified case studies illustrate the differences between clinical trials and clinical studies using the following four questions:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

NIH FAQs

These FAQs further clarify the application of the clinical trial definition.

NIH Decision Tree

Print this decision tree for an easy reference for the four questions that identify a clinical trial.

Use the NIH online tool to determine whether your study is a clinical trial: https://grants.nih.gov/ct-decision/index.htm