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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 US Department of Health and Human Services announced a 6 month delay of the revisions to the final rule.

  • The new effective date of the revised common rule is January 21, 2019
  • We will implement the following burden-reducing provision effective July 19, 2018:

Continuing review will be eliminated for certain minimal risk research.       
The IRB Office will conduct a brief administrative review at the time of continuing review for non-FDA, minimal risk research.  The revised Form 5 leads you through the process of determining whether continuing review is needed for your study or if you will only need to complete a portion of the Form 5 (without providing supplemental documents). Review the Continuing Review page on the IRB website for additional information.

Please contact the IRB Office with any questions at IRBOffice@tuftsmedicalcenter.org or ext. 6-7512.

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 types of studies will no longer require continuing review, and instead will require only an annual administrative check-in:

  1. The study is NOT regulated by the FDA under 21 CFR 312 (drugs) or 21 CFR 812 (devices)
  2. The study is eligible for expedited review, i.e. research activity is limited to the activities described in categories 1 to 7 of the OHRP Expedited Review Categories
  3. Research has advanced to involve only one or both:
    1. Data analysis, including analysis of identifiable private information or identifiable biospecimen, and/or
    2. Accessing follow-up clinical data from procedures that subject would undergo as part of clinical care; not specifically for research.

*Note: Eliminating the continuing review requirement does NOT apply to FDA-regulated research

What this means for your study:

  • If your study meets the above criteria and is still active, you will still need to complete an Administrative Annual Review using the new Form 5.
  • If your study is FDA regulated, you still need to submit a Continuing Review.
  • If your study does NOT meet the above criteria, you still need to submit a Continuing Review.
  • Make sure to submit by the deadline in order to avoid a lapse in IRB approval! Conducting research after IRB approval has expired for the study will constitute non-compliance.
  • Reportable New Information and modifications (amendments) to the approved research must be submitted to the IRB for review & approval regardless of whether Continuing Review applies.
  • The IRB will remove the expiration date from the validation stamp and will no longer validate the ICF at Continuing Review.
    • The ICF will only be validated at the initial review and whenever a modification (amendment) is made to the ICF.
    • The most recent IRB approved ICF must be used to consent subjects
  • Although you will still need to obtain updated financial conflict of interest (COI) forms from the PI & research team, you will only submit COI forms when there has been a change in COI for the PI or research team.
  • The Tufts MC Clinical Research Recruitment Website form is no longer required at the time of continuing review for Tufts MC studies that utilize an ICF.

For assistance in completing the new Form 5, please consult this Powerpoint Presentation for guidance. For a guided voiceover version of this presentation click here.

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