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Revised Common Rule

 There are three key revisions in the Common Rule that will impact our human subject research at Belmont:

 1) Elimination of Continuing Review of Research Under Specific Conditions

The revised Common Rule eliminates continuing review for many minimal risk studies. Unless an IRB determines otherwise, continuing review of research is not required if:

  • The research is eligible for expedited review.
  • The research has progressed to the point that it only involves data analysis.
  • If an IRB chooses to conduct continuing review even when these conditions are met, the rationale for doing so must be documented.

 Belmont IRB: Beginning January 21, 2019, eliminate automatic continuing review of expedited research unless, during the initial review process, IRB committee reviewers identify apparent reasons that annual reports need to be submitted. Examples of reasons for these reviews may include:

  • The research will be conducted internationally;
  • An amendment or incident report reveals new findings that require additional oversight; or
  • The investigator has had previous non-compliance.

 2) Informed Consent Revisions

Under the revised Common Rule, the requirements for informed consent have changed. Specifically, informed consent must begin with a concise and focused presentation of key information that will assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. The consent form must also be organized and presented in a way that facilitates comprehension.

 Belmont IRB: Revised informed consent processes and forms began January 21, 2019. Please see the forms section for the updated consent forms http://www.belmont.edu/irb/forms-instructions.html

 3) Exempt Research Revisions

There are 8 categories under revised Common Rule: (see next page for categories)

  • One category has been deleted (“Educational tests, survey and interview procedures, or observation of public behavior in public officials”);
  • Three categories have been modified; and
  • Three new categories have been added.

 Belmont IRB: Although the revised Common Rule began on January 21, 2019 for federally supported research, Belmont began to use the revised new categories fall 2018 with non-federally funded research. (Other IRBs across the country also initiated early adoption for non-federally funded research). The early adoption allowed us to begin the process of educating faculty, staff, and students to the revised/new exempt categories.

BU Exception: We will not be implementing two new exemption categories #7 (Storage/Maintenance of identifiable data/biospecimens obtained with broad consent) and #8 (Use of identifiable data/biospecimens obtained with broad consent) at this time. We are not implementing broad consent because the new requirements would impose added regulatory burdens due to tracking of individuals who do not provide consent and excluding their data from all future research. This decision can be revisited and updated if the need arises. Other IRBs (e.g., Duke, University of Michigan, University of Oregon) have made this same policy decision.

 

Revised Common Rule Categories of Exemption

 Category 1: Research conducted in established or commonly accepted educational settings. Revised to state that research involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

 Category 2: Research involving the use of educational tests, surveys, interviews, or observation. Revised to allow 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.

 Category 3: New: Research involving benign behavioral interventions (brief in duration, harmless, painless, not invasive, not offensive or embarrassing) with adults (e.g., solving puzzles under various noise conditions) Information collected (verbal or written responses, data entry, observation of subject including audiovisual recording) can be identifiable. Deception is allowable when subjects are prospectively consented in advance. Does not permit data collection via physical procedures (blood pressure, EEG, FitBit).

 Category 4: Secondary research use of identifiable private information or identifiable biospecimens. No consent is required as long as 1 of 4 criteria are met (e.g., publicly available information, information recorded such that subjects cannot be readily ascertained). Revised: Information or biospecimen collection allows for both retrospective and prospective collection.

Category 5: Revised: Public benefit and service programs and research and demonstration projects conducted or supported by a federal department or agency.

 Category 6: Unchanged: Allows for taste and food quality evaluation and consumer acceptance studies if certain criteria are met.

 Category 7: New: Involves the storage of identifiable biospecimens and identifiable private information. Broad consent is required.

 Category 8: New: Involves the secondary analysis of identifiable biospecimens and identifiable private information. The regulations require that broad consent for the storage, maintenance, and secondary research use was obtained.

 Also, some exempt categories allow for self-exemption or limited IRB review. Currently the Belmont IRB board does not allow faculty or students to utilize self-exemption. All exempt studies are reviewed so “limited review” does not apply.