The New Final Rule

Effective January 21st, 2019, there are new federal rules governing human subjects research (45 Code of Federal Regulations 46, Subpart A). These new federal rules go by many names. Here’s a summary:

    45 CFR 46 Regulations up to until 1/20/2019:
  • “Pre-2018” rules
  • Formerly known as The Common Rule

    45 CRF 46 Regulations after 1/21/2019:
  • “2018” rules
  • The Final Rule
  • The Common Rule

Why are they called “pre-2018” and “2018” rules?
The New Common Rule was supposed to be implemented in 2018, so they differentiated between the rules as “pre-2018” and “2018”. When the implementation date was delayed, they kept the old naming convention.

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Key Changes


Exemption Revisions

Exempt Category 1: Minor Revision, Same topic, Same Category number

Clarification: The research should not adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

Impact: Provides clarification on risk

Exempt Category 2: Minor Revision, Same topic, Same Category number

Clarification: Visual and audio recording are indeed allowed (as has been standard practice at WWU)

New: Allows for studies with identifiable subjects and sensitive questions to be eligible if the IRB conducts a limited review.

Impact: Allows for sensitive, identifiable data to be determined as exempt

Exempt Category 3: Major Revision, Same topic, New Category number

New: This category used to be WWU Exempt Category 7 and only available for non-federally funded studies. This category is now available for federally funded studies, though different requirements apply.

New Requirements:

Subjects have to prospectively agree to the procedures, including being misled if deception or incomplete disclosure is involved.

Data collection is limited to verbal or written responses, including data entry or audiovisual recordings.

WWU Flexibility Initiative:

An exemption category called "WWU Exempt Category A" is available for non-federally funded studies that would otherwise be eligible for Exempt Category 3, except:

If incomplete disclosure or deception is involved, and the subject does not prospectively agree to being unaware of or misled regarding the nature or purposes of the research, that the investigator can demonstrate that this is necessary for the integrity of the research. AND/OR

The study will include standard anthropometric measurements and vital signs as possible methods of data collection.

Impact: Federally funded studies are now able to access this exemption category

Exempt Category 4: Minor Revision, Same topic, Same Category number

New: Now allows for use of prospective data. The data does not have to be pre-existing at the time of the application approval. The researcher must not attempt to re-identify or contact the research subjects.

This category also covers when data is regulated under HIPAA as “healthcare operations,” “research,” or “public health” or when secondary research is conducted by or on behalf of a federal department or agency, using data collected or generated by the government for nonresearch purposes, and the information is subject to federal privacy standards and other requirements specified in the exemption.

Impact: Allows for prospective data to be determined as exempt

Exempt Category 5: Minor Revision, Same topic, Same Category number

New: Expanded to cover studies funded by a federal department or agency that are designed to study, evaluate, improve, or otherwise examine public benefit or public service programs.

Impact: Provides clarification on what is allowable under this category

Exempt Category 6: No Revision

Exempt Category 7: Major Revision, New topic, New Category number

New: This a new category for repositories of identifiable data and/or biospecimens using broad consent.

Impact: To be determined

Exempt Category 8: Major Revision, New topic, New Category number

New: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use if the following criteria are met: (1) Broad consent is obtained, (2) the IRB conducts a limited review, and (3) the investigator does not include returning individual research results to subjects as part of the study plan.

Impact: To be determined


Limited Review

Limited review is a new concept that will allow some research previously reviewed as expedited to become exempt. Some studies fall just outside of the spirit of exempt categories. When the IRB conducts a “limited review”, they review the study's data and security protections, which is normally not required for exempt eligible applications.

Limited review is involved in some cases for Exempt Category 2 and 3 and is required for the new Exempt Categories 7 and 8.

Impact: Provides more flexibility for certain research types while keeping safeguards in place


Waivers

A new criteria for a waiver, for research with identifiers, is that the research could not practicably be carried out without using the info or biospecimens in an identifiable form.

The IRB can now waive documentation of informed consent if the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research involves no more than minimal risk, and there is an alternative method for documenting that consent was obtained.

Impact: Supports the use of alternate methods of consent with certain cultural groups or communities and includes an additional safeguard for identifiable data


Informed Consent


Emphasis on Clairity: The New Final rule emphasizes that consent forms should be clear, focused, and designed to help participants decide whether to participate.

New Required Elements

  • A statement about whether or not data or biospecimens will be used for future research studies or distributed to another investigator without additional informed consent from the subject.

  • For federally funded research, a new section is required at the beginning of consent forms that provides a “concise summary” of the “key elements” of the research.

Additional elements to add if applicable:

  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.

  • For research involving biospecimens:
    • Whether biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit

    • Whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)

Impact: Provides more protection for subjects and not much additional work for researchers or IRB reviewers


Broad Consent

Broad consent is method of consent designed for repositories where data and samples may be used for unknown purposes in the future. This is an alternative to traditional informed consent, though many of the elements are the same. Broad consent forms have different requirements than informed conesnt forms.

Impact: To be determined


Single IRB

Federally funded, multi-site studies will be required to use a single IRB of record starting January 20, 2020. IRBs from the participating institutions will defer to the IRB of record for review, approval, and monitoring.

Impact: Very little WWU research meets the requirements for a single IRB, so this has relatively little impact. WWU also regularly enters into reliance agreements when more than one institution is involved, so our office is already doing this to some degree.


New Definitions


Clinical Trial
Clinical trial means 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 evaluation the effects of the interventions on biomedical or behavioral health-related outcomes.

Legally Authorizated Representative (LAR)
An LAR is clarified as an individual or judicial or other body authorized by applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behave of the prospective subject.

Impact: For Western researchers, these new definitions have little to no impact

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Changes That Have Already Been Implemented

Some of the elements of the New Final Rule have already been implemented at Western in Fall 2018.

  • The definition of "human subject", which now references "information and biospecimens" (replacing "data") and adds "obtaining, using, analyzing, or generating identifiable private information or identifiable biospecimens."

  • Certain activities are deemed as not human subjects research.

  • No more continuing review for expedited studies.

  • Benign behavioral intervention research, when non-federally funded, has been eligible for exemption.


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What to Expect

For new studies...

Our office will guide you through these changes. Continue using the online survey tools to help guide you. They won’t be perfect, but they will still allow researchers to determine if their research might be eligible for exemption.

For existing studies...

Our office will determine if on-going studies would benefit from, or should comply with the 2018 requirements.

Exempt Studies We recommend reviewing your consent form and adding any additional recommended language, if appropriate.

Expedited Studies We will contact you, if needed, to discuss any necessary modifications.

Full Board Studies Our office may contact you, if we determine that your study may benefit from transitioning to the new rules.