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Common Rule Changes

On January 21, 2019, revised Common Rule regulations (i.e., the “2018 Common Rule”) issued by the U.S. Department of Health and Human Services’ (HHS) went into effect. The Common Rule regulates research involving human subjects.

Below is a brief overview of some of the more notable changes that will impact SPH researchers. Our office also created a Common Rule informational video to provide guidance surrounding these changes.

The CUNY Central HRPP Office has also summarized the impact of Common Rule changes on CUNY HRPP policies and procedures here. Related information from the HHS Office for Human Research Protections (OHRP) is available here.

Please contact us at any time with questions.

**IMPLICATIONS FOR SPH IRB PROTOCOL**

The new Common Rule has implications for SPH researchers and both existing and future protocol in IDEATE, as described below.

FUTURE PROTOCOLS (created on or after 1/22/19)

IRB applications created following Common Rule implementation will need to comply with all new regulations. When developing a CUNY IRB application, SPH researchers will complete the updated CUNY IRB application template and should use the new CUNY consent templates for their research, found here under “Informed Consent.”

EXISTING PROTOCOLS (in-development or approved before 1/22/19)

  1. IRB applications in-development (pre-HRPP/IRB approval): On 1/22, IRB applications that are in-development (i.e., have not yet been submitted) or in various stages of the HRPP/IRB approval process (e.g., returned to the PI for modification, under HRPP review, or under IRB review) were automatically updated in IDEATE to reflect CUNY IRB application revisions that were made due to Common Rule changes. Beginning that day, PIs are required to complete these new portions of their applications, including attaching new consent documents, before HRPP/IRB approval can be granted.
  2. Active IRB protocols: Beginning on 1/22, PIs with active IRB protocols (i.e., those that have been approved) need to make modifications to their protocols during the following times:
    1. At the time of their first Amendment submission. The creation of an Amendment on or after 1/22 will trigger the population of Common Rule-related CUNY IRB application revisions that the PI will be required to complete (see below).
    2. At the time of their next Continuing Review (CR) submission. At the time of a PI’s CR submission, they should also create a protocol Amendment, which will trigger the population of Common Rule-related CUNY IRB application revisions that the PI will be required to complete (see below).

      Unless a PI is submitting an Amendment at the time of Continuing Review or for an unrelated purpose (e.g., altering study procedures, adding new personnel), they are NOT required to submit an Amendment to their existing protocol solely to comply with Common Rule changes.

In both of the above scenarios, PIs with existing protocol will be required to:
–Complete new questions/fields in the body of their IRB application (e.g., Participants<Consent tab).
–Attach new consent documents (using the new CUNY consent templates), including a new broad consent form (if applicable), ONLY IF participants are still being enrolled in the research.

Be advised that, with Amendment approval, the study’s expiration date will be removed to reflect the new Common Rule’s elimination of continuing review for qualifying minimal-risk research. Additionally, the exempt or expedited approval categories of a previously-approved protocol may change due to the new regulations.

Revised Human Subjects Definition

Although the criteria for what constitutes human subjects research has not changed, the actual text has. The definition of “human subject” has been changed to include “identifiable biospecimens” as well as how data and/or biospecimens have been collected or will be used.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The definition of “research” has also been expanded to list activities that are specifically deemed not to be research (e.g., oral history, journalism, public health surveillance, criminal justice or criminal investigative activities, and activities in support of intelligence, homeland security, defense, or other national security missions).

Impact: Provides greater clarification of definition.

New & Revised Exempt Categories

A description of new and revised exemption categories can be found here. Notable changes are also described below.

Minor revisions to existing categories

There have been some minor revisions to the following categories:

Exempt 1: Now includes a statement that the research cannot “adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.”

Impact: Provides clarification on risk.

Exempt 2: Includes a clarification that the data may involve visual or audio recording as well as a carve-out that allows for the collection of sensitive, identifiable data to be collected as long as a “limited review” is conducted by the IRB.

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

Exempt 4: This category has been revised to also include biospecimens, as well as special carve-outs for HIPAA-covered data, federally conducted research, and federally generated data.

Impact: Provides greater clarity on what is allowable under this category.

Exempt 5:  The revision provides further clarification about what are “research and demonstration projects that are conducted or supported by a Federal department or agency.” To note, research that is reviewed under this category has always been quite rare.

Impact: Provides clarification on what is allowable under this category.

New Exempt Categories

Exempt 3: This is a new category specific to “benign interventions” involving adults that allows for deception under certain conditions. Data may also be sensitive and identifiable as long as a “limited review” is conducted by the IRB.

Impact: “Benign interventions” are currently reviewed as expedited review, as there is no current exempt category that this activity would fit in.  With the Common Rule, this type of research would be permitted as an exempt review.

Exempt 7: This new category is specifically for identifiable data and/or biospecimen repositories as long as a “limited review” is conducted by the IRB.

Impact: Repositories are currently reviewed as expedited review, as there is no current exempt category that this activity would fit in. With the Common Rule, this type of research would be permitted as an exempt review.

Exempt 8: This new category pertains to the use of identifiable data and/or biospecimens from a repository as long as certain conditions are met.

Impact: The review of secondary use of identifiable data is currently reviewed as expedited review, as there is no current exempt category that this activity would fit in.  With the Common Rule, this type of research would be permitted as an exempt review.

Limited Review

Limited review is a new Common Rule activity that is designed to dovetail with several of the exempt categories. In essence, limited review provides a safeguard for activities that fall slightly outside the exempt categories. By conducting a limited review, the IRB has the opportunity to weigh in on research that may include potential risk and to ensure that safeguards are in place prior to confirming the exempt determination. Limited review is outlined for the following areas:

  • To ensure that broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of the regulations that pertain to informed consent;
  • To verify that broad consent is appropriately documented or a waiver of documentation is appropriate;
  • And, if there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Impact: Includes a special type of review to accompany some exempt categories for research that was not previously permitted to receive an exempt determination.

Broad Consent

As outlined in the Common Rule, broad consent is geared toward repositories for which the primary purpose is secondary research use, with the understanding that later use is not exactly known; broad consent is permitted as an “alternative” to the standard informed consent requirements. While some of the traditional elements are still required, additional elements that are specific to secondary research use such as commercial profit, whole genome sequencing, whether sharing will occur, return of results, and the length of time that the data and/or biospecimen may be stored have been added.

Impact: While broad consent will now be a requirement for the collection of data and/or biospecimen for secondary use, it provides a great deal more protection in terms of informing those who provided the data and/or biospecimen.

No More Continuing Review

Annual continuing review requests are no longer required in the following circumstances:

  • Research eligible for expedited review
  • Research reviewed by the IRB in accordance with the limited IRB review
  • Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

Impact: Reduction of administrative burden while not compromising human subject protections; any change to the research or unanticipated event that occurs is still required to be reported to the IRB.

Informed Consent Considerations

New language/Clarity

Consent forms must be clearer and more focused. Many of the added changes are intended to emphasize that information must be provided to facilitate a potential subject’s understanding of why one would participate or not.

Basic and Additional Elements

The following elements have been added:

  • If the research involves the collection of identifiable private information or identifiable biospecimens, a statement on whether the identifiers might be removed and information or biospecimens could be used for future research without additional informed consent;
  • A statement that biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
  • A statement about whether clinically relevant research results, including individual research results, will be disclosed to subjects;
  • A statement about whether the research project might include whole genome sequencing.

Impact:  Provides a great deal more protection in terms of informing those who provided the data and/or biospecimen and is not much additional work for researchers or IRB reviewers.

Single IRB Review

When more than one institution is involved in a research study, the regulations define this as a “cooperative research project.” In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects; however, this creates a situation where there are multiple IRBs involved, asking for multiple things, and creating an environment of duplication of effort.

In an effort to streamline the process and prevent duplication of effort, the use of one IRB for cooperative research will be required (a.k.a. “Single IRB” or “sIRB”).  However, there are certain restrictions on this requirement:

1) A Federal department or agency must be supporting or conducting the research;
2) The institutions that are involved must be located in the U.S.; and
3) The research sites must be located in the U.S.

The Common Rule regulation also goes on to mention types of research that are not subject to this requirement:

1) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe), or
2) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

Of note, the implementation of the sIRB requirement will not occur until January 20, 2020! However, don’t forget that the NIH has also imposed a sIRB requirement which has an implementation date of September 15, 2017 for NIH funded multi-site clinical trials.

Impact: As the University IRB regularly enters into reliance agreements when more than one institution is involved, not much will change as a result of this new provision. However, this may impact researchers if a selected reviewing IRB charges for their services if these costs have not been budgeted. Additionally, this may place increased demands on resources and time for the CUNY IRB if they are chosen as the IRB of Record.

How the Common Rule Differs from Previous Advanced Notices

(adapted from the OHRP press release) 

The Common Rule differs in important ways from the proposed rule. Some examples of proposals that, based on feedback from the public, are not being adopted include:

  • The Common Rule does not adopt the proposal to require that research involving non-identified biospecimens be subject to the Common Rule, and it does not require that consent be obtained in order to conduct such research. In general, researchers can continue to use such biospecimens in the way they are currently using them.
  • To the extent that some of the previous proposals relied on tools or standards that had not yet been proposed, the Common Rule either does not adopt those proposals or includes revisions to eliminate such reliance. Examples of items that were not included in the Common Rule include a template to be used for broad consent forms, and a decision tool to be used for making exemption determinations.
  • The Common Rule does not expand the policy to cover clinical trials that are not federally funded.
  • The Common Rule does not adopt the previous proposed concept of “excluded” activities. Generally, activities proposed to be excluded are now described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
  • The Common Rule does not include the proposed, standardized privacy safeguards for identifiable private information and identifiable biospecimens. Instead, in most respects, it retains the current approach to privacy standards.
  • The Common Rule does not adopt the proposal for more stringent criteria for obtaining a waiver of the consent requirements for identifiable biospecimens.

 

This overview was adapted from Harvard University’s Committee on the Use of Human Subjects.
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