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2018 Common Rule Requirements

Announcements

On this page, you will find the most current information regarding the implementation of the 2018 Common Rule Requirements at UCI. 

Please note that this website will be updated frequently, so you are encouraged to visit it often to stay informed.  

The Common Rule (45 CFR 46)

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991.

The Final Rule reflecting the 2018 Common Rule Requirements became effective January 21, 2019, with the exception of cooperative research (single IRB review) which will not be effective until January 20, 2020.

2018 COMMON RULE CHANGES

 REVISED COMMON RULE

January 21, 2019

  • Definition of Human Subject Research
  • Continuing Review
  • Exemptions
  • Informed Consent

SINGLE IRB OF RECORD

January 25, 2018

  • NIH Single IRB Policy

January 2020

  • OHRP Single IRB Policy
  • Required at UCI for HHS or NIH Supported Cooperative Research Approved on or After January 20, 2020!

UCI Transition Plan 

Research initially approved on/after January 21, 2019: All research, regardless of funding/support, will follow the 2018 Common Rule and/or FDA Rule   Research initially approved prior to January 21, 2019: Research will follow the 2018 Common Rule and/or FDA Rule.  IMPORTANT NOTE: Research must transition to the 2018 Common Rule and/or FDA rule IF a protocol is (or will be) associated with new or renewal federal funding awarded on/after January 21, 2019.

WHAT IS MEANT BY A NEW OR RENEWAL OF A FEDERAL AWARD?

New federal funding means an award of funds (i.e., grant, contract, cooperative agreement or other funding mechanism) to support a project not previously funded by the U.S. government. Renewal federal funding means an award of funds to support the next competitive segment of a project previously funded by the U.S. government.

Please use the tables below as quick references to determine if a study needs to transition to the 2018 Common Rule:

Table 1: Federal Award Types

Table 2: Example: Award Renewal Cycle 

HOW TO TRANSITION A PROTOCOL APPROVED BEFORE JANUARY 21, 2019 TO THE 2018 COMMON RULE:

Option 1: Continuing Protocol Application (CPA) - At the time of continuing review the Lead Researcher (LR) will be prompted with the following question: “Is this protocol associated with a new or renewal of a federal award?”  If the answer is yes, the LR will be required to transition at the time of CPA.

Option 2: Modification Application (MOD) or New IRB Application (APP) - Alternatively, the LR may choose to implement the tranisition prior to the CPA and may do so by submitting either a MOD or APP, depending on the LR's preference.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Option 3: For studies that do not require transition, LRs are encouraged to take advantage of the burden reducing efficiencies by electing to transition to the 2018 Common Rule via a MOD or an APP submission.

Burden Reducing Efficiencies for Investigators to Consider:

1) Re-evaluation of Level of Review – Certain Expedited research may now qualify as Exempt research.

2) Elimination of Annual IRB Review – Expedited research+ will no longer be subject to an annual review and will now only require an administrative check in every three (3) years. 

+Expedited research regulated by the Food and Drug Administration (FDA) or supported by the Department of Justice (DOJ) will still require annual review until which time these entities align with the 2018 Common Rule Requirements. 

ADMINISTRATIVE NOTES:

- An administrative checklist has been developed to help navigate the additional requirements of the 2018 Common Rule: Checklist - Transition to 2018 Common Rule.

- For those studies that are approved on or after January 21, 2019, in the case where the FDA may be more lenient (not requiring the 5th waiver criteria when considering waivers of consent), UCI may uphold the 2018 Common Rule in an effort to harmonize, while ensuring facilitation of research.

RESOURCES

OHRP

CITI TRAINING

  • At the time the revised Common Rule becomes effective, and your training records are active and current, you do not have to re-take the updated CITI learning modules as a result of the revised Common Rule.  The updated CITI learning modules will be available at the next interval when you are required to complete the refresher module.


NIH

Guidance from other federal agencies will be posted here

Summary of Changes to the Common Rule

 

Revised Sections of the Common Rule

Summary of Changes

Revised UCI Templates / Tools

Applicability

45 CFR 46.101

46.101(f) - When applicable, American Indian and Alaska Native Tribal Laws will be applied

Application for IRB Review: Section 9. Subject Populations/Data Sources

- Protocol Narratives:

Exempt: Section 4.B

Biomedical Expedited and Full Committee: Section 3.C.3

Social/Behavioral/ Educational Expedited and Full Committee: Section 3.B.3

- IRB Reviewer Checklists:

~ Exempt Research: Other Considerations

~ New Expedited or Full Committee Research: Item 18

~ Continuing Review (Long): Item 22

Definitions 

45 CFR 46.102

46.102(e) - Definition of Human Subjects includes identifiable biospecimens

46.102(l) - Examples of what are not considered human subject research

46.102(m) - Defines Written (or, in writing) as paper or electronic format

- Request for Determination of Non-Human Subject Research: Parts A & B

- Exempt Self-Determination Tool: Step 1

- Protocol Narrative: Exempt: Step 1

Assurance 

45 CFR 46.103

The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.

- IRB Application: Investigator's Assurance, Item 5

- Continuing Protocol Application: Lead Researcher Certifications 

- IRB Approval Letter: Grant Congruence Reviews

Exempt Research

45 CFR 46.104

Exempt categories 1-2 and 5 are further defined, and 6 remains the same

1: Normal educational practices not likely to adversely impact students’ opportunity to learn

2: Criteria iii specifies that an IRB can conduct a limited review for studies in which identifiable information is obtained/recorded

5: New section for research conducted by Federal employees

New categories are 3-4, and 7-8

3: Research involving benign behavioral interventions with adult subjects, in conjunction with the collection (verbal, written, data entry, audio/visual recording) of information is permitted with prospective consent and at least one of three additional criteria are met

4: Secondary research for which consent is not required is permitted if at least one of three additional criteria are met

7: Store/maintain identifiable private information/specimens for potential secondary research permitted by a limited IRB review Important Note: UCI will not adopt the option of broad consent provided in Category 7; see 2018 Exempt Review Categories for details.

8: Research involving the use of identifiable private information/specimen for secondary research use for which broad consent is required, is permitted when 3 additional criteria are met  Important Note: UCI will considered Category 8 on a case by case basis; see 2018 Exempt Review Categories for details.

- 2018 Exempt Review Categories

Exempt Self-Determination Tool: Section 1.2

- Protocol Narrative: Exempt: Section 1.2

- IRB Reviewer Checklist: Exempt Research: C. Risk Assessment 

IRB Review of Research

45 CFR 46.109

46.109(a) - Exempt Research that require limited IRB review as a condition of exemption.  Limited IRB Review is performed at an IRB Expedited Subcommittee meeting by an IRB Chair or an IRB Chair-designee.

46.109(f) - Continuing review is not required when:

Research eligible for expedited review

Research reviewed by the Limited IRB review process

Research limited to only: data analysis, or accessing follow-up clinical data (performed as part of clinical care).  

2018 Exempt Review Categories

Exempt Self-Determination Tool: UCI Exceptions

Protocol Narrative: Exempt: Section 1.2

- IRB Reviewer Checklists:

Exempt Research: C. Risk Assessment 

New Expedited or Full Committee Research: D. IRB Review Cycle

Continuing Review (Long): D. IRB Review Cycle

Criteria for IRB Approval 

45 CFR 46.111

46.111(a)(3) & 46.111(b) - Vulnerable populations: 

Pregnant women and handicapped/mentally disabled populations are no longer considered vulnerable.

Individuals with impaired decision-making capacity and economically/educational disadvantaged are considered vulnerable population.

46.111(a)(7)(i) - Include adequate provisions to protect privacy of subjects / maintain confidentiality of data. DHHS guidance forthcoming.

46.11(a)(8)  Approval criteria for a limited IRB review

- IRB Reviewer Checklists:

Exempt Research: C. Risk Assessment 

New Expedited or Full Committee Research: Subject Protections

Continuing Review (Long): Subject Protections 

Cooperative Research (sIRB)

45 CFR 46.114

The final rule mandates the use of a single IRB for multisite studies. Federal departments or agencies supporting or conducting the research can determine that the use of a single IRB is not appropriate for particular types of studies.

 - Website: National Institutes of Health single IRB (sIRB) Review for Multi-site Research

 - Implementation of sIRB for other Federal departments or agencies will be addressed in 2020

Informed Consent

45 CFR 46.116

This entire section has been revised.  A brief summary is outlined below:

46.116(a) - New requirement of Key Information at the beginning of the consent form 

46.116(b) - One (1) new Basic element of informed consent 

46.116(c) - Three (3) new Additional elements of informed consent

46.116(d) - Seven (7) elements of a Broad consent form

46.116(f) - Revised criteria for a General Waiver or Alteration of Consent

46.116(g) - New exception to Informed Consent: Screening, recruiting, determining eligibility is permitted under specific circumstances

46.116(h) - A copy of the template consent form must be posted on a federal website after the clinical trial (sponsored by a federal department or agency) is closed to recruitment and no later than 60 days after the last study visit by any subject. DHHS guidance is forthcoming.

IRB Application: Investigator's Assurance, Item 11

Continuing Protocol Application: Lead Researcher Certifications 

- Informed Consent Templates:

Consent Template: Biomedical

Consent Template: Social/Behavioral/Educational

Study Info Sheet: Expedited

Study Info Sheet: Exempt Focus Group

~ Study Info Sheet: Exempt Interview

Study Info Sheet: Online Survey

- Protocol Narratives:

Exempt: Section 5

Biomedical Expedited and Full Committee: Section 3.D

Social/Behavioral/ Educational Expedited and Full Committee: Section 3.C

Appendix O: Option A

Checklist: Informed Consent

- IRB Approval Letter: Posting of the Informed Consent Documents

Documentation of Informed Consent 

45 CFR 46.117

46.117(a) - Includes electronic format 

46.117(b) - Ensures that Key Information was presented first to the subject

46.117(c) - New criteria for a waiver of documentation (signed) of informed consent

- Informed Consent Templates:

Consent Template: Biomedical

Consent Template: Social/Behavioral/Educational

Study Info Sheet: Expedited

Study Info Sheet: Exempt Focus Group

Study Info Sheet: Exempt Interview

Study Info Sheet: Online Survey

- Appendix P: Option C

Checklist: Informed Consent

Frequently Asked Questions (FAQs)

For a PDF version of the FAQs click: here.

General Questions Relating to the Common Rule

1. WHAT IS THE COMMON RULE?

2. WHAT IS THE BACKSTORY OF THE 2018 COMMON RULE? HOW DID WE GET HERE?

3. WHAT IS THE PRE 2018 COMMON RULE?

4. WHY IS IT CALLED THE 2018 COMMON RULE IF IT GOES INTO EFFECT JANUARY 21, 2019?

Transitioning

5. MUST STUDIES APPROVED ON OR AFTER JANUARY 21, 2019 TRANSITION TO THE 2018 COMMON RULE? IF SO, HOW?

6. MUST STUDIES APPROVED BEFORE JANUARY 21, 2019 TRANSITION TO THE 2018 COMMON RULE?

7. CAN YOU CLARIFY WHAT IS MEANT BY A NEW OR RENEWAL OF A FEDERAL AWARD?

8. MY AWARD IS A FEDERAL 5 YEAR AWARD, IN ITS 3RD YEAR. IS THAT A RENEWAL? SHOULD THE RESARCH STUDY TRANSITION?

9. MY AWARD IS A FEDERAL 3 YEAR AWARD, IN ITS 2nd YEAR. IS THAT A RENEWAL? SHOULD THE RESARCH STUDY TRANSITION?

10. HOW DOES A RESEARCHER TRANSITION THEIR RESEARCH STUDY?

11. WHAT NEW SECTIONS OF THE PROTOCOL NARRATIVE WILL RESEARCHERS NEED TO COMPLETE?

12. (From OHRP) A STUDY INITIATED BEFORE JANUARY 21, 2019 WAS APPROVED USING THE WAIVER OF INFORMED CONSENT CRITERIA FOUND IN THE PRE-2018 REQUIREMENTS. IF AN INSTITUTION TRANSITIONS THAT STUDY, IS THE NEW WAIVER OF INFORMED CONSENT CRITERION IN THE 2018 REQUIREMENTS APPLICABLE TO THAT STUDY?

13. I NEED TO SUBMIT A MODIFICATION (MOD). I THINK I ALSO WILL NEED TO TRANSITION. WILL I BE REQUIRED TO TRANSITION AT THE TIME OF MY MOD?

14. I WANT TO TRANSITION NOW. WHAT ARE MY OPTIONS?

15. I AM DUE FOR A DE-NOVO REVIEW AT TIME OF CPA. I DO NOT HAVE A NEW OR RENEWAL OF A FEDERAL AWARD. WILL I BE REQUIRED TO TRANSITION TO THE 2018 COMMON RULE?

16. (From OHRP) IF A RESEARCH STUDY TRANSITIONS, DOES THE 2018 COMMON RULE APPLY RETROSPECTIVELY OR PROSPECTIVELY?

IRB Review & Approval Processing

17. (From OHRP) UNDER WHICH VERSION OF THE COMMON RULE SHOULD THE IRB REVIEW A MOD?

18. (From OHRP) AN INSTITUTION TRANSITIONS AN ONGOING STUDY TO COMPLY WITH THE 2018 REQUIREMENTS AND THE STUDY'S INVESTIGATOR MODIFIES THE CONSENT FORM TO BE CONSISTENT WITH THE 2018 REQUIREMENTS. MAY AN IRB REVIEW THE STUDY'S REVISED CONSENT FORM USING THE EXPEDITED REVIEW PROCEDURE TO VERIFY THAT THE CONSENT FORM IS IN COMPLIANCE WITH THE 2018 REQUIREMENTS?

19. IF A RESEARCHER ADDS IN SOME OF THE NEW ELEMENTS OF CONSENT TO THEIR CONSENT DOCUMENTS, DOES THIS MEAN THAT THE RESEARCH STUDY HAS TRANSITIONED TO THE 2018 COMMON RULE?

20. IF A STUDY WAS GRANTED MINOR CHANGES BEFORE JANUARY 21, 2019, AND THEN IS REVIEWED AND APPROVED ON OR AFTER JANUARY 21, 2019, DOES THE 2018 COMMON RULE APPLY?

21. IF A STUDY WAS TABLED BEFORE JANUARY 21, 2019, AND THEN IS REVIEWED AND APPROVED BY THE IRB ON OR AFTER JANUARY 21, 2019, DOES THE 2018 COMMON RULE APPLY?

22. IF A RESEARCH STUDY TRANSITIONS, WILL THE IRB APPROVAL LETTER BE UPDATED TO INDICATE THAT THE STUDY HAS BEEN REVIEWED PER THE 2018 COMMON RULE?

Exempt Research

23. FOR EXEMPT STUDIES, ARE ALL THE NEW CONSENT ELEMENTS REQUIRED FOR EXEMPT?

24. HAS KEY INFORMATION BEEN INCORPORATED INTO THE EXEMPT CONSENT / STUDY INFORMATION SHEET TEMPLATES?

Vulnerable Populations

25. NOW THAT PREGNANT WOMEN ARE OFFICIALLY NO LONGER CONSIDERED VULNERABLE, DOES SUBPART B STILL APPLY?


General Questions Relating to the Common Rule

1. WHAT IS THE COMMON RULE?

The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.

The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies. The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency.

You can see who has signed off on the Common Rule here.

2. WHAT IS THE BACKSTORY OF THE 2018 COMMON RULE? HOW DID WE GET HERE?

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. The Final Rule was initially anticipated to be effective January 19, 2018. On June 19th, HHS and 16 other federal departments and agencies announced an additional six-month delay in the general compliance date for changes made to the Common Rule. The general compliance date of the revised Common Rule (known as the “2018 Requirements”) is now January 21, 2019.

During the delay period (July 19, 2018, through January 20, 2019), regulated entities are required to continue to comply with the requirements of the current Common Rule (“pre-2018 Requirements”) with the following exception. Institutions have the option to implement three burden-reducing provisions of the revised Common Rule during the six-month delay:

1. The revised definition of “research”;

2. The allowance for no annual continuing review of certain categories of research; and

3. The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.

Institutions who choose to implement these burden-reducing provisions for particular studies, must assure that these studies also meet all 2018 Requirements beginning January 21, 2019. The UCI IRB chose to implement one of the three provision as noted below.

Effective July 19, 2018, UCI IRB will no longer conduct federal award-to-protocol congruence reviews. Principal Investigators supported by a federal award to conduct Human Subjects Research will be required to assure that their IRB protocol matches the federal award scope of work.

3. WHAT IS THE PRE 2018 COMMON RULE?

The current regulations under 45 CFR 46- Subpart A - in effect up until January 20, 2019.

4. WHY IS IT CALLED THE 2018 COMMON RULE IF IT GOES INTO EFFECT JANUARY 21, 2019?

See question # 2 above. With the allowance for the exceptions during the delay period the Common Rule went into effect - in part, in 2018.

Transitioning

5. MUST STUDIES APPROVED ON OR AFTER JANUARY 21, 2019 TRANSITION TO THE 2018 COMMON RULE? IF SO, HOW?

Yes. All studies must transition regardless of funding. Researchers will be asked to complete a new section of the Protocol Narrative, as well as re-order elements of consent to their consent documents so that key information is provided “up front.” Additional consent elements may be required. Additional questions may be posed relating to wavier of consent criteria. This may include completion of a revised Appendix. The Human Research Protections (HRP) Staff will work with Researchers on this process.

6. MUST STUDIES APPROVED BEFORE JANUARY 21, 2019 TRANSITION TO THE 2018 COMMON RULE?

It depends. At the time of continuing review [both the Short and the Long Continuing Protocol Application (CPA)], the Researcher will be prompted by HRP Staff at pre-review (until the electronic CPA is updated to allow this question):

“Is this protocol associated with a new or renewal of a federal award?”

If the answer is yes, the Researcher will be asked to transition at the time of CPA.

7. CAN YOU CLARIFY WHAT IS MEANT BY A NEW OR RENEWAL OF A FEDERAL AWARD?

Researchers are asked to please use the table below as a quick reference to determine if their study needs to transition to the 2018 Common Rule:

Federal Award Chart

8. MY AWARD IS A FEDERAL 5 YEAR AWARD, IN ITS 3RD YEAR. IS THAT A RENEWAL? SHOULD THE RESEARCH STUDY TRANSITION?

Researchers are asked to please refer to the below graphic. A renewal is not the same as a continuing. The research study will only need to transition to the 2018 Common Rule if it is at the time of their renewal of a federal award or are receiving a new federal award. If the award is continuing, the research study does not need to transition.

5 year award chart

9. MY AWARD IS A FEDERAL 3 YEAR AWARD, IN ITS 2nd YEAR. IS THAT A RENEWAL? SHOULD THE RESEARCH STUDY TRANSITION?

Researchers are asked to please refer to the below graphic. As with the above example, the research study will only need to transition to the 2018 Common Rule if it is at the time of their renewal of a federal award or are receiving a new federal award. If the award is continuing, the research study does not need to transition.

3 year award chat

10. HOW DOES A RESEARCHER TRANSITION THEIR RESEARCH STUDY?

At the time of CPA, Researchers may be asked to complete a new section of the Protocol Narrative, depending on which version of the document has already been completed (exempt, social-behavioral or biomedical) as well as re-order elements of consent in their consent documents so that key information is provided “up front.” Additional consent elements may be required. Researchers will be provided with the updated Consent templates and asked to review/ add in elements as applicable. Additional questions may be posed relating to wavier of consent criteria (see question # 12 below). This may include completion of a revised Appendix (O). The Human Research Protections (HRP) Staff will work with Researchers on this process.

11. WHAT NEW SECTIONS OF THE PROTOCOL NARRATIVE WILL RESEARCHERS NEED TO COMPLETE?

If the study involves screening of identifiable information or identifiable biospecimens to determine eligibility of prospective subjects, then the following section is required.

• Section 3D is a new section in the biomedical version.
• Section 3C is a new section in the social behavioral version.
• Section 9 is a new section in the exempt version.

12. (From OHRP) A STUDY INITIATED BEFORE JANUARY 21, 2019 WAS APPROVED USING THE WAIVER OF INFORMED CONSENT CRITERIA FOUND IN THE PRE-2018 REQUIREMENTS. IF AN INSTITUTION TRANSITIONS THAT STUDY, IS THE NEW WAIVER OF INFORMED CONSENT CRITERION IN THE 2018 REQUIREMENTS APPLICABLE TO THAT STUDY?

It depends. The 2018 Requirements include a new criterion for waiver of informed consent: if the research involves using identifiable private information or identifiable biospecimens, the IRB must determine that the research could not practicably be carried out without using such information or biospecimens in an identifiable form (§46.116(f)(3)(iii)). While a study must comply with the 2018 Requirements on and after its transition date an IRB does not need to review actions that occurred prior to a study's transition date (or January 21, 2019 for studies that transitioned during the delay period) for compliance with the revised Common Rule.

Thus, the 2018 Requirements' new waiver criterion is only relevant if subjects are still being enrolled in the study on and after the study's transition date (or on and after January 21, 2019 for studies that transition during the delay period). If all subjects have been enrolled in a study before the study's transition date (or before January 21, 2019 for studies that transition during the delay period), then the new waiver criterion at §46.116(f)(3)(iii) is not relevant because this element of waiver did not apply at the time that subjects were enrolled. If subject enrollment is ongoing on or after the study's transition date (or on or after January 21, 2019 for studies that transition during the delay period), an IRB must ensure that such enrollment complies with all of the waiver criteria outlined in the 2018 Requirements (including §46.116(f)(3)(iii)).

This will mean that, before these new subjects are enrolled, the IRB must review and approve the study in light of the 2018 Requirements' waiver of informed consent criteria, in order to make the determination that the research could not be practicably carried out without using the identifiable information or identifiable biospecimens. In order to streamline the study's transition to compliance with the 2018 Requirements, the IRB could have made such a determination during a review conducted prior to the study's transition date (or before January 21, 2019, for studies that transition during the delay period).

13. I NEED TO SUBMIT A MODIFICATION (MOD). I THINK I ALSO WILL NEED TO TRANSITION. WILL I BE REQUIRED TO TRANSITION AT THE TIME OF MY MOD?

No. Transitioning through a modification for studies initially approved prior to January 21, 2019 that are either at their time of federal renewal or a new award – is not required. Researchers can wait until their CPA to transition.

14. I WANT TO TRANSITION NOW. WHAT ARE MY OPTIONS?

Researchers can choose to transition via a MOD or a new IRB Application (APP). If via a MOD, please refer to question # 10 above. HRP Staff will work with the Researcher to ensure that their study documents are updated. If an APP, Researchers can use the IRB templates available on the IRB Apps & Forms page. All posted templates (including appendices) have been updated to accommodate the 2018 Common Rule.

15. I AM DUE FOR A DE-NOVO REVIEW AT TIME OF CPA. I DO NOT HAVE A NEW OR RENEWAL OF A FEDERAL AWARD. WILL I BE REQUIRED TO TRANSITION TO THE 2018 COMMON RULE?

Researchers who conduct greater than minimal risk research are required to update their study documents with the latest IRB templates every 7 years. Even though the research study will now have on file updated study documents (IRB templates), this does not mean that the study has transitioned to the 2018 Common Rule.

16. (From OHRP) IF A RESEARCH STUDY TRANSITIONS, DOES THE 2018 COMMON RULE APPLY RETROSPECTIVELY OR PROSPECTIVELY?

When an institution transitions studies initiated before January 21, 2019, the 2018 Requirements apply with respect to IRB actions and research-related activities that occur on or after the transition date. An IRB need not review IRB actions or research-related activities that occurred prior to the transition date in order to ascertain whether those actions or activities meet the 2018 Requirements. In other words, the 2018 Requirements apply only to future actions or activities (i.e., prospectively) beginning on or after the transition date.

For example: Assume that a study was initiated in May 2017. Subjects have been enrolled in the study using a consent form and process that complies with the pre-2018 Requirements. The institution determines and the IRB documents in December 2019 that the study will transition to the 2018 Requirements. In this example, there is no need to seek re-consent after the transition date from already-enrolled subjects using a consent process consistent with the 2018 Requirements, just because the study transitioned to the 2018 Requirements. However, any subject enrolled in the study on or after the transition date must be enrolled using a consent form that complies with the 2018 Requirements.

IRB Review & Approval Processing

17. (From OHRP) UNDER WHICH VERSION OF THE COMMON RULE SHOULD THE IRB REVIEW A MOD?

MODs will be reviewed and evaluated under the version of the Common Rule to which a study is subject, regardless of when the MOD is made. For example, if a study initiated before January 21, 2019 is not transitioned to the 2018 Requirements, any change to that study must be evaluated under the pre-2018 Requirements regardless of when the change is made. Thus, a MOD submitted and reviewed in 2025 would still be evaluated under the pre-2018 Requirements.

As another example, on April 5, 2022, an institution transitions an ongoing research activity. Before April 5, 2022, any protocol MOD for this activity would be reviewed under the pre-2018 Requirements. On and after April 5, 2022 (i.e., the study's transition date), MODs would be evaluated under the 2018 Requirements.

18. (From OHRP) AN INSTITUTION TRANSITIONS AN ONGOING STUDY TO COMPLY WITH THE 2018 REQUIREMENTS AND THE STUDY'S INVESTIGATOR MODIFIES THE CONSENT FORM TO BE CONSISTENT WITH THE 2018 REQUIREMENTS. MAY AN IRB REVIEW THE STUDY'S REVISED CONSENT FORM USING THE EXPEDITED REVIEW PROCEDURE TO VERIFY THAT THE CONSENT FORM IS IN COMPLIANCE WITH THE 2018 REQUIREMENTS?

IRBs may consider whether modifying the consent form to satisfy the 2018 Requirements represents a minor change to the research. If such a determination is made, the IRB may use the expedited review procedure to evaluate the consent form changes, as permitted under §46.110(b)(1)(ii).

19. IF A RESEARCHER ADDS IN SOME OF THE NEW ELEMENTS OF CONSENT TO THEIR CONSENT DOCUMENTS, DOES THIS MEAN THAT THE RESEARCH STUDY HAS TRANSITIONED TO THE 2018 COMMON RULE?

No. A Researcher may add in elements of consent as applicable to their study on their own or per the request of the IRB, as appropriate. This does not mean that the study has transitioned to the 2018 Common Rule.

20. IF A STUDY WAS GRANTED MINOR CHANGES BEFORE JANUARY 21, 2019, AND THEN IS REVIEWED AND APPROVED ON OR AFTER JANUARY 21, 2019, DOES THE 2018 COMMON RULE APPLY?

No. A protocol that received a “minor changes” memo from the IRB prior to January 21, 2019 has been given a conditional IRB approval. The final approval date could be on or after January 21, 2019, and the 2018 Common Rule does not apply.

21. IF A STUDY WAS TABLED BEFORE JANUARY 21, 2019, AND THEN IS REVIEWED AND APPROVED BY THE IRB ON OR AFTER JANUARY 21, 2019, DOES THE 2018 COMMON RULE APPLY?

Yes. A tabled protocol has not been given even a conditional IRB approval. The final approval date is on or after January 21, 2019, so the 2018 Common Rule applies.

22. IF A RESEARCH STUDY TRANSITIONS, WILL THE IRB APPROVAL LETTER BE UPDATED TO INDICATE THAT THE STUDY HAS BEEN REVIEWED PER THE 2018 COMMON RULE?

Yes. A notation will be made on the approval letter to reflect that the study was reviewed / transitioned to the 2018 Common Rule.

Exempt Research

23. FOR EXEMPT STUDIES, ARE ALL THE NEW CONSENT ELEMENTS REQUIRED FOR EXEMPT? I SEE THAT SOME ELEMENTS HAVE BEEN ADDED TO THE NEW EXEMPT TEMPLATE.

We encourage LRs to use our new exempt template which we updated to include some provisions of the Common Rule as it was felt they are informative for participants. At this time, we want to encourage use but we / the IRB can be flexible if not all elements work for that particular submission.

24. HAS KEY INFORMATION BEEN INCORPORATED INTO THE EXEMPT CONSENT / STUDY INFORMATION SHEET TEMPLATES?

Yes, this change only required re-organizing the study information sheet/s in the order in which OHRP has suggested that key information be provided up front.

a. Survey
b. Interview
c. Focus Group

Vulnerable Populations

25. NOW THAT PREGNANT WOMEN ARE OFFICIALLY NO LONGER CONSIDERED VULNERABLE, DOES SUBPART B STILL APPLY?
Yes. Although the regulations now no longer refer to pregnant women as vulnerable, completion of Appendix B as part of addressing Subpart B will be required when pregnant women, fetuses and neonates are a target enrollment population.

2018 Common Rule News & Announcements

News & Announcements

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