Revised Common Rule

May 1, 2019

The U.S. Department of Health and Human Services (HHS) and other federal departments and agencies have implemented a revised rule on the Federal Policy for the Protection of Human Subjects (also known as the Common Rule), effective January 21, 2019.

As part of the MSU HRPP implementation, many HRPP documents have been updated, including forms, HRPP Manual sections, and informed consent templates. The updated documents have been available on various HRPP webpages, including Templates, Informed Consent Templates, and in the HRPP Manual.

Included below is a summary of the HRPP Manual sections that have been updated. To view the HRPP Manual section, visit the HRPP Manual.

1-1, Federal Wide Assurance

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Removed CRIRB reference 

1-3, Use of Authorization Agreements

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Clarified that MSU does not enter Institutional Authorization Agreements for exemptions
  • Added information about the National Institutes of Health (NIH) Policy on Use of a Single IRB (sIRB) for Multi-Site Research
  • Updated reference to non-MSU IRBs to external IRBs
  • Added information about MSU’s participation in SMART IRB
  • Added information about the MSU HRPP external IRB submission process

1-4, Reliance on External Independent (Commercial) Institutional Review Boards

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Updated reference from commercial IRB to independent IRB
  • Updated criteria for which a research study may be considered for review by an independent IRB
  • Clarified that typically only new research studies will be eligible for independent IRB review
  • Clarified that MSU may require use of an independent IRB to meet NIH sIRB requirements
  • Updated information about the MSU HRPP independent IRB submission process, including review of an executed contract

1-5, Use of the National Cancer Institute Central Institutional Review Board

  • Updated information about the MSU HRPP submission process
  • Removed boilerplate language

2-2, Federal Guidelines and Regulations

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Added HRPP Manual sections in Additional Considerations

4-1, Applicability

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Added clarification regarding reliance upon another IRB as IRB of record

4-2, Authority of IRBs

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Removed CRIRB reference
  • Added reference to HRPP Manual 4-6, Responsibilities of IRBs

4-3, Determination of Human Subject Research

  • Updated to reflect the Revised Common Rule (2018 requirements), including removal of the Newborn Screening Research requirements

4-5, Responsibilities of the Institutional Review Boards

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Added other IRB requirements, such as documentation of informed consent, notification of actions, observation of consent and research, review more often than annually, verification from sources other than the investigator, prompt reporting to the IRB of changes, and review of research at convened meetings

4-6, Responsibilities of Researchers

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Updated HRPP contact information
  • Added PI responsibility regarding informed consent

4-7, Recordkeeping for Institutional Review Board Records

  • Updated to reflect the Revised Common Rule (2018 requirements)

4-11, Applicability of the Revised Common Rule (2018 Requirements)

  • New HRPP Manual section that describes the applicability of the Revised Common Rule (2018 requirements)

5-5, Meetings

  • Removed CRIRB references
  • Removed information about deadlines
  • Removed reference to lead review summary in materials available electronically

6-1, Criteria for Institutional Review Board Approval of Research

  • Updated to reflect the Revised Common Rule (2018 requirements)

6-2, Minimization of Risks

  • Updated to reflect the Revised Common Rule (2018 requirements)

6-2-A, Sound Research Design

  • Updated to reflect the Revised Common Rule (2018 requirements)

6-3, Risk Benefit Ratio

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Clarified that there may be no anticipated benefits to subjects and consideration should be given to the importance of the knowledge that may reasonably be expected to result

6-4, Informed Consent

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Added individuals with impaired decision-making capacity as an example of a vulnerable population
  • Added “commercial” to injury statements

6-4-A, Documentation of Informed Consent

  • Updated to reflect the Revised Common Rule (2018 requirements)

6-4-B, Waiver or Alteration of Informed Consent

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Clarified use of the FDA guidance document, “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects”

6-4-C, Parental Permission & Child Assent

  • Updated to reflect the Revised Common Rule (2018 requirements)

6-4-D, Waiver of Documentation of Informed Consent

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Removed statements that an investigator may request a waiver of documentation and that a waiver of documentation may be appropriate if one would usually not be asked to sign consent in a non research situation

6-4-E, Informed Consent Exception for Screening, Recruiting, or Determining Eligibility

  • New HRPP Manual section that addresses the Revised Common Rule (2018 requirements) new provision regarding screening, recruiting, or determining eligibility

6-4-F, Posting of Clinical Trial Consent Forms

  • New HRPP Manual section that addresses the Revised Common Rule (2018 requirements) new provision for posting clinical trial consent forms

6-5, Selection of Subjects and Recruitment

  • Updated to reflect the Revised Common Rule (2018 requirements)

6-6, Privacy, Confidentiality, and Anonymity

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Updated example of security of data to encryption

6-7, Data and Safety Monitoring

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Removed web hyperlinks

6-8, Special Categories of Research Subjects

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Included individuals with impaired decision-making capacity as an example of a vulnerable population

6-8-D, Individuals with Diminished Capacity

  • Updated to reflect the Revised Common Rule (2018 requirements)

6-9-A, Student Classroom Research

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Updated HRPP website reference

6-9-E, Emergency Research

  • Updated to reflect the Revised Common Rule (2018 requirements)

6-9-F, Multiple Research Sites

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Revised to reflect reliance process

8-1, Exemptions

  • Updated to reflect the Revised Common Rule (2018 requirements), including limited IRB review for exemptions
  • Revised to indicate a modification application should be submitted when there is a change in PI

8-2, Expedited Review Procedure

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Added the Revised Common Rule (2018 requirements) provision on documenting the rationale when the IRB determines that a study involves more than minimal risk, even when some or all of the research appears on the expedited review category list, or when the IRB determines that full board review is required even if the study is eligible for expedited review
  • Included individuals with impaired decision-making capacity as an example of a vulnerable population
  • Simplified language in the Review and Documentation of Waivers and Certain Vulnerable Populations
  • Removed reference to HRPP Manual 8-8, Flexibility Initiative

8-3, Committee Review Procedure

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Updated time period for investigator appeal of disapproval to 30 dates from the date the letter was sent

8-4, 45 CFR 46.118 Designation

  • Updated to reflect the Revised Common Rule (2018 requirements)

8-6, Modifications to an Approved Research Study

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Added consideration for research studies that may require verification from sources other than the investigator

8-7, Renewed Approval

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Added requirements after expiration of IRB approval

8-8, Flexibility Initiative

  • Updated to reflect the Revised Common Rule (2018 requirements) related to prisoners and exemptions
  • Removed reference to HRPP Manual 8-8-C, Continuing Review

8-8-A, Exemption Category 97

  • Updated to reflect the Revised Common Rule (2018 requirements) related to prisoners and exemptions

8-8-B, Exemption Category 98

  • Updated to reflect the Revised Common Rule (2018 requirements) related to prisoners and exemptions

8-9, Closure

  • Updated to reflect the Revised Common Rule (2018 requirements)
  • Deleted requirements after expiration of IRB approval and instead added reference to HRPP Manual 8-7, Renewed Approval
  • Simplified language related to closure requirements
  • Added requirement for submission of HRP-555 – Template – Appendix to the Closure – Final Report Form for FDA Regulated Studies Conducted Under an IND or IDE

11-1-A, Education: Investigators and Research Staff

  • Removed reference to a refresher module
  • Changed human research liaisons to compliance analysts