Updates to MSU HRPP Manual Sections

October 31, 2022

As part of Michigan State University’s (MSU) reaccreditation process, sections of the MSU Human Research Protection Program (HRPP) Manual were updated. 

Several new HRPP Manual sections were included in the updates:

Included below is a summary of the changes. Many updates did not change current processes (e.g., clarifying language, clarifying processes). Updated HRPP Manual sections are available at: https://hrpp.msu.edu/help/manual/index.html

HRPP Manual 1-3, Use of Institutional Authorization Agreements

  • Added reference to HRPP Manual 1-5, Use of National Cancer Institute Central Institutional Review Board

  • Added information about Single IRB requirements

  • Added information about SMART IRB process

  • Added information about considerations for reliance

  • Added information about the review process for Institutional Authorization Agreements

  • Added information about termination of reliance

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

  • Added information about Single IRB requirements

  • Removed procedural information about the external IRB submission process and added reference to the new HRPP Manual 8-11, External IRB Submissions

  • Added requirement that a finalized contract is required before submitting to an independent (commercial) IRB

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

  • Formatting edits (e.g., abbreviations)

  • Added a statement that the PI is responsible for the oversight of each NCI CIRB study and for assuring that NCI CIRB requirements and SOPs are followed

  • Minor updates to NCI CIRB submission process

  • Updated the prisoner review process so it is consistent with the current NCI CIRB process

  • Updates to the process for reporting potential local unanticipated problems and serious or continuing noncompliance so it is consistent with the current NCI CIRB SOPs

HRPP Manual 1-6, Institutional Review Board Registration

  • New HRPP Manual section that describes the process for registering IRBs

HRPP Manual 2-1, Ethical Principles

  • Updated title for ICH GCP (E6) (R2)

  • Updated webpage links

  • Spelled out an acronym

HRPP Manual 2-2, Federal Guidelines and Regulations

  • Removed listing of HRPP Manual sections and instead referenced overall HRPP Manual Section 2

  • Grammatical edits

HRPP Manual 2-2-A, U.S. Department of Defense

  • Updated to incorporate the revised DoD Instruction 3216.02, Protection of Human Subjects and Adherences to Ethical Standards in DoD-Conducted and -Supported Research (effective April 15, 2020)

  • Added that when a survey crosses DoD Components, additional review is required

  • Clarified reporting requirements to the DoD

  • Added information that needs to be included in the consent document for DoD studies

  • Added restrictions on use of human subjects for testing of chemical or biological agents

  • Added information about compensation

  • Clarified that MSU does not accept classified projects

HRPP Manual 2-2-B, U.S. Environmental Protection Agency

  • Added information to be submitted to the EPA Human Subjects Research Review Official

  • Added regulatory language in the Subpart K section for clarification

  • Added clarification that the IRB cannot approve certain research under Subpart L

HRPP Manual 2-2-C-i, U.S. Department of Justice, Bureau of Prisons

  • Grammatical edits

  • Clarified that requirements also apply to exempt determinations

  • Added Bureau of Prisons requirements

HRPP Manual 2-2-C-ii, U.S. Department of Justice: National Institute of Justice Funded Research

  • Grammatical edits

  • Updated “NIJ Form Request” to “request”

  • Removed outdated website link

  • Added several consent requirements for NIJ funded research

HRPP Manual 2-2-E, U.S. Department of Energy

  • Incorporated updated DOE  requirements

  • Added requirements from the Contractor Requirements Document (e.g., exemptions, multiple DOE sites, human terrain mapping, social media data, DOE federal and/or contractor employees as subjects, study of human in a systematically modified environment, informal internal review)

  • Updated requirements related to personally identifiable information

  • Updated reporting requirements

  • Clarified that MSU does not accept classified projects

HRPP Manual 2-2-F-ii, U.S. Department of Health and Human Services, National Institutes of Health Good Clinical Practice Training

  • Grammatical edits

  • Added bulleted lists to help simplify requirements

  • Removed reference to SABA and updated to ORA LMS

HRPP Manual 2-2-F-iii, Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health)

  • Grammatical edits

  • Added language from the NIH Single IRB policy and FAQs related to genomic data sharing and Single IRB requirements

HRPP Manual 2-2-G, Revised Common Rule Single IRB Requirement

HRPP Manual 2-2-H, Certificate of Confidentiality

  • New HRPP Manual section that describes the requirements for human research studies that involve a certificate of confidentiality

HRPP Manual 2-3, State and Local Guidelines and Regulations

  • Updated Michigan Compiled Law references

  • Updated from Michigan Department of Community Health to Michigan Department of Health and Human Services

  • Updated records related to HIV infection requirements

  • Updated child abuse or child neglect reporting requirements

HRPP Manual 2-4, International Conference on Harmonization Good Clinical Practice E6 (R2)

  • Grammatical edit

  • Clarified evaluation consideration by the IRB and added a reference to relevant HRPP Manual section

  • Clarified ICH-GCP expectation that the written consent form should be signed and personally dated by the participant or the participants’ legally authorized representative, and by the person who conducted the informed consent discussion  

HRPP Manual 3-1, MSU Human Research Protection Program Plan

  • Grammatical edits and acronym updates

  • Added explanation that other units not described in the document may be notified and/or assigned as an ancillary reviewer in the MSU IRB online system as appropriate

  • Updated information about ancillary review process, including examples of when and what units or individuals are notified

  • Added description of MSU Office of Audit, Risk, and Compliance

  • Added description of Department and/or College notification or access to IRB submissions 

HRPP Manual 3-3, Evaluation and Quality Improvement

  • Grammatical edits

  • Added Compliance office PI self-assessment process

  • Added sharing of information related to feedback surveys

  • Updated review timelines

  • Clarified evaluation process for chairs and vice-chairs

  • Clarified evaluation process for outreach activities

HRPP Manual 4-7, Recordkeeping for Institutional Review Board Records

  • Grammatical edits

  • Clarified retention requirements

  • Revised and added language regarding reliance documentation

HRPP Manual 4-8, Reporting Policy

  • Grammatical edits

  • Added citation for Revised Common Rule

  • Clarified that reporting applies to non-exempt studies

  • Added timeframe for reporting and review process when review of the report by relying sites is needed

  • Modified the minimum information needed

  • Clarified that the report will be sent in the format required by the federal department or agency when applicable

  • Updated report review process

  • Updated and clarified who the report will be sent to

  • Added description of the follow-up report process

HRPP Manual 4-9, Designation as Principal Investigator

  • Grammatical edits

  • Updated when an emeritus/retired faculty member may serve as PI

  • Clarified that librarians can serve as PI

  • Clarified that a paid appointment is needed to serve as PI, unless approved as a waived PI

  • Clarified that a PI who is appointed on an academic year basis remains responsible for the duty and non-duty period

  • Described the process for when a change in PI occurs, including when a PI leaves MSU

  • Updated the waived PI process, including what materials are needed and who reviews the requests, and clarified that the IO retains final authority on whether an individual can serve as PI on a human research study

HRPP Manual 4-12, Engagement

  • New HRPP Manual section that describes the criteria related to when an individual “engages” MSU in a human research study

HRPP Manual 5-2-B, Compliance Office

  • Grammatical edits

  • Clarified that protocols undergoing initial review receive compliance reviews

  • Added that site visit reports also include best practices

  • Incorporated remote monitoring

  • Added oversight related to Family Educational Rights and Privacy Act, General Data Protection Regulations, and applications to market a drug or device

  • Added that the manager of the Compliance office trains/acts as a resource for compliance staff

  • Added examples of units in which the compliance office manager interacts and communicates

HRPP Manual 5-2-C, IRB Office

  • Grammatical edits

  • Added tasks currently being performed by the IRB Manager (e.g., ancillary reviews, reporting, some of the duties of IRB administrators, roster updates)

  • Modified language regarding online systems and clarified record retention

  • Added cross training

  • Added tasks performed by IRB Administrator II (e.g., expedited FDA studies, studies with special federal funding requirements, requests for 45 CFR 46.118)

  • Added tasks performed by IRB Administrators III (e.g., rosters)

  • Added tasks performed by the reliance coordinator (e.g., assisting with implementation of reliance procedures, managing reliance submissions)

HRPP Manual 5-3, IRB Membership

  • Grammatical edits

  • Clarified information provided to the IO for IRB member nominations

  • Updated IRB membership composition to include regulatory language

  • Clarified role of alternate members

  • Simplified IRB registration information

  • Clarified determination of experienced

  • Added several IRB member responsibilities (AAHRPP, site visits)

HRPP Manual 5-4, Additional Expertise

  • Grammatical edits

  • Updated process of contacting an individual who may be asked for additional expertise

  • Clarified process if information is provided verbally

HRPP Manual 5-5, Meetings

  • Grammatical edits

  • Updated for remote IRB meetings

  • Clarified quorum requirements

  • Added information about attendance of guests

  • Added information about recording

  • Clarified meeting minutes requirements

  • Added that the minutes document actions taken by the IRB, including documenting the criteria for approval are met

  • Added that the minutes document votes for each protocol as numbers for, against, or abstaining

HRPP Manual 5-6, Contact Information

  • Removed reference to online feedback form

  • Clarified remote work as needed

  • Reformatted contact information

HRPP Manual 6-8-B, Special Categories of Research Subjects: Prisoners

  • Grammatical edits

  • Revised to indicate that the prisoner representative has the appropriate background and experience to serve in that capacity

  • Revised to indicate that presence of the prisoner representative at a convened meeting could be in-person or through web conferencing or teleconferencing

  • Added certification information for collaborative research studies

  • Added reference to HRPP Manual 2-2-A, U.S. Department of Defense

  • Added that a majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the IRB

  • Clarified that the IRB chair assigns the prisoner representative as a primary reviewer

  • Added the process if a subject becomes temporarily incarcerated

  • Added headers and made grammatical changes

HRPP Manual 6-8-E, Special Categories of Research Subjects: HIV and AIDS

  • Added webpage links to related guidance documents

  • Updated HRPP from IRB

  • Added confidentiality considerations

HRPP Manual 6-9-C, Community Based Research

  • Removed reference to online feedback form

  • Updated references

HRPP Manual 6-9-F, Multiple Research Sites When MSU is the Lead

  • Updated to focus on when there are multiple research sites and MSU is the lead (responsible for overall conduct of the study)

  • Added reference to Single IRB requirements

HRPP Manual 7-2, Significant Risk and Nonsignificant Risk Medical Devices

  • Grammatical edits

  • Updated document title

  • Clarified that if the FDA has already made the risk determination, the agency’s determination is final

HRPP Manual 7-7, Humanitarian Use Device

  • Updated the definition of a humanitarian use device to indicate that it impacts 8,000 individuals a year instead of 4,000

HRPP Manual 7-8-A, Clinical Research Billing Compliance Coverage Analysis

  • Updated language to indicate that if the study does not meet the criteria of a Medicare qualifying clinical trial and there are billable events that could generate a charge, a Billing Grid for Coverage Analysis is finalized by the Compliance Office and the PI

  • Added that Compliance staff will review federal qualifying clinical trials to assure compliance with agency requirements for billing

HRPP Manual 8-1, Exemptions

  • Grammatical edits

  • Added requirement for PI to confirm they will conduct study in accordance with researcher responsibilities if PI proxy submits the study

  • Clarified process to document the exempt determination

  • Updated ancillary review examples

  • Clarified process when a study does not meet the exempt criteria

  • Added non-exempt IRB review process of projects likely to have a significant adverse lasting impact on the subjects or likely that a reasonable person would find the interactions offensive

  • Clarified that limited IRB review exempt categories are not being used at this time

  • Clarified that more than minimal risk research requires non-exempt IRB review

  • Clarified parent or guardian permission requirements when research involves children

  • Clarified consent requirements

  • Updated circumstances when modifications are required for exempt research

HRPP Manual 8-2, Expedited Review Procedure

  • Grammatical edits

  • Added clarification regarding continuing review “when required”

  • Added clarification language “unless otherwise specified in law or regulation”

  • Clarified reviewer assignment process

  • Added reference to HRPP Manual 4-3, Determination of Human Subject Research and 8-1, Exemptions

  • Added a statement that when using the expedited procedure, reviewers are prohibited from disapproving research

  • Clarified use of the watermark applied through the MSU IRB online system

  • Removed reference to the Flexibility Initiative

  • Updated review timelines

HRPP Manual 8-3, Committee Review Procedure

  • Grammatical edits

  • Clarified lead review process

  • Clarified process when continuing review submissions also include modifications

  • Added review criteria that require additional documentation at convened meetings (diminished capacity, device risk determinations)

  • Clarified availability of documents in the MSU IRB online system

  • Clarified the modifications required to secure “approved” process

  • Updated information related to remote meetings

  • Clarified that other determinations may be made by the convened IRB (e.g., exemptions, not human subjects)

  • Updated review timelines

HRPP Manual 8-4, Request for 45 CFR 46.118 Designation

  • Grammatical edits

  • Clarified that a copy of the funding materials is needed

  • Clarified that either an exempt determination or IRB approval is needed

HRPP Manual 8-6, Modifications to an Approved Research Study

  • Added regulatory text

  • Clarified definitions of minor and non-minor changes

  • Clarified expedited review procedure process for modifications

  • Removed statement that the MSU IRB online system will not allow submission of an incomplete submission

  • Removed criteria for considerations related to further verification and replaced with reference to HRPP Manual 8-7, Renewed Approval

HRPP Manual 8-7, Renewed Approval

  • Grammatical edits

  • Expanded description of process to determine whether research that doesn’t require continuing review is active or could be closed

  • Added items that are included in the Click continuing review submission and updated consent finalization process

  • Added considerations for FDA regulated studies when research studies may require verification from sources

HRPP Manual 8-10, Site Visits

  • Grammatical edits

  • Added language regarding risk-based approach and reference to HRPP Manual 3-3, Evaluation and Quality Improvement

  • Added meeting remotely

  • Added process of IRB discussion of the site visit if there is no response from the PI

HRPP Manual 8-11, External IRB Submissions

  • New HRPP Manual section that describes the review process when MSU relies upon an External IRB for IRB review and approval

HRPP Manual 8-12, MSU as IRB of Record for Other Institutions

  • New HRPP Manual section that describes the additional process and procedures when another institution relies on MSU for IRB review and approval

HRPP Manual 9-1, Unanticipated Problems Involving Risks to Subjects or Others

  • Grammatical edits

  • Added a statement regarding conflict of interest

  • Clarified some of the examples that may be possibly related

  • Clarified MSU IRB online system process

  • Updated corrective actions

  • Added an explanation of communication with investigators and the appeal process

HRPP Manual 9-2, Noncompliance

  • Grammatical edits

  • Clarified that noncompliance applies to allegations of IRB noncompliance

  • Added information about conflict of interest

  • Updated materials made available to be consistent with the MSU IRB online system

  • Removed information about investigator’s attending convened IRB meeting and referenced HRPP Manual 5-5, Meetings

  • Updated corrective actions

  • Clarified information about misconduct investigations

  • Added that the appeal process will follow the process described in HRPP Manual 8-3, Committee Review Procedure

HRPP Manual 9-4, Subject Complaints

  • Grammatical edits

  • Clarified when complaints need to be reported to the IRB and how the complaints are reported (MSU IRB online system)

HRPP Manual 9-5, Unapproved Change in Protocol

  • Grammatical edit

  • Fixed incorrect regulatory citation and added regulatory citation for 2018 Requirements

HRPP Manual 10-1, Conflict of Interest

  • Grammatical edits

  • Updated name of Standards of Official Conduct for Senior University Administrators

  • Updated COI process to incorporate display and ancillary review assignment in the MSU IRB online system

  • Added section on management of financial conflicts of interest

  • Added section on education requirements related to conflict of interest

HRPP Manual 11-1-B, Education: IRB Members

  • Grammatical edits

  • Incorporated remote training

  • Removed reference to old learning management system, Saba

  • Removed reference to subscriptions

  • Removed reference to training at each meeting and added information about webinars

HRPP Manual 11-1-C, Education: HRPP Staff

  • Grammatical edits

  • Removed reference to old learning management system, Saba

  • Updated orientation checklist to clarify that its used to guide the training

  • Updated information to provide flexibility regarding meetings

  • Added information about webinars

  • Removed reference to subscriptions

  • Removed sentence regarding forwarding list-servs

HRPP Manual 11-2, Outreach and Engagement

  • Grammatical edits

  • Removed reference to online feedback form

  • Updated hyperlinks

HRPP Manual Guidance 12-4 Consent Form Guidelines

HRPP Manual Guidance 12-6 Pregnancy Testing When Research Involves Non-Contrast MRI of the Head

  • Removed criteria for research to involve children

HRPP Manual Guidance 12-7 Investigational Drug Accountability for Study Drugs

  • Added references to the PI or study team

HRPP Manual Guidance 12-10 U.S. Department of Defense Requirements – US Air Force

  • New guidance document that provides information specific to US Air Force requirements when conducting human research

HRPP Manual 12-11 – U.S. Department of Defense Requirements – US Navy

  • New guidance document that provides information specific to US Navy requirements when conducting human research