Operations Manual

Background

The Health Sciences Institutional Review Boards Office (HS IRBs Office) is home to two of the three IRBs on campus: the Health Sciences IRB (HS-IRB) and the Minimal Risk IRB (MR-IRB).

  1. About the Health Sciences IRBs - highlights FWA and IRB numbers, and IRB chair contact information
  2. HS IRBs Office: Contact Information – describes the various methods for contacting the IRB office and lists IRB staff
  3. Brief Overview of Regulatory Basis of IRB Authority and Review Responsibilities – provides an orientation to the IRB’s role and authority
  4. IRB Purview - describes what research each campus IRB oversees

Organization of the HS-IRBs

The HS-IRBs Office does not provide rosters to study sponsors and instead has issued the following documents to describe membership and expertise as well as how the committee complies with IRB and human subjects regulations.

  1. Health Sciences Institutional Review Board Compliance Statement – includes a summary of HS IRB membership
  2. Health Sciences Minimal Risk Institutional Review Board Compliance Statement – includes a summary of MR IRB membership

How to Identify Activities Subject to IRB Review

When UW-Madison employees or agents engage in human participants research or undertake certain activities that do not meet the definition of human participants research but nonetheless require UW-Madison IRB oversight, that project is subject to IRB review. The following resources are available to help identify when a project requires IRB oversight.

  1. Engagement in Human Participants Research at UW–Madison – this policy defines when UW–Madison employees or agents engage in human participants research as well as certain activities that do not meet the definition of human participants research but nonetheless require UW–Madison IRB oversight
  2. Guidance on Exemption: Not Human Subjects Research – describes when projects do not meet the definition of research or research involving human subjects and thus do not require IRB oversight
  3. Guidance on Research vs. Quality Improvement and Program Evaluation – provides guidance for determining whether a project constitutes human subjects research rather than quality improvement or program evaluation
  4. IRB QI/Program Evaluation Self-Certification Tool Guidance – provides a framework for assessing whether a project constitutes QA/QI/Program Evaluation (which does not require IRB oversight) vs. research and includes a link to the Self-Certification Tool
  5. Using Specimens/Information from Decedents: The Common Rule and FDA Regulations – clarifies that research involving decedents does not fall under IRB purview but may be subject to HIPAA Privacy Rule regulations
  6. What if my research involves the use of fetal tissue? – provides a link to the institutional policy, which requires IRB oversight of research using fetal tissue
  7. Guidance Regarding Self-Experimentation of Researchers as Study Subjects – outlines the requirements when investigators conduct research procedures on themselves
  8. Case Reports and Case Series Guidance – describes UW-Madison’s approach to handling case reports and when IRB oversight would be required
  9. Application Type Guidance – identifies the appropriate application to select in ARROW if a project would benefit from an IRB assessment as to whether the activities do not fall under IRB purview
  10. FAQ:
    1. What are the criteria to be engaged in human subjects research at UW-Madison?
    2. Does a pilot or feasibility study require IRB review and approval?
    3. Does my research with coded information or specimens require IRB review?
    4. Does research with existing datasets require IRB review?
    5. I am a student researcher, what IRB approval do I need?
    6. I have samples/images/data that I want to use in a research study. When do I need IRB review?

Preparing to Submit to the HS IRBs Office

If a project requires IRB oversight, then researchers must assume roles and responsibilities when conducting research involving human subjects. The following documents provide guidance regarding institutional requirements as well what documents researchers should review prior to submitting an application.

  1. Summary of Investigator Responsibilities – highlights key responsibilities for UW-Madison investigators conducting human subjects research
  2. Information for New Investigators – helps anyone new to the process of submitting an application to the UW-Madison IRBs
  3. Who may serve as a principal investigator on a protocol? – provides guidance regarding the qualifications required to serve as PI on a study involving human subjects
  4. Human Participants Research Training – provides links to training instructions
  5. What are the Human Subjects Research training (and other training) requirements? – clarifies what training must be completed prior to submitting to the HS IRBs Office
  6. Individual Conflict of Interest - What to Report – provides a guide to what outside activities are reportable as individual significant financial interests
  7. Outside Activities Reports/Conflict of Interest Committee – provides a brief summary of and links to requirements related to campus conflict of interest policies
  8. IRB Fee Policy – shows the IRB fees for new studies submitted to a UW Health Sciences IRB for review
  9. Health Sciences IRBs ARROW Help – provides an overview of navigating the online submission system, ARROW, as well as instructions for completing specific sections of the application
  10. Tips for Making IRB Review as Smooth as Possible – identifies important steps during each part of the IRB review process
  11. IRB Meeting Dates – lists upcoming IRB meeting dates for scheduling purposes (NOTE: IRB staff assign applications to a meeting 6 to 7 days prior to the meeting date)

Exempt Human Subjects Research

Some types of human subjects research qualifies for exemption, which means that when the research is federally supported that most of the federal requirements governing human subjects research do not apply to these studies. The UW-Madison also has identified some categories of human subjects research that is not federally supported or FDA-regulated or does not fall under VA regulations that qualifies for exemption. Exempt human subjects research still requires the Health Sciences IRBs to make a formal determination that the project qualifies as exempt human subjects research, either under federal or institutional requirements. Information about exemptions is below.

  1. Exempt Research – UW-Madison's policy and process for determining whether research involving human participants that is not FDA-regulated is exempt from applicable federal, state, and local regulations and the University's policies
  2. Exemption Guidance – identifies the categories of federally supported human subjects research that qualify for exemption
  3. Guidance on Institutional Exemption Categories under Campus Policy – identifies the categories of non-federally supported, non-VA, non-FDA human subjects research that qualify for exemption
  4. Identifiability Guidance – discusses what it means for data to be identifiable under the Common Rule (45 CFR 46) and the Health Insurance Portability and Accountability Act (HIPAA) and for a data set to be coded, de-identified, or anonymous
  5. FAQ:
    1. How can I tell if my study is exempt, and what categories of exemption can I choose from?
    2. Do I need to get consent for my exempt study?
    3. Can changes of protocol be submitted for exemptions?
    4. How does the 5-year expiration date affect my exemption?
    5. What are exemption renewals?

  6. Application Type Guidance – identifies the appropriate application to select in ARROW if a study qualifies for exemption
  7. Guidance on Research Involving Focus Groups – describes how focus group research may qualify for exemption
  8. What Happens After a New Application Is Submitted to the Health Sciences or Minimal Risk IRB: IRB Administrative Review and IRB Pre-Review
  9. Brief Summary of Investigator Responsibilities Related to the Protection of Human Subjects for Exempt Research – identifies some of the responsibilities that researchers assume when conducting exempt research involving human subjects

Before IRB Review: Scientific Review

The Health Sciences Human Research Protection Program requires scientific review of some non-exempt research studies before IRB review can proceed. Information about which studies require scientific review and the process are below.

  1. Evaluating the Scientific or Scholarly Merits of Proposed Research – describes the principles applied by UW–Madison IRBs in evaluating the scientific or scholarly merits of research protocols and how this evaluation is performed
  2. Scientific Review Requirement – outlines when a study is subject to scientific review
  3. What Happens After an Application Is Submitted to the Health Sciences or Minimal Risk IRB: Scientific Review – describes the different paths an application may take before the IRB review process begins
  4. Scientific Review: UW Comprehensive Cancer Center (UWCCC) Protocol Review Monitoring Committee (PRMC) – provides an general overview of the scientific review requirement for oncology studies
  5. Submitting the CRU Application in ARROW– describes the additional information needs to be provided for studies planning to use the Clinical Research Unit (CRU)
  6. Protocol Guidance – describes expected content of study protocols

IRB Review Policies and Procedures

All non-exempt Health Sciences IRBs applications undergo an administrative review and pre-review process by IRB staff. After a study is approved, changes, reportable events, and closure reports should be submitted to the IRB. For many studies, continuing review progress may also need to be submitted.

  1. Initial Review: Submission and Review Policy – describes the policies and procedures UW-Madison IRBs use for conducting initial reviews of research involving human participants
  2. Submitting the Application - Initial Review Flow Chart – provides an overview of the submission and review process for non-exempt initial reviews
    1. Application Type Guidance – describes the different types of applications that can be selected in ARROW
      1. Training Grant, Umbrella Grant or Core Grant – provides guidance on the application type of training grant, umbrella grant or core grant
      2. Protocol Development Activities (PDA) Guidance – describes the PDA application, which is used to facilitate the submission of grant application to the IRB for review when 1) research activities involving human subjects are planned for the future but have not been finalized (e.g. the grant incorporates a planning stage); 2) when an agency or organization requires IRB approval of the concept as part of the application for funding; and 3) when a research team has received a "just-in-time" requesting documentation of IRB approval
      3. Guidance for Analysis Centers – describes how the Health Sciences IRBs review research studies involving human subjects when the University of Wisconsin-Madison’s role for that study is limited to serving as an analysis center and what documents these research teams must submit for IRB review
      4. Guidance for Completing IRB Applications for Recruitment Registries or Repositories that Store Data and/or Tissue – outlines what research teams should consider when completing IRB applications for Registry or Repository studies in ARROW
      5. FAQ:
        1. When does something qualify as a Health Care Records Review Only application?
        2. What type of application do I need to submit to use samples/images/data for research purposes?

    2. Materials to Submit
      1. Guidance Regarding Types of Supporting Materials that Require IRB Review and Approval – provides common examples of materials that do or do not need to be submitted to the IRB for review
      2. Guidance for the Submission of Investigator's Drug Brochures (IDBs) and Package Inserts – identifies when an IDB vs. a package insert should be submitted to the IRB
      3. FAQ: Does the IRB require submission and review of Manuals for Procedures

    3. Administrative Review
      1. What Happens After a New Application Is Submitted to the Health Sciences or Minimal Risk IRB: IRB Administrative Review and IRB Pre-Review
      2. Guidance Regarding Federal Requirements for IRB Review of Grants – describes congruency reviews and when to submit grants to the IRB for review
      3. Completing the Funding Sections – describes how to complete the general funding page, the funded studies page and the funding information page
      4. FAQ: I have a new MSN#, but can't find it in the ARROW-RSP database (Funding Section Question 10.1), what do I do?

    4. Pre-Review
      1. What Happens After a New Application Is Submitted to the Health Sciences or Minimal Risk IRB: IRB Administrative Review and IRB Pre-Review
      2. Working with Reviewer Notes – provides guidance regarding how to respond to IRB requests via ARROW
      3. Cancer Center: Handling New Information During Pre-review – identifies when new information may be incorporated into the current submission, or may need to be submitted for separate review

  3. Criteria for IRB Approval
    1. Subject Selection and Recruitment
      1. Equitable Selection of Research Participants Guidance – describes what IRBs must evaluate when assessing whether the selection of research participants is equitable
      2. Subject Recruitment and Screening Procedures – provides links to guidance for recruitment and screening
      3. Mailed Recruitment Letter Guidance – outlines guidance on the information required by the IRB for studies that use recruitment letters, as well as the information that must be provided to potential subjects when mailed recruitment letters are used
      4. Telephone Recruitment and Screening Guidance – provides information required by the HS IRBs for studies that use telephone recruitment and/or screening, as well as the information that must be provided to potential subjects when telephone recruitment is used
      5. Use of Email for Research Purposes Guidance – guidance for study teams that will use email to communicate with human subjects during research studies
      6. Recruitment of Subjects with Status Relationship with the Research Team – addresses recruitment and enrollment of family members of the research team as well as students and employees (including fellows and residents) who may be in a status relationship with the investigators
      7. FAQ: What if my study team is not affiliated with a clinical department or unit but we need to recruit patients for our study?

    2. Vulnerable Populations
      1. Vulnerable Populations Guidance – outlines guidance on the inclusion of vulnerable populations in human subjects research, specifically the information that needs to be provided to the IRB when vulnerable populations will be subjects
      2. What should I consider before conducting research with vulnerable populations?
      3. Pregnant Women, Fetuses and Neonates: Regulations – provides an overview of federal regulations for studies involving these subjects
        1. Pregnancy Testing in Minor Research Subjects – describes issues to address in IRB applications when pregnancy tests will be performed in children participating in research
        2. MRIs and Pregnancy Status Guidance – presents guidelines for the method of determining pregnancy status as part of eligibility screening for studies in which (a) MRIs are performed for research rather than clinical purposes and (b) the study does not propose to enroll pregnant women

      4. Children: Regulations – provides an overview of the federal regulations governing research involving children
        1. Assent and Consent Requirements for Children – provides a guide for determining how a child's assent for research participation should be obtained and documented
        2. Research with Children and Prisoners – provides guidance for researchers with either of these populations

      5. Prisoners: Regulations – provides an overview of the federal regulations governing research involving prisoners

    3. Informed Consent
      1. Informed Consent Process, Elements, and Waivers – provides an overview of the regulatory requirements for informed consent
      2. Informed Consent – provides guidance and tools to help researchers develop processes and documents that are effective and meet regulatory requirements
      3. Informed Consent: Additional Model Language
        1. Audio Recordings, Video Recordings, Photographs Guidance – provides guidance about how to include these research activities in consent documents
        2. Clinically Relevant Information and Reporting Guidance – provides guidance for disclosing clinical relevant information to research subjects
        3. Radiation Risks Language Policy – provides guidance for studies that expose research subjects to radiation

      4. Oral Consent/Waiver of Consent Documentation – provides an overview of the regulatory basis for waivers of documentation of informed consent
        1. Waiver of Signed Consent – describes options and circumstances for requesting a waiver of signed consent

      5. Waiver of Informed Consent – describes federal requirements for waiving or altering informed consent
      6. Consent Process for Illiterate Research Participants – describes alternate consent process followed for subjects who are illiterate
      7. Consent Process for Legally Blind Research Participants – describes the recommended consent process for subjects who cannot read consent materials due to visual impairment
      8. Non-English or Limited English Speaking Research Participants Consent Process – provides guidelines for consent processes when subjects are not fluent in English

      9. Documenting Consent Electronically or for Remote Subjects Guidance – guidance on documenting consent obtained from subjects utilizing methods other than pen and paper

    4. Risks and Benefits
      1. What elements should I consider in my risk and benefit analysis? – describes what the IRB considers when analyzing the risks and benefits of proposed research or changes to research
      2. Data Safety Monitoring Plans (DSMP) Guidance – provides guidance on when a data safety monitoring plan is required and, if so, what it should include
      3. Adventitious Findings Guidance – provides guidance for handling incidental findings for research involving brain scans and a model for other research studies, such as those involving non-brain imaging and genetic testing
      4. Identification of Suicidality or Major Depression Guidance – describes follow-up requirements associated with the identification of suicidality or major depression
      5. Deception in Research Guidance – help researchers identify and plan for the use of deception in research
      6. Gene Transfer Studies Guidance – provides an overview of special submission, review, and reporting requirements for studies involving the deliberate transfer of DNA, or DNA or RNA derived from recombinant DNA (human gene transfer)
      7. Genetic Testing or Analysis – identifies guidelines to facilitate review of research involving genetic testing or collection of information that has genetic implications (e.g., pedigree publication, construction of family histories) and intended to assist both IRBs and research team
      8. Washout Period or Withholding/Postponing Standard Treatment Guidance – identifies guidelines to facilitate review of research involving genetic testing or collection of information that has genetic implications (e.g., pedigree publication, construction of family histories) and intended to assist both IRBs and research team

    5. Privacy and Confidentiality
      1. Privacy & Confidentiality – provides an overview of federal requirements related to privacy and confidentiality protections relevant to human subjects research
      2. Identifiability Guidance – discusses what it means for data to be identifiable under the Common Rule and the HIPAA and for a data set to be coded, de-identified, or anonymous
      3. What things should I consider to protect subjects' privacy and confidentiality of data?
      4. Guidance Regarding Research that Involves the Collection of Information about Illegal Substance or Alcohol Abuse – discusses what it means for data to be identifiable under the Common Rule and the HIPAA and for a data set to be coded, de-identified, or anonymous
      5. What is a Certificate of Confidentiality and do I need one for my research?
      6. Certificate of Confidentiality (CoC) Application Help – includes guidance for applying for CoCs when a study is not NIH funded

    6. Special Considerations/Other
      1. Understanding the NIH Genomic Data Sharing (GDS) Policy – provides an overview of the NIH requirement of the submission of large-scale genomic data, as well as relevant associated data, to an NIH-designated data repository
        1. FAQ: Do I need anything more than IRB approval for my NIH-funded study that involves large-scale genomic data analyses?

      2. Genetic Information and Nondiscrimination Act (GINA) Guidance – provides details about this federal law and how it affects human subjects research
      3. Working with or banking biospecimens , data, or images:
        1. Selecting the Review of Records/Data/Images Option on the Special Procedures Page
        2. Sending or Receiving Specimens/Data/Images Guidance – describes additional steps study teams may need to take if they wish to send specimens/data/images to or receive them from any site or personnel external to the UW-Madison/UWHC/Madison VA for a study that is currently approved by an HS IRB
        3. What are Material Transfer Agreements (MTAs) and when do I need one?
        4. What if samples/images/data are coming from an outside source?
        5. Recruitment Registry, Data Repository, and Tissue Repository Guidance – classifies various research models for storing data, specimens and images for future use and IRB review requirements
        6. Registry-Repository Overview Table – provides examples of scenarios in which study teams are creating, maintaining, sharing and/or using data, images, or tissues and the subsequent IRB requirements for these various scenarios

  4. Personnel Changes
    1. Key Personnel Guidance – identifies guidelines to facilitate review of research involving genetic testing or collection of information that has genetic implications (e.g., pedigree publication, construction of family histories) and intended to assist both IRBs and research team
    2. Personnel Change Guidance – provides guidance regarding requirements for informing the IRBs of addition and removal of study team members as well as changes in study team member roles
    3. Processing the Departure of a Principal Investigator Guidance – describes available options and next steps when a Principal Investigator (PI) on a Health Sciences Institutional Review Boards (HS-IRBs)-approved human subjects research study departs from the University of Wisconsin-Madison (UW-Madison)
      1. FAQ:
        1. Who may serve as a principal investigator on a protocol?
        2. How do you change the responsible principal investigator (PI)?

    4. How to Remove Study Team Members – describes the steps to follow to remove study team members in ARROW
    5. Listing Study Team Members in the Application – indicates who should be listed in an IRB application

  5. Expedited and Full Changes
    1. Guidance on Presenting Changes of Protocol to IRB – helps study teams present clear and complete descriptions of changes of protocol
    2. How to Complete Changes of Protocol – identifies the steps to follow to submit a change of protocol in ARROW to the IRB
    3. Timeframe for Submission of Changes of Protocol to the IRB – defines the timeframes to ensure prompt reporting of changes of protocol to the IRB
    4. Cancer Center: Submitting Changes with a 90-Day Review Deadline – provides tips for submitting changes of protocol for cooperative group studies that require IRB review and approval within 90 days
    5. Expedited Change of Protocol Guidance – provides guidance regarding what constitutes a minor change that can be reviewed under expedited procedures
    6. Re-Consenting Subjects Guidance – describes how to provide significant new findings and consent form revisions to research subjects
    7. FAQ: I have a change of protocol and a continuing review coming up. Which should I submit first?

  6. Continuing Reviews
    1. Continuing Review Submission Guidance – identifies the required submission timelines for continuing reviews
    2. Continuing Review: Submission and Review – describes the policies and procedures UW–Madison IRBs use for conducting continuing reviews of research involving human participants
    3. Continuing Review: UW-Madison Purview Enrollment Guidance – provides guidance on how to answer the subject enrollment questions in ARROW

  7. Reportable Events
    1. Events Requiring Reporting to the IRB – provides information regarding reporting requirements for each type of reportable events (unanticipated problems, noncompliance, new information)
    2. Unanticipated Problems and Serious Adverse Events – provides an overview of the federal requirements
    3. Reporting Requirements for Studies Involving Other Investigational Agents, Including Investigational Drugs – identifies the steps they need to take to report events for studies involving investigational drugs
    4. Reporting Requirements for Studies Involving Investigational Devices – identifies the steps study teams need to take to report events for studies involving investigational devices
    5. Health Sciences IRBs Protocol Exceptions and Deviations Guidance – describes cases when eligibility criteria and protocol deviations generally do not need to be reported to the IRB because they are not expected to adversely affect subject safety or data integrity
    6. Changes to Eliminate Immediate Hazards to Subjects Guidance – identifies the circumstances under which a change of protocol to a non-exempt, approved study can be implemented prior to IRB approval and the reporting requirements when these changes occur
    7. New Information Reporting Guidance – what the IRB considers to constitute "new information" and when a new information report must be submitted to the IRB for review
    8. Guidance Regarding Drug Shortages and Substitutions that Occur During the Conduct of Research Studies – assists research teams in identifying the steps they need to take in relation to the IRB should a shortage of a drug used within a research study occur
    9. Noncompliance – defines noncompliance that must be reported, specifies reporting deadlines, and describes how the reports will be evaluated and determinations made
    10. Guidance on Presenting Noncompliance Reports to the IRB – describes the process for study teams to complete a noncompliance report for submission to a Health Sciences IRB in ARROW
    11. FAQ:
      1. I received an Action Letter/CAEPR or a revised IDB from the Sponsor. Does this need to be reported to the IRB?
      2. How should investigators handle subject complaints?
      3. Who can I contact if I have concerns about human research protections at UW-Madison?

  8. Closures
    1. Protocol Closure Guidance – describes when and how to close studies
    2. How to Close Studies – identifies the steps to follow to submit a closure report in ARROW to the IRB
    3. FAQ: What documents related to IRB review should be maintained by the study team as part of the research record?

IRB Jurisdiction and Collaborative (Multi-site) Research

If your project or study involves collaboration with any sites and/or personnel outside the UW-Madison/UW Health/Madison VA then it is considered to be multisite research and IRB reliance issues will need to be addressed.

  1. Understanding Engagement in Research – provides a link to the federal guidance the UW follows to determine whether an activity engages an individual in human subjects research, which can require IRB oversight
  2. International Research Guidance – outlines considerations for researchers submitting IRB applications that involve sites outside the United States
  3. Working with Community Partners – describes when community partners are engaged in human subjects research and thus require IRB oversight for their activities
  4. IRB Application Guidance for Multisite and Collaborative Research Studies – describes how to prepare an IRB application for a multisite or collaborative research study (i.e., a study involving sites or personnel external to UW-Madison, UW Health, or the Madison VA); includes community-based research
  5. Sending or Receiving Specimens/Data/Images Guidance – describes additional steps study teams may need to take if they wish to send specimens/data/images to or receive them from any site or personnel external to the UW-Madison/UWHC/Madison VA for a study that is currently approved by the HS-IRBs
    1. FAQ:
      1. What are Material Transfer Agreements (MTAs) and when do I need one?
      2. What if samples/images/data are coming from an outside source?

  6. Collaborative Research and Single IRB Review Basics – provides an overview of the requirements for collaborative research and using single IRB review
    1. Overview of IRB Requirements for Multisite and Collaborative Research – defines multi-site research and describes additional requirements for such studies
    2. Single IRB Review FAQS – defines multi-site research and describes additional requirements for such studies
    3. IRB Reliance Terms and Definitions – a list of common IRB reliance terms and definitions
    4. Research and Sponsored Programs (RSP) Release of Grant Funds When Studies Are Ceded to Another Institution's IRB for Review and Approval – discusses processes for release of funding when an external IRB is used
    5. FAQ: Frequently Asked Questions about Exemptions, Not Human Subjects Research Projects, and Collaborative Research Requirements

  7. Single IRB Review Partners – describes a variety of IRB reliance partnerships that UW has entered into
    1. Guidance on the the UnityPoint Health - Meriter & UW IRB Partnership – provides guidance about research that involves patients, samples, or records from UnityPoint Health/Meriter Hospital
    2. Greater Plains Cooperative (GPC) Reliance Fact Sheet – describes GPC, a network of ten medical centers focused on improving healthcare delivery through ongoing learning, adoption of evidence-based practices, and active research dissemination
    3. Midwest Area Research Consortium for Health (MARCH) Reliance Fact Sheet – describes MARCH, a research partnership among 7 Midwest-based institutions
    4. Midwest Pediatric Surgical Consortium (MWPSC) Fact Sheet – describes MWPSC, a research partnership involving pediatric surgeons at 10 children’s hospitals
    5. StrokeNet Reliance Fact Sheet – describes StrokeNet, a research network focused on stroke prevention, treatment, and recovery that relies on a central IRB (at the University of Cincinnati) to provide IRB oversight for its studies

  8. When the UW-Madison Serves as the Review IRB for Other Institutions and Researchers
    1. HS-IRBs Guidelines for Serving as IRB of Record – identifies when the UW-Madison can accept oversight for external research personnel
    2. How to Submit an IRB of Record Request – identifies the steps to follow to request that the UW-Madison to serve as the IRB for personnel not at the UW-Madison, Madison VA, or UW Health
    3. How to Add a New Site to an Approved Study – provides an overview of the most common types of site additions
    4. NetID and Training Requirements for External Personnel When the Health Sciences IRBs Are IRB of Record – outlines the netID and training requirements for external personnel when the Health Sciences IRBs (HS IRBs) will serve as their IRB of record for a study
    5. Letters of Support for External Sites – when such letters may be needed, who should provide the letter, and suggestions for template language to include in the letter

  9. When the UW-Madison Cedes Review to External IRBs
    1. Guidelines for Ceding IRB Review to an External IRB – describes when studies likely to be ceded to an external IRB
    2. Eligibility – describes what research is eligible for review by an independent IRB
      1. FAQ: Should my industry sponsored research study be submitted to a commercial IRB?

    3. How to Submit a Request to Cede IRB Review to an External IRB – identifies the steps to follow to request that the UW-Madison to cede oversight to an external IRB
    4. When to Submit Changes and Reportable Events for Ceded Studies – this document describes how to prepare these consent and authorization documents, which should be submitted with any request to cede IRB review to an external IRB
    5. Study Team Responsibilities When IRB Oversight Is Ceded to an External IRB – highlights key responsibilities when the UW-Madison cedes IRB oversight to an external IRB
    6. Preparing Consent and Authorization Documents When Relying on an External IRB Review – describes how to prepare these consent and authorization documents, which should be submitted with any request to cede IRB review to an external IRB

Other Laws and Regulations That May Apply

In addition to the Common Rule and the FDA regulations, the Health Sciences IRBs are responsible for reviewing human subjects research in accordance with other applicable federal regulations, state laws, and local policies. This section outlines some of the common additional regulations and laws that are addressed in the IRB review.

  1. Federal Regulations
    1. FDA
      1. Review of FDA-Regulated Research Policy – identifies when and how the Health Sciences IRBs apply FDA regulations
      2. Control of Test Articles Used in Research Policy – describes the policy researchers must follow regarding the control of test articles that fall under US Food and Drug Administration (FDA) regulations and how the Health Sciences IRBs assess the control of test articles used in research
      3. Devices Implanted or Applied to Subjects Guidance – helps identify when a device constitutes a medical device and falls under FDA regulations
      4. Guidance on FDA Regulation of Medical Mobile Apps – includes important definitions and provides examples of mobile apps that are not medical devices, that are medical devices but will not be regulated by the FDA, and that are medical devices and will be regulated by the FDA
      5. Investigational Software Guidance – provides an overview of the information that study teams should include in protocol documents and ARROW applications for studies involving investigational software, to enable the Health Sciences IRB to evaluate the regulatory status of the software
      6. Guidance on Requirements by the FDA for the Investigator as a Sponsor – provides an overview of the responsibilities an investigator who holds an IND or IDE assumes under FDA Regulations
      7. Humanitarian Use Device Policy – describes the policies the UW-Madison Health Sciences IRB follows for conducting reviews of applications involving HUDs
      8. Emergency Use of Test Articles and of Humanitarian Use Devices Policy – describes the policy the UW-Madison Health Sciences IRB follows for the emergency use of test articles and the emergency use of HUDs
      9. Emergency, One-Time-Use – provides guidance and templates for emergency or one-time-use requests for test articles

    2. VA Research
      1. VA Research: Health Sciences IRBs Policy for IRB Review of Human Subjects Research that Falls Under VA Purview – documents requirements for research conducted under the purview of the Madison VA
      2. VA Research - Overview – identifies when research falls under Madison VA purview
      3. VA Research - Policy and Guidance – describes what is required when research occurs at the UW and the Madison VA as well as VA training requirements
      4. Endorsement and Approval of VA Research – provides guidance on obtaining VA R&D endorsement and approval of VA research
      5. Outline of the Endorsement Process – describes the requirement for VA R&D Committee endorsement prior to final IRB approval of non-exempt human subjects research
      6. VA Informed Consent Guidance – provides an overview of key VA requirements related to informed consent
      7. VA Template Documents – provides links to VA consent and authorization form templates

    3. FERPA
      1. Family Education Rights and Privacy Act (FERPA) Guidance – assists investigators with identifying when FERPA applies to human subjects research and when investigators must obtain consent for use of student education records for research purposes

    4. HIPAA
      1. Overview of Key Research Concepts under the HIPAA Privacy Rule – provides an overview of key concepts for research related to the HIPAA Privacy Rule
      2. HIPAA Authorization Guidance – provides links to campus policies related to research requirements related to the HIPAA Privacy Rule

    5. Other Federal Requirements
      1. Requirements for Registering with Clinicaltrials.gov – provides an overview of registration requirements

  2. State Law
    1. Issues in Human Subjects Research When State Law May Apply – describes how the UW–Madison IRBs assure compliance with state laws when reviewing research involving human subjects
    2. Which State Law(s) should be considered for research? – provides a link to guidance about which State laws may need to be applied to a human subjects research study
    3. Guidance for X-Ray Radiation Use in Research Studies for Non-Healing Arts Purposes – describes when Wisconsin Department of Health Services (DHS) approval is required
    4. Communicable Disease Guidance – describes issues related to collecting information about participants’ communicable disease status and the information study teams should provide to the IRB and to study participants when a study collects this information
    5. HIV Testing in Research Guidance – provides guidance for researchers on testing and reporting for HIV within the context of a research study, or for use of HIV test results for research purposes
    6. What if my research involves the use of fetal tissue? – provides a link to the campus policy covering research involving human fetal tissue

  3. Local Policies
    1. My study involves working with students, parents, or staff at K-12 schools. Are there any special requirements that I need to be aware of related to my IRB submission?



Keywords:   Doc ID:77306
Owner:Faye L.Group:Health Sciences IRBs
Created:2017-10-11 14:39 CDTUpdated:2018-05-31 11:12 CDT
Sites:Health Sciences IRBs
Feedback:  0   0