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  • 1 KC IRB Crosswalk: Completing the IRB Application (implemented 08.29.2019) Back to Top

    Guidance for Research Involving Human Subjects

    KC IRB Crosswalk: Table of Contents This crosswalk is meant as a tool for investigators, HSO staff, and IRB members and provides information about the KC IRB application process, specifically the questionnaire functionality. This information is meant as a tool only and should be considered guidance. Please contact the HSO if you are unsure how to answer a specific question.

    • Using the Crosswalk • Important Topics for Full Board & Expedited Studies

    Use the links in the table below to view the questionnaires and review Tips & Tricks for answering specific questions.

    Full Board/Expedited Questionnaires Initial Submission & Review

    Full Board/Expedited Questionnaires Post-Approval

    Exempt Questionnaires Questionnaires for Additional Types of Research

    • Conflicts of Interest • A – Level of Review Assessment • B – Lay Summary & Research Design • C – Sites & Collaborations • D – Recruitment Methods • E – Risks Benefits, Protections • F – Data Safety Monitoring • G1 – Children • G2 – Individuals Lacking Consent Capacity • G3 – Pregnant Women/Fetuses/Neonates • G4 - Prisoners • G5 – Transnational Research • H – Informed Consent Process • J – Child Assent & Parental Consent Process • K – HIPAA • L – VA Research • M – ClinicalTrials.gov

    • Amendment • Renewal:

    o Open to Enrollment – Enrollment continues; Closed to Enrollment – Research interventions continue or Clinical Follow-up Only Path

    o Open to Enrollment - No subjects consented to date Path

    o Data Analysis Only Path • Reportable Event (FYI) • Study Closure/Closeout Report

    • Conflicts of Interest • Exempt Research

    • Reliance Request • Humanitarian Use Device • Research Not Subject to Human Subjects

    Regulations

  • 2 KC IRB Crosswalk: Completing the IRB Application (implemented 08.29.2019) Back to Top

    Using the Crosswalk The crosswalk consists of two parts: Important Topics – provides a summary of the information you should have available when completing your application for a full Board or Expedited study. Description of each topic includes:

    o Information necessary for…: a short explanation of why the information is necessary for the IRB o Old HSO Forms: a reference to the HSO form where the information was previously requested o New Location: reference to the KC IRB tab or questionnaire where the information is now requested o References: a list of additional educational resources about the topic

    Questionnaires – viewable copy of the individual questionnaires available in KC IRB including hierarchy and logic and information about each question therein.

    The numbering system provided in the viewable questionnaires is included only for ease of understanding and readability, and to demonstrate the hierarchy of the questions. The numbers do NOT correspond to KC IRB.

    The Question ID corresponds directly to the question ID in KC IRB and can be used to identify the specific question during discussion, pre-review, and IRB review.

    The Appropriate Answer Types column provides information about the type of answer that KC IRB expects. Questions generally fall into one of the following categories:

    • Free Text • Y/N – indicates a Yes/No question • Multiple Choice – The crosswalk includes the available options and

    how many answers can be chosen. • Dropdown/List– The crosswalk includes the available options.

    The Tips & Tricks column provides suggestions from staff and IRB members regarding appropriate answers and regulatory expectations.

  • 3 KC IRB Crosswalk: Completing the IRB Application (implemented 08.29.2019) Back to Top

    Important Topics for Full Board & Expedited Studies The following is a list of items that you should be ready to describe in your IRB application. Description of each topic includes:

    • Information necessary for…: a short explanation of why the information is necessary for the IRB • Old HSO Forms: a reference to the HSO form where the information was previously requested • New Location: reference to the KC IRB tab or questionnaire where the information is now requested • References: a list of additional educational resources about the topic

    Topic Information necessary for…. Retired HSO Forms New Location References

    Please note that additional SOPs and guidance documents are also available on the HSO website

    Level of Review Identification of regulatory requirements • Protocol tab > Required Fields for Saving Document • KC IRB Questionnaire A – Level of Review Assessment

    HSO guidance: • Expedited Research

    Title Study identification Protocol tab > Required Fields for Saving Document

    Principal Investigator Study identification Protocol tab > Required Fields for Saving Document

    Funding Identification of additional requirements specific to funding sources

    • Protocol tab > Funding Sources panel • KC IRB Questionnaire B – Lay Summary & Research

    Design

    Study Description (objectives, hypothesis)

    • Study meets the definition of research • IRB reviewer understanding of the study

    SSS, Section I KC IRB Questionnaire B – Lay Summary & Research Design

    Number of Subjects • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)

    SSS, Section V Protocol tab

    Performance Sites • Selection of subjects is equitable (45 CFR 46, Criteria for Approval #3)

    • VA regulations for human subjects research

    • SSS, Section IV • Request Form – Transnational

    Research

    • Protocol tab > Organizations Panel • KC IRB Questionnaire C – Sites & Collaborations • KC IRB Questionnaire G5– Transnational Research • KC IRB Questionnaire L – VA Research

    HSO Guidance: • Research in International

    Settings

    Special Populations • Selection of subjects is equitable (45 CFR 46, Criteria for Approval #3)

    • Additional safeguards have been included to protect the rights and welfare of any subjects likely to be vulnerable to coercion or undue influence (45 CFR 46).

    • 45 CFR 46, Subpart B – Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research

    • SSS, Section V • Request Form for the Inclusion

    of Children in Research • Request Form for the Inclusion

    of Cognitively Impaired Individuals in Research

    • Request Form for the Inclusion of Pregnant Women, Human

    • Protocol tab > Participant Types panel • KC IRB Questionnaire G1 – Children • KC IRB Questionnaire G2 – Individuals Lacking Consent

    Capacity • KC IRB Questionnaire G3 – Pregnant Women, Neonates,

    Fetuses • KC IRB Questionnaire G4 – Prisoners

    IU HRPP Policies: • Adult Individuals Lacking

    Consent Capacity in Research • Children in Research • Pregnant Women, Fetuses,

    Neonates in Research • Prisoners in Research HSO Guidance:

    https://research.iu.edu/compliance/human-subjects/guidance/index.html https://research.iu.edu/compliance/human-subjects/guidance/expedited.html https://research.iu.edu/compliance/human-subjects/guidance/transnational.html https://research.iu.edu/compliance/human-subjects/guidance/transnational.html https://research.iu.edu/policies/human-subjects-irb.html

  • 4 KC IRB Crosswalk: Completing the IRB Application (implemented 08.29.2019) Back to Top

    • 45 CFR 46, Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

    • 45 CFR 46, Subpart D – Additional Protections for Children Involved as Subjects in Research

    Fetuses, and Neonates in Research

    • Request Form for the Inclusion of Prisoners in Research

    • Research with Adult Individuals Lacking Consent Capacity

    • Conducting Research with Children

    • Research Enrolling Prisoners as Subjects

    • Recruiting Students as Research Subjects

    • Research in International Settings

    Inclusion/Exclusion • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)

    • Risk to subjects are reasonable in relation to anticipated benefits (45 CFR 46, Criteria for Approval #2)

    • Selection of subjects is equitable (45 CFR 46, Criteria for Approval #3)

    SSS, Section V KC IRB Questionnaire B – Lay Summary & Research Design

    Study Procedures • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)

    SSS, Section VII KC IRB Questionnaire B – Lay Summary & Research Design

    Risks & Benefit Information • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)

    • Risk to subjects are reasonable in relation to anticipated benefits (45 CFR 46, Criteria for Approval #2)

    SSS, Section VIII KC IRB Questionnaire E – Risks, Benefits, Protections

    Protection Procedures • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)

    • Risk to subjects are reasonable in relation to anticipated benefits (45 CFR 46, Criteria for Approval #2)