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List of Paper Forms
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New Study - N/A.
Please note: all new study submissions must go through the eIRB system. This list applies to
existing paper studies. |
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Amendments/Modifications |
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Modification Request Form |
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Reportable Events |
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Protocol Deviation Report Form |
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Reportable Event Form (ver. 8-27-09) |
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VA Reportable Event Form (ver. 8-27-09) |
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Continuing Review/Reapproval/Renewal |
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Biomedical Renewal Form |
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Social/Humanist/Behavioral Renewal Form |
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Please include consent/assent forms, HIPAA
authorization forms, and revocation letters (where applicable) that were approved
at the last renewal. If you are proposing changes, please submit the version you
plan to use in the next approval period.
If your study has a HIPAA authorization form, please be sure to use the most
updated form. If your HIPAA authorization form indicates that a revocation letter
will be given to study subjects, please include that with your renewal. |
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HIPAA Privacy Rule Documents |
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HIPAA Patient Authorization Template – for use as separate document |
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Request for Approval of HIPAA Privacy Rule Waiver/Alteration of Patient Authorization (ver. 7/10/2008) |
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Grady Memorial Hospital |
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Research Oversight Application |
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Close-Outs |
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Close-out Form |
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Please submit by only one method! How to deliver your paper forms:
In person, by US, express, or campus mail to: Emory IRB, 1599 Clifton Road, 5
East, Atlanta GA 30322. Mail stop 1599-001-1AV
Fax to (404) 727-1358
Email: irb@emory.edu
Remember: submit just once by only one method. Thank you. |
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Consent Toolkit
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Emory Consent Templates |
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Biomedical Consent Template (ver. 8-27-09) |
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Biomedical Paper Consent Template (ver. 8-27-09) |
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Spanish Version of Consent Template (ver. 2-13-09) |
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Social and Behavioral Consent Template (ver. 8-27-09) |
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Emory/WIRB Consent Template (ver. 8-27-09) |
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Assent Template (ver. 8-27-09) |
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For Grady, CHOA, and VA templates, see below |
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Emory HIPAA Authorization, and Revocation Templates |
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HIPAA Patient Authorization Template |
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Revocation Letter Template |
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Spanish Version of the HIPAA Authorization Template (ver. 9-9-09) |
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Grady Consent Templates |
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Grady Consent Template (ver. 8-27-09) |
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CHOA Consent Templates |
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CHOA Consent Template (ver. 8-27-2009) |
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VA Consent Templates |
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VA Consent Template and Guidance (eIRB) |
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VA Consent Template and Guidance (Paper) |
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Worksheets for Waiver or Alteration of Consent, Documentation of Consent, and HIPAA Authorization |
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Waiver of One or More Elements of Informed Consent Worksheet (ver. 10-1-09) |
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Waiver of Documentation (signature) Requirement of Informed Consent Worksheet (ver. 10-1-09) |
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Request for Approval of HIPAA Privacy Rule Waiver/Alteration of Patient Authorization (ver. 7-10-08) |
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Consent Instructions and Guidance |
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Consent Template Instructions and Guidance for Sociobehavioral Studies |
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Document Stamping Template and Guidance |
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FDA: A Guide to Informed Consent |
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Informed Consent Basic Elements |
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Informed Consent Guidelines |
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Office for Human Research Protections Tips on Informed Consent |
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Sample Social and Behavioral Consent Forms |
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Simplification Guide to Medical Terms (Lay Language) |
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Other Researcher Tools
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General IRB Information |
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Membership Letter |
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Compliance Letter |
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Federalwide Assurance |
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Initial Submission Guidance and Documents |
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OHRP Human Subject Decision Charts |
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Sociobehavioral Studies: IRB Staff Checklist |
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Lay Summary Guidance |
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Biomedical |
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Sociobehavioral |
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Protocol Format |
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Biomedical |
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Sociobehavioral |
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Additional Study Documents |
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Advertising and Recruitment Guides & Information |
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Genetic Research Guidance |
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Guidance on Certificates of Confidentiality for Emory Researchers |
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Questionnaires, Rating Scales, Interviews |
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Researcher Links |
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Site Permission Letter |
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Data and Safety Monitoring Boards and Plans Guidance |
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DSMB/DSMP |
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NIH Policy on Data and Safety Monitoring |
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Drugs and Devices |
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Investigational Drugs and Devices |
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Reportable Events |
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External Event Review Guide for Researchers |
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Guidance for Reporting External Events |
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Noncompliance and Unanticipated Problems Guidance (ver. 8-31-09) |
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Reportable Events Guidelines (ver. 9-09-09) |
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Sample Summary of Events at Continuing Review |
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VA Reportable Event Form (ver. 8-27-09) |
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VA Reporting Requirements |
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Ancillary Review |
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Biosafety Review Guidelines |
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Conflict of Interest Guidance for Emory University |
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Grady Memorial Hospital Research Oversight (ROC) Application |
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Grady Memorial Hospital Research Oversight Committee (ROC) Overview and Guidelines |
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Vulnerable Populations Worksheets |
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Pregnant Women, Fetuses, and Neonates |
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Prisoner Subjects |
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Minor/Children Subjects Worksheets |
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Guidance Sheet for Cognitively Impaired |
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Research Involving Individuals with Questionable Capacity to Consent (NIH) |
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