Human Subjects (IRB)> Forms
February 2004 IRB Update
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ATTENTION RESEARCHERS AND RESEARCH STAFF
Important instructions for completing and submitting paperwork to the IRB Office .
1) You must download IRB Forms prior to each submission.
2) All paperwork must be typed.
3) All submissions must be signed by the principal investigator.
4) Attach a copy of all supporting documents (i.e., protocol, grant, consent/permission/assent forms, supplemental forms, recruitment materials, etc.).
5) Paperwork should be complete and correct at time of submission.
6) All original documents must be single sided. Please do not use staples. Use clips and rubber bands.
Failure to complete the forms and submission properly may result in your submission being returned to you!
NOTE: In order to be in compliance with Federal Regulations and to meet the standards for accreditation, we will constantly be revising our forms and may add additional forms.
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IRB Tips
Helpful IRB Tips
Form Updates
IRB Forms Update Page
IRB Initial Submission Forms
Initial Submission Instructions ( last update 10/16/07 )
Research Protocol Format (Use for investigator-initiated studies)
Request for Review of Expedited Research ( last updated 4/24/08 ) (original copy only)
Request for Review of Full Board Research (last updated 5/20/08)(30 COPIES REQUIRED)
Request for Exemption from UTMB IRB Review ( last updated 6/20/08 ) (original copy only)
Additional Collaborator Sheet for Initial Submissions (10/9/07)
Sample Consent/Permission/Assent Form
Sample Research Consent Form (last updated 7/8/08)
Sample HUD Consent Form (last updated 1/17/08)
Sample Consent Form for Tissue or Data Repository ( last updated 1/17/08 )
Parental Permission Form for Child to Participate in Research (last updated 7/8/08 )
Child Assent Form (last updated 9/07 )
Request for Waiver or Alteration of Informed Consent Requirements ( last updated 11/04 )
Notice of Research Participation Form
Depending on the type of research in which the subject is participating, it may be in the best interest of the subject’s safety or well-being to file a copy of the signed informed consent document in the subject’s medical record.
Notice of Research Participation Form
Vulnerable Population (Supplemental) Forms
Application for Inclusion of Pregnant Women as Research Subjects ( last updated 11/04 )
Application for Inclusion of Fetuses or Neonates as Research Subjects ( last updated 11/04 )
Application for Inclusion of Prisoners as Research Subjects ( last updated 10/04 )
Application for Inclusion of Children as Research Subjects ( last updated 12/04 )
Application for Inclusion of Mentally Incapacitated Subjects( last updated 1/17/08 )
Amendment/Modification Forms
Request for Protocol/Consent Modifications ( last updated 4/22/08 )
Request for Change of Principal Investigator ( last updated 09/07 )
Request for Change of Study Personnel ( last updated 5/16/08 )
Additional Collaborator Sheet for Modifications ( 5/16/08 )
Miscellaneous Form ( last updated 5/20/08 )
Adverse Events/Unanticipated Problem/Protocol Deviations
Internal/External Adverse Event and Unanticipated Problem Reporting Form ( last updated
01/17/08)
Protocol Deviation Report Form ( last updated 1/17/08 )
Study Closure Form
Request for Study Closure ( last updated 4/3/08 )
Additional Forms
Request for Establishment of a Tissue/Data Repository ( last updated 11/04 )
Clinical Trial and Multicenter Study Form ( last updated 04/07 )
IND Application Exemption Checklist
Request for device Research without an IDE ( NEW - 3/6/08 )
Investigator Request for Document Copy from IRB File ( last updated 04/07 )
Translator Declaration ( last revised 10/10/07 )
PowerPoint Presentations
History of Research Ethics and Regulations ( 11/99 )
IRB Structure and Function and Informed Consent Requirements ( 11/99 )
Send mail to the Institutional Review Board with questions or comments about this web site.
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