Protection of Human Subjects Downloads
OPHS-IRB
- Protocol Synopsis for Research Project Involving Human Subjects(DOCX)
- Short Form to Consent to Participate in a Research Project(DOC)
- Application for Waiver of HIPAA Authorization for Research Purposes(DOC)
- IRB Progress Report(DOC)
- Registering a Clinical Trial 5-2010(DOC)
- HIPAA Compliance Information(DOC)
- Biospecimens and Related Behavioral Health Data Protocol Synopsis 9-16-2010(DOC)
- Protocol Synopsis for Research Involving Surveys 9-2010(DOC)
- Sample Study Cover Letter(DOC)
- Research Statement(DOC)
- Spanish Short Form 9-2009 (DOC)
- Telephone Recruitment for a Survey or Interview Sample Phone/Voicemail/Call Back Scripts(DOC)
- Focus Group Instructional Guidelines from an IRB Perspective(DOC)
- New Research Study Protocol Review Form(DOC)
- Office for the Protection of Human Subjects / Institutional Review Board(DOC)
- Request for Review of Exempt Category Research Project 2-2002(DOC)
- Waiver of Documentation of Informed Consent Form A : 9-2009(DOC)
- Protocol Synopsis for Research Involving Materials (Data, Documents, Records) That Have Already Been Collected(DOC)
- Recruitment Materials – Advertisements(PDF)
- Cover Letter Sample(PDF)
- Informed Consent Authorization to Participate in a Research Project(PDF)
- Combined Lay Summary / Informed Consent(PDF)
- IRB Progress Report (pdf)(PDF)
- Request for Review of Exempt Category Research Project 10-2006(PDF)
- Guidance and Procedures for Investigators – Research Using Human Biological Materials 10-2009 (PDF)
- Consenting Non-English Speaking Subjects Using a Short Form(PDF)
- Guidance and Procedures for Investigators 1-2010(PDF)
- Informed Consent Authorization to Participate in a Research Project(PDF)
- Research Consent Form(PDF)
- New Research Study Protocol Review Form 6-2006(PDF)
- Guidance for Industry E6 Good Clinical Practice : Consolidated Guidance 4-1996(PDF)
- New Research Study Protocol Review Form 6-2006(PDF)
- Permission to Participate in Research and Use or Disclose Your Protected Health Information(PDF)
- Guidance and Procedures for Investigators 9-2009(PDF)
- Protocol Synopsis for Research Project Involving Human Subjects 5-2006(PDF)
- Directory of Protocol Deviation & Violation Codes V1.2 (PDF)
- Research Subject Information and Consent Form(PDF)
- Request for Review of Exempt Category Research Project 10-2006(PDF)
- Federalwide Assurance for the Protection of Human Subjects(PDF)
- Instructions for Flesch-Kincaid(PDF)
- Research Consent Form Public Health(PDF)
- Informed Consent Authorization to Participate in a Research Project Biomedical(PDF)
- Cover Letter Sample(PDF)
- Sample Informed Consent Authorization to Participate in a Research Project(PDF)
- Combined Lay Summary / Informed Consent Physiology(PDF)
- Permission to Participate in Research and Use or Disclose Your Protected Health Information 11-13-2008(PDF)
- Research Subject Information and Consent Form(PDF)
- HIPAA Compliance Information(PDF)
- Institutional Review Board Members Federalwide Assurance Roster 00005755 June 2014 (PDF)
- Guidance and Procedures for Investigators Reporting Protocol Violations(PDF)
- Language to be Incorporated into a Non-Clinical Consent Document(PDF)
- IRB Submission of Research(PDF)
- Instructions for CITI Login and Registration(PDF)
- IRB-OPHS Conflict of Interest Policy and Statement 5-18-2006(PDF)
- HIPAA Compliance Information(PDF)
- Is Your Project Human Subjects Research : A Guide for Investigators(PDF)
- Brian A Gladue, PhD(PDF)
- Institutional Review Board Offsite 02-2014(PDF)
- Biographical Sketch – Gladue(PDF)
- Waiver of Informed Consent – Form B 9-2009(PDF)
- Reporting Protocol Violations Form (pdf)(PDF)
- Consent Document Translation Affirmation Form(PDF)
- Curriculum Vitae Gladue 2009(PDF)
- Guidance and Procedures for Investigators Re-Contacting Subjects from Existing Research Studies 8-2009(PDF)
- Request for Review of Exempt Category Research Project 2-2012(PDF)
- Guidance on On-Site Serious Adverse Event Reporting(PDF)
- Serious Adverse Event Report Onsite 02-2014(PDF)
- HIPAA Compliance Data Use Agreement(PDF)
- Request for Review of Expedited Category Research Project 4-2009(PDF)
- HIPAA Compliance Data Use Agreement – External Use Only(PDF)
- Chart Review 01-06-2014(DOCX)
- When minors become adults during a research study(PDF)
- Data Storage and Security Recommended Language 10-2012(PDF)
- Application for Change of Key Personnel 2-2013(DOCX)
- Standard Operating Principles and Procedures 8-12-2014(DOCX)
- Standard Operating Principles and Procedures 8-12-2014(PDF)
- IRB Review Schedule FY 2013-2014(PDF)
- IRB Review Schedule FY 2014-2015(PDF)
- Expedited Review Application(DOC)
- Protocol Reporting Form 02-2014(DOC)
- Waiver of Documentation of Informed Consent Form A : 9-2009(PDF)
- IORG(PDF)
- Case Study Research – Protocol Application(DOCX)
- Existing Database Exempt Form – Jan 2014(PDF)
- Existing Database EXEMPT Form Jan 2014(DOCX)
- HIPAA Research Authorization Aug 2014_fillable-Word version(DOCX)