Responsible Conduct of Research - Forms

INITIAL APPLICATION FOR HUMAN SUBJECT RESEARCH:

NEW PROTOCOL APPLICATION

• Human Use Protocol Application
• Recruitment Advertisement
• Exempt Protocol Guidance and Application

HIPAA REQUIREMENTS:

• HIPAA Authorization
• Data Use Agreement
• HIPAA Waiver Request

INFORMED CONSENT FORM (ICF):

• Clinical Trial Studies ICF
• Minimal Risk Studies ICF
• IND Drug Model Language
• Tissue/Biological Specimen Banking ICF
• OHRP Decision Chart 10-ICF Altered/Waiver
• OHRP Decision Chart 11-CF Altered/Waiver
• Assent Information Sheet

CONFLICT OF INTEREST DISCLOSURE:

• Investigators’ Conflict of Interest Disclosure

IMPACT STATEMENTS (WRNMMC & WRAMC only Obtain Site Specific Templates in Right Frame)

• Resource Impact Statement Instructions at WRNMMC

NOTE: Other unified templates are being developed by the Integration Research Working Committee Task Group. Until these are available, please refer to the Study Site Specific Templates.

The quest for ever-improving patient care for military readiness as well as for overall family health is our defining mission. To us, this means that our health practices are founded on the latest medical knowledge with state of the art technology. Delivery of service must, in our view, be in the trusted hands of a staff that possesses a caring, warm, and sincere human touch.

• Scientific Review Template
• Research Coordinator Protocol Checklist
• Human Use Protocol
• Exempt Protocol Guidance and Application
• Standards of Conduct
• SECNAV 3900.39D PROTECTION OF HUMAN SUBJECTS
• Adverse Event Form
• Annual Report
• Medical Monitor
• BUMED Manuscript Instruction 5721.3a
• Completion and Termination Report
• Copyright
• FDA Annual Report
• HIPAA Preparatory to Research
• HIPAA Waiver
• Investigational Device Exemptions Report
• Travel Request Form
• TAD Travel Worksheet
• Humanitarian Use Device (HUD) Consent Form
  

• SOP Human Use Devices (HUDs)
• SOP Animal Research
• SOP HSR Elsewhere
• SOP Non-human Research

Request for Presentation and Publication Clearance (word doc) (PDF)

ALL STAFF - All manuscripts, articles, reports and presentations designed for professional and general public shall be submitted to Darnell Library, RCRS, Legal and the PAO for review and clearance before submission for publication or presentation. Link above to the Request for Presentation and Publication Clearance.

For guidance on publication ethics, editorial issues, and manuscript format, see the Uniform Standards for Biomedical Publication.