Forms & Resources

Forms & Resources

Applications and Guidance

• Application Form: Social/Behavioral or Biomedical Research*
  Use this form for exempt, expedited, or full board review.
• Information on the IRB Submission and Approval Process
  • Determination Form/Certificate- Do you need IRB review?
  • IRB Application Errors– Use along with the IRB Application to minimize common errors which lengthen the review process.
  • IRB Review Criteria by Application Section– Details what reviewers look for in your completed application.
• Use of Human Specimens Form *

Consent Form Templates

• Informational Sheet -(signature not required from subject) *
• Consent for Adults Form-(signature required from subject) *
• Assent for Minors Form -(signature required from subject)*
• Parental Consent Form– (signature required from subject)*
• Consent by Telephone *
• Glossary of Lay Terms to Use When Writing Consent Forms *

To continue a study or to close study/close file

• Continuation Form *
• Completion/File Closure Form *
• Non Compliance Reporting Form*
• Unanticipated Problem/Adverse Event Reporting Form*

Amendment/addendum request form

Amendment/Addendum Request Form*

Unanticipated problem/serious adverse event/noncompliance

What is an Unanticipated Problem/Adverse Event

Unanticipated Problem/Serious Adverse Event/Noncompliance Reporting Form*

HIPAA Forms

• HIPAA Application*
• Data Use Agreement *
• Authorization Form Template*

Policies and procedures

• IRB Standard Operating Procedures Manual
• NEOMED HIPAA Policy *
• Roles and Responsibilites of the NEOMED IRB
• What are Unanticipated Problems and Adverse Events
  • Reporting Unanticipated Problems, Serious Adverse Events, Noncompliance

Online training

NEOMED only accepts the CITI human subjects training modules.  Certification is valid for 3 years from the date of completion.

• CITI Human Subjects On-Line Training Certification

Other guidance

• Guidance Charts to Determine If Your Project is Human Subjects Research
• Guidance on Research Involving Biological Specimens and Coded Private Information
• Self Audit Form *

Student Research Projects Requiring IRB Review:
All student projects require a faculty PI listed on the IRB application who will mentor the project and help complete and review the IRB application prior to submission. If you are conducting research on NEOMED students, you are also required to seek permission from the college Dean(s) for the use of students as subjects.  All survey research must be administered through the Office of Institutional Research.   Also please keep in mind you will have to process any gift cards, etc. given as compensation (not “incentives” to ensure we are not coercing participants) with the accounting office.