IUB HUMAN SUBJECT FORMS

NEED HELP?
We understand that these new forms will require training and assistance. We are in the process of scheduling formalized training sessions. In the interim, any questions regarding these forms can be addressed to: IRB HELP@indiana.edu or (812) 855-3067.

SUBMIT FEEDBACK

The IUB IRB and the IU Office for Human Research Protection Programs (OHRPP) would like your feedback and suggestions regarding the new process for submission, review, and approval of research involving human subjects at IUB. Our goal is to further modify the process to better reflect the nature of the research done at IU-Bloomington and the needs of our researchers, while maintaining compliance with the federal regulations and University policies. We suggest that feedback and suggestions be organized in the following manner: the nature of the problem, issue, or complaint. concrete suggestion(s) for specific change(s). Please submit your feedback via email to: IRBFDBCK@indiana.edu

For all applications you will need to download the appropriate forms into your word processing software. To access the forms choose the link below that corresponds to your software package.

Please note: These forms should be completed using Microsoft Word on a Windows-based computer (PC). If you complete the forms using another operating system, e.g. Linux-based or MAC, you will experience problems and the IUB Human Subjects Office may not be able to properly read the forms.

When you have completed all applicable forms, please submit your entire application to iub_hsc@indiana.edu.

For new exempt research studies, please submit the following forms:

• Exempt Research Checklist
• All research instruments, e.g. recruitment materials, surveys, questionnaires, etc.

For new expedited research studies, please submit the following forms:

• Documentation of Review and Approval
• Expedited Research Checklist
• Summary Safeguard Statement
• Informed Consent Statement, as applicable
• Supporting documents, e.g. recruitment materials, surveys, questionnaires, etc.
• Studies subject to HIPAA only:
• Recruitment Checklist
• Authorization for the Release of Health Information for Research

For new full board studies (research greater than minimal risk), please submit the following items:

• Documentation of Review and Approval
• Summary Safeguard Statement
• Informed Consent Statement, as applicable
• Supporting documents, e.g. recruitment materials, surveys, questionnaires, etc.
• Protocol (see sample protocol for guidance, if needed)
• Studies subject to HIPAA only:
  • Recruitment Checklist
  • Authorization for the Release of Health Information for Research

For closeout and continuing review, please submit the following:

• Closeout Report
• Continuing Review - Closed to Enrollment
• Additional Documents to be submitted with the continuing review form:
  • Summary Safeguard Statement
• Continuing Review - Open to Enrollment
• Additional Documents to be submitted with the continuing review form:
  • Summary Safeguard Statement
  • Informed Consent Statement, as applicable
  • Supporting documents, e.g. recruitment materials, surveys, questionnaires, etc.
  • Studies subject to HIPAA only:
    • Recruitment Checklist
    • Authorization for the Release of Health Information for Research

The below document submission requirements pertain only to those research studies that have not undergone a complete re-review. If you are submitting an amendment to a research study that has already undergone a complete re-review (new forms have already been completed and reviewed by the IRB), you need only include the documents that are affected by the current amendment with your Amendment Form.

For an amendment to existing expedited or full committee research studies, please submit the following:

• Amendment Form
• Summary Safeguard Statement
• Informed Consent Statement, as applicable
• Supporting documents, e.g. recruitment materials, surveys, questionnaires, etc.
• Protocol (for full board studies only: see sample protocol for guidance, if needed)
• Other documents as applicable
• Studies subject to HIPAA only:
  • Recruitment Checklist
  • Authorization for the Release of Health Information for Research
• Please note: Requested changes should be highlighted or otherwise shown on the applicable forms and/or documents.

For an amendment to existing exempt research studies, please submit the following:

• Amendment Form
• Exempt Research Checklist
• Supporting documents, e.g. recruitment materials, surveys, questionnaires, etc.

For research that does not meet the definition of human subjects research but still requires review by the IRB, please submit the Application for Non-Human Subjects Research.

• Application for Non-Human Subjects Research

Depending on your study, additional forms may be necessary:

• For studies involving children: Assent To Participate in Research . Unless a waiver of assent will be required.
• For studies subject to HIPAA: Authorization for the Release of Health Information for Research. Unless a waiver of authorization will be requested.
• For studies involving children: Children Request Form
• For studies involving individuals who are cognitively impaired: Inclusion of Cognitively Impaired Individuals
• To report an event of noncompliance to the IRB: Noncompliance Reporting Form
• For studies targeting pregnant women: Inclusion of Pregnant Women, Human Fetuses, and Neonates
• For studies involving prisoners: Prisoner Request Form

 

Things to Remember

Principal Investigators and Co-investigators need to complete the conflict of interest disclosure, provide agreement to participate, and successfully complete the Human Subjects Protection test.

To complete the conflict of interest disclosure, please go to: http://www.researchadmin.iu.edu/cs-coi.html.

To provide agreements to participate in the research, please include an e-mail from each co-investigator and faculty sponsor stating their agreement to participate.

To complete the Human Subjects Protection Test, please go to: http://www.iupui.edu/%7Eresgrad/Human%20Subjects/human-menu.htm