IUB HUMAN SUBJECT FORMS

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. 

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

• Exempt Research Checklist
• All research instruments, e.g. 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, 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
• Continuing Review - Open to Enrollment

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:

• Amendment Form
  
• Assent To Participate in Research
• Authorization for the Release of Health Information for Research
• Children Request Form
• Inclusion of Cognitively Impaired Individuals
• Noncompliance Reporting Form
• Inclusion of Pregnant Women, Human Fetuses, and Neonates
• Prisoner Request Form

 

Instructions for Exempt Level Consenting Process

A Study Information Sheet may be used with most types of projects in the exempt level of review. A signed Informed Consent Statement will be required in some instances (e.g., when children are involved or when retaining / storing recorded interviews indefinitely), and may be substituted for the Study Information Sheet if the researcher wishes proof of participation. INSTRUCTIONS for preparation of these documents are available. SAMPLES of different types of these documents are available.