For all applications you will need to download the appropriate forms.
Tech Tip! Each form is available in two different formats, 
.rtf (rich text format) and 
.doc (Microsoft Word). MAC and Linux-based operating system users should use the .doc (Microsoft Word) format only as we have experienced problems upon receiving .rtf forms from those users.
When you have completed all applicable forms, please submit them to the email address listed under 'Contact us' to the left.
IUB Standard Operating Procedures
The IUPUI SOPs were adopted by Indiana University Bloomington (IUB) on 08/18/08.
The IUB Office of Research Administration is in the process of reviewing and revising
these procedures, as necessary and will post them once they are approved.
 New Research Submission Forms:
 Exempt Research Studies
Expedited Research Studies
Studies subject to HIPAA only :
Depending on your study, Additional forms may be necessary
For studies involving children:
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 individuals who are cognitively impaired:
Inclusion of Cognitively Impaired Individuals
To report an event of noncompliance to the IRB:
Noncompliance Reporting Form
To report an unanticipated problem to the IRB:
Prompt Reporting Form
For studies targeting pregnant women:
Inclusion of Pregnant Women, Human Fetuses,
and Neonates
For studies involving prisoners:
Prisoner Request Form
Full Board Studies (research greater than minimal risk)
Studies subject to HIPAA only:
Depending on your study, Additional forms may be necessary
For studies involving children:
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 individuals who are cognitively impaired:
Inclusion of Cognitively Impaired Individuals
To report an event of noncompliance to the IRB:
Noncompliance Reporting Form
To report an unanticipated problem to the IRB:
Prompt Reporting Form
For studies targeting pregnant women:
Inclusion of Pregnant Women, Human Fetuses,
and Neonates
For studies involving prisoners:
Prisoner Request Form
|
Amendment to Change Existing Study Forms:
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.
Amendment to Existing, Expedited or Full Committee Research
Please submit the following:
Studies subject to HIPAA only:
*Please note: Requested changes should be highlighted or
otherwise shown on the applicable forms and/or documents.
Please submit the following:
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
For studies involving children:
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 individuals who are cognitively impaired:
Inclusion of Cognitively Impaired Individuals
To report an event of noncompliance to the IRB:
Noncompliance Reporting Form
To report an unanticipated problem to the IRB:
Prompt 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:
Prior to submission, you must have completed the following
three required tasks:
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All research instruments, e.g. recruitment materials, 