The HRPP Toolkit provides investigators with a number of templates, worksheets, and checklists to assist with submissions. All documents can be located in the Endeavor Library.  There are a few different categories of documents:

  • Standard Operating Procedures (SOPs): These documents specify operating procedures and are primarily for administrative use. However, there are a few SOPs that are geared toward investigators (i.e. HRP-090 - SOP - Informed Consent Process for Research and HRP-091 - SOP - Written Documentation of Consent). 

  • Templates: These documents are designed to assist researchers in preparing study materials, such as IRB protocols, consent forms, and information letters. Use of the applicable HRPP protocol template and consent/information letter template is required as part of the IRB submission.

  • Worksheets: Documents providing guidance toward developing thorough materials for IRB review. Worksheets are resources that investigators should consult to ensure that their materials meet regulatory and institutional guidelines. 

  • Checklists: Checklists are required to be completed by IRB reviewers. The checklists are provided for investigators to consult and ensure that their materials meet the applicable elements. 

  • General Documents: Includes manuals and other informational materials. Most notably, this include HRP-103 - Investigator Manual.

  • Protocol Template for Exempt, Expedited, and Full Board Studies (HRP-503) - This form is requied for all submission requesting Auburn IRB to review human subject research activities.  

  • Reliance/Ceded Review Template (HRP-503b) - Complete this template if your project will require an external IRB review or if a single IRB is necessary on a multi-institution/collaborative project in which AU will rely on another IRB.

  • Non-Human Subjects Research Determination (HRP-503c): This form should be used when an investigator is unsure whether an activity meets the regulatory definition of human subjects research or when written documentation from the IRB is requested confirming that the activity does not constitute human subjects research and is therefore not subject to IRB oversight.

  • Developmental Approval (HRP-503d) - Under the federal regulations (45 CFR §46.118) certain types of applications for grants are submitted with the knowledge that human subjects may be involved, but definite plans would not normally be set forth in the application or proposal. 

  • Informed Consent Template (HRP-502) - This form should be used to develop an informed consent document for adults. You may delete sections that are not applicable to your study.

  • Information Letter (HRP-581) - This form should be used to develop an information letter. This format is used for exempt activities.

  • Minor Assent (HRP-578) and Minor Assent Script (HRP-579) - This form should be used to develop an assent script document for children. Assent scripts are typically used with young children or with individuals who are developmentally delays or affected in a way that they are unable to read or comprehend the standard written assent/consent. A full consent will be signed by the parent or legally authorized representative.

  • Parent Permission (HRP-580) - This form should be used to develop a parent permission document.