This Is Auburn Senior Vice President for Research & Economic Development Human Research Protection Program (IRB)

Endeavor Toolkit

The Endeavor Toolkit provides investigators with a number of templates, worksheets, and checklists to assist with submissions. 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. 
  • Templates: Forms that you will need to use for submissions to Endeavor.
  • 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 criteria for approval of the different elements of their research project. 
  • General Documents: Includes manuals and other informational materials. Most notably, this include HRP-103, the Investigator Handbook for Auburn University.
  • Appendices: This category includes supplemental materials that may need to be included with your submission, such as an MRI appendix, or an anonymous data collection assurance form. 
  • Protocol Template for Expedited and Full Board Studies (HRP-503) - Use this form if your research falls into an expedited research category, may present more than minimal risk, or will require full board review. Click here for a version of the template without instructions. 
  • Protocol Template for Exempt Studies (HRP-503a) - Use this form if you believe your project falls into one of the exemption categories. To determine if your research falls under an exemption category, please consult HRP-312 (Worksheet - Exemption Determination) and/or the HHS decision chart for exemption determination. Please note that the IRB has final determination over whether your research falls into an exemption category and may require you to complete an expedited form. Click here for a version of the template without instructions. 
  • 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. Please note that the AU IRB currently refers to WCG for FDA, multi-site/multi-institutional projects requiring a single IRB, prisoners or incarcerated individuals (subpart C), and other projects requiring special considerations as determined by the Institutional Official.
  • Non-Human Subjects Research Determination (HRP-503c) - This form should be used when an investigator is unsure of whether their research activities constitute human subjects research, or when they anticipate that correspondence from the IRB will be required to satisfy funding agency requirements or for presentation and/or publication purposes. Please consult HRP-093 (SOP - Human Subjects Research Determination) and HRP 310 (Worksheet - Human Research Determination) before completing this form. 
  • 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. These can fall under three categories: institutional type grants when selection of specific projects is the institution’s responsibility; research training grants in which the activities involving subjects remain to be selected; and, projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.
  • 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.
  • Informed Consent Template for Social and Behavioral Sciences (HRP-502a) - This form should be used to develop an informed consent document for adults. You may delete sections that are not applicable to your study. If your research involves at-risk or more than minimal risk procedures, biomedical procedures (e.g., MRI, biopsies, etc.), certain funding agencies, or is a clinical trial, please use HRP-502.
  • Information Letter (HRP-581) - This form should be used to develop an information letter. This format is used primarily for exempt activities, such as surveys and questionnaires, and for projects in which non-invasive, non-sensitive information is requested. 
  • Audio/Video/Photo Release (HRP-576) - This template should be used if the researcher seeks permission from a participant for other uses of video/audio recordings or photographs of the participant collected during the course of a research study. Permission to make a video/audio recording or take photos of the participant should be obtained during the consent process. Complete information about the video/audio/photo procedures must be included within the consent document.
  • Minor Assent (HRP-578) - This form should be used to develop an assent document for children. You may delete sections that are not applicable to your study.
  • Minor Assent Script (HRP-579) - This form should be used to develop an assent script document for children. Assent scripts are typically used with very 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 that should be used in conjunction with a minor assent document or script (please see HRP-578 and HRP-579). 
  • Data Repository Consent (HRP-582) - This form should be used for consenting adults when research data will be deposited into a data bank or repository. 
  • Data Repository Assent (HRP-582a) - This form should be used for obtaining assent from minors when research data will be deposited into a data bank or repository. 
  • Data Repository Parent Permission (HRP-582b) - This form should be used in conjunction with HRP-582a for obtaining parental permission when research data from a minor will be deposited into a data bank or repository. 

For all consent, assent, permission, and release documents, you must be age appropriate and use language that will be understood by your target population. Consent requirements are governed by 45 CFR 46.116(a)(b). Researchers should keep in mind that consenting is a process and not an individual document. For information about the consent process, please consult HRP-090, the SOP for informed consent. If you intend to request a waiver or alteration of the consent process, or a waiver of written documentation of consent, please consult HRP-410 and HRP-411, respectively.

If your research involves protected information such as educational information or medical information, you may need to take additional precautions. For HIPAA considerations, please see HRP-330 (Worksheet - HIPAA Authorization), HRP-441 (Checklist - HIPAA Waiver of Authorization), and HRP-903 (Appendix - AU HIPAA Authorization). For student records or educational information disclosures, please see HRP-331 (Worksheet - FERPA Compliance). 

 

  • HRP-306 - WORKSHEET - Drugs and Biologics
  • HRP-307 - WORKSHEET - Devices
  • HRP-308 - WORKSHEET - Pre-Review
  • HRP-309 - WORKSHEET - Ancillary Review Matrix
  • HRP-310 - WORKSHEET - Human Research Determination
  • HRP-311 - WORKSHEET - Engagement Determination
  • HRP-312 - WORKSHEET - Exemption Determination
  • HRP-313 - WORKSHEET - Expedited Review
  • HRP-314 - WORKSHEET - Criteria for Approval
  • HRP-315 - WORKSHEET - Advertisements
  • HRP-316 - WORKSHEET - Payments
  • HRP-318 - WORKSHEET - Additional Federal Agency Criteria
  • HRP-319 - WORKSHEET - Limited IRB Review and Broad Consent
  • HRP-330 - WORKSHEET - HIPAA Authorization
  • HRP-331 - WORKSHEET - FERPA Compliance
  • HRP-332 - WORKSHEET - NIH GDS Institutional Certification
  • HRP-333 - WORKSHEET - Certificate of Confidentiality
  • HRP-401 - CHECKLIST - Pre-Review
  • HRP-402 - CHECKLIST - Non-Committee Review
  • HRP-410 - CHECKLIST - Waiver or Alteration of Consent Process
  • HRP-411 - CHECKLIST - Waiver of Written Documentation of Consent
  • HRP-412 - CHECKLIST - Pregnant Women
  • HRP-415 - CHECKLIST - Prisoners
  • HRP-416 - CHECKLIST - Children
  • HRP-417 - CHECKLIST - Cognitively Impaired Adults
  • HRP-418 - CHECKLIST - Non-Significant Risk Device
  • HRP-441 - CHECKLIST - HIPAA Waiver of Authorization

 

  • HRP-900 - APPENDIX - Secondary Use of Data
  • HRP-901 - APPENDIX - MRI Appendix
  • HRP-902 - APPENDIX - Anonymouse Data Collection Assurance
  • HRP-903 - APPENDIX - AU HIPAA Authorization
  • HRP-904 - APPENDIX - Department Ancillary Review