511. New Projects: Submission Requirements for Expedited Review
Updated Oct. 4, 2019
The following requirements apply to each New Project submitted in IRBNet for Expedited Review (i.e., review by one or more IRB members, outside of a committee meeting).
For projects to be eligible for Expedited Review, participant risk must be no greater than minimal and research activities must be listed among the DHHS categories of research eligible for expedited review.
New projects for Expedited Review may be submitted at any time; meeting dates and deadlines do not apply to expedited reviews. New Projects are assessed for completeness; incomplete projects will not be forwarded for review until all required materials have been submitted.
Mandatory Submission Requirements for Expedited Review of New Projects
Complete the following steps for each new project submitted for Expedited Review:
- Confirm the PI and all members of the study team have completed the required training
- Create a New Project in IRBNet.
- Add Part I, Cover Sheet.
- Add Part II Application.
- Add recruitment materials.
- Add consent materials (e.g., information scripts or sheets; rarely consent or permission forms).
- Add study materials: assessment instruments, surveys, questionnaires, data collection logs.
- As applicable, Add study-specific materials/documents from the itemized list below.
- Share IRBNet access for all study personnel and the Responsible Official.
- Obtain the PI’s signature electronically through IRBNet.
- Obtain the Responsible Official’s signature electronically through IRBNet.
- Submit the project for Expedited Review
Study-Specific Submission Requirements for Expedited Review of New Projects
For new projects submitted for Expedited Review, additional materials are required as follows:
- Add Protocol Review Subcommittee review: Required for VA research.
- Add grant proposal, contract, or scope of work: Required for federally sponsored research.
- Add Research: Investigational Drugs or Research: Investigational Devices researcher form: Required for research involving drugs, dietary supplements, or devices when these do not require IND (drug) or IDE (device) per Expedited Review Category 1. (Research involving IND or IDE requires Full Committee Review; see submission requirements for Full Committee Review.)
- Add Research: Blood or Biological Specimens researcher form: Required when research involves the collection of human blood or biological specimens per Expedited Review Category 2 or 3.
- Add Consent Waivers researcher form: Required for the IRB to waive or alter DHHS requirements for informed consent or documentation of consent for minimal risk research projects ONLY when these are conducted/supported by a federal agency, or involve deception or incomplete disclosure or prisoners. All other minimal risk research may be excluded from DHHS requirements for informed consent under the University’s IRB Flexibility Policy. See IRB policies for informed consent for federally funded and select minimal risk research and for exempt and minimal risk research.
- Add HIPAA Authorization Template:Required to obtain authorization from participants for research involving disclosure of protected health information (PHI).
- Add HIPAA Waiver of Authorization researcher form: Required for the IRB to waive the requirement for written authorization for research involving disclosure of PHI.
- Add vulnerable population researcher forms: Required for research involving pregnant women, fetuses, or neonates; prisoners; children; or adults with cognitive impairment.
- Add Research: International researcher form: Required for research involving culturally sensitive or foreign populations.
- Add agency-specific researcher forms: Required for research conducted or supported by the DOD, DOE, DOJ, or EPA.
- Add Education Records/Classroom Survey researcher form: Required for research invoking FERPA or PPRA (e.g., research conducted in schools that receive funding from the DoEd)
- Add documentation of external institutional approval: Required when approval from an external body is necessary for the research to proceed (e.g., school district approval; approval to recruit TMCC students or employees)
NOTE: In some cases, external bodies require IRB approval before approving the research or research components (e.g., recruitment). Contact the RI with questions about obtaining approval from external institutions.
Additional Requirements for Independent or External Investigators Using the University IRB
Review IRB policy for independent or external investigators to use a University IRB and complete the following steps:
- Add principal investigator curriculum vitae.
- As applicable, confirm an Independent Investigator Agreement or IAA is attached by RI staff. In the latter case, AddExternal Investigator Request to Use University IRB.