Step 2: What to submit?

Before you submit

Determine who may serve as Principal Investigator:

Every research study requires a Principal Investigator (PI). This person takes full responsibility for the conduct of the study including the eligibility and training of the research staff. 

Students may not serve as Principal Investigators, instead they must include an eligible individual to be the Principal Investigator of their projects (see Investigator Manual for the list of eligible individuals). Although, a student may carry-out many of the protocol related functions as a "Protocol Director", the Principal Investigator retains responsibility for the overall conduct of the research.

Identify the Study Team:

Study team members are all individuals, both internal and external, who have a significant role in the research design, conduct or reporting of the research.  

Determine whether any member of the team has a Financial Interest related to the research. 

Complete Human Subjects Protection Training:

All study team members on active IRB studies must have completed Human Subjects Protection Training within the past 5 years. See the Training page for instructions.

Develop the Study Protocol:

The study protocol should include a clear description of the study's objectives, procedures, risks, benefits, recruitment, consent processes, and procedures to maintain confidentiality.

The HRPP Office has three Protocol Templates for use by the TAMU research community to describe human research activities.

Tip:  You are encouraged to use Worksheet HRP-314 to compose your Investigator Protocol in a way that addresses the criteria for approval.

Additional Committee Review and Approval:

If your research also includes animals, biohazards, collaborator and/or technology that are regulated by export control laws, you may need to receive approval or clearance from other compliance units. See the list of keywords for activities that may require additional compliance review.

International Research:

Research conducted by TAMU investigators in foreign countries remains under University purview and guidelines.  The TAMU IRB work to ensure that human subjects outside the United States receive equal level of protection as research participants inside the United States. While we do not impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or a meaningful consent and assent process.

The Office for Human Research Protection (OHRP) maintains a list of laws, regulations and guidelines on human research from over 100 countries.

Gather Support Documents:

Be prepared to attach several files to your submission.  When attaching each file, name it as you want it to appear in the IRB determination letter.  In iRIS, you will be asked to upload consent documents first, then all the other study documents.

Support documents may include:

Consent Documents:

  • TAMU consent form(s)
  • Child assent form(s)
  • PHI authorization form, waiver of PHI authorization
  • Verbal script of the information provided orally to participants
  • Debriefing Scripts
  • Sponsor or lead site-approved consent form(s)
  • IRB-approved consent forms from prior studies for use of secondary data or specimens

Templates for TAMU consent documents are located on the Templates, Forms, & SOPs page

Protocol

  • Protocol
  • Complete Sponsor Protocol (to include Lead Site for federally funded studies)
  • Thesis/dissertation proposal

Protocol templates for TAMU are located on the Templates, Forms, & SOPs page

Funding Information

  • Grant applications
  • Contracts
  • Sub-contracts

 

Recruitment Materials: 

  • Advertisements (including printed, audio and video)
  • Recruitment materials and scripts
  • Press Releases (when the study is open to accrual)

 

Data Collection Instruments

  • Survey questions
  • Interview questions
  • Focus group questions
  • Scales and measures
  • Participant observation checklist
  • Abstraction Forms
  • Case report forms
  • Audio/Video/Image prompts

 

Drug/Device Details for clinical trials:

  • Package Insert/Investigator Brochure
  • Verification of each IND number (one of these):
    • Sponsor protocol with the IND number
    • Communication from the FDA or sponsor with the IND number
  • Product labeling/Investigator Brochure
  • Device instructions
  • Verification of each IDE or HDE number (one of these):
    • Sponsor protocol with the IDE / HDE number
    • Communication from the FDA or sponsor with the IDE /HDE number

 

Special documents for International Studies

  • IRB approval letters or the equivalent from International Sites
  • Non-English versions of materials for participants
  • Translation Certification. See Template.

 

All Other Relevant Documents:

  • Data Safety Monitoring Board Report
  • Executed Agreements
    • Letters of support from sites where research will be conducted (site authorization letters, Memorandum of Understanding, Master Reliance Agreement
    • Institutional Authorization Agreements (IAAs)
  • Certificates of Confidentiality
  • Business Associate Agreement (BAA) or Data Use Agreements (DUA) for Protected Health Information.
  • Material Transfer Agreement (MTA)
  • Site Specific Authorizations (i.e public schools or other educational settings, private clinics, hospitals, nursing homes, government agencies or any other outside business or field site)

 

Next Step: How to submit?