Before you submit
Steps you will need to complete prior to submitting your application
This section provides an overview of the five steps you will need to complete prior to submitting to the IRB.
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 and Informed Consent:
The protocol is the working document that describes the study’s objectives, procedures, risks, benefits, recruitment, consent processes, and procedures to maintain confidentiality.
- The HRPP Office has Protocol Templates for use by the Texas A&M 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.
Informed consent is the process by which a volunteer confirms his or her willingness to participate in the research after being informed of all aspects of the research that are relevant to the volunteer’s decision to participate. Importantly, informed consent is more than a signature on a document. It requires an ongoing process of information exchange between the investigator and the research participant or the subject’s legally authorized representative (LAR) with adequate information pertaining to the research study; sufficient opportunity to consider aspects of the research, including the risks and benefits, and whether to participate; and the opportunity for the subject to ask questions and receive answers to those questions, thus minimizing the possibility of coercion or undue influence..
- Informed consent templates are located on the Templates, Forms, & SOPs page
- HRP-090 SOP Informed Consent Process for Research
- HRP-091 SOP Written Documentation of Consent
- HRP-336 Worksheet Review tool Consent Process
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.
Gather Supporting Documents:
It is important that you have all required supporting documents in place before you submit to the IRB so as not to delay IRB review. Some ancillary documents such as site authorization, approval from other compliance components, or relevant agreements with collaborating institutions may take extra time to acquire. Plan ahead!
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.
An approval stamp will be applied to all approved consent and recruitment documents in the bottom right corner. Be sure to leave room for the stamp by applying a 1 inch margin at the bottom of the documents.
Support documents may include:
|List of Supporting Documents|
|Texas A&M consent form(s)
Child assent form(s)
PHI authorization form, waiver of PHI authorization
Verbal script of the information provided orally to participants
Sponsor or lead site-approved consent form(s)
IRB-approved consent forms from prior studies for use of secondary data or specimens
Templates for Texas A&M consent documents are located on the Templates, Forms, & SOPs page
Complete Sponsor Protocol (to include Lead Site for federally funded studies)
Protocol templates for Texas A&M are located on the Templates, Forms, & SOPs page
|Advertisements (including printed, audio and video)
Recruitment materials and scripts
Press Releases (when the study is open to accrual)
|Data Collection Instruments|
Focus group questions
Scales and measures
Participant observation checklist
Case report forms
|Drug/Device Details for Clinical Trials|
|Package Insert/Investigator Brochure
Verification of each IND number (one of these): Sponsor protocol with the IND number OR Communication from the FDA or sponsor with the IND number
Product labeling/Investigator Brochure
Verification of each IDE or HDE number (one of these): Sponsor protocol with the IDE / HDE number OR 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
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)