HRPP Step 2

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. Although, a student may carry-out many of the protocol related functions as a "Co-PI", 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. 

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.

Additional Committee Review and Approval:

If your research also includes: animals; biohazards; collaborators; or technology that is regulated by export control laws, you may need to receive approval or clearance from other compliance units.

International Research:

Research conducted by A&M-SA investigators in foreign countries remains under University purview and guidelines.  The A&M-SA 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.

Collaboration(s) with another Institution

Researchers must consult with the IRB about reliance on an external IRB.

TX A&M-SA researchers may be involved in research that involves multiple organizations. IRB reliance agreements or Inter-Institutional Agreements (IIA’S) allow one IRB to review and serve as the single IRB of record (sIRB) for human research that is occurring at multiple sites or research that involves personnel from multiple institutions and documents respective authorities, roles, responsibilities, and communication between organizations. For any collaboration, our IRB Chair will evaluate the activities of the TX A&M-SA faculty, staff or student to determine if those activities engage TX A&M-SA in human research. This determination must be made by the IRB. If the activities engage TX A&M-SA in non-exempt human research, the researcher’s involvement in the collaboration may not begin until the TX A&M-SA IRB has approved the research or until an agreement to rely on another IRB is negotiated and that IRB has granted final approval.
As of 1/25/2018, all NIH-funded multi-site projects involving non-exempt human research are required to utilize a sIRB for the review of human research protections. The NIH policy applies to:

• NIH-sponsored multi-site projects, where the same protocol is used at multiple site
• U.S. sites only

The IRB Administrator is responsible for facilitating and maintaining IRB reliance agreements, in consultation with the Institutional Official (IO) or designee as needed. Reliance agreements may pertain to individual project or to a defined group of projects.
The TX A&M-SA researcher is responsible for knowing and complying with the policies and requirements of the sIRB. Responsibilities include, but are not limited to, completing required human protections training, not enrolling participants until the sIRB has approved the project, obtaining and documenting informed consent as required by the sIRB, reporting unanticipated problems or noncompliance, deviations and participant complaints, complying with requirements for project amendments, continuing reviews, project closure, data security, data monitoring reports and record retention and responding to the sIRB requests in a timely manner.

See IIA Workflow Diagram.

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.

A&M-SA consent form(s)
Child assent form(s)
Verbal script of the information provided orally to participants
Debriefing Scripts
IRB-approved consent forms from prior studies for use of secondary data or specimens
Protocol Submission Packet Includes:

Protocol
Complete Protocol if applicable (to include Lead Site for federally funded studies)
Protocol templates for A&M-SA are located on the Forms page
Grant applications
Contracts
Sub-contracts

Advertisements (including printed, audio and video)
Recruitment materials and scripts
Press Releases (to be used only when the study is open to accrual)
Data Collection Instruments
Survey questions
Interview questions
Focus group questions
Scales and measures
Participant observation checklist
Audio/Video/Image prompts
Special documents for International Studies
IRB approval letters or the equivalent from International Sites
Non-English versions of materials for participants
Translation Certification

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
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