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Apply Welcome to the Human Research Protection Program
Steps to Obtain IRB Approval
HRPP Step 1 - Is it Human Subject Research?
Is it Research?
Research is defined by DHHS as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstrations and service programs may include research activities”
Research is defined differently by the FDA and has additional requirements.
Is it a Human Subject?
A Human Subject is defined by DHHS as “a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information
*A Human Subject is defined differently by the FDA and has additional requirements.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). It must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Do I need to submit?
All individuals engaged in human subjects research that is supported by Texas A&M University-San Antonio; conducted by or under the direction of any faculty, staff, student, or agent of Texas A&M-San Antonio in connection with his or her institutional responsibilities; conducted by or under the direction of any employee or agent of Texas A&M-San Antonio using any property or facility of Texas A&M-San Antonio; or involved in identifying and contacting human research participants or prospective participants, must submit an application to the IRB prior to commencement of any research activities.
HRPP Step 2 - What to 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. 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.
Gather Support 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.
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
Recruitment Materials:
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
All Other Relevant Documents:
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
HRPP Step 3 - How to Submit
All required applications and required materials must be submitted via email to irb@tamusa.edu. You will receive an application received acknowledgment with an assigned IRB log number. Please use this log number with all future communications regarding this protocol. The application can be found at the link below.
HRPP Step 4 - After You Submit
What happens to my application once submitted?
Once your application is submitted and it has received its unique IRB number, the IRB Review Process begins.
1. Pre-Review
Once submitted, the Research Compliance Administrator will ensure that the application is complete and in keeping with the IRB’s requirements. You may be asked to make changes to the application and study documents during this time. This phase may take several rounds.
Once the Administrator has determined that the submission is complete, it will be sent to the IRB Chair for determination or review pathway; Exempt, Expedited or Full Board Review.
2. Review Type(s)
Studies Not Requiring Full Board Review (Exempt or Expedited)
Exempt Determination:
- If the study poses little to no risks and fits in one of theexempt categories the submission is reviewed by the Chair for an Exempt Determination.
- The study investigator may be asked by the Chair to make additional changes to secure final determination.
- This process may require several rounds of revisions and reviews. Plan accordingly.
- Once the Chair is satisfied with the submission, the final determination letter will be sent to the Primary Investigator via email.
- Very IMPORTANT: although Exempt Studies are determined not to fall under the purview of the IRB, thus do not expire or require filing a Continuing Review Form, investigators are still REQUIRED TO SUBMIT AN ANNUAL UPDATE FORM so the IRB can ensure no changes had been made that could affect the determinations category and/or studies are closed out in an appropriate manner.
- It is the responsibility of the Investigator to SUBMIT the ANNUAL UPDATE FORM at least 30 DAYS PRIOR TO THEYEARLY ANNIVERSARY of determination to irb@tamusa.edu. .
Exempt Review:
- If the study does not meet the criteria for an exempt determination, poses minimal risks, and fits in one of the expedited categories the Chair may request submission be sent to appropriate IRB members for review.
- The IRB reviewers will ensure that the criteria for approval are met.
- The study investigator may be asked by the reviewers to make additional changes to secure approval.
- This process may require several rounds of revisions and reviews. Plan accordingly.
- Once reviewers are satisfied, submission is forwarded to Chair for final determination/approval.
- The final approved protocol, approval memo and any stamped materials will be sent to the Primary Investigator via email.
- Protocols approved under the expedited Review pathway, shall expire one year from approval (unless PI request shorter time period) and REQUIRE FILING EITHER a Continuing Review Form if the PI wishes to continue the study or a Closure Form submitted to officially close-out the study.
It is the responsibility of the Investigator to SUBMIT the appropriate FORM at least 30 DAYS PRIOR TO THEEXPIRATION DATE to irb@tamusa.edu.
Full Board Review:
- If the study presents more than minimal risks to participants, or if the Chair determines that the study does not qualify for Exempt or Expedited Review, the study will be referred to the convened board for Full Board Review.
- The submission will be assigned By the IRB Chair to two IRB members for review.
- If the reviewers have questions, concerns or request edits, they will be relayed to the Investigator to be addressed, to the reviewers’ satisfaction, before the reviewers request the protocol be placed on the agenda for the next full board meeting.
- The project will be presented at a convened IRB meeting for discussion/determination.
- The review board convenes once a month, typically on the third Friday of each month. See schedule.
- The study will receive one of the following outcomes by the IRB:
- Approval
- Modifications required to Secure Approval,
- Deferred (the application lacks information or significant details but may be resubmitted after modifications), or
- Disapproved
3. Post Review
- For all review pathways, the review outcome will be communicated to the investigator via the administrator.
- If modifications or clarifications are requested, the application will be sent back to the investigators to revise and the process will start over. The revised application will be reassessed but the research compliance administrator and then routed back to the person requesting modifications (Chair or original reviewer).
- When the study is approved, an approval letter, approved protocol, (stamped-when applicable) study materials and stamped consent forms will be sent to the investigator.
HRPP Step 5 - After Approval
What happens after approval?
Once you have received IRB Approval Letter or an Exempt Determination Memo you may immediately begin data collection.
Modifications to the Protocol
Investigators may decide to make changes to their study protocol. Such changes may not be implemented by the research team until they have been reviewed and approved by the Vice/Chair.
However in the event that a modification is necessary to eliminate apparent immediate hazards to subjects ( 45 CFR 46.103b.4.iii ), the change may be implemented without prior IRB approval and should be reported to the IRB as a Reportable New Information. This will be handled by the IRB accordingly
Proposed modifications must be submitted through the research compliance administrator. It is important to remember that in addition to submitting an Amendment/Modification the study application, protocol and/or any of the study documents already finalized in your application may need to be updated to reflect those changes.
IRB Unanticipated Problems or Adverse Event Reporting
Examples of unanticipated problems or adverse events that should be reported to the IRB include:
- Publication in the literature or other finding that indicates an unexpected change to the risk/benefit ratio of the research;
- Breach in confidentiality resulting from a disclosure of confidential information or from lost or stolen confidential information, that may involve risk to that individual or others;
- Complaint of a participant or family member that indicates an unanticipated risk;
- Disqualification or suspension of investigators;
- Accidental or unintentional change to the IRB-approved protocol that involves risks or has the potential to recur;
- Deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research participant
- Any deviation from the IRB-approved protocol that increases the risk or affects the participant’s rights, safety, or welfare.
- If you believe you have suffered harm physically or psychologically from participation in a research study, please seek appropriate medical attention immediately then report the incident/problem to the Office of Research and Graduate Studies as soon as possible at 210-784-2317 or at irb@tamusa.edu.
Continuing Review
- Although, the regulations no longer require continuing review (CR) for certain categories of minimal risk research the investigators must be aware that the following requirements are still intact:
- PI may be required to submit an Annual Report (as indicated on the Determination Memo) so that we can verify there have been no changes that could affect the review category and/or make sure they are closed out.
- Any changes to the research must be submitted to the IRB for review and approval prior to implementation;
- Unanticipated problems or other reportable events as described in SOP HRP-029 must be reported to the IRB within 5 days of learning about the incident;
- Notifying the IRB of study completion;
- All FDA regulated research and any study greater than minimal risk still requires annual continuing review.
- Continuing Review is still required for all research approved before January 21, 2019 up until notifying the IRB of study closure;
- Upon initial review of any protocol, an IRB member may still request annual continuing review of any research if it would enhance the protection of subjects and the rationale is documented in the IRB records
See Step 2 above for Annual Report requirements
Continuing Review of human research projects is required for certain approvals under expedited categories 2 and 3 or all Full Board approved studies. The continuing review requirement is required until the research team has completed all study activities, as described in the IRB-approved research protocol.
When should I send my Continuing Review?
Submission date will be included in the Approval Letter.
The Principal Investigator is responsible for submitting the Continuing Review no later than 30 days before the study’s current expiration date to ensure adequate time for the IRB to review and approve it. For Full Board studies, it is recommended to submit the continuing Review 45 days before the expiration date.
While the IRB Admin will make every effort to notify Investigators of protocols’ upcoming expiration dates, it remains the responsibility of the Primary Investigator to submit the Continuing Review Form in a timely manner in a timely manner to avoid suspension of research.
What if my study has expired?
If IRB approval expires all Human Research procedures related to the protocol under review must cease immediately, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.
If the Principal Investigator believes it is necessary to continue a subject or subjects in a lapsed study for safety reasons or otherwise, contact the HRPP Office.
The investigator may resume the research activity only once continuing review and approval by the IRB has occurred.
NOTE: If a study is allowed to lapse by the research team or if a continuing review is not submitted and reviewed by the expiration date, the investigator will be restricted from submitting new IRB submissions until the continuing review has been approved.
Post Approval Reviews
Any active study is subject to a post approval review. Most of these reviews are not for-cause; they are what we call “routine” reviews. The purpose of these reviews is to help investigators stay in compliance, to monitor compliance and to educate. Reviews may also be requested by the IRB, HRPP or Institutional Official to investigate allegations of non-compliance or other incidents. These would be “for cause” reviews.
Closing the Study
All studies require closure upon completion. If all research-related activities with human subjects have been completed, and data collection and analysis of identifiable private information described in the IRB-approved research plan are finished, then the study should be closed with the IRB. Similarly, if the study was never initiated and the Investigators no longer have plans to pursue this project then the study should be closed with the IRB.
How do I close a study?
Complete the form at the link and submit to irb@tamusa.edu to close a study.
Voice a Concern
If you have a compliant, concern or question about a research study or about your rights as a research participant, please contact the Human Research Protection Program at irb@tamusa.edu
You can also submit a human subject’s research concern form or submit a report to Texas A&M-San Antonio Ethics Point .
If you have questions about whether an activity is Human Research contact the Human Research Protection Program.
Research with Children
When is written parental permission required for research with minors?
What else do I need to know when conducting research with minors in an educational setting?
Student/Classroom Research Projects
Do I need IRB review for A&M-SA classroom-based research projects conducted by students?
Do I need IRB review for A&M-SA classroom-based research projects conducted by faculty?
Recruitment
What is an appropriate recruitment method?
Consent Information
How do I obtain informed consent from participants ?
Do research participants have to sign a consent document?
How do I document consent or assent?
How do I obtain a waiver of alteration of informed consent?
Additional Resources
Research Ethics
Information about the ethical codes that serve as the foundation for the conduct of research with human participants may be found here:
The Belmont Report