Research Ancillary Review

Research protocols that are submitted to the Institutional Review Board (IRB) may require specialized review by other Texas A&M offices outside of the IRB. We refer to these as ancillary reviews.  

The ancillary review feature in the Huron IRB module is intended to support compliance reviews across multiple university oversight groups. Ancillary reviews, if required, can be initiated by the Principal Investigator (PI) or PI Proxy in Huron. The IRB staff typically assigns ancillary reviews during the pre-review of a submission if it has not already occurred.  

In some instances, but not all, the IRB can issue approval without the ancillary review being finalized (see IRB Yellow Light). However, some ancillary reviews affect subject safety and data privacy, and therefore the IRB cannot approve a project until the ancillary review is complete (see IRB Red Light).  

When the ancillary review impacts IRB approval, the investigator will be put in contact with the applicable institutional office to resolve the ancillary review issue. Please understand that some ancillary reviews may ask for changes to the design of the study or specific wording in the informed consent or other documents.  

Investigators can minimize delays by using current up-to-date templates and reaching out to all applicable ancillary review office(s) related to their research prior to IRB submission.  

Take the first step—see how simple it is to start an ancillary review in Huron

IRB

Green-Yellow-Red Light Guide

Green Light

IRB approval will be issued once the IRB review process is complete. No holds on ancillary review. 

Yellow Light

The IRB will work simultaneously with stakeholders (PI and other ancillary offices).  The IRB will issue final approvals once the IRB review process is complete, while the researcher continues to work directly with the appropriate ancillary review office(s).  The IRB outcome letter will note the pending ancillary approval(s). 

Red Light

Final IRB approval is held until the ancillary group(s) concludes their review. 

Ancillary Review TriggersTAMU Institutional OfficeIRB Red LightIRB Yellow LightIRB Green Light
Activities involving care, custody, or control of minors not within eye of parents (includes virtual communication) University Rule: 24.01.06.M1University Youth Programs for Minors   Contact Information: 979-862-3295 uyp@tamu.eduVirtual multi-day programs and/or with longitudinal component (more than a one-time program); multi-day in-person programs; any program with overnight component; any program where we take full supervisory (care, custody, or control) and parent or legal guardian are not present. Virtual Programming where activity is a single day or less and occurs only once; minimal in-person engagement, single day, half day or less; day or multi-day visits where activities are all low risk (classroom based activity or low physical exertion). Survey research where the survey is the only engagement; correspondence and all research done with teacher/program directors/adult supervisors only; half day (less than 4 hours) for one time visit with parent present at all times in the same room. 
Activities that include potential for, or instruction to participants that puts them at risk for, physical injury. This may include loud noises, extreme temperatures, toxic chemicals, controlled substances, working at elevated heights, etc. University Rule: 24.01.01.M4Environmental Health and Safety   Contact Information: 979-845-2132 ehs@tamu.edu  PI has not contacted EHS and potential risks for injury has been identified. Potential risk for injury has been identified, and PI is simultaneously working with EHS and IRB.  No potential risk for injury identified. 
Activities involving use of X-Rays, Lasers, Radiation producing devices required 25 TAC 289, TAMU Radiological Safety Program Manuals (tied to regulatory requirements under state licensing and registrations)Radiological Safety   Contact Information: 979-845-1361 radiological-safety@tamu.edu  Administration of a radioactive material to human subjects for research purposes; radioactive material (RAM); radiation producing devices (RPD); lasers III and IV. Use of Magnetic resonance imaging (MRI).   
Public distribution of food on campus   SAP 24.01.01.M4.02Food Safety   Contact Information: ehsd-food@tamu.eduPI has not contacted Food Safety and research involves food preparation; failed food safety inspection. Kitchen/food preparation area has up to date EHS approved inspection; PI simultaneously working with Food Safety and IRB.  
All university data must be safeguarded (e.g. via the IT controls required by the university, the federal government, in grants, contracts, etc.); all research data is classified as confidential per TAMU Controls Catalog DC-5 and must be protected as such; cloud services must meet minimum security requirements; the State has banned the use of certain technologies.   TAMU SAPS: 29.01.03.M0.01, 29.01.03.M0.02, 15.99.03.M1.03, 29.01.03.M0.13; 29.01.6 TAMU Controls Catalog requirements; TAMU Controls Catalog DC-5; TAMU Reviewed Cloud Services; State cloud services / TX-RAMP requirements; State ban on prohibited technologies.  Validation of IT controls   Contact Information: JJ@tamu.edu and Local Department IT TeamResearchers using personal devices instead of TAMU-owned, TAMU Technology Services-managed devices (e.g. computers, storage, etc.); using unapproved or personal cloud services instead of TAMU Technology Services-approved or TX-RAMP certified services; researcher and/or local IT working with cloud service vendor on TX-RAMP certification where the cloud vendor is seeking certification; cloud vendor backs out of TX-RAMP certification process, external parties not compliant with TAMU data requirements; not meeting IT requirements outlined in a contract; using a prohibited technology. Researcher choosing an alternative to a prohibited technology; contractual IT security requirements exceed university requirements and additional requirements being assessed or in process. 
 		Using only TAMU-owned endpoints (workstations, laptops, desktops); using only TAMU Technology Services-managed endpoints with all required agents installed; using only TAMU-approved or TX-RAMP Level 2 certified cloud services; any sponsor or contractually-required requirements that exceed university requirements have been satisfied and/or put in place. 
 
Activities/agreements triggering privacy laws (i.e. HIPPA, GDPR, Use of non-Texas A&M students’ data, etc.)   System Regulation: 29.01.03 SAP: 29.01.03.M0.09Privacy /Confidentiality   Contact Information: 1-833-261-1247 privacy@tamu.eduConfidential data being accessed, used or disclosed and Privacy Office risk assessment is pending or required agreements not initiated (includes international research); protocol lacks adequate controls to protect and maintain confidential data; external student records. PI working with Privacy Office (may include contracts office) and IRB simultaneously; required agreements are available in draft form; proposed language on controls/consent is included but does not fit requirements of applicable Privacy laws and therefore needs to be adjusted. All confidential data accessed, used or disclosed (PII, PHI, GDPR, FERPA, etc.) has required TAMU controls, consent and/or agreement (DUA, MTA, contract) as needed. 
A conflict of interest or commitment is created when personal, financial, or outside interests could unduly influence the design, conduct, or reporting of research, or interfere with the performance of institutional responsibilities. University Rule: 15.01.03.M1 & 15.05.04.M1Financial Conflict of Interest Disclosure   Contact Information: (979) 862-6419 coi@tamu.edu  Study personnel on funded research protocol have not disclosed; a disclosure is under review; an SFI has been identified without management plan in place; a management plan is pending. The COI office and IRB office can process simultaneously but there are no final approvals until all COI determinations are communicated to the IRB. Unfunded studies with no TAMU innovative technologies; all study personnel have up to date disclosures with no pending actions; any management plan and IRB protocol are congruent, and requirements met. 
International activity/collaborator   Federal Regulations SAP: 15.02.99.M1 & 15.05.04.M1 System Policy: 15.02 System Regulation: 15.05.04Export Controls/High Risk Global Engagement   Contact Information: (979) 862-6419 exportcontrols@tamu.edu  Research involves international collaboration, travel, shipments or transfer of data or embargoed or sanctioned countries and the research is pending Export Control review and approval.  Research involves no international collaboration, travel, shipments or transfer of data; no embargoed or sanctioned countries; all items subject to Export Controls have been cleared. 
Activities involving use of Texas A&M student data required per: FERPA System Regulation: 16.01.02 SAPS:13.02.99.M0.01 University Rule: 16.01.02.M1FERPA   Contact Information: 979-845-1145 ferpa@tamu.edu  Investigator is not course affiliated and has not received prior FERPA office approval for research use of student data or records. 
 		The FERPA office and IRB office can process simultaneously to help investigators meet one of the following conditions: (a) research using student data or records is accessed by authorized office or affiliated instructor and deidentified before provided to investigator, (b) student consent is obtained prior to accessing /using student records, (c) consent and protocol procedures are FERPA compliant. Research uses no TAMU student data or educational records or grades. 
Involvement of external collaborators, materials, data, etc. that may require an agreement.  System policy 15.04- Sponsored Research Services Contact Information:   Funded Agreements (sponsored grants and contracts) (979) 862-6777 Contact: assigned contract negotiator listed in Maestro   https://tamu funded research agreements     Un-funded agreements (MTAs, DTUAs, etc.) Contact: negotiations@tamu.edu   https://tamu unfunded research agreements  Research involves access or transfer of confidential data, protected data,  specimens or services and no agreement initiated with external parties. Contracts office and IRB work simultaneously; contract risk assessment determines no agreement needed or any required agreement is in draft form Research protocols without collaborators, third party services or transfer of data or specimens; research has existing grant, sub-award, contract, DUA, MTA, etc. in place with all collaborators and external services. 
Use of vertebrate animals in teaching or research required   Federal Regulations System Regulation:15.99.07 University Rule: 15.99.07.M1Animal Welfare/IACUC   Contact Information: (979) 845-1828 animalcompliance@tamu.eduResearch involves use of animals and the investigator is unable to obtain IACUC approval. Research involves use of animals and the animal welfare office has been notified to determine if IACUC approval is needed. Both offices will work simultaneously.Research involves use of animals and has IACUC approved protocol. 
Use of biohazardous material (i.e. human cells, blood tissue, saliva, biotoxin)   University Rule :15.99.06.M1 TAMUS Regulations, NIH Guidelines & BMBLBiosafety/IBC   Contact Information: 979.862.4549   biosafety@tamu.edu  The research involves biohazards and the investigator is unable to obtain Biosafety approval. Research involves use of biohazardous material (i.e. human cells, blood tissue, saliva, biotoxin) and the Biosafety Office has been notified.   Both offices will work simultaneously.     Research involves use of biohazardous material (i.e. human cells, blood tissue, saliva, biotoxin) and the permit is up to date and has confirmed IBC approval.