As a Texas Health and Human Services (HHS) employee or agent, how can I determine if I am engaged in human subject research?
The following link will assist HHS managers, employees and agents to determine if their participation is considered engaged in human subject research under the federal guidelines:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html. Please reference Texas state statutes, health codes, and administrative codes for further guidance.
Does the IRB need to look at this project?
Seek guidance from the program from which you are requesting the release of information or biospecimens to determine if an IRB application is required. Generally, the IRB reviews requests for the release of DSHS nonpublic information that is identifiable or potentially identifiable, laboratory biospecimens, personal information that is deemed legally discretionary and there is question whether the data should be released and when contact with human subjects is proposed in the application.
How can I request DSHS information or biospecimens?
A request for the release of DSHS information/biospecimens begins with the program. An assigned program contact will work with the applicant to determine if an IRB review and approval process is necessary.
What is the estimated time line from submission to determination?
The turnaround time is approximately 4-5 weeks after the program contact submits your application to the IRB.
What is the difference between full, expedited, and exempt review?
Full IRB Review – The application is reviewed by the IRB at a convened meeting. Full IRB review is required for most initial review applications, significant changes to approved protocols, and continuing review applications that have been determined to be more than minimal risk.
Expedited Review – The application may be reviewed by one or more designated IRB members rather than by a convened meeting review process. To qualify for expedited review, the research must present no more than minimal risk to human subjects.
Exempt Review – The application may be reviewed by one or more designated IRB members rather than by a convened meeting review process. To qualify for an exempt determination, the research must meet one or more of the exempt categories permitted by the federal regulations outlined in the Common Rule.
The IRB asks for a list of individual(s) on the Research Team Log. What is the definition of a research team member?
A research team member includes the Principal Investigator and all individuals who participate in the protocol design, interact with any human subject for research purposes, obtain the informed consent of human subjects for research purposes, obtain identifiable information or biospecimens for research purposes and access, use, study and analyze identifiable information or biospecimens for research purposes
Who is required to complete the Human Subject Research training?
All research team members must complete the Human Subject Research Training.
Which Human Subject Research training
certificates will the IRB accept?
The IRB accepts the Protecting Human Research Participants and Collaborative Institutional Training Initiative (CITI) training certificates. The IRB may consider training certificates issued from the investigator/team members’ home institution if the human research courses satisfy this requirement.
When do the Human Subject Research training certificates
need to be submitted?
The investigator and all research team member training certificates must be submitted with the initial review and each subsequent renewal. In addition, submit the training certificate for any new key personnel who are being added to the team with the amendment application.
Does the Human Subject Research
training expire?
Yes. The IRB will not accept training certificates that exceed five years from the issuance date.
What can I do to minimize delays to my project's approval?
- Use the most recent IRB forms
- Be sure to get all appropriate signatures
- Review your cover letter, IRB forms, surveys, advertisements, and informed consent document for typos, readability, and grammar
- Use the informed consent document checklist to ensure all elements of informed consent are present within your document
- Use the submission checklist to ensure all required documents are included in your submission
I am submitting an Informed Consent Document for
review. What information must be included in the form?
The IRB forms page has a checklist that includes the federal regulations and agency requirements. If you are requesting an alteration from the listed requirements, complete and submit the Waiver or Alteration of Informed Consent form.
Can I make changes to the protocol without informing the IRB?
No. All changes/modifications/amendments need IRB approval before the change can be implemented. Amendment applications are submitted to your program contact who will provide guidance and then forward your application to the IRB for review.
An unanticipated problem was discovered during the course of the study. What should I do?
Investigators are required to notify the IRB of an unanticipated problem immediately upon discovery. The notification must include sufficient details and a corrective action plan, if applicable. The information can be conveyed with a letter, memorandum
or lead site reporting form.
My IRB approval letter has an expiration date.
What should I do if I plan to continue my study beyond that date?
Prepare to submit a renewal application to your program contact. The program contact will forward your application to the IRB for review.
How long must I hold onto my records after my study closes?
The Code of Federal Regulations, 45 CFR 46.115(b) requires all "records relating to research, which is conducted, shall be retained for at least 3 years after completion of the research." "Completion of research" includes completing all data analysis.
How do I inform the IRB that my project has closed?
Complete and submit a
Final Report upon Termination of Project form.
I have completed data collection and am performing data analysis only. Do I need to renew my approval past the expiration date?
Yes. Your study is considered ongoing, even if you are "only" analyzing data (especially if you have data with identifiers).
My approval has expired. What should I do now?
Federal regulations do not allow research to continue past the approval expiration date. You must stop the research, "unless the IRB concludes that it is in the best interest of individual subjects to continue participation in research interventions or interactions." Enrollment of new subjects cannot occur after the expiration of IRB approval. This also applies to the release of data for use in the study. Contact the IRB to determine if you qualify for a grace period extension.