Frequently Asked Questions
- As a Texas Health and Human Services (HHS) employee or agent, how can I determine if I am engaged in human subject research?
- What type of data does DSHS consider ‘identifiable’?
- Does the IRB need to look at this project?
- How can I request DSHS information or biospecimens?
- Once submitted to the IRB, how long does it take for the application to be processed?
- What is the difference between full, expedited, and exempt review?
- What is the difference between an amendment, renewal, and renewal with amendment application?
- When Should the Special Populations box be checked on the HRP 301 form?
- Which individuals should be listed on the HRP-306 Research Team Log?
- Who is required to complete the Human Subject Research training?
- Which Human Subject Research training certificates will the IRB accept?
- When do the Human Subject Research training certificates need to be submitted?
- Does the Human Subject Research training expire?
- What can I do to minimize delays to my project's approval?
- When should the Principal Investigator submit an informed consent document vs. the HRP informed consent document waiver?
- What is the purpose of the HRP-314 Program Routing form?
- When do I need to include the HRP-315 data-linkage plan?
- Can I make changes to the protocol without informing the IRB?
- Can I amend the HRP series forms?
- Why do I need to submit the documents in a certain order?
- An unanticipated problem was discovered during the course of the study. What should I do?
- My IRB approval letter has an expiration date. What should I do if I plan to continue my study beyond that date?
- I no longer need the data from DSHS, what should I do?
- How long must I hold onto my records after my study closes?
- Should the estimated end date be the same as the data destruction date?
- I have completed data collection and am performing data analysis only. Do I need to renew my approval past the expiration date?
- My approval has expired. What should I do now?
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: Engagement of Institutions in Human Subjects Research (2008 HHS.gov). Please reference Texas state statutes, health codes, and administrative codes for further guidance.
What type of data does DSHS consider ‘identifiable’?
All DSHS data, except for suppressed publicly available aggregate data, is considered identifiable. In certain presentations of data, the combination of values can pinpoint just one or a few cases (e.g. a rare cancer in a small town). Even if the personal identifiable information (PII) is removed from the data set, the data are potentially identifiable. Therefore, all DSHS data are considered identifiable and should be treated as such. All identifiable data requires an IRB submission. Suppressed aggregate data is available to the public and does not require an IRB determination.
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.
Once submitted to the IRB, how long does it take for the application to be processed?
Complete applications submitted by the program to the IRB before the meeting submission deadline will be presented at the monthly IRB meeting. In addition to the IRB, new submissions must be reviewed by the Research Executive Steering Committee (R-ESC). A determination will be sent to the investigator once the R-ESC has met. The R-ESC meets monthly after the IRB meeting. New submissions on average can take 4-6 weeks from the IRB meeting submission deadline but may take longer. To review the IRB meeting dates and submission deadlines. Please visit the Schedules & Deadlines page.
Generally, amendments and continuing reviews are processed quicker than initial submissions, however, missing items or information will delay the IRB’s review of the submission.
If the submission is considered an expedited review, the investigator can expect a determination within 30 days of program submission to the IRB. Additionally, the continuing review application cannot be reviewed until it is within 30 days of expiration.
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 initial review applications, significant changes to approved protocols, and continuing review applications that have lapsed or 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. Expedited review does not mean quick. Additionally, initial applications cannot be expedited.
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. If the researcher believes that their application falls under the exempt category, they need to submit a full initial IRB application in order to receive a determination from the DSHS IRB.
What is the difference between an amendment, renewal, and renewal with amendment application?
Renewal Application: A renewal aplication is an IRB application that has already been reviewed by the IRB and the Research Executive Steering Committee. Principal Investigators should submit their renewal application to the program approximately 10 weeks before their expiration date. The IRB determinations expire 1-2 years after review depending on the risk level established at the initial review. Renewal applications typically qualify for expedited review, however, in certain circumstances may have to be reviewed at the full board.
Amendment Application: Principal investigators are required to submit an amendment application when there is a change to their protocol. Depending on the requested change, different application materials will need to be submitted. Please refer to the HRP-307 Amendment Application and the HRP-311 Amendment Checklist to determine which items need to be submitted with the amendment application. Amendment applications may fall under the expedited review category or need to be reviewed by the full board depending on whether the change is deemed as more than minimal risk by the IRB chair.
Renewal with Amendment Application: Principal Investigators need to submit a renewal with amendment application when their IRB Approval is about to expire and they are making changes to the most recently approved IRB application. Researchers need to submit the required materials for both the renewal application and the amendment application. Researchers should refer to the HRP-313 Renewal with Amendment Checklist and the HRP-307 Amendment Application to make sure they submit the required materials. If the amendment is more than minimal risk, it may cause the application to be reviewed by the Full Board.
When Should the Special Populations box be checked on the HRP 301 form?
The special populations box is found on the HRP 301 form. The intention of this box is to notify the reviewers if a special population is targeted in the proposed project. The IRB reviewer would need to make sure the protocol meets the federal guidelines specifically outlined for these populations. Anytime the project’s subject population targets one of these groups the appropriate box should be checked.
Which individuals should be listed on the HRP-306 Research Team Log?
Individuals who meet any of the following criteria should be on the HRP-306 Research Team Log:
- Principal investigator
- 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 and biospecimens for research purposes
- access, use, study, and analyze identifiable information and biospecimens
The Start Date is when the member is added to the team. The End Date is when the member was removed from the team.
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 Office for Human Research Protections, Protecting Human Research Participants or 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. It is up to the discretion of the IRB administrator and the IRB chair on whether the submitted training qualifies as HSR Training. Human Subject Research certificates must have been issued within the last five years.
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, investigators must 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
When should the Principal Investigator submit an informed consent document vs. the HRP informed consent document waiver?
Informed Consent is a voluntary agreement signed by the participant to enroll in a research study. Its purpose is to ensure that the participants understand the research and its risks. Informed consent is required for all human subject research.
The HRP-305 ICD checklist should be submitted in all submissions that have an informed consent document. The HRP-305 checklist includes federal regulations and agency requirements for informed consent documentation. In some circumstances, the researchers will not be able to include required one or more elements information in their study’s informed consent documents. In this case, the researcher will need to provide justification for each item not included in the informed consent document. Justifications should be written on the HRP-305 ICD checklist.
If it is not practical to obtain consent, the researcher may submit the HRP-304 in place of an informed consent document. Researchers must choose their justification for waiving from the options in the document.
What is the purpose of the HRP-314 Program Routing form?
The HRP-314 is an internal document to track signatures as the IRB application goes through the approval process. The purpose of the HRP-314 is to allow different programs to obtain signatures simultaneously to streamline the IRB submission process. Investigators are not responsible for completing the HRP-314.
When do I need to include the HRP-315 data-linkage plan?
The HRP-315 should be completed by the program when there is an internal data linkage. The principal investigator does not need to complete the form. This form only needs to be submitted at the initial review. If there is a change to the data linkage plan after approval, the HRP-315 should be updated and submitted as an amendment to the IRB.
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.
Can I amend the HRP series forms?
Requests to alter DSHS IRB’s established forms are, generally, not permissible. In the event an alteration of DSHS IRB‘s established forms is deemed necessary, the following items are expected:
- All new requests to alter DSHS IRB’s established forms are subject to Full Board Review.
- The Principal Investigator must submit an addendum justifying all deviations from DSHS IRB’s required forms.
- This addendum and the proposed alterations are subject to DSHS Office of General Council Review and approval before the protocol may be reviewed by the Full Board at a convened meeting.
- Any additional changes to the forms after the initial approval of amendments will need to go back to the full board for approval.
Why do I need to submit the documents in a certain order?
The Texas DSHS IRB has a review process and requires the documents to be in a certain order. The IRB receives upwards of 50 applications a month. It would be very time consuming for the administrator to re-order each submission, therefore, we request that programs submit the documents in the requested order.
Document Submission Order, as applicable
- HRP 301 – Application
- HRP 314 – Program Routing Form(s)
- Attorney approval email (if applicable)
- HRP 306 - Research Team Log
- Human Subject Research Certificates
- HRP 307 – Amendment (if requesting changes to the protocol)
- HRP-308 – Renewal progress report
- HRP 302 – Protocol Track Changes
- HRP 302 – Protocol Clean Copy
- Other IRB determinations
- HRP 304 and or 305 Informed Consent Document or Waiver of Informed Consent Document
- Program Checklist or Program Data checklist (if applicable)
- Researcher Protocol Document (if applicable)
If you need instructions on how to put applications in the proper order, please reach out to the IRB administrator.
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.
I no longer need the data from DSHS, what should I do?
The investigator must complete and submit a Final Report upon Termination of Project form to the IRB, destroy all the data, and submit a certification of data destruction from their institution.
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.
Should the estimated end date be the same as the data destruction date?
The ‘project end date’ is when all project activities have been completed, but the researcher needs to retain the data for retention purposes. The ‘data destruction date’ is when the investigator no longer needs to hold the data. The data is destroyed, and the IRB is closed.
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. The researcher 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.
If the DSHS IRB has not received a continuing review application by the IRB approval expiration date, the protocol will be administratively closed by the IRB. An administrative closure notice requesting a final report form and proof of data destruction will be sent to principal investigators and program contacts on the first business day of the month following the protocol's expiration.
If notification from the DSHS program requesting extended program approval time is received before the IRB approval expiration date, the program will have an additional 30 days to submit the protocol to the DSHS IRB.
To re-open the study, an initial application must be submitted for Full Board Review. The Principal Investigator must submit a signed letter of explanation with the re-submission detailing:
- the circumstances that led to the protocol closure;
- reasons why the investigator feels the research should be re-opened;
- corrective action the investigator has taken to avoid study expiration and closure in the future.
Principal Investigators who allow their protocols to lapse will be placed on probation for non-compliance.