UCSD Human Research Protections Program

UC San Diego, HRPP Home page

Frequently Asked Questions

1. What is the most common problem that delays approval/acceptance of a study by the IRB/HRPP?

The most common problem is not appropriately providing the information requested in the Research Plan instructions:

Without an appropriate response to the requested information, the IRB/HRPP cannot determine whether all criteria for approval/acceptance of a research study are satisfied and must request clarification and/or additional documentation, which will surely delay possible approval/acceptance of a study.

2. How can I best ensure the Research Plan provides appropriate information?

Read the instructions carefully and respond specifically and accurately. Also, use the "Project Reviewer" checklists that can be found on the HRPP website at https://irb.ucsd.edu/Checklists.shtml .

3. What is the second most common problem?

The second most common problem is consistency of information across all study documents. For instance, the number of subjects that may be enrolled in the study must be the same as noted on the application Facesheets, the Research Plan, and the consent/permission/assent documents. Also, if the Facesheets indicate that the study involves vulnerable populations such as children, prisoners, or cognitively impaired individuals, the study documents must include appropriate procedures to specifically address such populations. Inconsistencies result in requests for clarification/documentation, which will surely delay possible approval/acceptance of a study.

4. How can I ensure my consent/assent documents include all the necessary elements of an informed consent/assent?

Use the sample templates provided on the IRB/HRPP website for your specific situation. For instance, if you are obtaining consent for a Biomedical study, use the consent samples available at https://irb.ucsd.edu/Biomedical-Forms.shtml . If the study is a Social and Behavioral study, use the samples at https://irb.ucsd.edu/SBS-Forms.shtml .

5. What are the criteria that must be satisfied in order for the IRB/HRPP to approve a study?

Basically, there are eight criteria that must be satisfied to approve a study. These criteria can be found in the federal regulations as well as the UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP). The criteria include that risks must be minimized; there must be a favorable risk/benefit ratio; there must be an equitable subject selection; informed consent must be sought; informed consent must be documented; if appropriate, data collected on study must be monitored for safety; appropriate procedures are in place to protect the privacy of subjects and to maintain confidentiality of information obtained on study; and if appropriate, safeguards must be in place to protect vulnerable individuals. By using the appropriate reviewer's checklists, available here , you can help ensure these criteria have been satisfied.

6. How do I know if my project is human subjects research?

The IRB/HRPP website includes two checklists to determine whether a study is human subjects research. The checklists can be found at https://irb.ucsd.edu/Checklists.shtml .

7. What documents require the UCSD HRPP stamp-of-approval?

Any document that is requesting consent/permission/assent from a participant/parent for procedures done in association with a research study or a document that is being used to recruit a participant requires a stamp-of-approval. Documents that do not require a stamp-of-approval include a questionnaire unless the questionnaire includes wording to consent the participant.

8. How do I know if my research is subject to HIPAA?

If the research involves review of person-identifiable medical records, or the study results in new information that is added to medical records (such as a test of a new diagnostic or therapeutic agent or device), then it is using or creating protected health information (PHI) and is subject to HIPAA Privacy Rule provisions. More information about the HIPAA Privacy Rule can be found at https://irb.ucsd.edu/HIPAA-Information.shtml .

9. Does the HIPAA authorization require review and approval by the UCSD IRB?

By regulation, the UCSD IRB is not required to review the authorization and does not approve the authorization. It is up to the investigator to ensure that appropriate HIPAA authorization is obtained and the appropriate document is used. Note that the authorization cannot be revised and is not stamped approved by the IRB because the authorization is an institutional document.

10. How can I determine what type of form should be used for the type of study that is being proposed?

Review the Forms page on the IRB/HRPP website. This page includes a description of the type of study and the type of forms that should be used. The Forms page is at https://irb.ucsd.edu/forms-new.shtml .

11. I sometimes can't find something on the IRB/HRPP website. What should I do?

The IRB/HRPP website now includes a Topics page that should help you find an answer to your question. If you still cannot find the answer to your question after reviewing the website, please contact the HRPP Office at 858-246-HRPP (858-246-4777).

12. Who is responsible for obtaining continuing review approval?

It is the Principal Investigator's responsibility to obtain continuing approval for projects lasting longer than one year. The PI, therefore, should maintain internal systems to track when continuing reviews must be submitted. Although e-IRB system reminders can be useful, they should not be relied upon to avoid lapses in approval (due to volume of data and access by multiple users). Federal regulations require that IRB review and re-approval of projects be accomplished at intervals not greater than 365 days. If continuing review documents are not submitted before study expiration, a complete, "New" application must be submitted. If Initial and Continuing Reviews are granted, the maximum project lifespan is up to ten years (i.e., up to nine cycles of Continuing Review after Initial approval). No later than 45 days prior to the tenth anniversary of initial approval, the project must be resubmitted as a New Application. The title should include the word "Resubmission" after the title on the new application Facesheets.

13. What is expedited review?

Expedited review is a type of review that can be used for the initial and continuing review of projects and amendments/changes to an approved project when the project and/or amendment is considered minimal risk, does not require review by a convened IRB, and can be appropriately reviewed by the IRB Chair or an HRPP analyst. It does not mean the review will be done "faster" or will be put before other review requests.

14. What is the definition of minimal risk?

Minimal risk is defined by federal regulation as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." A slightly different definition is used for prisoners (see here ).

15. What is the difference between a waiver of documented consent and a waiver of consent?

When specific criteria are satisfied, such as the study is considered minimal risk, a waiver of documented consent or a waiver of consent may be granted for a study. These criteria are outlined in the federal regulations, the UCSD IRB/HRPP SOPPs, and in the application instructions that can be found here for Biomedical research studies and here for Social and Behavioral Sciences research studies. Basically, a waiver of documented consent would be granted when a subject is consented but the subject does not sign an informed consent document such as through the use of an oral consent. A waiver of consent would be granted when no consent will be obtained from the subject.

16. What is required for a pregnant partner or pregnant participant to be involved in a research study?

First, determine whether the pregnant partner/pregnant participant will be enrolled or continued to be enrolled in the study.

If the pregnant person will be enrolled or continue to be enrolled in the study, a "Research Involving Pregnant Women…" supplement must be completed, the Research Plan must reflect the enrollment of a pregnant person including specific aims, justification for the inclusion of a pregnant person, consenting procedures, consent form, if appropriate, risk and risk management procedures, etc. Satisfaction of the criteria for the involvement of the pregnant woman must be determined and approval of procedures associated with enrollment of a pregnant person must be documented by the IRB before the pregnant person can be enrolled on the study or continue to remain a participant on the study.

Also, if a pregnant participant withdraws or is withdrawn from the interventional portion of the study, but agrees to continued follow-up of associated clinical outcome information, the researcher must obtain the participant's consent for this limited participation in the study (assuming such a situation was not described in the original consent document). IRB approval of these procedures and consent document(s) is/are required. However, if it is determined that the pregnant person will not be enrolled in the study or continue to participate in the study, the Research Plan should provide justification for this determination, and if approved by the IRB, no further action may be required.

17. Can you explain how the current (as of June 1, 2018) approval dates for initial review and continuing review are determined?

For initial approval, the approval date will be the date when all criteria for approval of a research study have been satisfied. If the IRB determines the criteria have been met at an IRB meeting, the initial approval date will be the date of the IRB meeting. If the study was approved pending receipt of specific confirmation(s)/revision(s), the date those have been determined to be satisfied by the IRB Chair or the IRB Chair's designee will be date of initial approval.

For continuing review approval, if the review of the continuing review submission happens within 30 days before the current study expiration date, and the study is granted continuing review approval or approval pending receipt of specific confirmation(s)/revision(s), the "anniversary" date of last approval date will be used (not the date of the IRB meeting where the review was performed as was previously used). This date will be the month and day of the previous approval date with the current year. For example, if the last approval date was June 5, 2017, and the continuing review was performed within 30 days of this date, the continuing review approval date will be June 5, 2018.

18. I'm preparing a human gene transfer trial, and I need a Recombinant DNA Advisory Committee (RAC) determination letter from the Institutional Biosafety Committee (IBC) and the IRB. How do I obtain this letter?

The IBC will provide you with the RAC determination letter to be filed with the NIH Office of Science Policy . The HRPP and Environment Health & Safety have agreed that the IRB will defer to the IBC's RAC determination. For additional information, please contact the IBC at ehsbio@ucsd.edu . Please note that the RAC determination is not an IRB approval of the trial. Before enrolling participants on the trial, approval from the IRB must be in place along with any other required approvals.

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