Frequently Asked Questions

Research involving human subjects as participants or involving the use of data from human subjects must be reviewed by the IRB.

Research is the systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR § 46.102(l)) and designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publication or presentation).

When the research involves human subjects, defined 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 (45 CFR § 46.102(e)), then the Principal Investigator must submit an application for review of the study protocol by the IRB.

Click the clink to review the Human Subject Regulations 2018 Requirements Decision Charts.

There are four levels of review for IRB applications: Not Human Subjects Research, Exempt, Expedited, and Full review. The level of risk to the research participant and the types of research procedures used will determine which level of review is required.

Not Human Subjects

Certification of Not Human Subjects Status Projects in this category do not meet the federal definition of research. Projects can be reviewed by the IRB to obtain formal designation as “Not Human Subjects” research, which may be required by academic programs or for dissemination purposes. This category is most appropriate for non-generalizable evidence-based practice projects.

Exempt

Exempt research projects are projects that meet specific federal criteria and fall into one of six categories of research. Although studies in this category are technically exempt from the need for IRB oversight, all Exempt research must be initially reviewed and certified as to the Exempt status of the study by the IRB (45 CFR § 46.104), which requires the submission of an application for Exempt Review.

Expedited

Research studies which pose no more than minimal risk to subjects, as assessed by the IRB, may qualify for an expedited review process. This does not meet a “faster” review process—it simply means that the application may be reviewed through a process other than a full board review as designated by the chair of the IRB.

“Minimal risk means that 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” (45 CFR § 46.102(j)).

Full

Research studies that pose more than minimal risk to subjects must be reviewed by the full IRB. Initial, continuing (renewal) and amendment (modification) applications that involve greater than minimal risk to subjects, must be reviewed via the Full Committee review process and submitted at least two weeks prior to the monthly scheduled IRB meeting.

A full IRB review is a very rare occurrence at USD. Consult your designated IRB Representative or the IRB Administrator prior to submitting your application for full review.

Applications are submitted and reviewed online through the Cayuse IRB system. USD IRB application review is a collaborative process between the researcher, faculty advisor (if the researcher is a student), the IRB representative (“Org. Approver”) for your School or College and the IRB administration. The IRB has authority to approve, require modifications in the application to secure approval, or disapprove all human subjects research activities (45 CFR § 46.109).

The Principal Investigator should allow a minimum of 30 days for IRB review and any required application changes or edits. Therefore, IRB applications should be submitted, via Cayuse, 30 days prior to the anticipated start date for research. Applications seeking Full review must be submitted at least two weeks prior to the monthly scheduled IRB meeting. The Principal Investigator should be prepared to make revisions to the study application as required by the IRB.

Upon final review and approval by IRB, an email notification in the form of an official decision letter will be sent to the PrincipaI Investigator, the Co-Principal Investigator(s) and the faculty advisor.

Research may begin after IRB approval. The Principal Investigator, Co-Investigator(s) and Faculty Advisor will receive notification of IRB approval via email. No research activities, including recruitment or obtaining participant consent, may begin prior to the date of the IRB approval.

IRB applications are deferred and returned to the Principal Investigator when changes or revisions are needed. These changes may be required by the reviewing IRB committee member (Org Approver) or the IRB administrator. The changes may be administrative to ensure compliance with reporting requirements or may be substantive to ensure compliance with human subjects ethics requirements. Once the Principal Investigator makes the requested changes, they must resubmit the application. The application will undergo further review upon receipt of the edited application. In some cases, the Principal Investigator will need to revise the start date of the study to allow time for the continued review process.

Principal Investigators are required to submit any change in their study including researchers, purpose and significance, participants, recruitment, methodology, consent or confidentiality. A Modification application is submitted in Cayuse for review and approval. Changes may not be implemented prior to IRB approval.

Principal Investigators are required to submit a Renewal application in Cayuse, annually, on or before the anniversary of the approval date of their study.

Per USD IRB, it is the responsibility of the Principal Investigator to submit a Closure Application in Cayuse when all research or data collection is complete and de-identified. Note that once a study is closed, it cannot be reopened.

If you do decide to close your study, use this instrutional video as a guide.

Email questions to irb@sandiego.edu using your USD email contact information.

Cayuse is the external software platform used by USD for IRB submissions and reviews.

If this is your first time submitting an IRB application at USD, email irb@sandiego.edu using your USD email address to request for a new Cayuse user profile creation. Make sure to indicate whether you are student, faculty, or administrator. Students are required to include their faculty advisor’s name in order to gain Cayuse access. Detailed directions will be emailed to you on how to access the IRB Application in Cayuse IRB, via MySanDiego portal.

Watch these videos for an example of how to start, submit and certify a new IRB application in Cayuse.

• Creating an exempt application
• Creating an expedited application
  • Part 1
  • Part 2
  • Part 3
  • Part 4
• Creating a modification application
• Creating a renewal application
• Creating a closure application (note that once a study is closed, it cannot be reopened)

Once started, applications are considered current for 90 days, prior to submission in Cayuse. Any applications first started beyond the previous 90 days should be withdrawn and a new application initiated and submitted.

Email questions to irb@sandiego.edu using your USD email contact information. (USD ITS is not able to assist with technical difficulties in Cayuse.)

A faculty letter of permission is required for USD students submitting an IRB application. The Faculty Letter should come from the student’s course instructor or thesis/dissertation faculty advisor. It is an acknowledgement from the faculty member that they have reviewed the application and will oversee the research.

A letter template is available under Forms on the USD IRB website. It must meet the following requirements:

• Must be on USD letterhead and written by the faculty member.
• Include the study title as it appears on the IRB application
• Include the name of the Principal Investigator as it appears on the IRB application
• Signed and dated by the faculty member within 90 days of the IRB application submission.
• Confirm the primary responsibility of the advisor and the faculty's commitment to advise and oversee the research study.

A site letter of permission is a letter from the appropriate authority (e.g., Director of a community center, Principal of a school, etc.) granting the Principal Investigator permission to conduct their study at a specific site or location.

A letter template is available under Forms on the USD IRB website. It must meet the following requirements:

• Must be on the organization’s letterhead and written by the site authority or its designator.
• Must include the study title and name of the Principal Investigator as it appears on the IRB application.
• Must be dated within 90 days of the IRB application submission.
• Must be signed by the site authority.
• If the Principal Investigator plans to contact participants through the site’s contact list (email addresses, USPS addresses, telephone numbers, etc.), the site letter of permission must explicitly state permission to use such contact information.

Studies subjected to IRB review are not allowed to start until it is fully approved by the IRB.

For exempt, expedited, and full review applications, the proposed start date should allow a minimum of 30 days after the application is submitted and certified for IRB review, PI’s edits, and processing of the application.

The IRB cannot approve studies retroactively. Therefore, even if the proposed start date has already passed by the time a final IRB approval is issued, all activities involved in the study cannot start until the approval effective date stated on the final decision letter.

In all cases, recruitment documents must meet specific requirements. Please see specific guidelines in the Forms page.

Recruitment documents or scripts must be drafted using age or developmentally appropriate language and must include: What participants will be asked/invited to do; the length of time required to complete the research associated activities; how/where their involvement will take place (in person, one on one interview, group interview, online interview, etc.); if participation will be audio and/or video recorded; if any compensation is offered (if compensation is provided, it cannot be emphasized, i.e., cannot use large font to advertise compensation on a flyer); include the PrincipaI Investigator’s USD email contact information or USD department or office phone number (no personal contact information).

If the participant is a minor, then an additional recruitment solicitation must be made to the parent or guardian.

The Principal Investigator must inform participants during the study recruitment process regarding whether any recording of the participant, either audio or video, will be made and how it will be used by the researcher. An additional Video Recording Consent form is required for all video recordings. This form can be found on the USD IRB website under Forms. Participants have the right to opt out of the video or audio recording, as well as the study, at any time.

Participants may be offered compensation for their time or any other costs associated with participation in the research study. Compensation must be clearly stated in all study related documents as to the amount, value and method of receipt and that compensation will be available to all participants even if they do not complete the study. Compensation however, may not be emphasized in recruitment documents.

Participants must consent to being included in a research study. If the participant is a minor, they must give their assent and their parent or legal guardian must give consent. If the participant is an adult without legal capacity to consent, their legally authorized representative must consent. Please see templates provided for consent and assent forms in the Forms page.

Occasionally, the research is conducted in a manner that makes obtaining a physical signature that documents informed consent difficult (e.g., interaction over the internet). In such cases, the Principal Investigator can request a waiver of signed consent. Obtaining informed consent is still required, but no signature is obtained. The Principal Investigator is responsible for documenting that informed consent was obtained from the participant.

A waiver of consent can only be obtained under circumstances dictated by federal regulations (45 CFR § 46.116(e), (f)). The Principal Investigator should consult with the IRB Committee Member if they believe their study would merit waiver of consent.

Occasionally, the research is conducted in a manner that makes obtaining a physical signature that documents informed consent difficult (e.g., interaction over the internet). In such cases, the Principal Investigator can request a waiver of signed consent. Obtaining informed consent is still required, but no signature is obtained. The Principal Investigator is responsible for documenting that informed consent was obtained from the participant.

Federal regulations dictate the content and documentation of informed consent (45 CFR §§ 46.116, 46.117). To meet these requirements, USD IRB requires the use of approved Consent documents. The template for the approved consent documents can be found on the USD IRB website under Forms.

An additional consent form must be provided to the parent or guardian, if the participant is a minor.

A translation of consent forms for non-English speaking participants must be available and submitted in the Cayuse application for IRB review. Because the IRB may request changes in study documents, the IRB recommends that the Principal Investigator obtain IRB approval of all study-related documents in English first, and then submit a study Modification application with the non-English documents to avoid multiple translations of documents.

A translation of all study documents, including recruitment document(s) or script(s) for non-English speaking participants must be available and submitted in the Cayuse application for IRB review. Attestation of the accuracy of the translation by the translator may be required. Please contact the IRB regarding the need for attestation.

Because the IRB may request changes in study documents, the IRB recommends that the Principal Investigator obtain IRB approval of all study-related documents in English first, and then submit a study Modification application with the non-English documents to avoid multiple translations of documents.

Stop all research immediately and contact the IRB administrator, irb@sandiego.edu.

If your research study involves human subjects who lack the capacity to consent to participation in research, federal regulations permit researchers to obtain consent from a legally-authorized representative. The USD IRB provides guidance for USD researchers seeking surrogate consent to help researchers in the design of their research protocols with human subject participants. Refer to the guidance posted on our USD IRB website under Education and Resources, along with relevant forms and examples. A template for Adult Consent Form with Surrogate Decision Maker can be found under the Forms tab of the USD IRB website.

IRB of Record or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Authorization Agreement is a document defining the roles and responsibilities of the participating institutions and stating which institution will be responsible for IRB review/approval.

Forms for IRB of Record may be found on the USD IRB website under “Forms”.

Contact Office of Sponsored Programs: https://www.sandiego.edu/osp/

The Office of Sponsored Programs (OSP) and Institutional Review Board (IRB) work together when a study is part of a grant, and link the OSP application and the IRB application in Cayuse. All researchers on the project are required to complete Responsible Conduct of Research (RCR) training, in addition to CITI IRB training.

The Organizational Approver, “Org Approver”, is the IRB Committee Member(s) for your School or College.

Under the ethical principle of justice, recruitment of participants must be fair and equitable (45 CFR § 46.111(a)(3)). Recruitment efforts may not target potential participants based solely on personal relationships. Participants must be free to choose whether or not to take part in a research study without undue influence or coercion.

Snowball sampling, a recruitment technique in which research participants are asked to assist researchers in identifying other potential subjects, may be justified in some circumstances. Snowball sampling may not be appropriate for research involving sensitive topics. Please contact the IRB, irb@sandiego.edu, for guidance when using this recruitment technique.

Research may be conducted at more than one location. A site letter of permission is required for each location and the IRB application must identify the individual locations. When conducting research in the education setting, each individual school must be identified, including street address, and a school specific site letter of permission is required.

Conducting research with another institution is allowed. The Principal Investigator is required to identify which institution(s) will be responsible for review.

Independent IRB: USD IRB and other IRB(s) will independently review and approve this study protocol

External IRB: Another external IRB has already approved this protocol and USD's IRB approval is requested for research involving USD faculty and/or students

USD IRB is IRB of Record: USD's IRB will be the IRB of Record for all sites of a multi-site project

Federal regulations dictate specific requirements when conducting research with federally designated vulnerable populations, pregnant persons, fetuses, children and prisoners (45 CFR § 46.111(a)(3)), as well as individuals with impaired decision-making capacity (including those with substance use disorder or mental health conditions), or economically (such as unsheltered persons) or educationally disadvantaged persons (such as an adult having obtained less than a high school diploma). When contemplating research involving a vulnerable population, the Principal Investigator should consult with their IRB Committee Member or IRB Administrator, keeping in mind that the application may require a Full review. Applications for Full review must be submitted two weeks prior to the monthly scheduled IRB meeting.