IRB Manual_4.26

IRB MANUAL FOR RESEARCHERS

DEPAUL OFFICE OF RESEARCH SERVICES/RESEARCH PROTECTIONS orp@depaul.edu

Table of Contents PURPOSE OF THE MANUAL ........................................................................................................................... 3 INTRODUCTION TO DEPAUL IRB ................................................................................................................... 3 Purpose of the IRB .................................................................................................................................... 3 IRB Membership ....................................................................................................................................... 3 Research Requiring IRB Review ................................................................................................................ 4 IRB Review Process ................................................................................................................................... 5 How Often Does the IRB Meet? ................................................................................................................ 5 IRB Review Turnaround Time ................................................................................................................... 5 TYPES OF IRB REVIEW ................................................................................................................................... 6 Exempt Studies ......................................................................................................................................... 6 Expedited Review...................................................................................................................................... 7 Full Board Review...................................................................................................................................... 7 IRB SUBMISSION PROCESS ............................................................................................................................ 8 Who Can Serve as the PI? ......................................................................................................................... 8 PI’s Responsibilities ............................................................................................................................... 8 Faculty Advisor’s Responsibilities ......................................................................................................... 8 Mandatory Human Subjects Training ....................................................................................................... 8 Types of IRB Submissions .......................................................................................................................... 9 Initial Submission .................................................................................................................................. 9 Amendment .......................................................................................................................................... 9 Renewal................................................................................................................................................. 9 Prompt Report .................................................................................................................................... 10 Final Report/Study Closure ................................................................................................................. 11 How to Submit an Application in eProtocol? .......................................................................................... 11 Step-by-step Instructions for Submitting an Application in eProtocol ............................................... 11 1.

Follow this link to access eProtocol https://researchcompliance.depaul.edu/ ............................. 11

IRB PROTOCOL DEVELOPMENT................................................................................................................... 14 Subjects Identification and Eligibility Screening ..................................................................................... 14 Subject Recruitment ............................................................................................................................... 14 Convenience Sampling ........................................................................................................................ 15 Adult Volunteers ................................................................................................................................. 15 Inclusion of Minors ............................................................................................................................. 15 Inclusion of Minorities and Non-English-Speaking Individuals ........................................................... 15 Inclusion of Students........................................................................................................................... 15 1

Use of Student Coursework for Research Purposes ........................................................................... 16 Inclusion of Colleagues & Employees ................................................................................................. 16 Cross-Cultural Research ...................................................................................................................... 16 Snowball Recruitment ......................................................................................................................... 16 Advertisements and Recruitment Materials ....................................................................................... 17 Informed Consent ................................................................................................................................... 17 HIPAA Authorization ........................................................................................................................... 18 Implied Consent .................................................................................................................................. 18 Consent of Subjects Who Are Not Fluent/Literate in English ............................................................. 18 Assent of Children Participating in Research Projects ........................................................................ 19 Waiver of Parental Permission............................................................................................................ 19 Consent and Information Sheet Templates ........................................................................................ 19 Privacy ..................................................................................................................................................... 20 Secondary Subjects ............................................................................................................................. 20 Confidentiality ......................................................................................................................................... 20 Confidentiality vs Identifiability .......................................................................................................... 21 Confidential vs Anonymous ................................................................................................................ 21 Certificate of Confidentiality ............................................................................................................... 22 Risks ........................................................................................................................................................ 22 Benefits ................................................................................................................................................... 22 Research Data Management .................................................................................................................. 22 Compensation ......................................................................................................................................... 23 Reliance ................................................................................................................................................... 23 SMART IRB........................................................................................................................................... 24 Use of AI in Research .............................................................................................................................. 24 ATTACHMENTS............................................................................................................................................ 26 Exempt Application Questions in eProtocol ........................................................................................... 26 Expedited and Full Review Application Questions in eProtocol ............................................................. 27

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PURPOSE OF THE MANUAL This IRB Manual serves as a practical companion to DePaul’s Policy for Research Involving Human Subjects. The Policy establishes the overarching principles governing human subjects research at DePaul University. The Manual translates those principles into practical guidance for submitting protocols, obtaining approval, and maintaining compliance throughout the life of a study. In addition, the Manual clarifies the IRB review process, explains key concepts and elements of ethical research design, and offers sample application questions.

We hope that this Manual will assist you in preparing your IRB application and navigating the IRB process.

INTRODUCTION TO DEPAUL IRB Purpose of the IRB The IRB, or Institutional Review Board, is a committee established to review and approve research involving human subjects. Its primary purpose is to ensure that research is conducted ethically and in compliance with federal, state, and institutional regulations. At DePaul University, the IRB is formally appointed by the University President and operates under a Federal Wide Assurance (FWA) with the Office for Human Research Protections (OHRP). The IRB is a part of Research Protections of the Office of Research Services. General inquiries about the IRB should be sent to orp@depaul.edu The IRB follows the ethical principles of The Belmont Report and operates in compliance with 45 CFR 46 (the Common Rule), all other applicable federal and state regulations, and DePaul University’s Policy for Research Involving Human Subjects. The Policy stipulates that all research involving human subjects must be reviewed and approved by the IRB before its initiation.

IMPORTANT TO REMEMBER. The IRB cannot approve research retroactively. All research involving human subjects must receive IRB approval before any research activities begin, including recruitment, data collection, or interaction with participants. Conducting research without prior IRB approval is a violation of federal regulations and DePaul University policies.

IRB Membership IRB members are diverse faculty from the schools, colleges, and departments most actively conducting human research at DePaul, the Director of Research Compliance, other staff members in the Office of Research Services, and an unaffiliated community representative. Additional voting members with expertise in specialized fields may be included on reviews as needed, such as protocols involving prisoner populations. Information about current IRB membership is available on the IRB website.

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Research Requiring IRB Review The IRB reviews projects that meet the federal definition of research involving human subjects.

According to 45 CFR 46.102, this includes any systematic investigation designed to develop or contribute to generalizable knowledge, where data are obtained through interaction or intervention with living individuals or involve identifiable private information.

Projects that qualify as research involving human subjects under federal definitions include: • Studies of new drugs, devices, or interventions on participants to evaluate safety or effectiveness.

• Collection of biological samples, vital signs, or other health-related data from living individuals.

• Research exploring opinions, behaviors, or experiences of individuals through questionnaires or interviews.

• Observations of decision-making, cognitive processes, or social interactions in controlled settings.

• Studies of teaching methods or learning outcomes when identifiable student data is collected.

• Independent student research projects such as an undergraduate independent research project, master’s project, master’s thesis, dissertation, or similar work involving human subjects.

• Research that uses identifiable private information from existing datasets (e.g., medical records, student files).

Projects that fall outside the federal definition of research involving human subjects include: • Internal program evaluations or process improvements intended solely for institutional use, not for generalizable knowledge.

• Student projects conducted as part of coursework, where results are not intended for publication or dissemination beyond the class.

• Assessments of institutional services for internal decision-making, without plans to generalize findings.

• Analysis of datasets that have been stripped of all identifiers and cannot be linked back to individuals.

• Research using data that is publicly available (e.g., census data, published government statistics).

• Journalistic or oral history activities, including collecting information for reporting or documenting events, not for hypothesis-driven research.

IMPORTANT TO REMEMBER. Only the IRB has the authority to determine whether a project meets the federal definition of research involving human subjects and therefore requires IRB review. Researchers should not make this determination themselves. If there is any uncertainty, the project must be submitted to the IRB for assessment before any research activities begin.

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IRB Review Process The IRB conducts reviews through a structured process designed to ensure ethical and regulatory compliance. This process begins with the submission of a complete research protocol, including recruitment and consent forms, research instruments, and supporting materials. The IRB then determines the appropriate review category—exempt, expedited, or full board—based on the level of risk and the nature of the study.

The IRB review focuses on evaluating the how of research to ensure that all study procedures uphold ethical principles and regulatory requirements. The reviewers consider the methods by which participants are recruited, ensuring equitable selection and minimizing undue influence; the informed consent process, confirming that participants receive clear, comprehensive, and understandable information about the study, its risks, benefits, and their rights; and the procedures for data collection, verifying that these methods respect participant privacy and adhere to approved protocols. Additionally, the IRB assesses data safety and confidentiality measures to ensure that identifiable information is securely stored, protected against unauthorized access, and managed in compliance with institutional and legal standards. Through this comprehensive review, the IRB safeguards participant welfare and promotes the integrity of the research process.

Depending on its findings, the IRB may approve the study, request modifications, defer for additional information, or disapprove the protocol. Once approved, the IRB provides ongoing oversight through continuing reviews of research involving greater than minimal risk, monitoring amendments, and ensuring prompt reporting of adverse events.

How Often Does the IRB Meet?

The IRB meets monthly for full-board reviews of research protocols involving greater than minimal risk. Expedited and exempt studies are reviewed on a rolling basis. The IRB maintains a monthly schedule of full board meetings, which is publicly accessible on the DePaul IRB website under "Deadlines & Meetings."

IRB Review Turnaround Time At DePaul University, exempt and expedited submissions are typically reviewed on a rolling basis, with researchers advised to allow up to 7 business days for an initial decision. In contrast, full board reviews are aligned with the IRB’s monthly convened meetings during the academic year.

Protocols requiring full IRB review must be submitted a minimum of 3 weeks before the next scheduled date of the IRB meeting. Please check the IRB web page for meeting dates and submission deadlines. The turnaround time for full board review may range from 1 to 3 months, depending on the required modifications. Full board protocols submitted in late spring or early summer may experience delayed review until the fall, so researchers are encouraged to submit early and consult the IRB’s posted schedule.

The most important factors in presenting an application to the IRB are detail and clarity. Most of the questions and reasons for deferral or requests for modification/additional information have to 5

do with ambiguous or uncertain statements in the protocol, or a lack of information, especially about procedures, recruitment, risks, benefits, and informed consent.

To facilitate an IRB review, researchers can take several steps: • Submit a complete application to ensure that all required documents (consent forms, recruitment materials, research instruments, letters of support) are included. Double-check that all sections of the application are completed correctly and that all questions are answered.

• Respond promptly to IRB requests. If the IRB asks for clarification or modification, reply promptly and thoroughly.

• Plan ahead. Avoid last-minute submissions, especially for studies requiring convened review.

• Follow IRB-approved templates for consent forms and recruitment materials to reduce revision requests.

• Communicate with the IRB Office. Contact the IRB early for pre-review consultations or to clarify requirements.

IMPORTANT TO REMEMBER. If a Principal Investigator is unable to complete the required revisions within the 8-week timeframe, the protocol or submission file will be closed. To reopen IRB review, the Principal Investigator will need to resubmit the application.

TYPES OF IRB REVIEW Exempt Studies Research is exempt from IRB oversight if it poses no more than minimal risk and all research procedures fall within one or more of the exemption categories in the federal regulations (45 CFR 46.104). Most online surveys and interview studies that do not involve vulnerable populations, sensitive topics, or the combination of different types of data (e.g., interview and student records) qualify for exemption. Projects that may qualify for an exemption determination are reviewed by the Office of Research Services staff to determine eligibility. During the review, the IRB or ORS staff may grant an exemption determination or refer projects to the IRB for expedited or full Board review.

Each of the federal exemption categories may be applied to research subject to 45 CFR 46, Subpart B, Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research, if the conditions of the exemption are met per 45 CFR 46.104(b)(1).

Exempt status is not granted for research subject to 45 CFR 46, Subpart C. Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects, except where the research is intended for a broader subject population and only incidentally involves prisoners per 45 CFR 46.104(b)(2).

Exemptions 1, 4, 5, and 6 may be applied to research subject to 45 CFR 46, Subpart D. Additional Protections for Children Involved in Research. 45 CFR 46.104(b)(3) indicates special limitations in 6

the application of exempt status to research with children for exemption 2(i) and 2(ii). Exemptions 2(iii) and 3 cannot be applied to research with children.

FDA-regulated research may not be granted exempt status, except for Exemption 6.

Exempt determinations are valid for 10 years. If the research continues beyond 10 years, it must be resubmitted to the IRB as a new application.

Expedited Review An expedited review procedure exists for research protocols involving human subjects that meet the criteria for expedited review as outlined in the regulations (45 CFR 46.110). These include protocols that involve minimal risk to subjects and meet the criteria for one or more of the expedited categories, research eligible for expedited continuing review, or minor changes to the research approved by the full board. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that the risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

At DePaul, protocol submissions eligible for expedited review are reviewed by one or more voting members of the IRB or by the Office of Research Services staff who are experienced reviewers. The IRB reviewers have the authority to approve expedited projects or to refer them to the convened IRB for full Board review. The IRB members also review submissions such as continuing review applications and amendments that meet the criteria for expedited review.

Expedited approvals are valid for 5 years, unless otherwise noted. If the research continues beyond 5 years, it must be resubmitted to the IRB as a new application.

IMPORTANT TO REMEMBER. The term “expedited review” does not mean a fast review. Instead, it refers to a specific category under federal regulations for research involving no more than minimal risk and falling within federally designated categories (as defined in 45 CFR 46). Likewise, “exempt research” refers to certain types of minimal risk research that fall within specific federally designated categories and are exempt from the full requirements of 45 CFR 46 (the Common Rule). However, “exempt” does not mean the research is free from oversight—researchers must still submit the project to the IRB for determination of exemption before starting.

Full Board Review If a protocol involves greater than minimal risk to the subject or does not meet the criteria for one or more of the expedited categories, such as when the research involves vulnerable populations, deception, or procedures that are personally intrusive, stressful, or potentially traumatic, it is reviewed by the full board at a convened IRB meeting. Convened/full review is required for research involving prisoners.

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IMPORTANT TO REMEMBER. Although researchers may request an exemption or an expedited review, the determination of such resides with the IRB. The IRB reviewers, the IRB Chair, or the Director of Research Compliance may move any protocol to the convened/full review if they believe an additional level of scrutiny is required.

IRB SUBMISSION PROCESS Who Can Serve as the PI? Any faculty, staff, or student associated with DePaul may serve as the Principal Investigator (PI) on a human subjects protocol. Student investigators must have faculty advisors who will take responsibility for the scientific and ethical conduct of the student’s research.

PI’s Responsibilities

The PI is ultimately responsible for the ethical and compliant conduct of research involving human subjects. This includes ensuring that all study activities adhere to the IRB-approved protocol and applicable are applicable to federal, state, and institutional regulations. The PI is responsible for obtaining and documenting informed consent, safeguarding participant privacy and data confidentiality, and supervising all research personnel to maintain compliance. Additionally, the PI must report adverse events, unanticipated problems, and protocol deviations promptly to the IRB, submit amendments before implementing changes, and complete continuing review requirements to maintain approval. Accurate recordkeeping and secure data management throughout the study lifecycle are essential, as is closing the study appropriately when research activities conclude.

Through these responsibilities, the PI ensures the integrity of the research and the protection of participants.

Faculty Advisor’s Responsibilities

Faculty Advisors play a crucial role in the IRB process by ensuring that student research protocols adhere to ethical standards and comply with institutional policies. Faculty Advisors' responsibilities include: • Teaching students about ethical research practices.

• Assisting in the preparation and submission of human subjects research applications.

• Signing the Assurance Statement to certify the study's scientific merit, the qualifications of the investigator, and the adequacy of resources.

• Managing the approved research protocol in collaboration with the student PI to ensure completeness and adherence to departmental practices.

• Ensure that the student’s research is closed after completion.

Additionally, faculty advisors provide guidance on research conduct, including submitting modification forms, continuing review forms, and prompt reports in the eProtocol system.

Mandatory Human Subjects Training

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All DePaul individuals (faculty, staff, or students) engaged in conducting human subject research, including faculty sponsors supervising student researchers, are required to complete the CITI online course titled Faculty/Staff/Outside Collaborators/Students before they will be approved as personnel on a research protocol. DePaul University has subscribed to the CITI online training program for researchers to meet this initial and continuing educational requirement. Review Instructions for How to Register and Complete CITI Training on the Research Protections website.

IMPORTANT TO REMEMBER: To ensure that completed CITI training records are automatically uploaded into eProtocol, the researcher’s "DePaul ID" in the Institutional Profile section of their CITI Member Profile must match their Outlook Directory Alias, which can be found in the rightmost column. This ID is also the eProtocol User ID. If these IDs do not match, the CITI training records will not auto-populate in eProtocol. Submitting an application without CITI training completion records may delay the IRB review process.

Types of IRB Submissions Initial Submission

An initial IRB submission refers to the first application submitted by a researcher to obtain IRB approval for a new study involving human subjects. This submission includes a comprehensive protocol outlining the study’s objectives, design, methodology, and procedures for participant recruitment and consent. Researchers must provide detailed information on potential risks and benefits, data collection and storage methods, confidentiality protections, and plans for monitoring participant safety. Supporting documents such as consent forms, recruitment materials, and study instruments are also required. The purpose of the initial submission is to allow the IRB to conduct a thorough review to ensure compliance with ethical standards and federal regulations, including the protection of participants’ rights and welfare. Approval of the initial submission is mandatory before any research activities involving human subjects can begin.

Amendment

Changes to research procedures or methods (including but not limited to recruitment and enrollment processes, funding source or status, inclusion/exclusion criteria, changes in the target population, changes in proposed subject number, changes in performance sites), documents, or research personnel can be made via an amendment to the approved protocol. An amendment must be reviewed and approved by the IRB before the change can be initiated. The amendment submission should include any revised materials, such as consent documents, recruitment materials, etc., that have been altered. Some revisions may be eligible for exempt or expedited review. Substantial revisions, particularly those that increase the risk posed to subjects, may require review by the convened IRB. Renewal

All research that the IRB has approved via full board review must undergo continuing review via a renewal application as frequently as determined by the Board (at least annually), when any of the following conditions apply: • •

Data collection is ongoing; or There will be additional contact with subjects.

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When submitting the renewal application, the investigator must include all information on progress made to date, the number of research subjects seen, and any problems encountered. If recruitment and enrollment of subjects are ongoing, the submission should include a copy of any consent documents or recruitment materials that will continue to be used. If changes to the research are made during the continuing review, an amendment form and a revised protocol incorporating those changes must be submitted with the continuing review application. If any protocol documents are revised in the amendment, copies of the revised documents (consent documents, recruitment materials, and revised measures) must be submitted for review.

IMPORTANT TO REMEMBER. Most expedited protocols are no longer required to undergo annual continuing review, but the IRB may deem this necessary for any given protocol.

Prompt Report

Prompt reports are used for the timely submission of information regarding events or changes that may affect the rights, safety, or welfare of research participants or the integrity of the study. Prompt reporting enables the IRB to take appropriate actions to mitigate risks, protect participants, and maintain compliance with federal regulations and institutional standards. Failure to report promptly may result in suspension of research activities or other corrective measures.

At DePaul University, adverse events, including unanticipated problems involving risks to subjects or others (UPIRSOs), and subject complaints must be reported to the Office of Research Services within 72 hours. When an unforeseen or unexpected adverse reaction is research-related, serious, and indicates that changes need to be made to the research to prevent harm to subjects, all research activities must be suspended immediately.

In reporting an unanticipated problem, adverse event, or subject complaint, researchers should: • • • • •

Describe the incident in sufficient detail to allow an informed review of the occurrence.

Describe any necessary changes to the protocol to minimize risk to subjects in the future or the rationale if no changes are made.

Describe any steps taken to address the occurrence.

Describe any necessary changes to the consent and any plans for re-consenting current subjects, or provide the rationale if no changes to the consent are required.

Explain why the overall risk/benefit relationship of the research is still acceptable in light of the information concerning this incident.

On receiving notification of such incidents, the IRB reviews the report to determine whether revisions to the protocol or consent documents are merited. The PI will be notified of the review results, including whether revised materials are necessary. If the UPIRSO or adverse event was serious and the research was halted, the IRB will inform the PI when research activities may resume.

A summary of all serious adverse event reports, UPIRSOs, and subject complaints will be distributed to the full Board in the meeting agendas, at the meeting following the completion of the review of the event. When deemed necessary by the IRB sub-committee, an event may be reviewed by the convened IRB. 10

Finally, as it is often difficult for the IRB to put the nature and potential consequences of adverse events, unanticipated problems, or subject complaints into context, the IRB asks that the continuing review application summarize information on UPIRSOs, adverse events, and subject complaints.

Investigators are required to track these types of events submitted to the IRB. IMPORTANT TO REMEMBER. It is the responsibility of every investigator to review individual events as they occur and take corrective action, if necessary.

Final Report/Study Closure

Researchers must submit a final report for non-exempt studies to close the IRB protocol. Closure of a protocol is appropriate when: • • •

Data collection has been completed; and There will be no additional contact with subjects; and Data analysis is complete, or analysis of research data continues, but the data are deidentified, and there are no plans to re-identify data and recontact subjects.

Transcriptions may be retained, so long as the actual audio/videotapes have been destroyed. Voice or video recordings, even if unlabeled, are considered identifiable. In some cases, audio/videotapes and other identifiable information may be retained if participants have consented to their identifiable information being retained for future research.

When investigators with active protocols leave the institution, they must notify the DePaul Office of Research Services to arrange for the protocol to be closed.

Under Federal regulations, investigators must retain their research records, including submissions to the IRB, copies of approval letters and approved study documents, copies of correspondence to and from the IRB, and signed consent documents, for a minimum of 3 years after the completion of the research and its closure with the IRB.

How to Submit an Application in eProtocol?

DePaul IRB uses eProtocol online application system to submit human subjects research for review.

In eProtocol, there are three main options for a new application: exempt, expedited, and full board.

There is also an option for applications related to classroom research activities that do not fall under the federal definition of human subjects research. Each application type has a specific set of questions tailored to the activity or protocol being submitted. This ensures that the information collected is relevant and appropriate for the review process.

See application questions for exempt and expedited/full review studies in Attachments.

Step-by-step Instructions for Submitting an Application in eProtocol

1. Follow this link to access eProtocol https://researchcompliance.depaul.edu/ 2. Use the DePaul University campus connect username and password to log into eProtocol.

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3. Do not use the back button for the browser when working in eProtocol. You must use the drop-down menu, breadcrumbs, or the system navigation, or you will be kicked out for unauthorized access.

4. To start a new application within eProtocol, go to the IRB tab and then click “Create Protocol”.

5. Personnel Information. Once a new protocol form opens, you will see your name and information, including CITI training. The required training is the CITI course titled “Faculty/Staff/Outside Collaborators/Students.”

6. If you have DePaul co-investigators, enter their information in the appropriate section. Any personnel working with you who are not affiliated with DePaul and who do not need access to the system would be entered into the ‘Other Personnel’ section. If you are working with someone external to DePaul and want them to have direct access to the system, you will need to submit a request for a Friend of DePaul account to ORS. They then could be listed in the Key Research Personnel section.

7. Click “next” button and complete any applicable Funding Information.

8. Click “next” button and indicate if you have any Conflicts of Interest.

9. Click “next” to advance to Protocol Information.

10. In the Application type checklist tab, choose the type of review required for your study.

Depending on the level of review, eProtocol will provide you with a different set of questions. The following questions apply to expedited and full review studies. eProtocol generates fewer questions for exempt studies. Answer No or N/A if the question does not apply to your research.

11. Enter the Project Information in the next tab, including the title, dates, and whether this is faculty/staff/student research.

12. For the Performance Sites tab, if you have an engaged or non-engaged performance site, include this information. A site is engaged when its personnel aid in active recruitment, consent, data collection, provide funding, or include a member of the research team.

Generally, websites, survey delivery sites, or listservs are not performance sites, but rather recruitment venues. Another example of a non-engaged performance site is a collaborator who is merely forwarding an email on your behalf.

13. Click “next” and complete the Background information about the study, focusing on the history of your legacy study and activities that have been implemented.

14. Click “next” and complete the Research Objectives section. These may be presented as hypotheses, aims, goals, or research questions. Please state your aims, goals, hypotheses, or questions in a manner consistent with your methodology. Explain how data for the study will be collected.

15. In the Target Study Population Questions tab, include your population numbers and give a rough estimate of the male and female numbers. We ask for the male and female numbers to ensure equitable subject selection, which is one of the requirements for approval.

However, it is fine to conduct research that collects info on one gender, or the numbers may be unbalanced due to working with a specific target population or profession, such as teaching or nursing.

16. Include your Inclusion Criteria and the corresponding Exclusion Criteria, which should be the opposite of the inclusion criteria.

17. In the Target Study Population Checklist tab, indicate if your research involves a vulnerable population.

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18. In the Subject Recruitment and Privacy tab, please check all the recruitment tools to be used, as well as complete the section on how you will be identifying and recruiting your subject population, if still applicable.

19. In the Informed Consent Process tab, indicate how you plan to consent your subjects, if applicable, and whether you are requesting a waiver of informed consent or an alteration of consent for any part of the research or a waiver of documented consent. The Adult Consent Template for expedited and full board review studies and the Information Sheet for exempt studies are located on the IRB website under Forms/Documents for Expedited/Full Board Review.

20. In the Research Protocol Summary/Plan of Work tab, provide a summary of the research activities that are to be completed. State the basic procedures or treatments clearly and concisely in non-technical language. All testing, evaluations, and interventions related to the research being conducted must be described. Describe any data that will be collected about the subject and how it will be collected and analyzed.

21. In the next tab, describe the Resources/Facilities that may be needed and are available to perform the remaining research activities.

22. In the next tabs, describe any potential Risks, Benefits, and Alternative Treatments or procedures, if applicable.

23. Answer questions about Confidentiality.

24. In the Payment, Compensation, Reimbursement tab, indicate if you will be paying subjects, then include this information here, as well as the payment amount and how & when subjects will be compensated. Payment plans should involve proration if multiple tasks over time are part of the research. Indicate if there will be any costs to the research subjects and any plans for reimbursement of costs for injury-related care.

25. If you are working with SONA subject pools, then this section would include the credit amount to be awarded. Please refer to the Psychology subject pool and the CDM/COMM subject pool guidance on credit allotment.

26. Next, answer the questions about Data and Safety Monitoring.

27. In the next tab, include a description of how you will handle Complaints or Unanticipated Problems. Include how you will record the issues and alert the IRB following the current IRB reporting policy.

28. Complete the HIPAA and FERPA tabs, if applicable to your research.

29. The Attachments tab is where you will be adding all supplemental documents. Generally, the attachments tab should include 1) any data collection measures (surveys, interviews, datasets), 2) other institutions’ approval letters/letters of support/letters of collaboration (if applicable), 3) all recruitment documents, 4) the information sheet(s), and 5) any other documents that a potential participant will view or aid in the IRB review of your research protocol. For guidance on audio and video recording, please refer to the ORS website. The information sheet and consent form have specific templates available on the IRB website.

These templates can be revised and edited to your research needs.

30. Click “next” and complete the Assurances section by checking the box and providing the date. Once you click “next” after the assurances section, you may see a pop-up that prompts you to complete specific questions or sections required for review or approval. Once you have finished all mandatory questions or sections, click on the “submit form” tab. A pop-up box will open, asking whether you want to submit your protocol. Click “yes,” and your protocol will be automatically sent to the IRB for review through the eProtocol system.

31. After the protocol has been submitted, it will be reviewed by the IRB. If the application is incomplete or if the answers are confusing, you may receive an email requesting clarifications 13

or revisions. Please make any requested revisions in the form itself and the supplementary documents, and describe the changes in the comments section of the eProtocol system.

Once you have provided a second assurance, the protocol will be submitted again for review and approval.ro

IRB PROTOCOL DEVELOPMENT Developing an IRB protocol should be grounded in ethical research design and requires careful planning to ensure respect for persons, beneficence, and justice—the core principles of ethical research outlined in the Belmont Report. These principles are operationalized through specific research procedures such as equitable participant selection, informed consent, risk minimization, and robust data protection measures. This section of the manual clarifies the key elements of the research protocol that adhere to the principles of ethical research design.

Subjects Identification and Eligibility Screening Subject Identification (Pre-Screening) includes activities to locate or identify individuals who may be eligible for a study (e.g., database queries, chart reviews, referrals). Eligibility Screening involves assessing an individual against inclusion/exclusion criteria to determine whether they qualify for participation. Investigators must ensure that subject identification and eligibility screening procedures uphold ethical principles of respect for persons, beneficence, and justice.

• Inclusion/exclusion criteria must be scientifically justified and documented in the IRBapproved protocol.

• Access to identifiable data for pre-screening must be limited to authorized study personnel.

• When screening involves interaction/intervention or collection of sensitive information, consent for screening must be obtained.

• Screening tools such as scripts and questionnaires must be IRB-approved and written in plain language appropriate to the population, including translations as needed.

• Ineligible participants must be notified that their data will be destroyed.

IMPORTANT TO REMEMBER: Only the minimum necessary information should be collected to determine participants' eligibility. The questions in the screening instrument must align with the eligibility criteria outlined in the research protocol. Any additional information beyond the specified eligibility criteria should be collected after the participant has provided consent for the study.

Subject Recruitment Researchers utilize various methods to recruit participants for research studies. It is the investigator's responsibility to ensure that these recruitment methods are free from coercion and undue influence.

Additionally, subjects must be given adequate time to consider their participation in the research. All recruitment letters, advertisements, and announcements must undergo IRB review and be submitted along with the protocol application. Any recruitment or informational materials created after the IRB approval of a project must be submitted to the Board as an amendment for review and 14

approval before they can be included in the project. Specific circumstances related to the recruitment of research participants are detailed below.

Convenience Sampling

Investigators should have a valid reason for using a specific population, particularly when the population may be considered disadvantaged or vulnerable. The mere accessibility of research subjects is not a sufficient rationale for using them in a research study.

Adult Volunteers

Investigators should avoid recruiting research volunteers from staff under their supervision or students in their own classes. The IRB suggests recruiting potential subjects from outside the investigator's department or from courses taught by other professors. In this manner, interested individuals will seek out the investigator and will not feel coerced by an investigator in a position of authority over them.

Inclusion of Minors

Federal regulations governing human subject research define minors as persons who have not attained the legal age of consent in the applicable jurisdiction. Researchers must provide an acceptable justification for including or excluding minors in the research.

Inclusion of Minorities and Non-English-Speaking Individuals

All eligible individuals, regardless of race, ethnicity, creed, color, religion, sexual orientation, gender identity, or economic status, should have an equal chance of being recruited into a research study.

Minorities and non-English speaking individuals should not be excluded from the research unless there is a scientific justification for such exclusion.

Inclusion of Students

In some cases, it may be necessary to recruit students for participation in faculty research. If there is a good scientific reason for including students, researchers should: • Inform students that their participation is voluntary and will not affect their class standing, grades, or other benefits under the researcher's control.

• Offer alternative activities to students who may decline participation in the research.

• Limit the use of extra credit points as a reward for participating (they should be used only when the research is closely tied to the course subject matter and should be proportionate to the task performed).

• Keep financial rewards commensurate with the risks of participation.

• Limit the use of class time for recruiting subjects or collecting data.

• Inform students who might participate about the review process, the rationale for the study, the process of data collection, and the researcher's interest; and • Include in the research protocol plans for minimizing the risk of coercion in the recruitment process. For example, having a co-investigator who does not have a direct relationship with the students conduct the recruitment and/or informational or consent process.

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Use of Student Coursework for Research Purposes

Students must be informed if their coursework will be used for research, and their consent must be obtained to ensure voluntary participation. Consent should clarify: • Participation is voluntary and will not affect grades.

• How data will be used, stored, and shared.

• Whether assignments will be anonymized.

If consent is not feasible (e.g., archival data), IRBs may allow a waiver of consent if risk is minimal and privacy protections are strong.

In minimal-risk educational research, if coursework is collected for future research, students should be informed of this in the course syllabus. The syllabus includes a research intent statement explaining: • Coursework may be retained and analyzed for future research.

• Participation is voluntary and will not affect grades.

• How confidentiality will be maintained.

• Contact information for questions or concerns.

• Students can opt out without penalty.

Inclusion of Colleagues & Employees

Researchers who include colleagues or subordinates as research subjects must provide a rationale other than convenience for selecting them and show that the recruitment method does not lead colleagues to believe they will be compromised by declining to participate.

Cross-Cultural Research

Researchers engaged in cross-cultural research should give particular attention to the use of culturally appropriate assessment instruments and procedures, the language(s) used in conducting the research, and the language preferences and language variability of the research subjects.

Researchers developing studies involving members of a particular racial, ethnic, cultural, linguistic, gender, or sexual orientation group should develop an appropriate level of familiarity with that group's language, behavior, social mores, customs, and traditions.

Snowball Recruitment

Researchers often start with an initial group of contacts, hoping that these individuals will recommend other qualified potential subjects. This type of sampling is commonly used in case studies and qualitative research in psychology, sociology, and anthropology. It can also be applied in genetic studies, where it is important to recruit the relatives of the initial subject for direct interviews.

When reviewing snowball recruitment procedures, the IRB will assess whether the study involves sensitive topics and whether the original subject is being asked to disclose information about a third party without that person's consent.

To mitigate risks in snowball recruitment, researchers can ask participants if they would share information about the study with potential subjects. Researchers can provide an information sheet 16

or recruitment flyer for this purpose, allowing interested individuals to contact the researcher directly. This method avoids ethical concerns related to cold calling or sharing identifiable information without consent. All recruitment materials used in snowball recruitment must be submitted to the IRB for approval to ensure compliance with DePaul policies.

Advertisements and Recruitment Materials

All advertisements or recruitment materials must be submitted to the IRB for review and approval, including flyers, newspaper ads, radio and television announcements, bulletin board tear-offs, email letters or announcements, and posters. Advertisements or recruitment materials should be submitted with the application or as soon as the Principal Investigator develops them, so they can be approved before use. Advertisements and recruitment materials should be free from exculpatory language and not claim, explicitly or implicitly, that the research is a treatment or is superior to any current practice.

Informed Consent Informed consent is a voluntary agreement from research participants based on full disclosure of procedures, risks, and benefits. It should be viewed as an interactive process between the researcher and the subject, rather than merely collecting signed documents. Consent can also be obtained verbally without a signature.

All informed consent documents should be submitted to the IRB for review and approval. Consent forms should include all information about the study that any reasonable person would need and want to know before agreeing to participate in the project. At a minimum, consent forms should provide a description and explanation of study procedures, risks and discomforts, potential benefits, contact information for the investigator and the Office of Research Services, and treatment alternatives (if appropriate). When the consent documents are revised, the version date is then updated to the current version date.

The consent form should be written in the second person ("You") and at a language level appropriate for the subject. The document should not use language such as "you understand" or exculpatory language that leads the subject to believe they are being required to give up their rights.

Remember that the subject is primarily interested in what will happen to them rather than in the material, samples, or data collected, so the research procedures should be thoroughly explained.

Adult consent forms for the general population should be written at the 8th-grade reading level to facilitate comprehension.

Assent forms should be written at a level appropriate for the age, experience, maturity, and condition of the minors who will be asked to participate. If the researcher plans to enroll children aged 7 to 17, multiple assent documents or processes may be necessary to ensure the language is appropriate to the child's age group and comprehension level. Additional requirements for obtaining parent/legal guardian permission and subject assent will depend on the risk/benefit determination.

Investigators should seek assent and permission from the subject and/or parent/legal guardian in circumstances that provide the subject and/or parent/legal guardian with sufficient information and timelines to consider participation.

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The assent/consent/parent/legal guardian permission documents or scripts (for verbal procedures) (and, when appropriate, translations and back translations) for each study must be submitted to the IRB with the protocol and must be approved prior to the commencement of any research activity that involves the use of human subjects.

HIPAA Authorization

When HIPAA applies to the research, the subject must provide HIPAA authorization in addition to informed consent. This can be in the form of either: • A combined consent/HIPAA authorization, which is a single document that meets the regulatory requirements for research consent and HIPAA; or • A consent form and a stand-alone HIPAA authorization form.

The combined consent/HIPAA authorization has the advantage of requiring a single document and a subject's signature on only one document.

Implied Consent

Implied consent is a process in which a person indicates their agreement to participate in a study through their actions, rather than by signing a written consent form or giving verbal consent.

Participation itself—such as completing a survey, clicking “submit,” or allowing observation—serves as evidence that the individual agreed to participate in the research after receiving adequate information.

Implied consent is only appropriate for minimalriskminimal risk activities where: • Data is collected through interactions such as online surveys.

• No identifying or sensitive information is collected, or the privacy and confidentiality risks are low.

• A written signature is unnecessary or would increase risk (e.g., linking identity to a sensitive topic unnecessarily).

With implied consent, investigators provide an Information Sheet that functions as the consent document.

The Information Sheet must explain: • The purpose of the study • What participation involves • Risks and benefits • Voluntary nature of participation • How data will be used and protected • Contact information for questions or concerns After reading this information, the participant indicates agreement by: • Filling out and returning a paper survey • Clicking “I agree” or proceeding to the next page of an online survey • Remaining in a setting where non-interactive observation is conducted Consent of Subjects Who Are Not Fluent/Literate in English

In cases of a language barrier, it is the investigator's responsibility to ensure that subjects receive the informed consent form in a language they understand. Investigators must obtain assistance from a 18

person fluent in that language to translate the informed consent form and/or serve as an interpreter.

When a written consent form is translated into another language, a copy of the translated form must be reviewed and approved by the IRB before incorporation into a study. The IRB must also approve any translated verbal consent scripts. If the investigator is the translator or the translator is not a professional service, the IRB application materials should include information about the translator's qualifications for providing the translation services When planning on enrolling subjects who are non-English speaking the investigator needs to assess whether it is feasible to communicate with the subject throughout the research process and whether the language barrier might lead to errors in the research. It is important to remember that consent is an ongoing process throughout the research and does not end once the consent document is signed.

IMPORTANT TO REMEMBER: For non-English speaking participants, all assents/consents/parent/legal guardian permissions must be translated, and a translator statement attesting to the accuracy of translation must be submitted to the IRB for review.

Assent of Children Participating in Research Projects

Federal regulations require the IRB to ensure that additional protections are provided for children participating in research, depending on the degree of risk and benefit the IRB determines is involved. Such protection may include obtaining a child's assent or "affirmative agreement" to participate and obtaining permission of parents or legal guardians. The assent of children and adolescents participating is required by regulation, except when the IRB determines that a child is not capable of providing assent or when the research is of potential direct benefit to the child's wellbeing and is available only in the context of research. The DePaul IRB considers the age of assent to begin at age 7. Because Illinois law defines the age of consent or adulthood as age 18 (with some exceptions), children ages 7-17 should assent to research. For children under the age of 7, only parent/legal guardian permission is required. It may be necessary to use both verbal and written assent processes, or multiple written assent forms with varying levels of information, to address the age and comprehension level of children across different age groups.

In determining a child's ability to provide assent, the IRB considers the child's age, maturity, and psychological state. Even when not required by regulation, the IRB always encourages investigators to involve children in the consent process when appropriate and feasible.

Waiver of Parental Permission

Currently, federal regulations allow waiving parental permission when requiring it would not be considered reasonable. This situation may occur in specific areas of adolescent health research, such as research on sexually transmitted diseases, birth control usage, high-risk behaviors, AIDS prevention, etc. Whenever it is reasonable to obtain parental permission, it must be obtained. When an investigator determines that parental permission is unreasonable, the investigator may request a waiver of parental permission. The IRB will consider the investigator's request and determine whether the waiver of permission is permitted under federal regulations.

Consent and Information Sheet Templates

To facilitate the drafting of informed consent forms, the IRB has developed templates for projectspecific consent documents. Researchers must use the templates provided by DePaul on the IRB webpage. Researchers are encouraged to review “Instructions for Completing the Adult Consent Template” and “Sample Language for Consent Documents” posted on the IRB website for any 19

additional language that may be pertinent to your study (e.g., Amazon MTurk, HIPAA, FERPA, PPRA, etc.).

Privacy Privacy is a crucial factor in human subject research. It refers to participants' willingness to allow access to themselves and their information. Researchers must consider how, when, and where participants are approached, how their private information is collected, and who has access to it.

Privacy concerns often arise during the recruitment process, particularly regarding how subjects are identified and contacted. Researchers need to evaluate whether their methods could be perceived as invasive to participants' privacy.

Most research in the social and behavioral sciences focuses on private behaviors, except for observational studies of public behavior. Protecting the privacy of research participants during screening, consenting, and conducting the research involves: • • • • • •

Approach participants in a setting or location that preserves their physical privacy and minimizes the risk of information being overheard by unauthorized individuals.

Conduct research procedures in person and in a private setting.

Capture and review data in a private setting.

Ensure that only authorized research study personnel will be present during research-related activities.

Ensure that only authorized research study personnel will have access to research data.

Limit the collection of information about participants to the amount necessary to achieve the aims of the research.

Secondary Subjects

An important issue in research participant privacy is the protection of "secondary subjects," who are individuals not involved in the research but about whom information is collected. For instance, researchers may ask participants about family members' health or lifestyle, making those family members secondary subjects. Since federal regulations classify them as human subjects, their privacy must be safeguarded in the same way as that of primary subjects. In minimal risk research, IRBs may waive the requirement for informed consent from secondary subjects, but consent may still be required unless a waiver is justified.

Confidentiality Confidentiality is crucial for research subjects, as it concerns how data collected for research purposes is protected from disclosure. Each protocol should specifically address confidentiality, with the Principal Investigator ensuring that identifying information is not recorded or released unnecessarily, unless required by law. Data, whether electronic or hard copy, must be stored securely, and researchers should have plans for the proper destruction or storage of identifiable data after a study concludes.

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IMPORTANT TO REMEMBER. If researchers wish to retain identifiable data post-study, they must disclose it in the informed consent process. Participants should be informed of which identifiable data will be retained (e.g., names, contact information, medical records) and why (e.g., future research), where it will be stored, and how it will be protected.

Confidentiality vs Identifiability

Confidentiality and identifiability are closely related but distinct concepts. Identifiability refers to whether a participant’s identity can be determined from the information collected.

Data may be: • Directly identifiable (e.g., name, medical record number).

• Indirectly identifiable, where combinations of variables (e.g., age + ZIP code + diagnosis) could reveal identity • Not identifiable, if no reasonable means exists to link the data to a specific person.

Identifiability is about the nature of the data itself.

Confidentiality refers to how researchers handle, store, and protect any data that could identify participants. Confidentiality protections apply because data are identifiable or could become identifiable.

These protections include: • Removing or coding identifiers • Using secure storage, encryption, and access controls • Limiting who can see identifiable data • Ensuring data is reported only in aggregate form • Preventing unauthorized disclosure Confidentiality is about the researcher’s responsibility to safeguard identifiable information.

Confidential vs Anonymous

Confidential means that researchers know who the participants are or could identify them, but they promise to protect that information from disclosure. Key characteristics of confidential data include: • Identifiers are collected or could be inferred, but are kept secure.

• Researchers use coding, encryption, access controls, and secure storage to protect identities.

• A linking file (master list) may be retained to connect participants to study IDs. • Data can be re-identified by authorized research staff if needed (e.g., for follow-up).

Examples of confidential research include: • Interviews where names and voices are recorded.

• Clinical studies that collect medical information.

• Surveys that collect email addresses and/or IP addresses.

Anonymous, on the other hand, means that no one—not the researchers, not the institution, not third parties—can identify participants or link them to their data. A study is anonymous when no names or identifiers are collected, and no key or code exists that could later re-identify the data.

Examples of anonymous research include: • A paper survey with no identifying questions.

• A web survey that does not collect IP addresses, email addresses, or device information.

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IMPORTANT TO REMEMBER. If re-identification is possible in any way, even theoretically, the research is not anonymous. It should be described as confidential.

Certificate of Confidentiality

A Certificate of Confidentiality (CoC) is an important legal safeguard that protects the privacy of research participants by preventing the forced disclosure of identifiable and sensitive information. It shields researchers and institutions from being compelled—via subpoenas or court orders—to release participants’ names, contact info, biometric data, or other sensitive research information across civil, criminal, administrative, legislative, or other legal proceedings. NIH-funded studies (grants/awards started or ongoing after Dec 13, 2016) that gather or use identifiable, sensitive information are automatically issued a CoC—no separate application is needed. If the study is not NIH-funded or NIH funding has ended, an investigator may apply for a CoC via the NIH eRA portal. Once issued, NIH notifies the PI and the Institutional Official and provides the CoC confirmation, or "term and condition" to include in the study's consent form.

Risks Risk includes not only physical pain or discomfort, but also psychological or sociological harm, invasion of privacy, loss of confidentiality, harassment, and lessening of an individual's dignity. For example, the use of interviews, questionnaires, or the review of a child's school records may produce psychological discomfort, embarrassment, or a breach of confidentiality, and should be considered risks. Inconveniences such as loss of time or pay are included in this category. In addition, indicate what will be done to minimize the effects of risks, discomforts, or inconveniences, as well as what precautions will be taken to avoid or reduce potential risks. When using records or personal data, state what steps will be taken to ensure confidentiality.

Benefits Potential benefits can apply directly to the subject in question or be indirect, such as improvements for others or the advancement of scientific knowledge. In every instance, it is important to evaluate the risk-benefit ratio of a study and to state the rationale for believing that the potential benefits to the subject, others, or society outweigh the risks. In cases of no direct benefit, the investigator should demonstrate that risks are so minimal as to warrant a benefit that may consist only in the furtherance of general scientific knowledge.

IMPORTANT TO REMEMBER. When evaluating risk versus benefit, the IRB focuses on short-term benefits that result directly from participation in the study, rather than long-term benefits that cannot be guaranteed.

Research Data Management Research Data Management is the care and maintenance of the data that is produced during the course of a research cycle. It is an integral part of the research process and helps to ensure that your data is properly organized, described, preserved, and shared. Funding agencies (especially the federal government) are increasingly requiring data to be made publicly available and the creation and

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execution of a Data Management Plan (DMP), a formal document that specifies what researchers will do with the data during and after their research project.

Please refer to the DePaul University Library website for a How-To Guide to Research Data Management.

Compensation Compensation for research participation is often appropriate and can include travel reimbursement, babysitting fees, lunch, or small gifts. However, compensation should not be so substantial as to serve as an inducement to participate, regardless of the risk. Subjects should not be required to complete the research to receive compensation, and if they withdraw, they must be compensated for what they completed. The amount of compensation should be clearly stated in consent forms but not framed as a benefit. Compensation may be prorated across visits or activities, and the IRB must review and approve all compensation forms to ensure they do not exert undue influence.

DePaul University allows compensation for research subjects through various methods, including checks, cash, and tangible items. Researchers must ensure that any payments for research participation are commensurate with the tasks performed. The IRB-approved consent document must inform participants about the payment amount and the payment plan. Payments exceeding $200 per participant, per study, within a single calendar year require the collection of identifying information. The IRB has created template language for the information sheet, consent, parent/legal guardian permission, and assent documents that help to explain to the research subject that, to receive payment, they may need to provide additional information to the researcher so that DePaul can be compliant with United States Internal Revenue Service (IRS) tax laws.

IMPORTANT TO REMEMBER. When offering a raffle, the consent form must clearly state the odds of winning a prize. This is required for transparency, informed decisionmaking, and to prevent undue influence by clarifying that participation does not guarantee a prize.

Reliance Reliance for non-exempt research refers to an arrangement where one institution’s IRB relies on another institution’s IRB for review and oversight of a study. This is common in multi-site studies or collaborations. Reliance occurs when two or more institutions enter into an agreement—often called an IRB Authorization Agreement (IAA) or Reliance Agreement—to avoid duplicative IRB reviews.

One IRB becomes the IRB of Record, responsible for reviewing and overseeing the research for all relying sites.

Reliance agreements are used for non-exempt research. Exempt determinations are made by each participating IRB individually. External investigators involved in exempt research should collaborate with their IRB to identify the specific requirements for their participation in the study.

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Reliance agreements are executed between Institutional Review Boards (IRBs) or their respective institutions, not individual investigators. Investigators may not begin the research until a reliance agreement is finalized with each site.

By operating at the institutional level, reliance agreements ensure that ethical review and protections for human subjects are maintained consistently across all participating sites. Investigators do not have the authority to negotiate or execute reliance agreements; instead, these agreements are managed by the IRB offices or designated institutional officials to ensure compliance with federal regulations and institutional policies. This process promotes efficiency in multi-site research while safeguarding participant rights and welfare.

IMPORTANT TO REMEMBER. Although investigators may request a reliance agreement, it is up to the IRB to decide whether to enter into such an agreement with another IRB. Reliance agreements are considered on a case-by-case basis.

SMART IRB

The SMART (Streamlined, Multisite, Accelerated Resources for Trials) IRB platform facilitates reliance agreements among participating institutions. SMART IRB provides a pre-negotiated master reliance agreement and an online system to document roles and responsibilities, eliminating the need for separate agreements for each site. Under this arrangement, one IRB will serve as the IRB of Record (Reviewing IRB), conducting initial and continuing review for all participating sites (Relying IRBs). Relying institutions will provide local context information, such as state laws and institutional policies, through the SMART IRB system. This approach ensures compliance with the NIH Single IRB policy and the Common Rule cooperative research requirement (45 CFR 46.114), while promoting efficiency and consistency in multi-site review.

DePaul University is a participating institution in SMART IRB. Review instructions on the SMART IRB website and speak with the ORS/Research Protections about using the SMART IRB agreement.

Use of AI in Research Advances in Artificial Intelligence (AI) have expanded the ways investigators design studies, manage data, analyze results, and communicate findings. Although AI offers transformative potential for research, it also poses risks, including increased threats to privacy and confidentiality, and skewed, biased, or unreliable results.

Because of these concerns, IRBs expect researchers to disclose all uses of AI and address associated risks, including those related to accuracy, bias, privacy, and data security.

Use of artificial intelligence (AI), including generative AI tools, machinelearningmachine learning models, automated dataanalysisdata analysis systems, or AI-enabled decisionsupportdecision support tools, must be fully disclosed in the IRB application and in all relevant study documents, including the informed consent form. Investigators must describe how AI will be used, what data it will access, who will have control over the system, and how risks to participants will be mitigated.

Consent documents and IRB applications must include a clear description of risks associated with the use of AI tools in research, which may include: • Potential for unauthorized access or data breaches.

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• Risks associated with transmitting data to external AI platforms.

• Possibility of re-identification of de-identified data through AI inference.

• AI-generated outputs may be incomplete, biased, or incorrect.

• Potential for unequal error rates across demographic groups.

Participants should be informed: • Whether outputs are generated through non-transparent or proprietary systems.

• Whether AI vendors may retain or use data for system training.

• Limitations on the ability to fully delete data once submitted to an AI system.

• Potential for secondary use of data outside the study.

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ATTACHMENTS

Exempt Application Questions in eProtocol • • • •

Personnel Information Funding COI Protocol Information o Application Type Checklist o Exempt Categories o Project Information o Performance Sites o Background o Research Objectives o Target Study Population Questions o Target Study Population Checklist o Subject Recruitment o Information Sheet Process o Privacy and Confidentiality o Broad Consent o Payment, Compensation, Reimbursement o Subject Complaints, Unanticipated Problems o HIPAA o FERPA o Attachments o Assurances

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Expedited and Full Review Application Questions in eProtocol • • • •

Personnel Information Funding COI Protocol Information o Application Type Checklist o Exempt Categories o Project Information o Performance Sites o Background o Research Objectives o Target Study Population Questions o Target Study Population Checklist o Subject Recruitment o Informed Consent Process o Research Protocol Summary/Plan of Work o Resources o Potential Risks o Potential Benefits o Available Alternatives o Confidentiality o Payment, Compensation, Reimbursement o o Costs to Subjects o Data and Safety Monitoring o Subject Complaints, Unanticipated Problems o HIPAA o FERPA o Attachments o Assurances

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