Protection of Human Subjects

Federal regulations require that all research involving the use of human subjects undergo review by an Institutional Review Board (IRB) to ensure that ethical research is being conducted. CSUN's IRB, the Committee for Protection of Human Subjects (CPHS), is composed of scientists, non-scientists, and community members with diverse backgrounds to support a comprehensive review of all human subjects research projects. The CPHS is regulated by the Office for Human Research Protections, part of the federal Department of Health and Human Services.

All researchers and faculty advisors involved in human subjects research must complete Human Subjects Research training through the CITI Program. This training should be completed before beginning a Cayuse application.

CSUN uses Cayuse IRB to manage new protocol submissions, renewal applications, modification requests, and protocol deviation or adverse event reporting. For more information, see the relevant sections below.

Note: Student investigators should request Cayuse access using this form.

Student Researchers

IRB information for student researchers

The CSUN IRB supports student-led research involving human research participants, as long as such projects have faculty oversight. IRB approval must be obtained before any work with subjects begins; this includes any recruitment, data collection or other research activities. If you have questions about whether your project is subject to review by the IRB, please contact IRB staff at irb@csun.edu.

Throughout the year, IRB staff have outreach events specifically for student investigators. Be on the lookout for announcements from Graduate Studies, BUILD PODER, ARCS and other research groups on campus. Staff are also available to present to graduate and undergraduate classes about the history of research ethics, as well as about the IRB review process.

Some guidelines for getting started with your IRB application:

• All research staff need to have completed a CITI Human Subjects Research training course before submitting the protocol. Please consult your advisor or IRB staff for more information.
• Student investigators will need to request access to Cayuse using this form. (https://www.csun.edu/research-sponsored-programs/cayuse-irb-access-request)
• Your faculty co-Investigator should be indicated in question A4a of the Cayuse application. Faculty co-Investigators must certify the protocol in Cayuse when it is submitted. Student protocols that are not certified will encounter delays.
• Please have your study instrument (questionnaires, surveys, interview guides etc…) and any flyers or other recruitment materials prepared before you start your protocol. Small edits to these documents can be made during the review process, but they should be largely complete when submitted.
• Templates for Informed Consent documents are linked within the Cayuse application.

If the CSUN IRB determines that your study is subject to full committee review, we will require that your faculty advisor is named as lead Investigator. Research that may require full committee review includes research with protected populations (such as children, prisoners or people with decisional impairments), research using risky methods such as deception, and research that involves more risk to participants than what they would encounter in everyday life.

Activities that Require Human Subjects Review

NOTE: Please review all of the information provided. If you are still not sure whether your research involves human subjects please contact the office of Research & Sponsored Programs at 818-677-2901 or irb@csun.edu.

Definition of Human Subjects Research

Human subjects research is any research or clinical investigation that involves human subjects.

When considering whether an activity meets the definition of human subjects research per DHHS Regulations 45 part 46 one must consider two federal definitions: research and human subject.

Research is as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A "systematic investigation" is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.

Examples of systematic investigations include:

• surveys and questionnaires
• interviews and focus groups
• analyses of existing data or biological specimens
• epidemiological studies
• evaluations of social or educational programs
• cognitive and perceptual experiments
• medical chart review studies

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations.) However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication.

Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.

Examples of activities that typically are not generalizable include:

• biographies
• oral histories that are designed solely to create a record of specific historical events
• service or course evaluations, unless they can be generalized to other individuals
• services, courses, or concepts where it is not the intention to share the results beyond the CSUN community
• classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
• quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the CSUN community.

A human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.

• Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject.
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Note: Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require Human Subjects review and approval.

Educational Activities that are not Human Subjects Research

Although all human subjects research requires prior institutional approval, not all data gathering by students constitutes human subjects research. To be research, an activity must be designed with the intent to develop or contribute to "generalizeable knowledge." Clearly, some classroom activities are designed to teach research techniques and have no such intent.

Simulations of human experimentation and course-assigned data collection do not constitute human subjects research if the activities are designed for educational purposes only; and

• the data will not be generalized outside the classroom (reporting of data within the class is acceptable because the activities were performed solely for teaching purposes); and
• the data will not result in a master's thesis, doctoral dissertation, poster session, abstract, or other publication or presentation; and
• the student volunteers or other participants are clearly informed that the activities are an instructional exercise, and not actual research.

Any activity that is a clinical investigation or involves medical intervention or procedures, even when they are a part of a course curriculum, always constitutes human subjects research and requires prior Human Subjects Committee review and approval.

Educational Activities that are Human Subjects Research

If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review before beginning the study.

There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge. For more information, please see the definition of human subjects research.

• An instructor is surprised at some of the unique findings that appeared when students completed surveys as part of a classroom activity. The instructor would like to do additional analysis on the data and submit it for presentation or publication when the course ends. The instructor's intent has changed and an IRB application is necessary because the instructor will now be analyzing existing data that was collected for a non-research purpose.
• An undergraduate junior psychology major wishes to conduct research in the hopes of having a publication to list on her application to graduate school. She plans to devise an experiment, enroll subjects, analyze the results and write a manuscript. This is human subjects research. Prior IRB review and approval is necessary.

Protocol Submission Process

Cayuse Protocol Development

All new protocol applications must be submitted electronically using Cayuse IRB. Faculty will login using their CSUN credentials. Student researchers must request access to Cayuse IRB by completing this form. Students should allow three business days for access to be granted.

Please note: Firefox and Chrome are the recommended browsers for the Cayuse platform.

Attachments and Additional Documents

In addition to describing your study procedures in the Cayuse protocol, you may be required to additional documents. Templates for commonly used forms such as consent forms, Bill of Rights, and permission letters are available on Box (note: Portal login required). Further information about consenting requirements is available in the next section.

Additional items that need to be reviewed by the Committee and should be attached in your Cayuse protocol may include:

• All data collection instruments, survey items, etc. (including both original and previously validated measures)
• Lists of interview or focus group questions or themes
• Descriptions and/or photos of novel equipment
• All recruitment material (e.g. fliers, newspaper/craigslist ads, recruitment emails/letters, social network recruitment postings or advertisements)

After submitting your protocol

Your protocol will be reviewed and classified as exempt, expedited, or requiring full committee review at the next committee meeting (see Meeting Dates and Deadlines). IRB staff will conduct a pre-review to ensure the protocol is complete and internally consistent; if discrepancies or missing information are found, you may be asked to make specific changes at the pre-review stage. Once a protocol has passed pre-review, exempt and expedited protocols will be assigned to a CPHS committee member to review, and full review protocols will be assigned to the next full board meeting.

Once your initial review has been completed, you will receive an alert from Cayuse notifying you that comments to your protocol are available within the system, and the protocol will be returned to you for editing. You can use the commenting feature in Cayuse to reply directly to your reviewer, or simply make the requested changes. When you are finished editing your protocol, simply resubmit and certify the protocol, and it will be automatically reassigned to your reviewer. A protocol may go several rounds of revision before receiving approval, as additional information can be elicited during the revision process.

Full Committee Dates and Deadlines

Note: Exempt and expedited protocols are reviewed on a rolling basis, year-round . Only projects requiring full committee review are subject to the dates described below.

Deadline dates for submission of protocols to be reviewed by the full committee are set three weeks prior to each meeting. Meetings are usually held the fourth Tuesday of each month. Deadlines and meeting dates for the upcoming academic year are as follows:

Summer Protocol Submissions

Researchers may continue to submit protocols during June and July on a rolling basis. Protocols that are determined to meet exemption or expedited review criteria will be reviewed on a first-come, first-served basis. Some research activities may require full committee review, especially those that involve vulnerable populations or that may present greater than minimal risk to participants. These protocols may not be reviewed until the first CPHS meeting in August. Deadlines for full committee meetings will resume in the fall semester as noted in the table above.

Informed Consent

Required Documents

• If your protocol involves only adults (adults are people 18 years and older), please provide an Adult Informed Consent Form.

• Agreement from minors (under 18 years of age) in human subjects research is called assent, rather than consent; only the adult parent or guardian can legally provide consent. If your protocol involves children or adolescents, please provide a Minor Assent Form and a Parent/Guardian Consent Form. Note: If you are recruiting at a high school, some students are 18 years of age and do not need parental consent, but rather should provide their own consent using an adult consent form .

• If your study involves a medical experiment as defined under California Health and Safety Code, Sections 24170-24179.5, the inclusion of the Bill of Rights is also required (available in English or Spanish). At the discretion of the IRB, inclusion of a Bill of Rights may also be requested for some studies that are not medical experiments; this will be determined during the review process.

• If you are conducting recruitment or data collection activities off-campus, a Permission Letter from the institutional authority at your chosen location may be required before your protocol is approved to begin.

Please note, all of our consent, assent, and permission forms are templates to be used and modified to fit your study. Each form has instructional language included to tell you how to modify the form, and which language needs to stay. Please be sure to delete all instructional language before submitting the form.

Waivers of Consent

In certain limited situations, it is possible for the IRB to grant a waiver of documented informed consent. The IRB may consider a waiver request when:

• the research involves no more than minimal risk to the subjects;
• the research could not practicably be carried out without the waiver or alteration;
• the waiver or alteration will not adversely affect the rights and welfare of the subjects; and
• whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If you feel a waiver may be appropriate, please ensure that your Cayuse protocol has provided ample justification of the above listed criteria.

Important Informed Consent Process Reminders

• Do not use an unapproved consent form. Approved consent forms bear the stamp of the IRB, including approval and expiration dates.
• Do not use an expired consent form. Confirm the approval and expiration date is within the IRB approval period.
• If changes are made to the informed consent document during the course of the study, it is the investigator's responsibility to ensure that participants sign the latest approved version of the consent document.
• Do not verbally interpret the English version of the consent form into other languages. Investigators must use an IRB-approved, translated consent form. Subjects cannot waive their right to receive a translated informed consent document.
• Make sure to provide the participant their own copy of all consenting documents, including consent or assent form, Bill of Rights, etc.

The responsibility of ensuring that a potential participant understands the research and the risks and benefits involved falls upon the Investigator, not upon the potential participant.

Protocol Modification/Renewal Process

Renewal and Modification Process

1) Renewal or Modification for protocols that were initially submitted in Cayuse: These studies will have an IRB number in the format: IRB-FY19-###

Please use the Cayuse Native renewal and modification process. Log into Cayuse IRB and enter the Study Details section for your study. On the top-right of the page will be a blue button that says “+ New Submission”. Click on this and chose “Renewal” or “Modification”, and then complete the submission form, submit and certify. Renewals and modifications can no longer be completed with one form, you will have to start a separate submission for each one.

2) Renewal of protocols that were previously approved on PDF and have not expired : These studies will have an IRB number in the format 1718-###-x

To renew a protocol, please submit a cover letter outlining the need for the renewal, and include the following:

1. The number of subjects accrued since the last IRB review of the protocol and (for ongoing studies) the total number accrued for the study;

1. A summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since last IRB review;

1. A summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review;

1. Any relevant multi-center trial reports;

1. Any other relevant information (especially information about risks associated with the research);

1. A copy of the current informed consent document (without the approval stamp) and any newly proposed consent documents; and

1. Any other changes to the study (e.g., personnel, measures, procedures, etc.)

Please submit your renewal request with the above documentation via email to at least 30 days before the protocol expiration date. Studies that have expired will need to be re-submitted as new protocols through Cayuse IRB.

3) To modify protocols that were previously approved on PDF and have not expired : These studies will have an IRB number in the format 1718-###-x

To request a modification to your protocol, please submit a cover letter briefly outlining the newly proposed changes and the need for the modification. In addition to this letter, all appropriate documents that are affected by the modification will need to be submitted. Please indicate the new and/or modified content using the “track changes” function in Microsoft Word.

Common documents that are typically affected by modifications are:

• Consent Forms (Adult, Parental, Adolescent/Child)
• Recruitment Materials
• Data Collection Materials

Please submit your modification request via email t o irb@csun.edu. Studies that have expired will need to be re-submitted as new protocols through Cayuse IRB.

Protocol Deviations and Adverse Events

Incident Reporting: Protocol Deviations and Adverse Events

Sometimes, departures can occur from the procedures described in an IRB-approved protocol. Various terms are used to describe these departures, including “protocol deviations,” “protocol violations,” “protocol variances,” and “non-compliance.” We will refer to all of these departures with the term " protocol deviation ."

Other times, even when the approved protocol is followed exactly, problems may arise on that involve risks to human subjects. These problems may be anticipated or unanticipated, and they may be related or unrelated to participation in the research study. These problems will be described as " adverse events ."

1) Incidents that occurred on research that w as initially submitted in Cayuse: These studies will have an IRB number in the format: IRB-FY19-###

Please use the Cayuse Native incident reporting process. Log into Cayuse IRB and enter the Study Details section for your study. On the top-right of the page will be a blue button that says “+ New Submission”. Click on this and chose “ Incident ”, and then complete the submission form, submit and certify.

2) Incidents that occurred on protocols that were previously approved on PDF : These studies will have an IRB number in the format 1718-###-x

Email irb@csun.edu with a brief description of the protocol deviation or adverse event, and we will send you the forms to report the incident.

Frequently Asked Questions - FAQs

What do I need to do if I intend to perform human subjects research?

You have already taken the first step by visiting this website. Next, go to Protocol Submission Process and read all instructions, and download and fill out the appropriate forms.

What if I am a student or faculty member at CSUN, but I intend to do research at another institution (e.g., K-12 schools or hospitals)?

You still need to submit your project to CSUN's human subjects committee. You also need to submit a letter of approval from the other institution. Some institutions have their own human subjects committee that you may be required to submit to. If they require this, then your letter of approval should come from their committee.

If you intend to do research at a school, the approval letter should come from the principal. However, if you intend to do research at multiple schools in one district, you are required to obtain approval from each principal of each school. Also, If you intend to conduct research at Los Angeles Unified School District (LAUSD) schools please note that LAUSD requires that you also submit your human subjects protocol to their Research Review committee for review and approval. Most organizations will not approve your protocol until you have received approval from CSUN’s Human Subjects Committee. Therefore, you may submit the required letters of approval from the organizations where you are recruiting after the CSUN Human Subjects Committee has given you conditional approval of your study. This means that the Committee may approve your protocol, but cannot give you formal approval to start your study until we have the required approval letters.

Is there a deadline to submit my protocol to be reviewed by the Committee?

Most studies are eligible for exempt or expedited review, and these are considered on a rolling basis. The sooner you submit your protocol, the sooner it will be reviewed.

For studies requiring full committee review, the Committee meets once per month during the academic year, and the deadline to submit is 3 weeks prior to each meeting. See Deadlines & Meeting Dates for the current submission schedule. Please note that the Committee does not meet during the months of January, June, or July.

How soon after a full board meeting will I hear from the IRB?

You will receive comments within two to four weeks following the meeting. It's important to understand that protocols are rarely approved without requiring at least minor modifications. You will be notified whether your protocol was approved, requires modifications and re-submission to the Committee, or whether you need only make minor modifications that do not require full committee re-review.

What if I intend to conduct human subjects research in another country?

International research is bound by numerous additional considerations, of which CSUN's IRB approval is only one part. If you intend to conduct human subjects research outside the United States, there may also be additional regulations that you will have to follow in the other country. Please email the IRB as early as possible for guidance specific to your research project and location.

What if I disagree with the requested revisions?

Click on the “How to Appeal” accordion section below to learn how to engage the IRB if you disagree with a request or determination made by the reviewer of your protocol.

Recruiting CSUN Students, Faculty or Staff into Outside Research

As an outside researcher, if you wish to recruit CSUN students, faculty or staff from a specific department or campus organization, please contact that department or organization directly for permission to recruit. The CSUN IRB can not grant permission on behalf of other campus entities . As a professional courtesy, we ask that you send the CSUN IRB a copy of your approval letter to keep on file in case we receive any questions from research participants.

If you are working with a CSUN faculty member who is engaged in the research, please contact IRB staff at irb@csun.edu to determine if a reliance agreement is required between CSUN and the IRB of record for the study.

If you are a member of the CSUN community and you have questions about a request from an outside researcher, the IRB staff are available to consult before you decide to grant permission. This is not limited to academic departments or to faculty, we are happy to provide advice to student organizations as well.

How to Appeal

If you disagree with a request or determination about your study, please follow these steps to engage the IRB in considering your perspective.

1. Respond to the reviewer in Cayuse. If an investigator feels that a requested change to their study protocol or materials is unduly burdensome without a clear benefit to participant health and safety, the first step is always to engage the reviewer in conversation. We often find that these disagreements can be attributed to miscommunication between the reviewer and the investigator, and that fundamentally irreconcilable views on the ethical acceptability of the research are quite rare. Therefore, we ask that the investigator first use the "Add Comment" feature within Cayuse to provide a clear justification of both the burden presented by the requested change and why participant rights are not potentially affected. There may be some dialogue on these points, and it is important to have this communication exchange preserved in the context of the original IRB application.

Please note: further appeals and/or escalation will not be considered until there is evidence of a conversation between the reviewer and the investigator in Cayuse. Investigators will be redirected to Step 1 until complete.

2. If the conversation is truly at an impasse, email a request for subcommittee review to irb@csun.edu with the following information:
- Study protocol number (e.g., IRB-FY##-###)
- Request for "subcommittee review" of a reviewer's determination, stipulation, or required change
- The specific item number(s) of the disputed change (e.g., "F3a")
The IRB Analyst will respond within two business days confirming receipt of your subcommittee review request.

3. A subcommittee of three or more IRB committee members, excluding the initial reviewer, will be convened to review the disputed item(s), including all prior conversation and justifications between the initial reviewer and the investigator. Please note that subcommittee members will access the entire application for context that may inform the disputed content. Subcommittee members may include alternate members of the IRB, but will not include anyone with a conflict of interest on the specific protocol (such as a co-investigator or faculty advisor). The subcommittee will document their opinions about the disputed item(s) in the appropriate section(s) of Cayuse; note, however, these discussions may not necessarily be visible to the investigator.

4. In the event that the subcommittee ultimately agrees with the investigator, the disputed revision will be removed. Investigators are still responsible for revising the application to comply with all non-disputed revisions and re-certifying the application upon resubmission. If the subcommittee ultimately agrees with the initial reviewer, the requirement to revise the protocol accordingly will stand. In either case, the determination and next steps will be sent by email from irb@csun.edu to the investigator.

5. If the subcommittee found in favor of the initial reviewer and the investigator still wishes to pursue appeal, the investigator should reply directly to the determination email (from irb@csun.edu ) requesting chair-level review . The IRB chair and vice-chairs will examine the accrued evidence and written opinions to date. If the chairs determine that there is merit to the investigator's dispute - i.e., if it is an ethical gray area; if the dispute reflects ambiguity or inconsistency in the IRB process; or if the discussion highlights a need to establish new policy - the chairs will bring the question before the full committee at the next convened IRB meeting, and the full committee will vote.

6. The vote of the full IRB committee is considered final and cannot be overruled by administrative action. The determination of the committee will be communicated to the investigator via email within five business days of the IRB meeting at which the issue was discussed.

As a reminder, the IRB is an independent oversight committee charged with ensuring the ethical treatment and protection of human research subjects. Although the IRB reports to the Institutional Official and the IO appoints committee members, the IO only has the authority to shut down IRB-approved research that is deemed to be non-compliant, harmful or unethical, or poses insufficiently managed risk or liability to CSUN. The IO may not override an IRB requirement or approve research the IRB has previously disapproved .

Committee for Protection of Human Subjects

IRB Class Presentations

The IRB office is happy to announce that class presentations are now being offered. If you are teaching a graduate -level methods or capstone course and would like your class to be more informed on the IRB , protection of human subjects and /or the submi ssion and review process, a class presentation may be beneficial to you.

In addition to class presentations, the IRB administrative staff also offers in-office appointments to both faculty and student investigators. If you would like a Cayuse tutorial, have questions about the initial submission process , or reviewer comments, we would be more than happy to assist. If you are interested in scheduling a class presentation or an in-office appointment, please email us at irb@csun.edu and one of our analysts will coordinate a date and time.