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 firstname.lastname@example.org.
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:
- 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.
Deadlines & Meeting Dates
Please 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 (except for the December meeting, which is different due to the winter break). Deadlines and meeting dates for the upcoming academic year are as follows:
Protocol Deadlines (electronically)
August 6, 2019
August 27, 2019
September 3, 2019
September 24, 2019
October 1, 2019
October 22, 2019
October 29, 2019
November 19, 2019
November 26, 2019
December 10, 2019
February 4, 2020
February 25, 2020
March 3, 2020
March 24, 2020
April 7, 2020
April 28, 2020
May 5, 2020
May 19, 2020
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.
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?
Yes, 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 the meeting will I hear from the Committee?
You will hear back from two weeks to 30 days following submission. 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 review.
What if I intend to conduct human subjects research in another country?
If you intend to conduct human subjects research outside the United States, there may be additional regulations that you will have to follow in that other country. You must contact the institution at which you intend to do your research to learn about their requirements. CSUN's Human Subjects Committee will require that you show evidence of approval from the institution at which you intend to perform research.
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.
Informed Consent Process
Explanation of the Research
Investigators (or IRB approved designees) must use the following steps in order to orient the potential subject to the purpose of the research and why they might wish to participate:
- Step One: The Investigator (or IRB approved designee) must explain the study to the potential subject verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation, etc.), and must allow the potential subject ample opportunity to ask questions.
- Step Two: Following this verbal explanation, the potential subject should be provided with a written consent form and afforded sufficient time to consider whether or not to participate in the research. "Sufficient time" can range from hours to days, depending on how long it reasonably takes to evaluate the procedures, risks, potential benefits, and alternative treatments.
- Step Three: After allowing the potential subject time to read the consent form, an Investigator listed on the consent form should meet with the potential subject and answer any additional questions s/he may have.
Subject Comprehension Assessment
The responsibility of ensuring that a potential subject understands the research and the risks and benefits involved falls upon the Investigator and not upon the potential subject.
- It is critical to the consent process that the Investigator not only field questions but also asks questions.
- Asking questions can further the discussion, elicit questions from the potential subject, prompt the potential subject to think more carefully about the study, and help the Investigator decide whether the person has adequately understood the study.
- Useful questions will be open-ended and non-directive. Rather than asking for yes or no answers, they ask for explanation because these questions often can be answered in a variety of ways, and do not already contain the correct answer.
- Open-ended questions are often introduced with "what," "where," "how often," "when," and "please describe."
Examples of open-ended questions are:
- "Just so that I'm sure you understand what is expected of you, would you please explain to me what you think we're asking you to do?"
- "Describe in your own words the purpose of the study."
- "What more would you like to know?"
- "What is the possible benefit to you of participating in this study? What are the possible risks?"
- "Can you describe what the alternatives to participation in this study are?”
Important Informed Consent Process Reminders:
- Do not use an unapproved consent form.
- Do not use an expired consent form. Confirm the approval and expiration date is within the IRB approval period.
- Changes will be made to the informed consent document during the course of the study. It is the Researcher's responsibility to ensure that the individual signs the latest 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 subject with the Subject’s Bill of Rights (required for studies involving medical experimentation as defined by State law; all clinical investigations).
Protocol Initial Submission Process/Consent Forms
All applications for initial protocols are to be submitted electronically using Cayuse IRB.
Please note: Firefox and Chrome are the recommended browsers for the Cayuse platform. Faculty will login using their CSUN credentials. Student researchers must request access to Cayuse IRB by completing this form. Students must allow three business days for access to be granted.
Instructions to use Cayuse IRB to create an initial submission can be found here (.pdf).
The information below specifies the types of consent and assent forms you will need for your study. All of our consent/assent 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.
If your protocol involves only adults (adults are people 18 years and older), please provide:
If your protocol involves medical research, please provide:
At the discretion of the CSUN IRB, and as determined through IRB review, the inclusion of the Bill of Rights in Human Subjects research will only be considered mandatory if it involves a medical experiment as defined under California Health and Safety Code, Sections 24170-24179.5. The inclusion of the Bill of Rights will be considered optional for all Human Subjects research, at the discretion of the IRB, if its activities do not fall under the auspices of California Health and Safety Code, Sections 24170-24179.5.
Agreement from minors in human subjects research is called assent, rather than consent. Minors are individuals under 18 years of age. If your protocol involves children or adolescents, please provide:
You will also need:
Keep in mind that if you are recruiting at a high school, some students are 18 years of age and do not need parental consent, but rather can provide their own consent with an adult consent form and will need to sign their own Bill of Rights.
If you are also involving parents as participants in the study then you will need to obtain consent from parents for their own participation using the adult consent form.
For more information about the consent process and how to use the forms once your protocol is approved please go to Informed Consent Process.
Form(s) required for research conducted at off-campus institutions (e.g. other universities, churches, private businesses, etc.)
An approval letter from the institutional authority at an off-campus location is required before your protocol may be approved to begin. You do not need to submit this form at the time of review because many institutions want to be sure that our Committee has provided at least tentative approval before they give permission for you to conduct your study. However, before the Committee can provide you with final approval we will need to know that the institution where you are collecting your data has approved you recruiting and/or conducting your research at their site.
If the institution where you are collecting data has their own Human Subjects Committee (Institutional Review Board- IRB), then you need not submit the letter above, but instead submit an approval letter from the institutions IRB if they wish to serve as the IRB of record for your protocol.
Additional items that you may use in your data collection and will need to be reviewed by the Committee:
- All data collection instruments (validated, and original)
- List of interview or focus group questions or themes
- Survey questions
- Descriptions and/or photos of novel equipment
- Recruitment material (e.g. fliers, newspaper/craigslist ads, recruitment emails/letters, social network recruitment postings)
After submitting your protocol
Your protocol will be reviewed and determined to be exempt, expedited or reviewed at the full committee meeting following the deadline day on which you submitted. Go to Deadlines & Meeting Dates to see the list of upcoming deadlines for submission.
If your protocol went to the full committee meeting and was not approved, you will either be required to make very minor revisions, which you will be informed can be returned via email, or you will be informed that your protocol needs significant development and will need to be re-submitted to a future full committee meeting. You will be informed of the above via email.
It is suggested that you keep your approval and your signed consent forms (after obtaining participant’s signature) for 5 years (American Psychology Association guidelines). You do not need to submit the signed consent forms to our office once they are signed by the participants.
Protocol Modification Process
This process should be used to modify protocols that have previously approved and have not expired.
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 to
Protocol Renewal Process
This process should be used only to renew protocols that were previously approved and have not expired.
To renew a protocol, please submit a cover letter outlining the need for the renewal, and include the following:
- The number of subjects accrued since the last IRB review of the protocol and (for ongoing studies) the total number accrued for the study;
- 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;
- A summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review;
- Any relevant multi-center trial reports;
- Any other relevant information (especially information about risks associated with the research);
- A copy of the current informed consent document (without the approval stamp) and any newly proposed consent documents; and
- Any other changes to the study (e.g., personnel, measures, procedures, etc.)
Please submit your renewal request with the above documentation via email to email@example.com at least 30 days before the protocol expiration date.
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 firstname.lastname@example.org 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 email@example.com 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 firstname.lastname@example.org) 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 (IO; currently Dr. Sheree Schrager, Managing Director of Research and Sponsored Programs) 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.