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
Daniel N. Rastein at 818-677-2901 or
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
Deadline dates for submission of protocols to be reviewed by the Committee are three weeks prior to each meeting by 5 PM on the deadline day. Meetings are usually held the fourth Tuesday of each month (except for the December meeting, which is different due to the winter break.)
Protocol Deadlines (Due by 5:00 pm)
August 8, 2017
August 29, 2017
September 5, 2017
September 26, 2017
October 3, 2017
October 24, 2017
November 7, 2017
November 28, 2017
November 28, 2017
December 5, 2017
February 6, 2018
February 27, 2018
March 6, 2018
March 27, 2018
April 3, 2018
April 24, 2018
May 1, 2018
May 22, 2018
Answers to Frequently Asked Questions about Submission Requirements:
- Protocols are due by 5PM on the deadline day in University Hall 275.
- Number of copies required: one original signed protocol
- Protocol packet must be collated and stapled.
Summer Protocol Submissions
Researchers may submit protocols during June and July on a rolling basis. There are no deadlines during these summer months. Protocols that are submitted between June 1st and July 31st will be reviewed on a first come first served basis. Please note that some research activities may require full committee review, especially those that involve greater than minimal risk to participants. Protocols that are greater than minimal risk may not be reviewed until the first SACPHS meeting in August. Deadlines for new submissions and full committee meetings will resume in Fall semester as noted in above dates.
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.
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 researchers must submit the following 2 forms:
If your research requires international travel, your travel must be approved by the Office of Insurance and Risk Management. Please visit http://www-admn.csun.edu/risk/ for procedures and guidelines.
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.
If your protocol involves children or adolescents you need the appropriate assent form(s) for your population.
Agreement from minors in human subjects research is called assent, rather than consent. Minors are individuals under 18 years of age. The two assent forms we have available are:
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)
- Curriculum Vitae
Organizing your protocol packet:
Please submit only one set of materials. Multiple copies of the protocol packet are no longer required for submission.
Following is the order in which your protocol packet should be for submission to the Committee:
- Human Subjects Protocol Approval Form
- Project Information Form
- Adult Consent/Parental Consent
- Assent forms
- Bill of Rights
- Recruitment materials
- Data Collection Instruments
- Debriefing (required by the psychology department for psychology studies)
- Researcher Curriculum Vitae
- Off-campus approval if applicable and available to you from outside institution
- Any miscellaneous informational items
Remember to sign your Human Subjects Protocol Approval Form and students make sure that your advisor signs your form in the designated location after he/she has reviewed and approved of your protocol.
The packet must be organized as outlined above and either paper-clipped or stapled together. Packets must be submitted to University Hall 275.
Go to Deadlines & Meeting Dates to see the list of upcoming deadlines for submission.
After submitting your protocol
Your protocol will be review and determined to be Exempt, Expedited or reviewed at the full committee meeting following the deadline day on which you submitted.
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:
- Protocol Approval Form
- Project Information Form
- Consent Forms (Adult, Parental, Adolescent/Child)
- Recruitment Materials
- Data Collection Materials
Please submit one hardcopy of your modification packet to the Research and Sponsored Programs (RSP) office in UN 275. You may also 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
- New Protocol Approval Form with items #5 and #7 updated to reflect renewal;
- Most recent version of the Project Information Form and all additional related documents.
Please submit one hardcopy of the documentation above to the Research and Sponsored Programs (RSP) office, in UN 275, 30 days before the protocol expiration date.