Research and Graduate Studies

Protocol Submission Process

Forms

All researchers must submit the following 2 forms:

  • Human Subjects Protocol Approval Form
     / 
    Choose the appropriate form for you – either the faculty researcher version or the student researcher version. The student researcher form includes a signature requirement for the faculty advisor.

International Travel:

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.

Additional Documents

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:

  1. Human Subjects Protocol Approval Form
  2. Project Information Form
  3. Adult Consent/Parental Consent
  4. Assent forms
  5. Bill of Rights
  6. Recruitment materials
  7. Data Collection Instruments
  8. Debriefing (required by the psychology department for psychology studies)
  9. Researcher Curriculum Vitae
  10. Off-campus approval if applicable and available to you from outside institution
  11. 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 265.

Go to Deadlines and Meeting Dates to see the list of upcoming deadlines for submission 

After submitting your protocol

Your protocol will either need to be reviewed at the full committee meeting following the deadline day on which you submitted, or will go directly to the committee Chair for review. Once the protocol is reviewed either by the Chair, or the full Committee it takes a minimum of 30 days to respond to researchers with any requested revisions from the Committee, or approval.

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.

If your protocol was approved, you will receive a hard copy approval letter and stamped consent forms (with the Committee’s approval stamp) via regular mail.

You must keep your approval and your signed consent forms (after obtaining participant’s signature) for a minimum of 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.