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'm 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 SACPHS?
Yes, the Committee meets once per month during the academic year and the deadline to submit is 3 weeks prior to each meeting. See Schedule of Submission Deadlines and Meeting Dates for more information. 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 the committee on the status of your project a minimum of 30 days 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 review.
Why was my project held up and not reviewed even though I submitted it on time?
If required documents are missing, the Committee does not have enough information to perform a thorough review and analysis of the project. Following are some of the documents and required information, which, if not submitted, will delay review.
- Faculty advisor signature on Human Subjects Approval Form
- Faculty researcher or student researcher signature on Human Subjects Approval Form
- Questionnaires and data collection instruments
- Informed Consent Form
- Project Information Form
Your protocol will not be submitted to the committee for review until all required documents have been submitted to the Office of Research and Sponsored Projects.
When does human subjects approval expire?
Approval for human subjects research protocols does not necessarily last for 12 months and expires 365 days after review. If your project was reviewed and approved at the Human Subjects Committee meeting held on June 14, 2010, approval expires June 13, 2011. Using the same example above: If your protocol was reviewed at the June 14, 2010 meeting, but was not approved until August 14, 2010, approval will still expire by June 13, 2011 (365 days after it was reviewed, but only 10 months after it was approved).
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 find out what their requirements are. CSUN's Human Subjects Committee will require that you show evidence of approval from the institution at which you intend to perform research.