Human Subjects Review for Student Research

All research including human subjects should be reviewed by a human subjects committee. Undergraduate, Credential, and Master’s level student researchers are required to submit their applications to the College Research Review Committee for Human Subjects Review.

Some applications will be approved in the College Committee while other applications will need to also be reviewed and approved by the University Institutional Review Board (IRB) after being reviewed by the college.

Whether or not an application requires secondary university review is based on the risk level assigned by the College Committee. Students should work with their advisors to identify the most likely risk level assignment before submitting their application, and plan their timeline to accommodate both the College and University reviews if necessary.

Review of human subject research applications is regulated by federal regulations from the Office of Human Research Protection (OHRP) and university policy. For more information and details about the University Institutional Review Board (IRB) Human Subjects Research.


Risk Levels

Exempt

Some research categories have been identified as exempt by the federal regulations.  The research must still be reviewed by the committee to determine whether it truly fits into these categories.  Examples include research in established courses on instructional techniques, observational research on adults not children, surveys with adults where data are recorded in a way that participants cannot be identified, analysis of existing data where participants are anonymous, etc.  See the Exempt Decision Trees  for more information on determining whether your research might fit into an exempt category.

Research classified as exempt risk level by the College Committee does not need secondary review by the University IRB.

Minimal Risk

Research that is categorized as minimal risk is research in which the probability and magnitude of harm or discomfort anticipated for participants are no greater than what might be encountered in daily life or during the performance of routine physical or psychological examination or tests.

Research classified as minimal risk must go to the University IRB after the College Committee reviews the application.  Minimal risk applications can be reviewed by the University IRB as expedited review – for expedited review applications can be submitted at any time and feedback from the review is returned within 2 weeks.

Greater Than Minimal Risk

Research classified as greater than minimal risk is research where the probability of harm or discomfort or magnitude of possible harm (physical, psychological, social, or economic) from participation in the research study are more than what might be encountered in daily life.

Greater than minimal risk classification in the College Committee requires secondary review by the University IRB and will require review by the convened board.  The University IRB board meets once a month, the due dates and meeting dates are listed on the Office of Research Affairs' Review Categories and Timelines.

Note that working with certain populations, like children, can increase your risk level under certain circumstances because these groups are designated as vulnerable populations by the federal government and provided additional protections.  For example, when working with children you will need both the child’s assent and the parent’s consent to for their participation, and will need to be sure that they are free from pressure to participate from adults in a position in authority.  This can make research with your own students or children tricky to meet these protections.

Not Reviewable Research

Some research projects do not meet the federal definition of research reviewable by the human subjects committee. Research projects that do NOT involve; (a) interaction or intervention with people, or (b) obtaining private, individually identifiable information about living individuals are not required to be reviewed. If this is the case, fill out the student exempt form and submit that to the CRRC chair. Please note that many research projects involve interaction or intervention while collecting data; these projects must be submitted and approved by CRRC.


How to Apply

Step 1

After you finalize your methodology completely fill out the Human Subjects Research Application found in the Human Subject Research Page.

You should completely fill out this form, even if it means repeating yourself.  Answer all parts of each question, but do not provide information not asked for.  Do not cut and paste big sections from your petition or chapters and do not say “see attached” or “see below”, provide all of the relevant information in the form.

Step 2

After your petition has been approved, have the completed human subjects application forms signed by your research sponsor approving that they have read it for correctness and completeness.  

Step 3

Scan your forms and all supporting documents, including consent forms, questionnaires or interview questions, NIH training certificate, etc. into a PDF and email it to the committee chair (see contact information below) with the title: COE Human Subjects Review – YOUR LAST NAME in the title of the email. (There are copy machines in the library that can help you scan to PDF if you don’t know how to do this on your computer, as well as computer labs that will allow document to PDF conversion.  If you are having difficulty, please contact the committee chair for additional instructions.)

Note: There is information and examples on the university IRB website (provided in Step 1) on how to prepare consent forms, online surveys, etc.

Within 24 hours of submission you will receive an email confirming that your application has been received by the College Committee.


Due Dates

The College Research Review Committee generally meets 1:30-3:00pm on the third Thursday of each month.  Applications are due to the chair 10 days before the meeting, on a Monday.  Feedback from the meeting is returned to PI’s generally within 4 days following the meeting.

Fall 2017 Application Deadlines for Submission by Students

September 11th for the September 21st meeting

October 9th for the October 19th meeting

November 6th for the November 16th meeting

December 11th for the December 21st meeting


Training

Starting in Fall 2014, everyone who submits a human subjects application needs to have completed the appropriate training and education to meet the university requirements.

Student researchers need to complete a Human Subjects tutorial provided by NIH and provide a copy of their completion certificate with their human subjects application.  The link to the tutorial is below with instructions for registration:

NIH Training Guidance

  1. https://phrp.nihtraining.com/users/login.php
  2. Click the “Register” button
  3. Complete form to create an account
  4. Complete the courses
  5. Attach a copy of the certificate to the application (either department application and university application)

Please note that many research courses include EDGR 260 and many 250 courses require the completion of this tutorial as part of their course.  If you completed it in a course you should be able to log back in to the system and re-print your completion certificate.


Questions
Dr. Melissa Holland, Chair of College Research Review Committee
Phone: (916) 278-3927 | Email: mholland@csus.edu
(Please allow 24 hours for responses to email messages and 1-2 weekdays for responses to phone messages)