Proposing Human Subject Research

Below are the application forms, instructions and supplementary material resources for proposing to conduct human subject research as a CSUMB researcher or with CSUMB participants. Use of all forms and supplementary materials is for human subjects research purposes only.

After completing all application materials, submit your protocol and all required supplementary documentation to:

Office of Grants & Contracts
Attn: Jennifer Bliss, Human Subjects Coordinator
Alumni & Visitor Center (Building 97, Room 120)
100 Campus Center, Seaside CA 93955

For questions about a specific human subject research protocol, researchers are encouraged to read the Human Subjects in Research web pages carefully, reference CSUMB's Human Subject Research Guidelines, and then contact a CPHS member or administrator at the Office of Grants & Contracts.

 

Forms

Instructions

Application

For CSUMB student, staff and faculty submitting new protocols.

 Guidelines for Informed Consent

External Researcher Agreement

For non-CSUMB researchers with approved protocols from their institution's IRB.

  

Request to Waive Signed Consent

For researchers requesting to inform but NOT COLLECT SIGNATURES from participants (submit this with a consent narrative).

Guidelines for Consent Waivers

Request to Waive Consent

For researchers requesting to NOT INFORM PARTICIPANTS (i.e.: deceptive research).

  

CPHS Change Form (OtterID required) 

For CSUMB student, staff and faculty requesting changes to approved protocol including minor and major modifications and extension requests.

This is an online submission and no physical signature is required.

 CSUMB's Quick Guide to HSR Change Requests

External/Other Applicants (no OtterID): CPHS Change Form

For non-CSUMB affilates requesting changes to approved protocol including minor and major modifications and extension requests.

This is a paper-submission form and physical signature authorization required. 

  

Adverse Event Report

For all researchers reporting complaints, problems, or other adverse effects of the research.

  

CPHS Project Review Form (OtterID required)

For CSUMB student, staff and faculty reporting Expedited/Level II and Full Board Review/Level III Continuing Review and Close Out.

This is an online submission and no physical signature is required.

 CSUMB's Quick Guide to Continuing Review

External/Other Applicants (no OtterID): CPHS Project Review Form 

For non-CSUMB affilates reporting Expedited/Level II and Full Board Review/Level III Continuing Review and Close Out.

This is a paper-submission form and physical signature authorization required.
 

 

Consent Templates

As a courtesy, the following templates are provided as a reference in developing your consent forms and/or narratives. These templates are intended as one of many resources researchers will utilize in developing appropriate consent materials.

Use of these forms on university letterhead is permitted for human subject research purposes only. To obtain university letterhead for other purposes, go to: http://marketing.csumb.edu/brand-identity-guide/letterhead-digital.

NOTE: Final consent forms and/or narratives must meet the Guidelines for Informed Consent and may not be changed after the protocol is approved unless a CPHS Change Form is submitted and changes are approved.

Consent Templates Instructions

Consent

For adult participants - signature collected (typical consent form).

 Guidelines for Informed Consent

Consent - Spanish

For Spanish-speaking adult participants - signature collected (typical consent form in Spanish).

  

Consent Narrative

For adult participants - no signature collected (use with Request to Waive Signed Consent).

Guidelines for Consent Waivers

Consent Narrative - Spanish

For Spanish-speaking adult participants - no signature collected (use with Request to Waive Signed Consent).

  

Parent/Guardian Consent

For parents/guardians of minor/child participants (typical parental consent).

  

Parent/Guardian Consent - Spanish

For Spanish-speaking parents/guardians of minor/child participants (typical parental consent form in Spanish).

  

Assent

For minor/child participants (use with Parent/Guardian Consent).

  

Assent - Spanish

For Spanish-speaking minor/child participants (use with Parent/Guardian Consent in Spanish).

  

Audio/Video Consent

For participants who will be recorded (use with appropriate consent form).

  

Audio/Video Consent - Spanish

For Spanish-speaking participants who will be recorded (use with appropriate consent form).

  

Photograph Consent

For participants who will be photographed (use with appropriate consent form).

  

Photograph Consent - Spanish

For Spanish-speaking participants who will be photographed (use with appropriate consent form).

  

 

Site Authorization

If your research activities are to take place off-campus, you must provide site authorization from an appropriate authorizing representative where you intend to conduct research. 

Guidelines on site authorization are provided in the Human Subject Research, Guidance Standards and Practices, Section 2.3.3: Collaborative Research and Section 4.16.7: Transportation of Data.

Following are instructions and templates for use in developing your research protocol and obtaining site authorization relevant to your project.

Site Authorization Instructions & Templates

Conducting Research at Schools
Posted by Jennifer Bliss on Jan 31, 2012 -