Human Subjects

ALL THESIS/PROJECT STUDENTS MUST OBTAIN HUMAN SUBJECTS APPROVAL BEFORE DATA COLLECTION BEGINS OR THE EQUIVALENT FOR A PROJECT

For the Protection of Human Subjects, the Division of Social Work Committee reviews 2 risk levels: “exempt” and “minimal risk” for student research. For “greater than minimal risk” research, the University Committee reviews those applications/protocols. We report to the University Committee and follow their guidelines with some minor modifications such as the number of copies and where to submit. Here is a link to the University Guidance and Procedures of the IRB, which contains all the information you need to prepare your request (see page 15 for the application): RACA Research Integrity and Compliance

We have some additional information to help you complete your application (aka protocol) review request on page 2 of this document. After you complete your application review request, your faculty sponsor (research advisor) must review and sign your request. For submission of application dates, review dates, and response letter dates see page 4 of this document.

Submit 3 copies to the Division of Social Work for ALL risk levels: “exempt,” “minimal risk,” and “greater than minimal risk” research.  In the case of “greater than minimal risk” research, the DIVISION OF SOCIAL WORK COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS (CPHS) will first review your application or protocol, assess and determine the level of risk, and then provide you with a letter indicating whether the level of risk requires you to submit your application/protocol to the university committee or the CSUS Committee for the Protection of Human Subjects.  If your study is determined to be “greater than minimal risk,” then the CPHS in the Division of Social Work will provide you with a level of risk letter.  This level of risk letter must accompany your application/protocol and you must then submit eleven copies of your application and all related materials (e.g., consent form, questionnaires or surveys, appendices, etc.) directly to the University Office of Research and Sponsored Projects, Hornet Bookstore, Suite 3400, for further review and approval.

***PLEASE NOTE THAT YOUR HUMAN SUBJECTS APPLICATION MUST FIRST BE SUBMITTED TO THE Division of Social Work REGARDLESS OF THE RISK LEVEL, one week before the committee’s review date listed at the bottom of this document.

• Please visit the RACA website for Human Subjects information and download the Request for IRB Review Application Form (available in RTF, PDF, or DOCX)

• Institutional Review Board Guidance and Procedures for the Protection of Human Subjects

• University’s CPHS Requirements for Online Surveys

• HHS OHRP Human Subjects Regulations Decision Charts

• CITI Research Ethics Education Program

• RACA Research Integrity and Compliance Frequently Asked Questions

Additional Information for Completing the
Request for Review by the Committee for the Protection of Human Subjects (CPHS)

1. In completing the Request for Review form, be sure to include the following information for the questions cited:

- Number of subjects in study

- Source of subjects

- Criteria for inclusion and exclusion

In studies in which subjects are drawn from special groups whose capabilities to provide informed consent may be absent or limited, a rationale must be provided. Such groups would include: children, prisoners, residents or clients of institutions for the mentally ill or mentally retarded, the senile who are confined to institutions, whether by voluntary or involuntary commitment, some sensory-impaired such as the blind or deaf, the unborn child or fetus, and pregnant women insofar as the unborn child or fetus is involved.

• Frank discussion of potential problems involving the subject group
• Circumstances under which subjects will be recruited and any inducement that may be offered.

2. Documentation of informed consent: written, oral or modified presentation

• Written presentation: attach a copy of the consent form
• Oral presentation: describe in detail the substance of what will be said to the subject and how the subject's decision will be recorded
• Modified presentation: describe in detail the reasons and methods for modifying the presentation from a written or oral presentation for informed consent
• If no informed consent will be obtained, the reasons for this should be explained.  This is acceptable only in proposals deemed by the CPHS to be “exempt.”

3. Describe precautions taken to minimize any risk to the physical, psychological or social safety of the subject.  Describe how the privacy of the subject will be protected. (Note that the use of social security numbers as identifiers for subjects who are students at CSUS will not protect their privacy since these numbers are commonly used to identify students.)

4a. Purpose of the proposed study

b. Design

c. Procedures

d. Potential benefits to: the field (theoretical, empirical, practical); society; the individuals involved or the population from which the individual subjects were selected

e. Academic background and experience of the investigators as they relate to the proposed study

• Type of study (exploratory, descriptive, co relational, experimental, etc.)
• Location of the study

5. Standard or commonly used tests, questionnaires, etc. which are to be used should be named and described. Copies of newly developed documents or ones not in common use should be attached. Any risks in their use should be described.

6. A description of any physical procedures to be used and any possibility of physical discomfort or harm should be made.

7. Describe any equipment, instruments, drugs or pharmaceuticals that will be used and what risk is involved in its use. Any special procedures involving electrical devices, radioisotopes or investigational new drugs (INDs) must be described. Approval from appropriate campus, state, or federal agencies must be obtained before CPHS approval can be granted. Unusual electrical devices must have the approval of the Environmental Health and Safety Officer. Radioisotopes or research involving any source of radiation must first be approved by the Radiation Safety Committee, and "new" drugs must first be approved by the Federal Drug Administration.

• State the level of risk to human subjects and give reasons.

"Exempt" research. Please see Guidance and Procedures of the IRB PDF policy manual page 8 for examples of exempt research. While exempt research does not need the approval of the CPHS, the CPHS must receive sufficient information to determine whether the proposed research is exempt. Research that does not involve human subjects would be considered exempt.

"Minimal Risk" research. Research in which the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Use of an informed consent form is required.

"Greater than Minimal Risk" research. Research which involves some risk (physical, psychological, or social) to subjects. Please see Guidance and Procedures of the IRB PDF policy manual page 8 for details of psychological or social risk. Use of an informed consent form is required. Research that is "Greater than Minimal Risk’ can only be approved by the University CPHS.

Be sure to sign and date the Request for Review application/protocol form. The faculty research advisor must sign the student’s proposal indicating concurrence in the evaluation of risk, and attesting to the completeness and accuracy of the information contained in the Request for Review application/protocol form. Submit three copies to: Division of Social Work, Committee for the Protection of Human Subjects (CPHS), Social Work Office, Mariposa Hall 4010. (For research that is determined to be "Greater than Minimal Risk" category or level, submit eleven copies directly to the University Office of Research and Sponsored Projects, Hornet Bookstore, Suite 3400, only if the Division of Social Work Committee for the Protection of Human Subjects has reviewed your application/protocol and has indicated to you in writing that you need to submit your application/protocol directly to the University CPHS.

Dates for Submission and Review of Human Subjects Applications 2012-2013: