Human Subjects

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

For protecting human subjects in research activities, the Division of Social Work Research Review Committee (DSWRRC) reviews all "Human Subjects Protocol Application – Request for Review by the Sacramento State Institution Review Board (IRB)" forms, further herewith referred to as the “application”, but only has the legal authority to determine whether a research activity meets the federal definition of research and “Exempt” level of research.  All risk levels of possible determinations (i.e., “Exempt,” “Minimal Risk” and “Greater than Minimal Risk”) for student research activities will be first reviewed by the DSWRRC.  Any application determined to be above “Exempt” level will be required to be resubmitted to the University’s Committee for the Protection of Human Subjects, also known as the Institutional Review Board (IRB).

The DSWRRC on human subjects reports to the University IRB and follows their guidelines at the Division level except for the number of application copies, three (3) copies are required, and the submission location, which is at the Social Work Office. For preparation information of your application materials, please review the Guidance and Procedures of the IRB manual (on the RACA website), at the link below, which contains all the information you need, pay particular attention to the application information on page 15 of the manual. You must also download the application, at the same link below.

Social Work Human Subjects Submission Dates

♦  CSUS Human Subjects Forms  ♦

***PLEASE NOTE THAT YOUR APPLICATION MUST FIRST BE SUBMITTED TO THE DSWRRC REGARDLESS OF THE RISK LEVEL***

Please review the additional information below to help you complete your answers to certain questions on your application. Be sure to provide answers to all applicable questions.  After you complete your application, be sure to sign and date your application form. Your faculty sponsor (research Advisor) must sign your application indicating concurrence in the evaluation of risk, and attesting to the completeness and accuracy of the information contained in the application form. For application submission dates, review dates, and response letter dates, please see the table below.

Question 1 - Describe the following:

     A.  Purpose of the proposed study

  • Potential benefits to: the field (theoretical, empirical, practical); society; the individuals involved or the population from which the individual subjects were selected
  • Academic background and experience of the investigators as they relate to the proposed study

     C.   What is the design of the study?  (i.e., explain the qualitative, quantitative or mixed method type of design).

  • Type of study (exploratory, descriptive, co-relational, experimental, qualitative, quantitative, etc.)
  • Data sources
  • Design and Data Analysis

     D.  What are the procedures of the study? (i.e., include the sample type, information on how the data is being collected); the data collection method (i.e., survey, in-depth interviews, focus groups, etc.), and who is collecting the data?

  • What is the location of the study

     F.   What is the plan for the protection of the data obtained? (i.e., include the security measures, data handling procedures, retention procedures, data destruction date and who has access to the data).

Question 2 -  Who will participate in this research as subjects (e.g., how many people, from where will you recruit them, what are the criteria for inclusion or exclusion)?  How will you engage their participation (e.g., what inducements, if any, will be offered)?  How will you avoid any real or perceived conflict of interest as a researcher (e.g., role, power relationships, monetary)?

  • Source of subjects - circumstances under which subjects will be recruited and any inducement that may be offered.
  • Number of subjects in study
  • Frank discussion of potential problems involving the subject group

Question 3 - How will informed consent be obtained from the subjects?  Attach a copy of the consent form you will use.  If a signed written consent will not be obtained, explain what you will do instead and why.  (See Appendix C in Guidance and Procedures for examples of consent forms, an example of an assent form for children, and a list of consent form requirements.  Also see the section on Informed Consent in Guidance and Procedures.)

  • 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 challenged, the senile who are confined to institutions, whether by voluntary or involuntary commitment, some sensory-impaired persons such as the blind or deaf, the unborn child or fetus, and pregnant women insofar as the unborn child or fetus is involved.
  • Documentation of informed consent: written, oral or modified presentation
  • If no informed consent will be obtained, the reasons for this should be explained.  This is acceptable only in proposals deemed by the IRB to be “exempt.”
  • 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 

Question 5 - Describe the content of any tests, questionnaires, interviews, surveys or other instruments utilized in the research.  Attach copies of the questions.  What risk of discomfort or harm, if any, is involved in their use?

  • State the level of risk to human subjects and give reasons. 
  • Standard or commonly used tests, questionnaires, etc. which are to be used should be named and described and copyright material approval should be secured prior to submission. Copies of newly developed documents or ones not in common use should be attached. Any risks in their use should be described.
  • Describe precautions taken to minimize any risk to the physical, psychological or social safety of the subject.

Question 6 - Describe any physical procedures in the research.  What risk of discomfort or harm, if any, is involved in their use?  (The IRB will seek review and recommendation from a qualified medical professional for any medical procedures.)

  • State the level of risk to human subjects and give reasons.
  • Describe precautions taken to minimize any risk to the physical, psychological or social safety of the subject.

Question 7 - Describe any equipment or instruments that will be used in the research.  What risk of discomfort or harm, if any, is involved in their use?

  • State the level of risk to human subjects and give reasons.
  • Describe precautions taken to minimize any risk to the physical, psychological or social safety of the subject.

Question 8 - Will any devices, drugs or pharmaceuticals be used in the research?  If so, describe their use and any possible risk or discomfort.  (If so, the IRB will seek review and recommendation from a qualified medical professional.)

  • 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.

Question 9 - Taking all aspects of this research into consideration, what risk level do you consider this study to be?

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

OR

"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. Research that is "Minimal Risk’ can only be approved by the University CPHS/IRB.

OR

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

Be sure to sign and date  your application form. Your faculty sponsor (research Advisor) must sign your application indicating concurrence in the evaluation of risk, and attesting to the completeness and accuracy of the information contained in the application form. For application submission dates, review dates, and response letter dates, please see the table below.

Submit 3 copies of your application to the Division of Social Work office for ALL risk levels: “Exempt,” “Minimal Risk,” and “Greater than Minimal Risk” research. 

 In the case of “Minimal Risk” and “Greater than Minimal risk” research, the DSWRRC will first review your application, assess and determine the level of risk, and then provide you with a letter indicating whether the level of risk requires you to resubmit your application to the DSWRRC or to the CSUS Committee for the Protection of Human Subjects (aka IRB).  If it is determined that the level of risk is greater than “Exempt” you must attach a copy of the letter from the DSWRRC to your application to the University IRB. You must then submit 11 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 Building, Suite 3400, for further review and approval.

 

Dates for Submission and Review of Human Subjects Applications 2014-2015:

 



Dates for Submission



Dates for Review



Expect Response Letter by

Friday, September 12, 2014

September 24, 2014

October 1, 2014

Friday, October 3, 2014

October 15, 2014

October 22, 2014

Friday, October 24, 2014

November 5, 2014

November 12, 2014

Friday, November 14, 2014

November 26, 2014

December 3, 2014

Friday, December 5, 2014

December 10, 2014

December 17, 2014

Friday, January 30, 2015

February 11, 2015

February 18, 2015

Friday, February 27, 2015

March 11, 2015

March 18, 2015

Friday, March 20, 2015

April 8, 2015

April 15, 201

Friday, April 24, 2015

May 6, 2015

May 13, 2015