Human Subject Research - DMISS PROGRAM

IMPORTANT

All DMiss HSR Proposals must be reviewed and approved before you may begin your research.

Any data gathered prior to approval may not be used in your DMiss coursework or dissertation.

MODULE 1: PREEMPTIVE WORK DOCUMENTS FOR HSR to HELP ASCERTAIN RISK

DMiss  HSR Preemptive Form - this document is not your HSR proposal, nor is it a sample of what your HSR proposal should look like. This document describes risk categories to help you think through these categories in regards to the research you anticipate. It gives you next steps in this human subject research discernment process [NIH Certificate and the Field Research Worksheet].

DMiss  Field Research Worksheet -This document is not your HSR proposal, nor is it a sample of what your HSR Proposal should look like. This document seeks to help you think through and answer questions which will help us assess the risk category of your proposed research. This will help us best prepare with you if your proposal needs to go to a full HSR Committee (HSRC).

RISK: Risk level is mandated by the definitions. Including a plan for adverse events or actions to mitigate risk in your proposal does not move the proposal into a different risk category.
   

MODULE 2: PREPARING YOUR HSR PROPOSAL

Review the following: 

  1. HSR Module 2 Classroom Presentation  
  2. HSR Process Overview Chart [Visual overview of the process] 
  3. Guidelines document for each section of the HSR Proposal. 
  4. Confidentiality or  Anonymity?
  5. Adverse Events
  6. Informed Consent (Template): Think of the Informed Consent as a legal document between you and your research participants.  While your formal HSR Proposal may list all these things, remember the participants in your study aren't reading your full proposal. All they will know is what you disclose to them in the Informed Consent. The Informed Consent is not the same as an invitation to participate in your research. You may have a separate invitation to participate with as much or as little information as you'd like. Please click on the "Informed Consent Template" to see what is required. You want to offer participants a copy of the Informed Consent as well, so that they have something to refer back to should then need to contact you. 
    Assent Template (working with minors) 
    Informed Consent: Example 1
    Informed Consent: Example 2

Examples of completed HSR proposals:    

HSR Proposal Example 1 

HSR Proposal Example 2  

SUBMITTING YOUR HSR PROPOSAL

When you are ready to submit your proposal, make sure it includes the following or it will be returned to you:

  1. Certificate of successful course completion
    As pre-intensive work to your Module 2 complete the free National Institutes of Health online certification course
    Submit the certificate as an appendix of your HSR Proposal (see How to Attach a PDF File to a Word Document). 
  2. HSR Proposal Coversheet   HSR Proposal Coversheet (Word Doc)   Creating Your Digital Signature
  3. Letters of Permission from Organizations; Sample Letters: Asking/Receiving Permission from Organizations
  4. FACULTY Mentor Approval ChecklistYour Module 2 Methods professor will review and sign off on your HSR Proposal.
    They will then submit the following checklist when they submit your proposal for review:

If your proposal is minimal risk, it will go through an expedited review via the DMiss Office.  If your proposal is more than minimal risk, it will be reviewed at an upcoming HSRC meeting. You will be given the appropriate submission deadlines in advance so that you can best plan with your Methods professor when to submit the proposal to the full HSRC.  Approvals are good for one year.

MODULE 3: STEPS FOR CONTINUING REVIEW

Projects are granted approval for one year only. The initial HSR review is based on the researcher's best assessment about anticipated results, risk, and procedures. It is only after research has begun that the real risks can be evaluated and the preliminary results used to compute the actual risk/benefit ratio. Therefore, If data collection continues beyond the one year deadline, investigators should apply for renewed approval. The investigator is required to submit a proposal that helps assess progress, significant new findings, and additional risks if any.

If your initial proposal was reviewed and approved by the DMISS Office, please submit the following to alyz@fuller.edu.

If your initial proposal was reviewed and approved by the HSRC, please submit the following to alisonwong@fuller.edu.

  1. The HSR Proposal Cover Sheet
  2. A 2-3 page protocol summary 
  3. A 2-3 page status report on the progress of the research

The protocol summary should be based on the original HSR proposal, and should contain the following information: study title, investigator(s), brief description of the hypothesis/research questions, recruitment procedure, informed consent/assent process, participant characteristics, approximate number of participants, types of questions asked, and risk level/benefits ratio.

The status report should indicate what research activities have concluded and which are ongoing, explicitly noting the intended research activities for this next year, assuming your continuation is approved.  Also include the number of participants accrued, a summary of any amendments of modifications to the research, a summary of any adverse events of unanticipated problems involving risks to participants or others, a summary of any interim research findings, and a copy of any revised or newly proposed informed consent/assent document(s). Remember, be sure to also include the intended research activities for the upcoming year.

Continuing review proposals will be assessed according to the following questions: 

  1. Are the actual risks and benefits as anticipated and does the protocol adequately provide for continuing assessment of the balance between risks and benefits
  2. Have any subjects been seriously harmed?
  3. Has the HSR committee been informed of any unforeseen problems or accidents that may have occurred?
  4. Since the last HSR review, have subjects been informed of any important new information that might affect their willingness to continue participating in the research?
  5. Do the consent documents need to be revised? 
  6. Has due care been used to reduce risks and increase the likelihood of benefit? 
  7. Are the procedures agreed upon at the beginning of the research still being used? 
  8. Should HSR approval be continued, or should approval be suspended or terminated?

OTHER TUTORIALS & GUIDELINES 
US Dept of Health and Human Services guidelines (this includes links to related laws in over 100 other countries)
Code of Ethics for the American Anthropological Association
Risks and Wrongs in Social Science Research: An Evaluator's Guide (by J. Michael Oakes)
Frequently Asked Questions and Vignettes

 
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