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.
   

PREPARING YOU HSR PROPOSAL

Review the following:
HSR Module 2 Classroom Presentation 
HSR Process Overview Chart [Visual overview of the process]

Guidelines document for each section of the HSR Proposal. 

Informed Consent

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. However, your Informed Consent needs to have the following: Description of the project; procedures; risks or discomfort; benefits of this study; confidentiality; treatment available; voluntary participation and withdrawal; questions, rights and complaints; any compensation; how to reach you about withdrawal or further questions; your mentor's name and contact information. You want to offer participants a copy of the Informed Consent as well.  
Informed Consent Template
Assent Template (working with minors)

Informed Consent: Example 1

Informed Consent: Example 2

Examples of complete 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:

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). 

HSR Proposal Coversheet

HSR Proposal Coversheet (Word Doc)                 Creating Your Digital Signature

Letters of Permission from Organizations

Your 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:

FACULTY Mentor Approval Checklist

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.


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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