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: PREPARATORY 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 your professors work with you to assess the risk category of your proposed research. This will help them best prepare you for when your proposal is reviewed by the HSR Committee (HSRC).

RISK: Risk level is mandated by the definitions. Plans and actions to mitigate risk in your proposal does not move the proposal into a different risk category. Your professors will help you think through what plans and actions you might need to help mitigate against risk. 
   

MODULE 2: PREPARING YOUR HSR PROPOSAL  

Review the following: 

  • HSR Module 2 Classroom Presentation   
  • Confidentiality or  Anonymity?
  • Adverse Events
  • 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) 
  • If you plan to use a research assistant, you will want to have them sign a confidentiality agreement. The HSRC can provide a sample template for you.

SUBMITTING YOUR HSR PROPOSAL 

Please visit HERE for the most updated versions of the HSR New Study Form, Addendum, and Continuing Review Forms. 

Your Module 2 professor and/or the HSRC representative will walk you through the New Study Form form during your Module 2 class time.

NOTE: ALL risk levels (minimal, moderate, high) should be sent to Alison Wong, alisonwong@fuller.edu. 

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

If your proposal is minimal risk, it will go through an expedited review via the HSRC.  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.  Please see "Steps for Continuing Review" below.

CHANGING A STUDY: SUBMITTING AN ADDENDUM

Before making any changes to an approved study, an addendum form must be submitted and approved, highlighting the changes proposed. All addenda should be submitted to alisonwong@fuller.edu. This includes, but is not limited to, changes in research personnel, consent, assent, research instruments, addition of new instruments, changes or additions to advertising, and other changes in protocol. You can submit an addendum at any time to alisonwong@fuller.edu. Work with your Module 2 Methods professor for sign off before submitting your addendum to the HSRC.

Please visit HERE for the most updated versions of the HSR New Study Form, Addendum, and Continuing Review Forms.

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.

Beginning February 18, 2016, all proposals, whether initially reviewed by the DMiss Office or the HSRC, should be submitted to Dr. Alison Wong: alisonwong@fuller.edu

Consult the HSRC Continuing Review Reviewer Form to read the requirements for renewal that the HSRC uses when conducting a continuing review.

Please us the fill-in-able Continuing Review Form.  Submit your completed form to Dr. Alison Wong: alisonwong@fuller.edu

This form will walk you through what you need to address as you seek continuation in your research.

Please visit HERE for the most updated version of the Continuing Review Form.

We suggest you refer back to your originally approved proposal to make sure that you are accounting for where you are in the process with each of those things noted in the original proposal at the time of your continuing review submission. 

You will be asked 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.

You want to 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.  You will 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: 

  • Are the actual risks and benefits as anticipated and does the protocol adequately provide for continuing assessment of the balance between risks and benefits
  • Have any subjects been seriously harmed?
  • Has the HSR committee been informed of any unforeseen problems or accidents that may have occurred?
  • 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?
  • Do the consent documents need to be revised? 
  • Has due care been used to reduce risks and increase the likelihood of benefit? 
  • Are the procedures agreed upon at the beginning of the research still being used? 
  • Should HSR approval be continued, or should approval be suspended or terminated?

CLOSING A STUDY: FINAL REPORT FORM

Once you have completed the methods outlined in your approved proposal and all data collection AND data analysis are finished, you must submit a Final Report. This report confirms that the research is completed and research activities associated with your study have come to an end.  The Final report should be completed before your current approval expiration date. If you have not already submitted a Final Report form, you will be required to submit a Final Report form after successfully defending your dissertation.

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: PREPARATORY 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 your professors work with you to assess the risk category of your proposed research. This will help them best prepare you for when your proposal is reviewed by the HSR Committee (HSRC).

RISK: Risk level is mandated by the definitions. Plans and actions to mitigate risk in your proposal does not move the proposal into a different risk category. Your professors will help you think through what plans and actions you might need to help mitigate against risk. 
   

MODULE 2: PREPARING YOUR HSR PROPOSAL  

Review the following: 

  • HSR Module 2 Classroom Presentation   
  • Confidentiality or  Anonymity?
  • Adverse Events
  • 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) 
  • If you plan to use a research assistant, you will want to have them sign a confidentiality agreement. The HSRC can provide a sample template for you.

SUBMITTING YOUR HSR PROPOSAL 

Please visit HERE for the most updated versions of the HSR New Study Form, Addendum, and Continuing Review Forms. 

Your Module 2 professor and/or the HSRC representative will walk you through the New Study Form form during your Module 2 class time.

NOTE: ALL risk levels (minimal, moderate, high) should be sent to Alison Wong, alisonwong@fuller.edu. 

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

If your proposal is minimal risk, it will go through an expedited review via the HSRC.  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.  Please see "Steps for Continuing Review" below.

CHANGING A STUDY: SUBMITTING AN ADDENDUM

Before making any changes to an approved study, an addendum form must be submitted and approved, highlighting the changes proposed. All addenda should be submitted to alisonwong@fuller.edu. This includes, but is not limited to, changes in research personnel, consent, assent, research instruments, addition of new instruments, changes or additions to advertising, and other changes in protocol. You can submit an addendum at any time to alisonwong@fuller.edu. Work with your Module 2 Methods professor for sign off before submitting your addendum to the HSRC.

Please visit HERE for the most updated versions of the HSR New Study Form, Addendum, and Continuing Review Forms.

MODULE 3: STEPS FOR CONTINUING REVIEW/RENEW A STUDY

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.

Beginning February 18, 2016, all proposals, whether initially reviewed by the DMiss Office or the HSRC, should be submitted to Dr. Alison Wong: alisonwong@fuller.edu

Consult the HSRC Continuing Review Reviewer Form to read the requirements for renewal that the HSRC uses when conducting a continuing review.

Please us the fill-in-able Continuing Review Form.  Submit your completed form to Dr. Alison Wong: alisonwong@fuller.edu

This form will walk you through what you need to address as you seek continuation in your research.

Please visit HERE for the most updated version of the Continuing Review Form to renew your study.

We suggest you refer back to your originally approved proposal to make sure that you are accounting for where you are in the process with each of those things noted in the original proposal at the time of your continuing review submission. 

You will be asked 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.

You want to 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.  You will 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: 

  • Are the actual risks and benefits as anticipated and does the protocol adequately provide for continuing assessment of the balance between risks and benefits
  • Have any subjects been seriously harmed?
  • Has the HSR committee been informed of any unforeseen problems or accidents that may have occurred?
  • 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?
  • Do the consent documents need to be revised? 
  • Has due care been used to reduce risks and increase the likelihood of benefit? 
  • Are the procedures agreed upon at the beginning of the research still being used? 
  • Should HSR approval be continued, or should approval be suspended or terminated?

CLOSING A STUDY: FINAL REPORT FORM

Once you have completed the methods outlined in your approved proposal and all data collection AND data analysis are finished, you must submit a Final Report. This report confirms that the research is completed and research activities associated with your study have come to an end.  The Final report should be completed before your current approval expiration date. If you have not already submitted a Final Report form, you will be required to submit a Final Report form after successfully defending your dissertation.

Please visit HERE to for the most updated version of the Final Report Form, to close your study.  

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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