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Research Proposal of Recruitment and Selection - DOC

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					                              CHECKLIST FOR PREPARING
                       A HUMAN PARTICIPANTS RESEARCH PROPOSAL
                FOR REVIEW BY THE EDGEWOOD COLLEGE HUMAN PARTICIPANTS REVIEW BOARD

Instructions: The Human Participants Review Board will be evaluating the proposed research on the information found
in the below checklist. Use this checklist to help prepare the detailed research protocol and consent materials for Board
review. Place a check () after the item below if you have complied with the statement, or NA if the item is not
applicable to your study. This checklist MUST be attached to the protocol submitted for HPRB review.

_______    1. All investigators have completed an IRB Online Tutorial and the training Completion
              Certificates are attached to the proposal.
           2. The research protocol and consent form use understandable lay language.

           3. The objectives of the project are clearly specified.

           4. The description of research participants is appropriate for the study:
                            a. Number of participants

                              b. Age or age range of participants

                              c. Gender

                              d. Ethnic or racial background of participants (if applicable)

                              e. Health status (if applicable)

                              f. Rationale for inclusion of vulnerable participants (if applicable)

           5. Plans for recruitment and selection of participants are succinctly and clearly described:
                             a. Participation

                              b. Prevention of coercion

                              c. Compensation or rewards are explained

           6. Research procedures describe:
                           a. Where the research is going to be conducted

                              b. Who and how many investigators are involved

                              c. What data gathering instruments will be used

                              d. Frequency and duration of treatment or procedure

                              e. Training of persons administering treatment

                              f. The time frame of the project


           7. Potential risks and discomforts (physical, psychological, social, or legal) are adequately
              described.

           8. Measures are described for assuring the availability of professional intervention in the
              event of adverse effects to the participants.
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9. Potential benefits to participants (if any) and importance of expected knowledge to be
   gained are clearly stated.

10. If appropriate, provisions for protecting participants’ identities:
                   a. Data collected will be anonymous (no identifying information)

                  b. Data collected will include a coding system

11. Mechanisms for safeguarding confidentiality of data described including:
                a. Where data will be kept

                  b. Who has access to data

                  c. Period for keeping data

                  d. Plans for disposition or disposal of records

12. The method for obtaining informed consent is clearly described.

13. Participant consent form (or written document addressing consent for participants if
    separate from the consent form) includes the following:
                  a. The project clearly described in readable, easy to understand lay terms

                  b. The nature and purpose of the research

                  c. The procedures to be followed

                  d. What is required of the participant, including the time and duration of
                     participants' participation

                  e. Any foreseeable discomforts or risks

                  f. Any foreseeable benefits

                  g. The extent to which data will be held confidential

                  h. The voluntary nature of participation and withdrawal

                  i. The investigator's (and for student projects, the research advisors) name
                     and telephone contact numbers

                  j. Space for participants’ signature and date

14. This checklist has been completed and attached to the research protocol.




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