EFIC HRPP Reviewer Worksheet EFIC HRPP Reviewer and Site Information Name * Name First First Last Last Title * Institutional Affiliation * Email * Phone * May the University of Utah IRB (UU IRB) contact you to follow up if additional information is needed relating to your review of this Community Consultation Plan? * Yes No EFIC HRPP Reviewer STATEMENT OF ASSURANCE I understand that my role is to provide the University of Utah IRB with insight into my local community and to provide recommendations to help the University of Utah IRB make an informed decision regarding the community consultation plan for my local site. I understand that all final determinations relevant to the approval of this study will be made by the University of Utah IRB, and that I am serving as a consultant to provide site-specific recommendations for the community consultation period of this study. I do not have a conflict of interest (personal, financial, academic or other interest) in reviewing this community consultation plan that would prevent me from providing fair and objective recommendations. If you agree with the above statement, please select "Yes" below and continue. If you do not agree, please contact us at uuirbreliance@utah.edu to discuss other options for your site. * Yes, I agree Cultural, Demographic, Geographic, and Economic Considerations Please provide information about your local community as it may relate to a research study where an Exception from Informed Consent (EFIC) for emergency research may occur. What is the anticipated geographic area that participants may be recruited from at your site? What is the ratio of rural to suburban to urban populations in this geographic area? Do you have any minority populations that should be considered? Yes No Do you have any particular populations of affluence or poverty that may require special methods of outreach in order to inform them about the research? Yes No How would you describe your community’s access to healthcare and awareness of existing clinical research efforts in the area? Please provide more information about your responses above, if needed. Languages and Local Educational and/or Literacy Information Please provide information about your local community as it may relate to a research study where an Exception from Informed Consent (EFIC) for emergency research may occur. Does your site have a significant non-English speaking population? Yes No What languages? Religious, Social, and Political Considerations Please provide information about your local community as it may relate to a research study where an Exception from Informed Consent (EFIC) for emergency research may occur. What are the predominant religions in your area? Do they have any beliefs that may affect their willingness to participate in research or to accept an EFIC model? Has your community experienced any major events (i.e. local/national tragedies, heated social or political issues, etc.) that may require added sensitivity when considering an appropriate community consultation plan for this study? What are the dominant political inclinations of your community? Please provide more information about your responses above, if needed. Participant Selection Please provide information about your local community as it may relate to a research study where an Exception from Informed Consent (EFIC) for emergency research may occur. Are there populations being targeted by this study that may be more likely to be enrolled than others? Yes No Are recruitment procedures designed to ensure a representative sample of participants? Yes No Will certain disadvantaged or vulnerable groups be over or underrepresented? Yes No Will potential risks and benefits be reasonably distributed across the community as a whole? Yes No Please provide more information about your responses above, if needed. Community Consultation Plan Criteria Please answer each question with respect to the proposed Community Consultation and Public Disclosure activities proposed at your local site. 1. Please provide a brief description of your site's community consultation plan, as well as any thoughts, questions, or concerns you may have relating to the proposed plan. * Yes No N/A 2. Are the proposed community consultation methods based on appropriate factors such as the size of the communities, the languages spoken within those communities, and the targeted research population and the heterogeneity of the population? * Yes No N/A 3. Do the type and frequency of consultation activities facilitate broad community discussion with representative samples of the community? * Yes No N/A 4. Do the proposed Community Consultation materials include an accurate representation of the risks and benefits of the project, as well as a clear indication that study procedures will take place without informed consent from individual participants and/or Legally Authorized Representatives? * Yes No N/A 5. Does the proposed Community Consultation Plan include adequate methods for participants to exclude themselves from participation? * Yes No N/A 6. Does the proposed Community Consultation Plan include methods for receiving and incorporating feedback from the community into the research protocol? * Yes No N/A 7. Does the proposed Public Disclosure plan include adequate methods for dissemination of information after the investigation is completed so that communities and scientific researchers are aware of the study’s results? * Yes No N/A 8. Overall, is this research appropriate for your community? * Yes No OtherOther 9. Do you have any additional information to provide the IRB? * Submit If you are human, leave this field blank. Do you need assistance from our team? Contact Us
