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Guidance for Principal Investigators

  1. Templates for recruitment and consent: When creating recruitment materials or consent forms, please use the templates provided on our website (http://www.umflint.edu/humansubjects/sample_templates). Our templates will have the most current required language and format. This ensures required elements are not missed.
     
  2. Consent form readability: Readability is determined by vocabulary choice and sentence structure/length but it should also be tailored to the population that you are working with. 8th grade reading level is recommended. Avoid technical jargon.
     
  3. Consent form elements: Please use the OHRP consent form checklist before submitting your application. (Website: http://www.umflint.edu/humansubjects/sample_templates) When the risk is greater than minimal risk please review the additional elements on the OHRP consent form checklist to see what might be required.
     
  4. Confirming comprehension during the consent process: For complicated research protocols, confirm people’s comprehension by asking them to summarize what they think they will be doing as part of the study, as part of the consent process.
     
  5. Approved consent and recruitment forms: Once your study has been approved, use the approved version of consent forms and recruitment materials located under the documents tab in eResearch. This pdf version is stamped by eResearch so that the watermark for study approval date is included. Please keep the header blank to accommodate the eResearch stamp.
     
  6. Site approval letters: If you are conducting research off campus, supporting letters from the organization are necessary. Site approval letters should be on organization’s letterhead, signed by the director of the organization, and should include date, study title and researcher names.
     
  7. Record keeping: Accurately document all study activities and procedures, including any subject screenings, in a manner that would allow an independent observer to reconstruct the study as it happened.
    • All consent forms and identifiable data should be kept in a locked cabinet.
    • Electronic data should be protected by using encryption.
    • Study Teams should generally retain financial and programmatic records, supporting documents, statistical records, and all other materials for a period of 3 years from the date the termination report is submitted in eResearch.
       
  8. Longitudinal Data Collection: When subject data will be collected over a period of time researchers need a way to identify subjects. For confidentiality, please use an identifier code to protect subject identity. Store the code key separately from the data. Identifier codes should be unique to your study. They should not contain information that can be tied back to subjects like social security numbers, student id numbers or medical record numbers.
     
  9. When changes are needed for an approved study: If you need to make changes to your original study, prepare an amendment request in eResearch. Access the approved application in eResearch by using the link on the last page of the amendment form.
    • Leave originally approved wording in place.
    • Add a date marker (e.g. <AME 10/25/18>) at the bottom of the relevant section you are revising and describe what changes you are making.
       
  10. Uploading revised documents: If you are making changes to any research documents, such as consent forms or recruitment materials, go to the relevant section of your approved application in eResearch. Use the “upload revision” button to submit the final version of the document.
    • Using the “upload revision” button retains the original version and stacks the newest version on top.
    • If you would like to upload a version with “track changes”, please upload it in Section 44 of eResearch and label it to indicate it uses track changes.

  11. Project Termination. Once your study is complete and you have finished your analysis of identifiable data please use the eResearch application to create and submit a Termination report.