Information the Investigator Provides to the IRB

  1. Professional qualifications to do the research, including a description of necessary support services and facilities and evidence of completion of a course on the protection of human subjects.
  2. Appropriate OSCC review form, including protocol summary.
  3. Complete study protocol which includes/addresses:
    1. Title of the study and summary of the research to be conducted.
    2. Purpose of the study, including the expected benefits obtained by doing the study, and how risks are reasonable in relation to expected benefits.
    3. Sponsor of the study.
    4. Subject inclusion/exclusion criteria, including scientific and ethical reasons for excluding subjects who might otherwise benefit from the research.
    5. Justification for including any special or vulnerable populations—such as minors (a “minor” is defined in Ohio as an individual under the age of 18), prisoners, individuals with disabilities, those who are economically or educationally disadvantaged or individuals with cognitive impairments—if applicable.
    6. Study design, including, as needed, a discussion of the appropriateness of research methods.
    7. Description of procedures to be performed.
    8. Provisions for managing adverse reactions.
    9. Circumstances surrounding consent procedure, including setting, subject autonomy concerns, language difficulties and vulnerable populations.
    10. Procedures for documentation of informed consent, including any procedures for obtaining assent from minors, using legally authorized representatives, witnesses, translators and document storage.
    11. Remuneration to subjects for their participation, if any.
    12. Any compensation for injured research subjects.
    13. Provisions for the protection of the subject’s privacy.
    14. Extra costs to subjects for their participation in the study, if any.
    15. Inclusion/exclusion of women, minorities and/or children.
  4. Investigator’s brochure, when one exists.
  5. The case report form, when one exists.
  6. The proposed informed consent document, including translated consent documents, as necessary, and any request for a waiver of the requirement to obtain informed consent, considering the likely subject population(s).
  7. Copies of advertisements and surveys, questionnaires or other materials provided to subjects.
  8. Copies of relevant grant applications, if any.
  9. Agency permission for access to subjects/resources/data to complete the study.
  10. Requests for changes in the study after initiation including changes to consent forms.
  11. Reports of unexpected adverse events and unanticipated problems involving risks to subjects, including, if available, data safety monitoring reports.
  12. Progress or interim reports documenting protocol violations, deviations and any other instances of investigator noncompliance.