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IRB: Responsibilities of Investigators and Sponsors

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Responsibilities of Investigators and Sponsors

By electronically signing and submitting an application to the Institutional Review Board (IRB) or Exempt Review Committee (ERC), investigators and sponsors/advisors affirm that:

  1. They are familiar with the policies and procedures of Marywood University regarding human participants, as presented on the IRB or ERC website. They subscribe to the standards described and will adhere to the policies and procedures explained therein.
  2. They are familiar with the published guidelines for the ethical treatment of participants (e.g., Code of Federal Regulations, Title 45 Part 46, Title 21 Part 50 and Title 21 Part 56, etc.), including those associated with their particular field of inquiry (as published by the American Psychological Association, American Sociological Association, NASW Code of Ethics, etc.).
  3. They are familiar with and will adhere to official policies in their school or department concerning research activity (e.g., Psychology Department, School of Social Work Research Committee, etc.).
  4. They have completed the required IRB training through the CITI program.
  5. They will take proper measures to ensure confidentiality and security of all information obtained from the participants.
  6. They understand that upon consideration of the nature of their project, the IRB or ERC administrator may change the category of review or may request a full application for review of the research at his/her discretion and convenience.
  7. They understand that no part of the proposed research may be carried out until they have received full and final approval from the IRB or ERC. This includes participant recruitment and collection of data.
  8. They understand that Marywood University's IRB or ERC has the authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements, or that has been associated with unexpected harm to participants.
  9. They understand that all research is bound by regulations and must be kept for the longest applicable period (minimum of 3 years or longer, see Records Retention).
  10. They understand that a status reports is due six months from the date of approval, even if the research was a class assignment.
  11. They understand that a final status report is due prior to the expiration date, unless a researcher is applying for continuing review (see #12). They also understand that research is considered to be complete only after data collection and analysis are finished.
  12. They understand that once approved, the approval is only valid for one year. If research will continue beyond one year, they must reapply to the IRB prior to the expiration date by submitting a continuing review (renewal) application and all required materials.
  13. They understand that if approval expires, all research activities must cease as of the expiration date until they apply for continuing review (renewal) and that renewal has been reviewed and approved by the IRB or ERC.
  14. They understand that if they make any revisions to approved research, however minor, they must notify the IRB or ERC and receive final approval for the revisions prior to implementation.
  15. They will notify the IRB or ERC of any deviations which occurred from the approved protocol.
  16. They will notify the IRB or ERC, Assistant Vice-President for Research, and the Dean or Departmental Chairperson of any physical, psychological, or social injury suffered by a research participant due to his or her participation in a research activity.
  17. They are aware that members of the research team (principal investigators, co-investigators, sponsors, research assistants, etc.) may not enroll in their own projects as subjects.

    By electronically signing an application to the IRB or ERC, sponsors/advisors affirm that they agree to the above, AND:

  18. They have thoroughly read the application and agree to sponsor the study.
  19. They affirm that no data has been collected by the researcher.

 


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