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As the Principal Investigator (PI) of an Investigator Sponsored Study (ISS), the PI is responsible for initiating and conducting, alone or with others, the ISS with obligations of a sponsor and investigator.

This area is to help investigators and site staff better understand the roles and responsibilities involved with conducting ISS.

Topics Include:

Researcher Responsibilities:

If your submission is approved, you will be expected to fulfill the following responsibilities:

  • Signed and dated CV
  • Institutional Review Board/ Independent Ethics Committee (IRB/IEC) approval, if applicable
  • IRB/IEC Continuing Review documents, if applicable.
  • IRB/IEC approval letter, IRB/IEC approved protocol, IRB/IEC approved informed consent (ICF), and IRB/IEC approved subject material, as applicable
  • Executed research study agreement
  • Register the study with a clinical trial registry and provide the name of this registry, if applicable
  • Throughout the study, report any changes in conduct of the study. This includes enrollment changes, subject status, IRB/IEC updates, and any other relevant information
  • Throughout the study, report any Product/Device Related Adverse Events (AEs) to Abbott Point of Care (APOC) and local regulatory agencies, as applicable
  • Maintain product accountability records for all products provided by APOC throughout the study. Abstracts, Posters, Manuscripts must be reviewed with Abbott prior to submission
  • Follow any regional and local guidelines, regulations or policies that are available and may apply
  • Investigators, Sponsors, and IRBs/IECs must have a working knowledge and understanding of Good Clinical Practice (GCP) in order to assure the best protection of human subjects involved in research.

Ethical Research Principles


  1. Ryan KJ, Brady JV, Cooke RE, Height DI, Jonsen AR, King P et al. The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. J Am Coll Dent. 2014 Summer; 81(3):4-13.
  2. General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer; 81(3):14-8.
  3. The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2: 181-2.

Abbott Point of Care

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