VI. What does your electronic signature mean?

What does your electronic signature mean?

Good question.

If you are the Principal Investigator, your electronic signature accompanying the IRBNet electronic submission certifies that the research activity as approved by the IRB of record will be conducted in full compliance with Stony Brook University’s Policies and Federal regulations governing human subject research.

Furthermore:

You confirm (in consultation with my chair and dean as required), that you have adequate resources to conduct and complete the Study compliantly and safely. Specifically:

  • You have assessed that the proposed subject population(s) are available in sufficient numbers to meet the study requirements,
  • You have sufficient funds to conduct and complete the research compliantly and safely
  • Your study team and you have sufficient time to conduct and complete the research compliantly and safely
  • You have assessed that the named study team is qualified to compliantly conduct the research, and effectively monitor the safety and welfare of the enrolled research subjects

You ensure that all members of your study team:

  • Are fully aware of their involvement in this study, as well as the details of the associated protocol,
  • Will only be involved in research procedures for which they have been trained, and, where required, currently certified and/or licensed.

You ensure prompt reporting of any revisions or amendments to the research activity for review and approval by the IRB of record prior to commencement of the revised protocols, with the only exception to this policy being those situations where changes in protocol are required to eliminate apparent, immediate hazards to the subject,

You ensure prompt reporting to the IRB of record and to SBU’s Office of Research Compliance (via the electronic submission system) of any non-compliance and/or unanticipated problems (including unanticipated serious adverse events) affecting risk to subjects or others,

You assume full responsibility for selecting subjects in strict accordance with the inclusion/exclusion criteria outlined in the approved application materials

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