Submitting Human Research Projects for Review

What to submit

1. Research plan/protocol  should include/address all of the relevant scientific, procedural, logistical, and administrative information about your research project, including:

  • the title of the project
  • background information necessitating the conduct of the project
  • the purpose of the project
  • subject eligibility (inclusion/exclusion criteria)
  • specific procedures and methods of the project
  • a list of all of the data variables to be collected (this is particularly important on retrospective studies)
  • protection of human subjects (including privacy and confidentiality)
  • statistical analysis section
  • literature citation

 

Please also note that if you wish to conduct retrospective research, it is important that you specifically indcate all of the data points to be collected and the time frame for the retrospective period of review (e.g., 1/1/95 - 12/31/2004). If you do not specifically indicate these elements in your initial submission, your submission will either be returned for correction or approval will be deferred pending revision to address these elements, as this information provides the documentation necessary to determine which level of review is allowable per the federal regulations.

2. Consent form  If you plan to conduct prospective research that will involve direct and/or active involvement of human subjects, you will need to prepare an informed consent document, also known as a research consent form (unless you can justify why obtaining consent and privacy authorization is not practicable). There are several consent form templates in the iRIS system for your reference and use. These templates are provided to ensure the inclusion of elements required by federal regulations and local policy.

3. Data collection form or case report form on which to record the data variables (or if you are recording data electronically, a list of data variables to be colected will suffice in lieu of a hard copy data collection form).

4. CV(s) or biosketch(es)


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