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Information for Investigators

Any research or clinical investigation, whether funded or unfunded, that involves human subjects conducted by NSU faculty, staff, or students shall be under the jurisdiction of the IRB. The IRB is responsible for determining and assuring that:

  1. the welfare and rights of human subjects are adequately protected and informed consent given, if necessary;
  2. human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of research;
  3. the necessity and importance of the research outweighs the risks to the subjects; and
  4. the researcher(s) is/are qualified to conduct research involving human subjects.

ATTENTION: No participants may be approached or any research activities begun until you have received official IRB approval along with an approval memo and documents.

Below you will find information regarding the steps in the IRB process and what is required from you, the investigator. Read this information carefully. If you have questions regarding the IRB process, please contact your College Representative for further guidance.

Any activity that meets either of the following listed below, requires review and approval by the Nova Southeastern University (NSU) IRB:

  1. The Department of Health and Human Services (DHHS) definition of both “research” and “human subjects”
  2. The Food and Drug Administration (FDA) definitions of both “clinical investigation” and “human subjects”

Use the following checklist to determine if your study requires NSU IRB approval:

Visit our IRBManager Resources page for more information regarding the completion of this form.

Below you will find information regarding the steps in the IRB process and what is required from you, the investigator. Read this information carefully. If you have questions regarding the IRB process, please contact your College Representative for further guidance.

  1. Read all of the information for investigators on this webpage.
  2. Complete the required CITI Human Subjects Protection Training.
  3. Create a profile in IRBManager.*
  4. Complete the Researcher Qualification xForm.*
  5. Complete and submit the New Protocol Submission xForm.*
  6. File for Continuing Review, Amendment, and Closure to a study.*

 *Information for completing steps 3-6 can be found on the IRBManager Resources webpage.

As an investigator, you are responsible for the following:
  1. Completing the New Protocol Submission xForm and receiving offical IRB approval prior to approaching any participants or beginning any research activities. Upon approval, you will receive an approval memo and other documents.
  2. Conducting study as approved in your New Protocol Submission xForm and filing an Amendment xForm prior to implementing any changes to your study.
  3. Annually, filing the Continuing Reivew xForm if your study is still collecting or analyzing data.
  4. Submitting a Closing Report xForm upon completion of all research related activities, including data analysis.
  5. Reporting any unexpected or adverse events immediately to the IRB Office.
  6. Maintaining current CITI Human Subjects Training.

The Office of Human Research Protections provides Human Subject Regulations Decision Charts that are useful in understanding the different levels of IRB Review.

The following links provide an overview of the NSU IRB review process from the initial submission of your research protocol to the final approval.

Please click here to download a PDF version of this information: IRB Review Process Flow Map
The convened IRB meets once a month to review protocol submissions that require full review procedures. Please click HERE for the scheduled meetings of the convened IRB.

NSU Office of Sponsored Programs

  • Provides support services and training to NSU faculty and staff in identifying, securing, managing, and ensuring compliance with external and internal funding for NSU's research, community service, and training initiatives.

NSU Office of Clinical Research

  • Provides support to NSU faculty conducting clinical trials.

NSU Office of Health Care Compliance

  • Seeks to achieve quality assurance and zero tolerance of fraud and abuse by fostering corporate integrity and strict adherence to all laws and regulations.
  • All questions regarding the HIPAA policies should be directed to the Office of Corporate Compliance.
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