Information for Investigators

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Any research or clinical investigation, whether funded or unfunded, that involves human subjects conducted by NSU faculty, staff, and/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.

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:

• Does my study need NSU IRB approval? (Checklist)

If after completing the above checklist, you believe your study may not need IRB approval, please complete the Human Subjects Research Determination xForm in IRBManager. 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. For student investigators, please read the Student Investigators Guide and verify you have the following:
   
   1. For student research related to a thesis/dissertation, students must receive official approval of their thesis/dissertation proposal prior to beginning the IRB process.
   2. For student research unrelated to a thesis/dissertation, students must receive approval of their research proposal from their academic/faculty advisor prior to beginning the IRB process.
3. Review the NSU IRB Guidance Sheets and other helpful links listed on this page.
4. Complete the required CITI Human Subjects Protection Training.
5. Create a profile in IRBManager.*
6. Complete the Researcher Qualification xForm.*
7. Complete and submit the New Protocol Submission xForm.*
8. Additional requirements:
   • Exempted submissions: File Amendments and an annual Exempt Research Status.*
   • Expedited & Full submissions: File Amendments, Continuing Review, and Closing Report.*

 *Information for completing steps 5-8 can be found on the IRBManager Resources webpage.

1. For student investigators: Receiving official approval of your thesis/dissertation or research proposal prior to beginning the IRB process.
2. Completing the required CITI Human Subjects Protection Training. This training must be kept current by all study team members for the duration of the study until it has been officially closed. Recertification is required every 3 years.
3. Completing the New Protocol Submission xForm and receiving official IRB approval prior to approaching any participants or beginning any research activities. Upon approval, you will receive an approval memo and other documents.
4. Conducting study as approved in your New Protocol Submission xForm and filing an Amendment xForm prior to implementing any changes to your study. This applies to all submission; exempted, expedited, and full review.
5. For Exempted submissions; annually filing the Exempt Research Status xForm.
6. For Expedited and Full review submissions; annually filing the Continuing Review xForm if your study is still collecting or analyzing data.
7. For Expedited and Full Submission; submitting a Closing Report xForm upon completion of all research related activities, including data analysis.
8. Reporting any unexpected or adverse events immediately to the IRB Office.

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.

• Initial Review Process
• Expedited Review Process
• Full Review Process

Survey Instrument Development Guidance

This guidance sheet provides an overview of how researchers gather preliminary information, test research design or methods, and develop survey instruments for their research submission. 

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 HIPAA policies should be directed to the Office of Health Care Compliance.

• Office for Human Research Protections - U.S. Department of Health & Human Services
• Ethical Codes & Research Standards - OHRP
• International Compilation of Human Research Standards
• Food and Drug Administration (FDA)
• Family Educational Rights and Privacy Act (FERPA)
• Protection of Pupil Rights Amendment (PPRA)
• Health Information Privacy & HIPAA