Faculty, Staff Researchers and Faculty Mentors

The IRB has updated its submission requirements for faculty, adjunct faculty, and staff conducting research involving human subjects. All projects meeting the definition of research with human subjects must receive IRB review and approval before implementation. Key changes include the requirement for a comprehensive research protocol with all new submissions, the use of an FDU email address for research activities, and adherence to strict guidelines for data security and participant confidentiality.

The IRB is committed to safeguarding the rights and welfare of research participants, ensuring that human subjects research at Fairleigh Dickinson University (FDU) is conducted ethically and responsibly. The following applies to all research involving human subjects conducted by FDU or its affiliates.

Submission Requirements

Please see this link: New Study Submission Instructions

Additional Requirements and Information

Research Protocol Requirement

  • A formal research protocol is required for all projects meeting the definition of research with human subjects. This includes projects submitted for an exempt determination.
  • Submission instructions MUST be deleted before submission.

FDU Email Address Requirement

Email Use and Recruitment at FDU

  • An FDU e-mail address is required to be utilized in ALL FDU research projects reviewed by the FDU IRB for recruitment purposes and all official business regarding your study. If another option is necessary, the process and justification must be submitted to, reviewed, and approved by the IRB administration before implementation. This will be done on a case-by-case basis and is not the preferred method. Please note that external e-mail addresses are not protected or covered by FDU servers.
  • FDU listservs are NOT allowed to be used for research recruitment purposes. Please do not ask the administration to send any emails on your behalf through FDU. Please contact organizations to assist with social media recruitment, the use of building flyers.

Data Security and Confidentiality Requirements

  • All human subject research data must be secured and stored safely. NO direct private identifiable information and identifiable protected health information can be stored on a portable device (such as a USB key, laptop, iPad, other tablet, and smartphones).
  • If a portable device is needed for recording interviews, the device must be secured (password/Face ID locked, lock box, lock drawer, etc.), and recordings MUST be transcribed as soon as possible. If a recording must be retained, this information must be described in the research protocol with a specific justification, the length of time the recording will be retained, and all protections included to protect the subjects’ identity and their private information. It is HIGHLY recommended that the interview recording be transcribed with the deletion of all identifiable information as soon as possible, especially if the data contains highly sensitive and private information. It is understood that some professional research societies require an original recording. Please ensure to uphold the ethical principle of Respect for Persons and Non-Maleficence (Do no harm) by ensuring this data is secured to the utmost ability. Any retention of raw identifiable data also MUST be described in the consent form, and all security measures protecting the data.
  • Pseudonyms should be used and NOT directly identifiable information. Participants should be reminded not to disclose their names if being recorded for their protection from a breach of confidentiality. All data should be password protected, stored properly, so it is not accessed by individuals outside of the research team, and data-encrypted software should be used, if available. This information must be detailed in the protocol.
  • If data is to be coded or a link must be reattained to a master code key list, the following is required and must be described in the protocol.
  • The Code Key should be in a manual security method (the use of pen and paper) and stored in a locked desk or cabinet.
  • If a portable device must be used, no identifiable information may be retained on the portable device. A destruction method/mechanism software must also be used and described to delete any coded private information in case the device is stolen, lost, or misplaced. This must also be reported to the IRB as a Reportable Event and Unanticipated Problem. Please see this link for more information.

Google Forms and other external data collection resources may be used ONLY if Protected Health Information (PHI) and/or Personal Identifiable Information (PII) are NOT collected or recorded. If PHI and/or PII are being collected electronically, Qualtrics must be used. 

Faculty Mentors

  • All Faculty Sponsors must be full-time FDU-appointed faculty. If a student requests an adjunct faculty member, a full-time faculty member must be appointed as a second mentor in case the adjunct faculty member leaves the Institution before the student’s project is completed.
  • All faculty sponsors/mentors MUST have a current CITI certification in human research protection.
  • All mentors are required to supervise and assist the student investigator in the ethical conduct of the student’s study. If the student leaves the Institution while an approved study is active and does not notify the IRB, it is up to the Faculty Mentor to notify the HRCM and close out the study.