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Protecting Human Subjects at RIT

The Human Subjects Research Office (HSRO) was established to safeguard the rights and welfare of all human subjects who participate in research projects conducted at RIT. In compliance with Federal law and institutional policy, all research activities involving human subjects or human material MUST be submitted to the HSRO and gain approval before the research begins. Research activities conducted by the faculty, staff, and students of RIT, or outside researchers gathering data at RIT, are subject to the Policy for the Protection of Human Subjects in Research, RIT´s official policy in the Institute Policies and Procedures Manual.

Anticipate between fifteen and twenty business days for an initial review. This applies to new research as well as modifications and ammendments to existing research projects. Review depends on many factors and this is just an estimate. Review may take longer depending on the complexity of the research and if your research:

  • includes children or other protected groups,
  • includes deception, or
  • focuses on the development of a device.

If you submit after Week 10 in the Semester you may not receive approval in time to conduct your research before the Semester ends.

Drawing from RIT´s policy and the Federal Regulations guiding research with humans, the HSRO and the Institutional Review Board (IRB) may approve, modify, or disapprove new protocols or modifications to existing protocols based upon consideration of human subjects protections. Annual progress reports from Investigators may be requested depending upon the category of research .

Criteria for Approval - For Both New Research and Modifications to Previously Approved Research 

For a research activity to be approved, the following criteria must be satisfied:

  • The risks to subjects are minimized as much as possible.
  • The risks to subjects are reasonable in relation to anticipated benefits.
  • The informed consent process is adequate - note, ALL research projects should include consent information even if subjects are not required to sign a consent form
  • The research plan makes provisions for the safety of the subjects during the data collection process
  • Provisions are in place to protect the privacy of subjects and maintain confidentiality of data
  • Appropriate safeguards are included within the study to protect the rights and welfare of Federally defined vulnerable subjects(pregnant women, fetuses, children, and prisoners)

These criteria ensure that the privacy and welfare of the research participants are adequately protected.

This site is intended to provide you with the information you will need to determine:

  • whether a review is needed,
  • what sort of review is appropriate, and
  • what procedures should be followed in submitting an application.

There are several categories of review; each submission is scanned to determine which category it fits into, and then reviewed accordingly.  To make this determination, a number of questions are considered. Please go to How Does the IRB Work for more details.