Overview of Human Subjects Research Office

Research that falls into an Exempt category is reviewed within the HSRO, and research that falls into an Expedited category is reviewed within the HSRO, utilizing additional reviewers as needed.

The IRB assembles to discuss research activities that do not fall into an Exempt or Expedited category, and activities that may meet the requirements to be considered Exempt or Expedited but focus on topics that benefit from review by a group.

Initial Review takes 15-20 business days; this is an estimate as it depends on the complexity of the activity and the volume of reviews received by the HSRO. This applies to both new research as well as modifications to previously approved research, and research approved at another institution that will also be conducted at RIT.

IRB meetings are scheduled as necessary by the HSRO; investigators will be notified by the HSRO if their activity needs IRB review.

Research approved by other institutions will be reviewed using the same criteria and process as an activity unique to RIT. In order to approve research, RIT is obligated to determine and document that federal requirements are satisfied.

The Human Subjects Research Office carries out its role by:

• Reviewing all research activities at RIT that include human subjects
• Developing operating and administrative policies that deal with human subjects protections
• Providing guidance on all regulatory aspects of human subjects research
• Providing educational activities related to human subject protections
• Providing administration of the functions of the Institutional Review Board (IRB)

The HSRO and the IRB will:

• Review research to ensure it meets the criteria found in the Federal Regulations
• Confirm that the research doesn’t expose participants to unreasonable risk
• Conduct continuing review as appropriate to make sure protections remain consistent
• Consider adverse events and other information that may be relevant to the research
• Assess suspected or alleged protocol violations, complaints from participants, and violations of RIT policies

As a result of review, the HSRO and the IRB may:

• Approve, disapprove or terminate research activities
• Require modifications in protocols, including previously approved research
• Require documentation of informed consent or allow waiver of documentation
• Require that additional information be given to participants if it adds to the protection of their rights and welfare

The IRB is managed by the HSRO. Members have a variety of backgrounds and bring a varied set of skills and expertise to the review process. As required by Federal Guidelines, this diversity fosters a well-rounded review. RIT can add new branches as our research efforts evolve.

The IRB assembles to discuss research activities that do not fall into an Exempt or Expedited category, are greater than minimal risk, and activities that may meet the requirements to be considered Exempt or Expedited but focus on topics that benefit from review by a group.

If an activity needs to be reviewed by the IRB and a meeting date is not already scheduled it can take several weeks to arrange and provide sufficient for Members to review the materials. Investigators should take that into consideration when they are anticipating a data collection start date. Researchers should also be aware that it may take some time to address any questions brought up by the IRB and additional review will be necessary before they can begin data collection.

• Research at RIT
• Sponsored Research Services
• Sponsored Programs Accounting
• Federal Office for Human Research Protections (OHRP)

Questions regarding the status and submission of new and continuing research protocols should be directed to hsro@rit.edu.

Questions regarding research activities, determining whether an activity requires review by the IRB, and training should be directed to hmfsrs@rit.edu.

The HSRO resides in the Office of the Vice President for Research.