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Standard Operating Procedures

On January 21, 2019 the Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule) will be effective.

Substantive revisions were made to the regulations to “modernize, strengthen, and make more effective” (HHS 2017) the current system of oversight that has been the federal Common Rule since 1991. The revisions are intended to:

  • Better protect human subjects involved in research
  • Facilitate research
  • Remove ambiguity
  • Reduce regulatory burden

Information about the modifications can be found on the OHRP website. CITI Program also has a module on the Revised Common Rule .

 Impact on Researchers

  1. Increased number of research categories approved under Exempt review
  2. Comtinuing review no longer necessary for most non-exempt research activities
  3. New Consent Process requirements

The RIT review process will continue as it is currently with some modifications to existing forms and some researchers may be required to submit additional information.  The updated HSRO website will be online January 21, 2019 and the HSRO will assist researchers with the transition during the next few months.

  1. How to submit an application
    • Download the appropriate Form A and complete as thoroughly as possible. Refer to the section How Does the IRB Work for additional information about what the Institutional Review Board (IRB) will be looking for as the proposal is reviewed.
    • Submit the Form A and all supporting documents by emailing them to
    • You will allso need to submit a hard-copy of the Form A complete with signatures and hard-copies of the supporting documents to the HSRO, University Services Center, Suite #2400. These can be dropped off or sent via inter-office mail
    • Supporting documents include:
      • Project Abstract - this should be written so that someone who is not familiar with your field of research will understand the activity
      • Consent forms
      • Assent forms
      • Letter of support if data collection site is a school or after-school program
      • Any advertising materials (flyers, posters, emails to prospective participants, etc.)
      • Surveys, interview questions, instruments
      • Any activity subjects will perform
      • Certificates of human subjects protection training
      • Any additional materials that seem appropriate to your study
  2. Review
    • Submissions go through an initial review in the Human Subjects Research Office (HSRO). The Form A and supporting documents are reviewed for completeness and clarity. If there are any questions or missing items the Investigator will be contacted for additional information.
    • Research that is considered exempt will be approved at this time, and a signed Form C, IRB Decision Form, will be sent to the Investigator. The Investigator can begin data collection.
    • Research that is considered expedited will be reviewed by the Chair or an appointed member of the Board. This review is set up at the convenience of the reviewer's schedule and will take additional time after the initial review by the HSRO. After review, the research will either be approved, deferred pending additional information, or deferred to the entire Board at a convened monthly meeting.
    • Research that is deferred pending additional information will be approved once all of the questions and concerns have been addressed.
    • Research that is deferred to a Board meeting will be discussed at a convened Board meeting; after review it will either be approved, deferred pending additional information, or disapproved. If it is approved a signed Form C, IRB Decision Form, will be sent to the Investigator and data collection can begin. If it is deferred, the Investigator will need to submit additional information and then it will be reviewed again. If it is disapproved, the Investigator can submit with revisions and may request a hearing with the Board.
  3. Continuing Review
    • All research projects must be reviewed every 12 months; Investigators will be contacted and sent a Form F within two months of the one year anniversary date.  The Form F requires a status of the project and whether human subjects are still taking part.  The Form has directions for completion and submission.
    • If Investigators do not receive the Form F within two months prior to the anniversary date they should contact the HSRO.  It is the responsibility of the Investigator to ensure that documentation is received by the HSRO.
    • IRB approval expires automatically at the one year anniversary date.
  4. What the IRB expects in a submission
    • The Institutional Review Board (IRB) is an administrative body established to safeguard the rights and welfare of all human subjects who participate in research projects conducted by RIT. In compliance with Federal law and institutional policy, all research projects involving human subjects or human material must be reviewed and approved by the IRB.
    • The overall criteria for IRB approval:
      • 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.
      • Where appropriate, the research plan makes provisions for the safety of the subjects during the data collection process.
      • Where appropriate, there are adequate provisions 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 the vulnerable subjects.
      • These criteria ensure that the privacy and welfare of the research participants are adequately protected. All faculty and students engaged in such research should submit requests for IRB approval prior to beginning their work. This applies to all research activities
      • For more in-depth information about what the IRB expects to see in a submission go to the How Does the IRB Work section for a complete description of all of the topics the IRB takes into consideration when reviewing a research activity.