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
Impact on Researchers
- Increased number of research categories approved under Exempt review
- Continuing review no longer necessary for most non-exempt research activities
- 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.
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, modifications and amendments to existing research projects, and research approved at other institutions. Review depends on many factors and this is just an estimate. If you submit after Week 10 in the Semester you may not receive approval in time to conduct your research before the Semester ends.
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.
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.
- Selection of subjects is equitable
- Informed consent will be sought from each prospective subject or their legally authorized representative and appropriately documented
- The research plan makes provisions for monitoring the data collected to ensure safety of the subjects
- Provisions are in place to protect the privacy of subjects and maintain confidentiality of data
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
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 Reviewing Research for more details.