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
- 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.
- How to submit an application
- Download the appropriate Form A and complete as thoroughly as possible. Refer to the section Reviewing Research for additional information about what the HSRO will be looking for as the proposal is reviewed.
- Submit the Form A and all supporting documents by emailing them to email@example.com
- Make sure to check the top of the Form A and the HSRO website for instructions on submitting your materials; this process may be revised from time to time to accommodate institutional changes and world events.
- 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
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
Documentation for any devices used during data collection
Certificates of human subjects protection training
Any additional materials that seem appropriate to your study
- 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.
- If the necessary criteria for approval are met, research that is considered exempt will be approved after the initial review, and a signed Form C, IRB Decision Form, will be sent to the Investigator and data collection can begin.
- Research that is considered expedited may be reviewed by experienced reviewers as well as the HSRO. This 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 and a signed Form C, IRB Decision Form sent to the Investigator.
- 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.
- An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year; unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:
(i) Research eligible for expedited review in accordance with §46.110;
(ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii);
(iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
(A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
If continuing review is required the Form C Approval Letter will indicate the date continuing review must take place by; 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.
- If continuing review is indicated, IRB approval expires automatically at the one year anniversary date.
- 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.
- 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.
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, even those already approved by another institution.
For more in-depth information about what the IRB expects to see in a submission go to the Reviewing Research section for a complete description of all of the topics the IRB takes into consideration when reviewing a research activity.