IRB NAVIGATION
Institutional Review Board
Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018
The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019.
DO YOU HAVE A QUESTION REGARDING YOUR RESEARCH PROJECT?
DO YOU HAVE A PROBLEM THAT YOU WOULD LIKE TO REPORT?
The University is required to comply with the federal regulations governing review of research that involves human subjects (see the IRB Human Subjects Policy). Annually we must assure the Office for Human Research Protections (OHRP) that the University is complying with the requirements of 45 CFR 46. This is an NIH reference, but has been incorporated virtually verbatim into the regulations of 16 other federal agencies; additionally, the regulations state that the University will apply the same standards to all projects involving human subjects, regardless of funding or funding source. Activities are to be reviewed as proposals, and may not wait until funding for the activity is forthcoming.
The regulations then necessarily apply to evaluations, providing services, demonstration projects, and other activities not typically thought of as “research.” They are systematic collecting of data and they, by virtue of publication, public presentation, thesis, dissertation, or project report, contribute to generalizable knowledge. It is immaterial whether the project is funded by commercial entities, funded by governmental agencies, or unfunded. Any activity involving human subjects is subject to review, including soliciting questionnaires and surveys, videotaping activities, audio taping, observing behavior, and obtaining individually identifiable data about a person.
45 CFR 46 defines “Research” as a systematic investigation (i.e. the gathering and analysis of information) designed to develop or contribute to generalizable knowledge. (46.102(d)) For more information, view Is My Project Research?
45 CFR 46 defines “Human Subjects” as a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (46.102(e.1)) For more information, view Does My Project Involve “Human Subjects”?
IRB Name: Colorado State U IRB #1
IRB Affiliation: Colorado State University
Oversight Authorities: United States: Federal
FWA Number: 00000647 (expires 01/10/2022)
IORG (Institution/Organization) number: 0000122
IRB Number: 00000202 (expires 08/14/2021)
IRB Name: Colorado State U IRB #1
IRB Affiliation: Colorado State University
Oversight Authorities: United States: Federal
FWA Number: 00000647 (expires 01/10/2022)
IORG (Institution/Organization) number: 0000122
IRB Number: 00010468 (expires 08/14/2021)
The Institutional Review Board and Its Membership
Committee members must be familiar with the diverse regulations, including those of the Health and Human Services, the Food and Drug Administration, the Department of Education, and the State of Colorado. They must be current on recent interpretations of the regulations from the federal Office for Human Research Protections (OHRP) and elsewhere. The federal regulations specify the minimum requirements for membership at §45 CFR 46.107.
Although they each represent their own academic expertise, they are committees of the institution and must reflect community and institutional values and standards. Committee members devote 7-12 hours per month, 12 months per year, to IRB meetings and protocol reviews; the IRB Chairs are involved in an additional 25 hours or more per month reviewing responses and protocols, discussions with researchers, and problem resolution. Membership on the IRB is a service responsibility; members are not paid. The Research Integrity & Compliance Review Office (RICRO) serves as the administrative support unit for the IRB, acting on behalf of the Committees and serving as a consistent contact point and resource for information.
IRB members serve a three-year term, which may be renewed. New members are nominated by the IRB and appointed by the Vice President for Research in consultation with the Deans of the colleges conducting human research and the involved Department Heads/Chairs. The University’s Bioethicist is a permanent appointment. The rosters of the IRB are approved by OHRP to verify the committee is consistent with the intent of the federal regulations. Normally new members join at the start of the University’s new fiscal year, in July.
| Biomedical (BMR) IRB (00010468) | ||
|---|---|---|
| Matthew Hickey, Ph.D. 491-5727 | Regular Member, Professor, Chair of the BMR IRB | Department of Health and Exercise Science |
| Bruce Cooper, M.D. | Regular member, Physician, Community representative | Medical Director Health District of Northern Larimer County |
| Tammy Felton-Noyle, CIP, CCRP | Regular member, Scientific | RICRO |
| Steve Matthews, M.D. | Regular member, Physician | Hartshorn Health, CSU |
| Ketul Popat, Ph.D. | Regular member, Associate Professor, Scientific | Mechanical Engineering Department |
| Bernard Rollin, Ph.D. | Permanent Member, Professor, Non-scientist | Philosophy Department |
| Kimberly Cox-York, Ph.D. | Alternate Member, Instructor, Scientific | Food Science and Human Nutrition |
| Susan Gloeckner | Alternate Member, Non-Scientific | HDS Technology |
| Kirk McGilvray, Ph.D. | Alternate Member, Research Scientist/Scholar, Scientific | Mechanical Engineering Department |
| Jennifer Peel, Ph.D. | Alternate Member, Associate Professor, Scientific | Environmental and Radiological Health Sciences |
| Social, Behavioral, and Educational Research (SBER) IRB (00000202) | ||
|---|---|---|
| Matthew Rhodes, Ph.D. | Regular member, Professor, Chair of the SBER IRB, Scientific | Psychology Department |
| Gene Gloeckner, Ph.D. | Regular member, Professor, Associate SBER IRB Chair, Social Scientist | School of Education |
| Moti Gorin, Ph.D. | Regular member, Assistant Professor, Non-Scientific | Philosophy Department |
| Joel Painter, MSW | Regular member, Non-Scientific, Prisoner Representative, Community Representative | Jacob Center |
| Evelyn Swiss, CIP | Regular member, Non-Scientific | RICRO |
| David Williams, JD | Regular member, Non-Scientific, Alternate Prisoner Representative | Department of Philosophy |
| Claire Calhoun, CIP | Alternate Member, Scientific | Export Control |
| Elizabeth Hicks, BS | Alternate Member, Scientific | Community Member |
| Olivia Kail, BA | Alternate member, Non-Scientific | Student Representative |
| Daniel Lennox | Alternate member, Scientific | Student Representative, Computer Science |
| Sarah Olson, MA | Alternate member, Non-Scientific | International Programs |
| Type of Review | Average Days to Approve | Number of Current Active Protocols | Number of Amendments |
|---|---|---|---|
| Expedited Review | 33 | 578 | 263 |
| Full Committee Review | 38 | ||
| Amendments by Expedited Review | 7 | ||
| Exempt Review | 15 | 295 |
6 Month period from June 30th, 2013 – December 31st, 2013; Number of days are Calendar days