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MSU Denver

What is the IRB and what is its purpose?

The Review Board is composed of members of the MSU Denver faculty and staff and the community at-large.  Members of the IRB are tasked with protecting the rights and welfare of participants in research studies.

The IRB reviews and makes determinations on proposed human subjects research that is conducted by or in collaboration with MSU Denver faculty, staff, and/or students.  The IRB follows regulatory requirements and the ethical principles of Respect for PersonsBeneficence, and Justice in reviewing research that involves participants and/or identifiable private information.

The following are excerpts from 45 CFR 46, the Health and Human Services, Office of Human Research Protections regulations governing the makeup and function of Institutional Review Boards:

§46.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

(e) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB

§46.108 IRB functions and operations.

In order to fulfill the requirements of this policy each IRB shall:

(a) Follow written procedures in the same detail as described in §46.103(b)(4) and, to the extent required by, §46.103(b)(5).

(b) Except when an expedited review procedure is used (see §46.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

§46.109 IRB review of research.

(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.

(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117.

(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

IRB Members

 

Lisa Badanes, Ph.D.

IRB Chair

Assistant Professor

Department of Psychology

[email protected]

 

Mike Heathcote

Human Subject Protection Program Manager

[email protected]

 

Maureen Flynn, Ph.D.

Assistant Professor

Department of Psychology

[email protected]

 

Raymond Gornell, Psy.D.

Staff Psychologist

MSU Denver Counseling Center

[email protected]

 

Siva priya Santhanam, Ph.D., CCC-SLP

Assistant Professor

Department of Speech, Language & Hearing Sciences

[email protected]

 

Di Jia, Ph.D.

Assistant Professor

Department of Criminal Justice & Criminology

[email protected]

 

D. Tyler Coyle MD, MS

Community Member

University of Colorado Anschutz Medical Campus

[email protected]

IRB Meetings

Fall Semester 2021:

  • September 3rd
  • October 1st
  • November 5th
  • December 10th

Most human research studies do not require review by the convened IRB, but rather are reviewed via an exempt or expedited process.  Studies that require oversight from the full IRB are those studies that involves greater than minimal risks to subjects.

Proposed studies that may require full Board review should be submitted at least six months prior to the planned start date of the research.   Please contact the HSPP as soon as possible if you believe your project may require a full board review.

***Investigators should note that the IRB does not convene during the summer months.***

IRB meetings are not open to the public and adhere to confidentiality measures outlined in the federal regulations and guidance.

Message from Elizabeth Jinks, Director of OSRP

The IRB is a vital part of ensuring the protection of the rights and welfare of human subjects who participate in research at MSU Denver. Faculty, staff, and community members volunteer significant and intensive university-level service that not only requires a deep understanding of federal and state regulations and university policies, but also application of those regulations and policies to maintain the utmost integrity of human subjects’ protection. Service on the Board includes (but is not limited to):

  • Attendance at monthly meetings which includes reasoned discussion and reviews – Board members attend approximately 6-8 full board meetings per academic year; these meetings may consist of full board reviews, routine training, policy discussions, and/or a variety of other issues as necessary.
  • Individual reviews of protocols – Board members routinely review Expedited protocols on their own time either based upon quantity received and/or expertise required.
  • Full board reviews when necessary – All board members are responsible for thoroughly reviewing protocols that have been recommended for full board review.
  • Initial and on-going training – Board members are required to complete IRB member-specific modules of CITI training, maintain these credentials, and participate in regular scenario training.
  • Recruitment and assessment of new members (as needed) – Board members reach out to the university and the community to help fill in membership gaps; additionally, they utilize assessment tools to ensure new members will be a good “fit” for the Board.
  • Serve as “ambassadors” to MSU Denver’s research community – Board members often help colleagues prepare protocols, may present to departments, classes, or other groups about human subjects research ethics, represent at the annual Undergraduate Research Conference, and facilitate training sessions throughout the University.