The University of Colorado at Colorado Springs (UCCS) is committed to teaching, scholarly and creative work, and service. Concomitantly, the University is committed to the conduct of these activities according to the highest ethical standard. For projects involving humans as subjects of research, UCCS is guided by the ethical principles regarding research involving humans as subjects as set forth in the Declaration of Helsinki and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research's Ethical Principles and Guidelines for the Protection of Human Subjects of Research: The Belmont Report. In addition, UCCS is committed to insuring that all human subject research, regardless of funding source, follow the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (except that reporting requirements for non-DHHS projects shall be waived). Thus, campus policies and guidelines conform to federal regulations. The UCCS IRB for Human Subjects is registered with the federal government (IRB #00000973; FWA #00002481).
The following broad principles are the basis for UCCS policy concerning review of research involving humans:
The IRB Policies and Procedures apply to all research involving human subjects research, which is funded and unfunded, and sponsored and not sponsored and carried out by UCCS students, faculty, or other University employees, on or off campus, where human subjects participation occurs.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to the development of generalizable knowledge. Activities that meet this definition constitute research, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information regardless of its source. Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also includes that which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
(adapted from 45 CFR 46.102)
All proposals to conduct research involving human subjects must be submitted to the UCCS campus IRB. The investigator must obtain IRB approval or clearance before undertaking the research. Research involving human subjects may not proceed until written approval is received by the investigator from the IRB. Investigators may submit a completed IRB request for review, a research summary, consent document(s), and a copy of the Methods and Human Subjects section(s) if funding has been applied for or received for your project. The items above must be submitted via email to the IRB Chair at email@example.com. Exempt and Expedited Requests for IRB Review are usually processed within 10 business days. For research needing Full review, investigators must submit an electronic copy to the IRB Chair at firstname.lastname@example.org no later than ten (10) business days before the monthly IRB meeting. Typically Full reviews may take more than 25 business days to review and approve. The Board usually meets on the last Tuesday of the month during the academic calendar; summer meetings are scheduled if necessary.
Research in this category involves risks or stressors that are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Please note: The researcher is most vulnerable for allegations of scientific misconduct should the exempt status be challenged. If in doubt, request an expedited or full review. Note that the IRB Chair must determine that a project qualifies for an exempt review.
Research qualifies for exempt if it falls in one of the following six categories:
For research in this category, investigators must submit to the IRB Chair one copy of the following: a completed Request for IRB Review form, which includes a Research Summary, consent document(s), and all other relevant material. Do not proceed with the research until you have received written IRB approval.
Research that poses only minimal risk to adult human subjects and does not deal with sensitive or personal aspects of the subject's behavior may be granted an expedited review under one or more of the conditions listed below (if carried out through standard methods). Research with minors (children aged 17 years and under) may not be reviewed under the expedited category.
For research in the expedited review category, submit to the IRB Chair one copy of the following: a completed Request for IRB Review form,, which includes a Research Summary, consent document(s), and all other relevant material. Do not proceed with the research until you have received written IRB approval.
Research involving more than minimal risk or vulnerable human subjects who are not specifically exempted in IV - A of this policy must undergo a full IRB review. Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. Vulnerable subjects include children under 18 years, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, persons not proficient in the language of the research study, and any subjects likely to be vulnerable to coercion or undue influence.
Examples of research that may involve more than minimal risk (mental or physical) include:
Researchers needing full review are encouraged to submit to the IRB Chair a draft of their materials at least two weeks before the scheduled IRB meeting. A completed application is due to the Office of Sponsored Programs for distribution to the IRB members at least 10 working days before the meeting. Researchers are invited to attend IRB meetings to answer questions. (For dates and locations of meetings, see irbmeetings.) Do not proceed with the research until you have received written IRB approval.
The IRB uses eight specific review criteria:
(adapted from 45 CFR 46.111, 116, 117)
The IRB shall approve, disapprove, or approve with revisions all proposals. The investigator may proceed only after written notification of approval. Proposals approved subject to revisions, require that revisions and/or clarification be submitted in writing to the IRB Chair. The IRB may give the Chair authority to act on revisions. Written notification of approval after revisions are made must be received by the investigator prior to proceeding with the research.
No research proposal will be finally disapproved until it has been reviewed in accordance with the full review procedures set forth in this document. If the IRB disapproves a research proposal, a written statement of the reasons for its decision will be given to the principal investigator. The investigator will have an opportunity to respond in person or in writing.
(adapted from 45 CFR 46.109)
Research that is approved by IRB may be subject to further review by the Vice Chancellor for Academic Affairs (VCAA). However, the VCAA may not approve research that has not been approved by the IRB.
(adapted from 45 CFR 46.112)
On November 7, 1997, UCCS adopted the following policy set forth by the VCAA and IRB Chairperson regarding students involved in data collection and research.
Students are responsible for adhering to this policy. Students may not undertake human subjects research without a faculty sponsor. Students are subject to the provisions set forth in The University of Colorado Policies and Procedures Regarding Student Conduct and Discipline as well as the CU System and the UCCS Scientific Misconduct and Fraud policies and procedures.
In order to be approved by IRB, at least one faculty sponsor is required for each student research project. The faculty member shall be responsible for the oversight of the conduct of the research and adherence to all applicable University policies and procedures.
Submission and approval processes for student research are identical to those for other research covered by this policy.
The involvement of students in research is common in the social and behavioral sciences. Student participation in research provides researchers with readily available subjects and students can benefit both from the research experience, along with any compensation offered by the researchers. Although the federal regulations do not provide explicit protections for students as subjects, their involvement may present special concerns to researchers and the IRB. Potential concerns include:
Thus, for minimal-risk studies, the regulations allow for a waiver of parental permission. For studies involving more than minimal risk, researchers should either restrict participation to students 18 or older, or obtain both parental permission and the student's assent for the minor to participate.
Federal regulations require reevaluation of approved research at intervals that are appropriate to the degree of risk. At the time of its initial review, the IRB will determine the renewal date. If the project is to continue past the expiration date, then the investigator must submit a Request for Renewal form to the IRB Chair. The investigator must submit the Request in time for review and approval by the one-year anniversary date of the previous approval. If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop. Enrollment of new subjects cannot occur after the expiration of IRB approval.
The IRB may require continuing review of any research at more frequent intervals than 12 months whenever in its opinion the degree of risk justifies such review. Additionally, IRB has the authority to observe or have a third party observe the consent process and the research. Such individuals are required to comply with confidentiality standards governing the ongoing research.
(adapted from 45 CFR 46.109)
Minor changes in previously approved research that do not increase risk to subjects during the period for which the research is approved need not be submitted for additional IRB approval. Any changes that affect the risks to subjects must be approved by IRB prior to implementing the changes. In addition, the IRB must be notified of any changes in principal investigator(s) or faculty sponsorship. Investigators must submit changes in writing to the IRB Chair on the Report of Change form.
(adapted from 45 CFR 46.110)
In the conduct of cooperative research projects, each institution is responsible for the rights and welfare of human subjects and for complying with 45 CFR Part 46. Therefore, investigators must submit for UCCS IRB approval all research to which this policy is applicable, unless there is an agreement in writing from a Federal Department or Agency head outlining joint review arrangements.
(adapted from 45 CFR 46.114)
The Health Insurance Portability and Accountability Act of 1996 ("HIPAA") was written to allow for insurance portability but also as a Privacy Rule to protect the privacy and security of a person's identifiable health information. The purpose of this policy is to provide researchers with the information they will need to comply with the Privacy Rule associated with HIPAA.
HIPAA (Health Insurance Portability and Accountability Act): The 1996 Act to regulate the transfer and collection of PHI between and within covered entities defined as (a) health care plans; (b) health care clearinghouse, and (c) health care providers who electronically transmit any health information.
Protected Health Information (PHI): All individually identifiable health information that is either created or received by a health care entity that includes information about the past, present or future physical or mental health of a person, the provision of health care to a person, or payment for care. Includes information in written, electronic, or oral form. Includes information created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse.
Authorization: The HIPAA equivalent of consent for use or disclosure of a person's PHI. Required elements for an authorization form include:
The HIPAA authorization can be a separate document from the consent form, or the required elements can be incorporated into the consent form. The UCCS-approved HIPAA authorization form can be found in Authorization Form A.
Authorization should be obtained in each of the following two circumstances:
Waiver of Authorization: Waiver of Authorization can be obtained if the following three criteria have been met:
When applying for a waiver of authorization, the investigator must complete the "Waiver of HIPAA Authorization" form. Uses and disclosures of PHI pursuant to the waiver must be limited to the minimum necessary to achieve the research purpose. This means that if you use a waiver to collect PHI, you must only collect the bare minimum of information from patient records that is necessary to answer the research question.
Examples of when a waiver may be utilized:
Example 1. A researcher would like to conduct a retrospective chart review at Treatment Center X. Waiver of consent is appropriate since it is impractical to attempt to contact the many patients that a retrospective chart review entails, and the chart review is considered to be minimal risk. [NOTE: If only de-identified data are recorded, then it is not considered to be PHI, and no waiver of authorization is required.]
Example 2. A researcher has a list of patients who were involved in his previous study and would like to re-contact these patients to participate in a follow-up study. The investigator would apply for a waiver of authorization to pull medical records to find the patients' current phone numbers. The investigator will still need to use an authorization form when enrolling the subjects, but in order to obtain this PHI before contacting the patients, a waiver is required.
De-Identified Data: Health information is considered de-identified when it does not identify an individual and the health care entity has no reasonable basis to believe that the information can be used to identify an individual.
Research involving de-identified data will not be required to adhere to HIPAA regulations requiring authorization.
De-identified data includes none of these 18 identifying links:
Limited Data Set. Limited Data Sets include research that falls under HIPAA regulations but does not require researchers to obtain authorization or waiver of authorization. Researchers can collect data that retains the following types of identifiers:
Researchers using a limited data set will be able to use the data only for research purposes but may not use the limited data set to contact subjects.
Recruitment of Subjects. No researcher may contact potential subjects with whom the researcher does not have a clinical relationship, without authorization. If a researcher wishes to recruit subjects into a study, then the researcher must request that a physician who does have a clinical relationship with these subjects obtain authorization from the subjects to release information to the researcher (Authorization Form B). Alternatively, the care-providing physician can give the patient the contact information about the study.
The IRB meetings are generally held the last Tuesday of each month during the academic year, and in July during the summer months. The Chair of IRB may convene additional meetings as necessary to handle business. Members must be notified at least 72 hours in advance of any such meetings. The Chair may cancel meetings when there are no proposals to be reviewed.
OSP is the repository for IRB records. OSP shall keep the following documentation of IRB activities on file for at least 3 years:
The IRB shall have at least seven members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the University. The IRB shall be sufficiently qualified through the experience and expertise of its members, their diversity, 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 necessary professional competence to review specific research activities, 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.
Every non-discriminatory effort will be made to ensure that IRB does not consist entirely of men or women. The IRB will not consist of members of a single profession or discipline and shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non scientific areas. The IRB will have at least one member who is not affiliated with UCCS except for IRB membership.
(adapted from 45 CFR 46.107)
The Research Integrity Officer (RIO) is the responsible official for appointing members to the IRB, as follows:
The RIO may seek nominations from the IRB, Deans, Directors, the Faculty Assembly Chair, or others as appropriate.
The IRB shall consist of a minimum of nine members from various disciplines. One of the members shall be appointed by the RIO as Chair of the IRB. To ensure there is succession training, the RIO shall appoint another IRB member to serve as Co-Chair.
The Chair will typically receive two course releases per year and the Co-Chair will typically receive one course release annually. Alternative compensation may be given as deemed appropriate in consultations with the relevant department chair, dean, or other unit head.
The Chair shall be appointed for a three year term. At the end of the three year term the Co-Chair shall be appointed as Chair for the next three year term and a new Co-Chair will be appointed. While a person will not serve consecutive terms as the Chair, previous service as Chair shall not prohibit an individual from becoming Chair again in the future. The previous Chair shall continue as a member.
Insofar as possible, the RIO will appoint at least one faculty member from these campus units to be members of the IRB:
- College of Engineering
- School of Education
- Graduate School of Public Affairs
- Beth-El College of Nursing and Health Sciences
- College of Letters, Arts, and Sciences (at least 2 members)
- College of Business
- Library and Information Services
In addition, the RIO shall appoint at least one person from the community, i.e, not an employee of the university, to be a member.
The Research Compliance Coordinator shall participate as recorder and administrative support.
The IRB Policies and Procedures shall not be in conflict with 45 CFR Part 46 or other applicable Federal, State, or local law or regulations and shall be changed as may be necessary to eliminate any conflict.
Students, staff, faculty or administration may propose a change to any section of the policy at any time. Such requests must be made in writing to the IRB Chair and shall be considered at the subsequently convened IRB meeting, provided the change was requested at least 10 working days prior to the meeting. Changes shall be voted on by the IRB and any change obtaining a majority vote of those members present shall be forwarded to the VCAA for action.
Changes required by federal regulation shall be read into the minutes of a convened IRB meeting and forwarded to the VCAA for review and concurrence prior to implementation. Should the VCAA disagree with the IRB recommendation, a meeting between the IRB and the VCAA will be held to discuss the recommendation.
Training in human subject protection is required for IRB members, Principal and Co-Principal Investigators, and Faculty Advisors. Training must be completed before a protocol will be reviewed by the IRB. Instructions to complete the training are posted on the human subjects' website (http://www.uccs.edu/osp/). Individuals shall be required to complete a review once every three years.
Section XIII. PI Responsibilities
After IRB approval is obtained, it is the Principal Investigator’s responsibility to:
· Provide the IRB with all protocol and consent form amendments and revisions, as well as all advertisements recruiting study subjects to the IRB.
· Renew all Expedited and Full protocols prior to the expiration date indicated in the Approval letter from the IRB.
· Report the status of Exempt protocols each year, prior to the anniversary of the original approval date.
· Report any unanticipated and unintentional adverse events to human subjects to the IRB Chair or designee within 5 business days via email email@example.com.
· Report any changes that affect the risks to subjects as well as any changes in principal investigator(s) or faculty sponsorship. Changes must be approved by IRB prior to implementing the changes (http://www.uccs.edu/osp/).
· Notify the IRB when the project is complete.
· Report any Conflict of Interest or Perceived Conflict of Interest to the IRB.
· Conduct research in an ethical and appropriate manner, refraining from Scientific Misconduct activities which include, but are not limited to, plagiarism, falsification, fabrication, and failure to protect the confidentiality of human subjects in research.
· Adhere to all policies and procedures set forth by the University and by the IRB as well as all applicable local, state and federal regulations.
Failure to comply with these responsibilities may result in suspension or termination of the protocol and