IRB Policy and Procedures

Policy and Procedures Regarding

Institutional Review Board (IRB) for the Protection of Human Subjects (IRB)


I. Policy

II. Statement of Ethical Principles

III. Applicability of these Policies and Procedures

IV. Submission Procedures
A. Criteria for Exempt Review
B. Criteria for Expedited Review
C. Criteria for Full Review

V. Approval Process
A. Criteria for Approval
B. Actions by the IRB
C. Actions by the University

VI. Students as Researchers and Subjects
A. Applicability of Policy
B. Student Responsibility
C. Faculty Responsibility
D. The Submission and Approval Processes
E. Students as Subjects

VII. Continuing Review, Minor Changes, and Cooperative Research
A. Continuing Review
B. Minor Changes to Approved Research
C. Cooperative Research

VIII. IRB Policy for HIPAA Compliance

IX. Meetings and Records
A. Meeting Dates and Times
B. The Meeting
C. IRB Records

X. IRB Membership
A. General Principles of Membership
B. Selection of Members


XI. Changes to Policies and Procedures
A. Compliance to Applicable Regulations
B. Continuing Review

XII. Continuing Education




I. Policy

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).



II. Statement of Ethical Principles

The following broad principles are the basis for UCCS policy concerning review of research involving humans:

  1. Whereas, the participation of humans in research projects may raise fundamental ethical and civil rights questions, all such research, funded and unfunded projects, sponsored and not sponsored which is carried out by UCCS students, faculty, or other University employees, on or off campus shall be covered by the UCCS Institutional Review Board for the Protection of Human Subjects (hereinafter referred to as the IRB) in Research Policies and Procedures covered by this document
  2. All activities involving humans as subjects must provide for the rights, safety, health, and welfare of each individual.
  3. The direct or potential benefit to the subject and the importance of the knowledge gained must outweigh any inherent risk to the individual.
  4. Participation in research must be voluntary and informed consent procedures must conform to the IRB Policies and Procedures.
  5. An individual does not abdicate any rights by consenting to be a research subject. A subject has the right to refuse to participate or may withdraw from research at any time without penalty or loss of benefits to which the subject would otherwise be entitled.
  6. Safeguarding information about an individual that has been obtained in the course of an investigation is a primary obligation of the principal investigator.
  7. The primary responsibility for protection of human subjects rests with the principal investigator, with support, approval, and monitoring by the University as set forth in the IRB Policies and Procedures.



III. Applicability of these Policies and Procedures

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.

Definitions:

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)



IV. Submission Procedures

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 irb@uccs.edu. 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 irb@uccs.edu 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.

A. Criteria for Exempt Review

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:

  1. research conducted in established or commonly accepted educational settings, involving normal education practices, such as research on regular and special education strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Special note for research in schools: In order for a project involving educational research (research conducted in classrooms) to be reviewed under the exempt category, the investigator must supply a letter from the appropriate school district official that certifies that the project meets the following conditions. The research activities will: a) not differ in any significant ways from the normal range of activities of the classroom, school, or district; b) involve only customary and non-controversial instructional goals; c) not deny any students educational benefits they would otherwise receive; d) promise direct benefits (at least in the form of evaluative information) to the classroom, school, or district; e) incorporate adequate safeguards to protect the privacy (i.e., anonymity or confidentiality) of all individuals who might be subjects of the research; or f) involve only existing data on students which are non-identity specific. If the investigator cannot provide this documentation it will be necessary for the proposal to be reviewed by the full committee under the regular review process.
  2. research involving the use of educational tests (i.e., cognitive, diagnostic, aptitude, and achievement tests), survey procedures, interview procedures or observation of public behavior, unless specific individual human subjects can be identified, directly or through identifiers linked to the subjects, and disclosure of their identity could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation
  3. research involving the use of educational tests (i.e., cognitive, diagnostic, aptitude, and achievement tests), survey procedures, interview procedures, or observation of public behavior that is not exempt under category 2 of this section, if the human subjects are elected or appointed public officials or candidates for public office, or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter
  4. research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject
  5. research and demonstration projects which are conducted by or subjected to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels or services under those programs
  6. taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains an ingredient at or below the level and for a use found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

    (adapted from 45 CFR 46.101)

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.

B. Criteria for Expedited Review

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.

  1. collection of hair and nail clippings in a non-disfiguring manner, deciduous teeth, and permanent teeth if patient care indicates a need for extraction
  2. collection of excreta and external secretions including perspiration, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor
  3. recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (e.g., x-rays, microwaves)
  4. collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant
  5. collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
  6. voice recordings made for research purposes
  7. moderate exercise (not including stress testing) by healthy volunteers
  8. the study of existing data, documents, records, pathological specimens, or diagnostic specimens
  9. research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the research will not involve stress to subjects beyond that routinely experienced in daily life or during the use of noninvasive procedures routinely employed in clinical practice
  10. research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

    (adapted from 45 CFR 46.110 and 46 FR 8392)

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.

C. Criteria for Full Review

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:

  • Surveys or questionnaires that solicit information regarding personal or sensitive aspects of the subjects' behavior, including sexual practices, instances of child or sexual abuse suffered by the subject, criminal activities, drug and alcohol use, or studies of eating disorders.
  • Stress testing, drug and alcohol use by the subjects for research purposes, and studies where subjects are asked to do more than moderate physical exercise that could result in injury to the subject.

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.



V. Approval Process

A. Criteria for Approval

The IRB uses eight specific review criteria:

  1. Risks to subjects are minimized. This is made possible by using procedures that are consistent with sound research design and which do not expose subjects to unnecessary risk, and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  2. Risks to subjects are reasonable in relation to anticipated benefits, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB does not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as a research risk that falls within its purview.
  3. Selection of subjects is equitable. In making this assessment the IRB takes into account the purposes of the research and the setting in which it will be conducted. The IRB is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons.
  4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator must seek consent under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimizes the possibility of coercion or undue influence. The information given to the subject or the representative must be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or that appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
  5. Required elements of informed consent are present. The IRB may waive or modify this requirement under certain circumstances. Any modification to informed consent procedures must be fully justified in writing.
    1. General elements of informed consent:
      1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
      2. a description of any reasonably foreseeable risks or discomforts to the subject;
      3. a description of any benefits to the subject or to others that may reasonably be expected from the research;
      4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
      5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
      6. for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
      7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights (including a referral to the IRB Chair), and whom to contact in the event of a research-related injury to the subject; and
      8. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

 

  1. Additional elements of informed consent: when appropriate, one or more of the following elements of information shall also be provided to each subject:
    1. a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
    2. anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
    3. any costs to the subject that may result from participation in the research;
    4. the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
    5. a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
    6. the approximate number of subjects involved in the study.

 

  1. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  2. Whenever appropriate, there are provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  3. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, (e.g., children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons) additional safeguards have been included in the study to protect the rights and welfare of these subjects.

(adapted from 45 CFR 46.111, 116, 117)

B. Actions by the IRB

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)

C. Actions by the University

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)



VI. Students as Researchers and Subjects

A. Applicability of Policy

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.

  1. Classroom Activities Involving Data Collection

    Courses sometimes require students to undertake small projects in which other people are interviewed, observed, or otherwise serve as human subjects. The purpose of these course projects is to provide students with a closer view of social, educational, or psychological processes, and/or with an opportunity to practice the same methods of observation customary to the various disciplines. Examples might include giving a child a test of some cognitive process, or actually working in a community as a participant observer. Because such activities are not undertaken with the goal of developing or contributing to generalizable knowledge, the IRB does not consider them to be research as such. Consequently, course projects (which do not involve more than minimal risk to participants) do not require review of the IRB. If there is concern that classroom activities involve more than minimal risk or vulnerable human subjects, faculty are encouraged to contact members of the IRB for consultation and/or submission.

    Any potential risks which might be incurred by subjects in practice of this sort are the responsibility of the faculty member. It is the instructor's responsibility to protect people's privacy, dignity, and welfare. Instructors and their teaching/research assistants need to be familiar, in advance, with what each student will be doing in his or her project, and to discuss human subject protection issues with the student. Explicit recognition of the importance of human subject protection issues should be an integral part of introducing students to research methodologies in any discipline.
  2. Student Research Projects

    Any student-initiated and/or student-conducted data collection activities designed to develop or contribute to generalizable knowledge, and which uses human subjects, require clearance by the IRB. This includes graduate theses, dissertation research, and honors theses.

    Student research projects are reviewed using the same principles and guidelines followed by the IRB for the protection of human subjects in general. Responsibility for obtaining the IRB approval for student research resides equally with the student and the faculty advisor (the signatures of both are required on the review protocol).

B. Student Responsibility

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.

C. Faculty Responsibility

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.

D. The Submission and Approval Processes

Submission and approval processes for student research are identical to those for other research covered by this policy.

E. Students as Subjects

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:

  1. Underage Students. Minors (students under 18 years of age) can be included in the subject pool, as long as the research meets the criteria listed in 46.116(d), which includes the following:
    1. The research involves no more than minimal risk to subjects.
    2. The waiver of consent will not adversely affect the rights and welfare of the subjects
    3. The research could not practicably be carried out without the waiver.
    4. Whenever appropriate, subjects will be provided with additional information after participation.

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.

  1. Potential for Coercion. Student participation in faculty research can raise questions regarding their ability to exercise free choice because of the possibility that grades or other important factors will be affected by their decisions to participate. To protect against coercion, faculty-investigators should advertise for subjects generally (e.g., through subject pools or notices posted in the school) rather than recruit individual students or students enrolled in their classes. In addition, faculty researchers need to take special care to protect prospective participants from adverse consequences of declining or withdrawing from participation.
  2. Requiring Research Participation. Requiring participation in research for course credit (or extra credit) is controversial. To diminish or eliminate the coercive aspect of student participation for course credit, students are to be given the choice of equitable alternative activities (e.g., write a brief research paper or attend faculty research colloquia). Students who do choose to participate in studies should be given several studies to choose from; these studies must not involve more than minimal risk; and students should be able to withdraw from the study at any time without losing the extra credit.



VII. Continuing Review, Minor Changes, and Cooperative Research

A. Continuing Review

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)

B. Changes to Approved Research

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)

C. Cooperative Research

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)



VIII. IRB Policy for HIPAA Compliance

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.

Definitions:

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:

  1. Specific description of what PHI will be used or disclosed
  2. Who may use or disclose PHI
  3. Who may receive the PHI
  4. Purpose of the use or disclosure
  5. Statement of how long the use or disclosure will continue. "No expiration date" is allowed for research purposes.
  6. Right to revoke authorization.
  7. Notice that the information may be disclosed to others not subject to the Privacy Rule.
  8. Right to refuse to sign authorization
  9. The subject must sign the form and receive a signed copy for the authorization to be valid.

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:

  1. When requesting permission from a patient to have their name, address and phone number or other health information released to an investigator for recruitment into a research study; or
  2. When enrolling a subject into a specific research study to request permission to collect their PHI as related to the research study. This second circumstance occurs simultaneously with the consent process.

Waiver of Authorization: Waiver of Authorization can be obtained if the following three criteria have been met:

  1. The research is no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
    1. an adequate plan to protect the identifiers from improper use and disclosure
    2. an adequate plan to destroy the identifiers at the earliest opportunity
    3. adequate written assurances that the PHI will not be reused or disclosed to any other person or entity.
  2. The research cannot practicably be carried out without a waiver; and
  3. The research cannot be done without this specific PHI.

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:

  1. name
  2. address including city, county, precinct, zip code
  3. all elements of dates (except year) for dates directly linked to an individual (birth date, admission date, discharge date, date of death) [For all subjects over 89 years, all elements of dates including year that are indicative of their age cannot be used; however, age can be aggregated into a category of age 90 or older.]
  4. telephone numbers
  5. fax numbers
  6. e-mail addresses
  7. social security numbers
  8. medical record numbers
  9. health plan beneficiary numbers
  10. account numbers
  11. certificate/license number
  12. vehicle identifiers
  13. device identifiers
  14. Web Universal Resource Locators/Identifiers
  15. Internet Protocol address numbers
  16. Biometric identifiers including finger or voice prints
  17. Full face photographs and comparable images
  18. Any other unique identifying number, characteristic, or code

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:

  1. Admission, discharge and service dates
  2. Birth date
  3. Date of death
  4. Age (including over age 89)
  5. Geographic information (except street addresses) such as city, state, and five-digit zip code

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.



IX. Meetings and Records

A. Meeting Dates and Times

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.

B. The Meeting

  1. Quorum. A majority of IRB members must be present to conduct business. The IRB cannot act on a proposal unless at least one member whose primary concerns are in a non-scientific area is present. Members present may, by simple majority vote, defer agenda items if they believe requisite members of IRB are not present.
  2. Order of Business. The agenda for IRB meetings shall be:
    1. Review of and action on minutes of previous meetings
    2. Old and New Business related to IRB functioning
    3. Review and discussion of, and action (if needed) on exempted or expedited proposals
    4. Review and discussion of, and action on continuing proposals
    5. Review and discussion of, and action on substantive changes to previously approved proposals
    6. Review and discussion of, and action on new proposals (in order of submission)
    7. Other business
  3. Actions. The meeting shall be conducted in accordance with Robert's Rules of Order (most recent edition). The committee must adhere to section V- B, Criteria for Approval, during deliberations on specific proposals. Proposals shall be approved, approved with revisions, disapproved, or tabled until a specified future date by majority vote of those members present.
  4. Attendance by non-IRB members. IRB meetings are generally open to all members of the University community and the community at large. The IRB members may, on majority vote, close meetings for compelling reasons, as long as such closure is not in conflict with 45 CFR Part 46 or other applicable Federal, State, or local law or regulations. Anyone may speak for or against a proposal but remarks must be based only on the Criteria for Approval as stated in section V-B of these procedures. The Chair may limit the duration of comments or the number of speakers for and against a proposal to serve the best interest of committee functioning. Written comments received by the Chair prior to the meeting will be read into the minutes or distributed and appended to the minutes, insofar as they address the Criteria for Approval.
  5. The IRB may, at 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 to IRB.

    Only IRB members may vote.

    (adapted from 45 CFR 46.107(f))
  6. Conflict of Interest. IRB members and anyone speaking or submitting written comments must declare any potential conflict of interest in advance. Members may speak for but may not vote on their own proposals, proposals of students they are sponsoring, or any proposal in which IRB member is or is likely to be a participant. Written comments shall explicitly address any conflict of interest or its absence.
  7. Minutes. The IRB will keep minutes of the proceedings. The minutes must show attendance; actions taken by IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and, a written summary of the discussion of controverted issues and their resolution.

    (adapted from 45 CFR 46.115)

C. IRB Records

OSP is the repository for IRB records. OSP shall keep the following documentation of IRB activities on file for at least 3 years:

  1. Copies of all proposals received, scientific evaluations (if any) that accompany the proposals, copies of all internal and external correspondence related to each submitted proposal, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects (if any).
  2. Minutes of IRB meetings.
  3. Records of continuing review activities.
  4. Copies of all correspondence between IRB and the investigator.
  5. A list of IRB members including name, earned degrees, representative capacity, indications of experience such as board certifications, licenses, etc., sufficient enough to describe each member's chief anticipated contributions to IRB deliberations, and employment or other relationship between each member and the institution.
  6. Written procedures for IRB.
  7. Statements of significant new findings provided to subjects as required by the consent documents.



X. IRB Membership

A. General Principles of Membership

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)

B. Selection of Members and Chair

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.

 



XI. Changes to Policies and Procedures

A. Compliance to Applicable Regulations

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.

B. Continuing Review

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.



XII. Continuing Education

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 irb@uccs.edu.

· 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