| IRB Protocol Guidelines
The Institutional Review Board (IRB) is required by University policy to review all proposed research involving human subjects to be conducted under the auspices of the institution (e.g., by faculty, students, staff) to help ensure that they conform to ethical standards. As such, the board shares responsibility for the protection of human subjects, researchers, and the University. The board is committed to carrying out this charge in a manner that will support and assist researchers. Ultimately, the responsibility for maintaining ethical standards and protecting human rights rests with the individual researcher (and research advisors of UNC students). The IRB review is required as an added measure of reassurance and as a local resource for the interpretation of ethical guidelines. Engaging in research with human subjects without IRB approval puts the researcher and institution at risk and constitutes a violation of University policy. For research and research-related activity involving human subjects (subjects), the University of Northern Colorado is guided by the ethical principles set forth in the Declaration of Helsinki, the National Commission for the Protection of Human Subjects of Research: The Belmont Report, and Title 45, Part 46 of the Code of Federal Regulations. The following principles are primary considerations of the UNC IRB: Researchers must provide for the safety, health, and welfare of subjects. Rights, including the right to privacy, must not be unduly infringed upon. The direct or potential benefits to the participant and/or the importance of the knowledge gained must outweigh the inherent risks to the participant; risks are always to be minimized. Participation must be voluntary and informed consent must be obtained, unless these requirements are expressly waived by the IRB. An individual does not give up any rights by consenting to participation and has the right to withdraw from a project at any time or may refuse to participate without loss of benefits to which the participant is otherwise entitled. Information about subjects is to be safeguarded (i.e., researchers must maintain confidentiality, to the extent allowed by law).
Human subjects research is operationally defined as a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy § 45CFR 46.102(d)]. Generalizable knowledge is defined by the UNC IRB by whether results are published, bibliographically available (e.g., dissertations and theses), presented outside the University setting (e.g., at a conference), or developed for others to build upon (e.g., pilot data collected for an investigator from another institution). It should be noted that: Research-related activity where data from subjects who are not class members are collected by students as a class exercise or for course credit, where the findings are not expected to be disseminated beyond the university context, is the responsibility of the instructor. Instructors supervising such research-related activity must be familiar with IRB policies and issues, as reflected in this procedures manual, in order to ensure that subjects in student projects are treated ethically (e.g., risks are low, written informed consent is obtained as necessary, confidentiality is maintained). It is recommended that instructors complete the Online Tutorial prior to supervising such projects. This tutorial requires approximately 90 minutes to complete. If the students in a course are to engage in research, as defined above, then the instructor is responsible for obtaining prior omnibus approval for all the projects from the IRB. This umbrella approval takes the form of an Exempt-status IRB application (see below) by the course instructor that will set forth the parameters of the students' research. Only Exempt-status research may be covered by the omnibus approval; student research that falls outside this category (see below) must involve an individual IRB application. The omnibus approval must be renewed every four years. Instructors supervising course-related, student research must be familiar with IRB policies and issues in order to ensure that research subjects are treated ethically (e.g., risks are low, written informed consent is obtained as necessary, confidentiality is maintained). Instructors must complete the Online Tutorial prior to supervising such projects. The certificate (included with the tutorial) documenting tutorial completion must be printed and filed with the IRB. Certification must be renewed every four years. Pilot research may take many forms. Sometimes pilot data are disseminated by presentation or publication or in a report to a granting agency, other times they are not. Sometimes pilot research involves testing a survey instrument with colleagues or students, perhaps as part of an educational exercise. Other times it might involve an experimental manipulation with subjects (sometimes from vulnerable populations) from outside the university. Researchers are urged to err on the side of caution and to consult with an IRB member if uncertain how to proceed. IRB approval is not needed for curriculum projects, workshop evaluations, and administrative review projects (program evaluations) if results are not to be distributed outside of the institutional setting. If, after the fact, it is thought that data collected for a non-research project are worthy of dissemination to a wider audience, then an IRB application is required for what is then considered archival research (i.e., research activity involving already-collected data).
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When the IRB reviews a protocol, it determines whether the following eight requirements are satisfied. Risks to subjects are minimized by using procedures consistent with sound research design, by not exposing subjects to risk unnecessarily, and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. Risks to subjects are reasonable in relation to anticipated benefits, if any, 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 that subjects would receive if not participating in the research). The IRB does not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among research risks or benefits that fall within the purview of its responsibility. Selection of subjects is equitable. In making this assessment, the IRB takes into account the purposes of the research and the setting in which the research will be conducted. The IRB is particularly cognizant of the special problems of research involving a vulnerable population. Subjects should share equally in foreseeable benefits and risks. Informed consent will be sought from each prospective participant or the participant's legally authorized representative in accordance with, and to the extent required, by 45CFR46.117. Informed consent will be appropriately documented. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Step 1 - Determine the Review CategoryResearch involving human subjects or data derived from human subjects falls into one of three categories. Based on the federal guidelines, the following descriptions are intended to assist you in determining into which review category your research fits. If you have questions, please contact an IRB consultant or one of the Co-Chairs of the IRB. Students should first contact their research advisors. In order to establish that a research project is exempt, the lead investigator (LI) must complete an Application for Exemption From IRB Review, including an Application Cover Page and an Application Narrative. The Cover Page must indicate "Exempt" at the top. Final determination as to whether a research project is exempt rests with the IRB. If the project is judged to be exempt, the LI need not resubmit the application for continued review as long as there are no modifications in the exempted procedures. An IRB Co-Chair, or his/her designee, will review individually Applications for Exemption From IRB Review. Generally, research that does not propose to disrupt or manipulate subjects' normal life experiences, or incorporate any form of intrusive procedures, may be declared exempt from IRB review. Research activities are exempt from the IRB review when the ONLY involvement of human subjects falls within one or more of the following categories: Research conducted in established or commonly accepted educational settings, involving normal educational practices (e.g., instructional strategies, curricula, or classroom management).
Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement) if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Research involving survey or interview procedures of observation of public behavior, unless all of the following exist:
information obtained is recorded in such a manner that the participant can be identified, directly or through identifiers linked to the participant; any disclosure of the human participant's responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation; and the research deals with sensitive aspects of the participant's own behavior, such as illegal conduct, drug use, sexual behavior, and alcohol use.
All research involving survey or interview procedures are exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office. 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 subjects. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, possible changes in methods or levels of payment for benefits or services under those programs.
Taste and food quality evaluation and consumer acceptance studies if:
wholesome food without additives are consumed, a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety Inspection Service of the US Department of Agriculture.
EXEMPTIONS DO NOT APPLY TO RESEARCH INVOLVING pregnant women, fetuses, human in vitro fertilization, and prisoners. Further, the exemption in item 2, above, DOES NOT APPLY TO CHILDREN, EXCEPT for research involving observations of public behavior when the researchers do not participate in the activities being observed. |
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The lead investigator must complete an Application for Expedited IRB Review, including an Application Cover Page and an Application Narrative. The Cover Page must indicate "Expedited Review" at the top.Research that is judged to involve no more than minimal risk to subjects and includes appropriate informed consent procedures can be reviewed in an expedited manner. The expedited procedure will involve the independent review and recommendation for approval of an IRB Co-chair and at least one IRB consultant (or the other Co-chair). Minimal risk means that the "probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests [46.102(i)]." Often, research involves at least minimal levels of risk (e.g., mild anxiety or embarrassment) to the subjects. It is the researcher's responsibility to consider these possible physical or psychological risks. As risks rise, safeguards must be considered by the researcher. Examples of safeguards against improbable events are: emergency medical procedures in the event of unexpected accident, seizure, or illness during the data collection and emergency psychotherapeutic procedures in the event of unexpected psychological trauma. The greater the probability of any such risk, the greater the responsibility of the researcher to provide such safeguards for the protection of subjects' safety and well being. Other risks to consider, though not an exhaustive list, would include: possible excessive negative reaction of subjects to the introduction of sensitive stimulus information during the research procedures, the potential for extreme effects on subjects' relationship status as a result of research participation, any strong reactions to procedures that may violate subjects' belief systems, and the possibility of moral violations as perceived by the subjects. In instances where the research might cause an emotional reaction in the participant, researchers should identify a contact organization (including a phone number) that can help subjects work through any emotional reaction the research has evoked. The following are the federal criteria for research that may be reviewed in an expedited manner. Research activities that: present no more than minimal risk to human subjects, AND involve only procedures listed in one or more of the categories described below.
NOTE: Activities should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on the list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. The categories in this list apply regardless of the age of subjects, except as noted. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing; unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
RESEARCH CATEGORIESCategory 1Clinical studies of drugs and medical devices only when: Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (NOTE: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Category 2 Collection of blood samples by finger stick, heel stick, or venipuncture as follows: From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an eight week period and collection may not occur more frequently than two times per week; OR From other adults and children considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an eight week period and collection may not occur more frequently than two times per week.
Category 3Prospective collection of biological specimens for research purposes by noninvasive means. Examples are: hair and nail clippings in a non-disfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization.
Category 4
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples are: physical sensors that are applied either the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy; weighing or testing sensory acuity; magnetic resonance imaging; electrocardiography; electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Category 5Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects, 45 CFR 46.101(b)(4). This category refers only to research that is not exempt. Category 6Collection of data from voice, video, digital, or image recordings made for research purposes. Category 7Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects, 45 CFR 46.101(b)(2) AND (b)(3). This category refers only to research that is not exempt.
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Full-Board reviews are conducted only during the fall and spring semesters. The Lead Investigator and all co-investigators must submit evidence of ethics training. They are to complete the Human Participant Protections Tutorial. This will require approximately 60-90 minutes, and the available certification of completion must be submitted with the Full Board review application. On the Application Cover Page for IRB Review Form, applicants should indicate "Full-Board Review". Research that is judged to involve more than minimal risk, as defined earlier in this document, must be submitted for Full-Board review. Full-Board review is necessary when researchers plan to use procedures that are personally intrusive and/or have the potential to produce stress or trauma beyond what is likely to be encountered by the subjects in their everyday lives. When an application for Full-Board Review is received in the SPARC office it is forwarded to one of the IRB Co-Chairs who verifies its status and then calls for a meeting of the entire board. The LI is invited to present the proposal to the board at this meeting. After presenting the proposal and answering any questions, the LI is excused from the meeting while the board deliberates further and then votes to approve (as is, or with revisions), not approve, or table (e.g., if more information needs to be gathered or an expert external to the board consulted). Please note that it may take several weeks to convene a Full-Board meeting and Full-Board meetings are not conducted during the summer. The description of the nature of participation should not be misleading or untruthful. However, there are times when full disclosure would jeopardize the research. For example, subjects might not be informed of the actual purpose of certain procedures in order to obtain unbiased results. No more than such mild deception can be tolerated in a study submitted for expedited review. However, researchers should be aware that information that may affect the objectives of the study may not be withheld if it relates to the risks subjects may face and hence might affect their willingness to participate. Any intentional deception involving misleading or untruthful information provided to the subjects must be considered in a Full-Board review. Intentionally misleading or providing untruthful information to subjects is not considered to be a desirable procedure. All other possible alternative research strategies should be explored and eliminated before settling on a deceptive approach. Should a researcher choose to implement a deceptive strategy, it will be necessary to provide a clear justification of the procedure to the consultants as well as additional measures to protect subjects. Justification must consider: 1. Alternative research methods that would not require the adoption of deceptive practices (e.g., role playing, gaming approaches, simulation strategies, etc.). 2. The value of the research being conducted. Though scientific gain is not a total justification, it is necessary to demonstrate increased benefit to offset the increased participant risk where deception is involved. 3. Steps taken to further insure participant safety. Deception is taking advantage of the participant's willingness to participate and thus renders the participant vulnerable to increased psychological or physical harm. Steps must be taken, and clearly explained in the proposal, to protect against harm to the subjects. 4. Where deception is used and the consent document intentionally omits information or misleads the participant, it is important to repair this deficiency. A thorough debriefing of the subjects may be desirable, in which the deceptive strategy is explained and justified and an apology for the deception is issued. Deceptions with potential long-term negative implications for subjects should be avoided. It is also desirable, at the time of debriefing, to allow subjects to withdraw permission to include their data in the results and to destroy any records of their participation.
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