Institutional Review Board

Overview

Nebraska Wesleyan University is committed to protecting the dignity, rights, safety and welfare of all human subjects who participate in research carried out by our students, faculty, and/or staff. The NWU Institutional Review Board (IRB) is the federally recognized body at the university charged with oversight of such research.

The IRB is guided by the ethical principles of Respect for Persons, Beneficence, and Justice set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) from the U.S. Department of Health and Human Services’ Office of Human Research Protections. The latter, commonly known as “The Common Rule,” incorporates the ethical principles from the Belmont Report in the following ways:

Respect for persons

• Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 46.116.
• Informed consent will be appropriately documented, in accordance with, and to the extent required by 46.117.
• When appropriate, 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, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Beneficence

• Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) 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 should consider 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 should 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 those research risks that fall within the purview of its responsibility.>
• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Justice

• Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

Studies Requiring IRB Review

All projects that involve (1) human subjects, (2) systematic research, and (3) the intention to contribute to generalizable knowledge require IRB review.

1. Human Subject is defined as a "living individual about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." (45 CFR 46.102)

2. Research is defined by federal regulations at 45 CFR 46.102), as "a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

   This definition was revised in the 2018 Requirements version of the Common Rule to specifically exclude the following activities:

   • Scholarly and journalistic activities (for example, oral history, journalism, biography, literary criticism, legal research, and historical scholarship)
   • Public health surveillance activities
   • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order or criminal investigative purposes
   • Authorized intelligence, homeland security, defense, or national security mission operational activities.

3. To generalize is to derive general conclusions from particulars. Although some qualitative research may be less generalizable than some quantitative research, it is not the case that only hypothesis-driven, replicable research may be considered generalizable. Even research about the most narrowly defined topic (such as, an individual case study or an isolated community study) may be intended to contribute to a body of knowledge (such as, the function of culture, expression of gender, or political views of marginalized community members).

   There is no regulatory guidance on the meaning of generalizability. The essential consideration is whether it was the researcher's intent to contribute to a body of knowledge or whether the results were replicable. It really depends on the intent.

If your project satisfies all three of these conditions, then an application must be submitted to the NWU-IRB for review.

IRB Review Categories

If your project requires IRB review, then it can be submitted under one of the following three categories: Exempt, Expedited, or Full Board Review.

It is assumed that a project requires full board review unless: (1) It involves minimal risk to participants, and (2) it falls into one of the exempt or expedited sub-categories listed below. If a project involves more than minimal risk, then it must undergo a full board review even if it satisfies one of the exempt or expedited sub-categories.

Minimal risk means “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during performance of routine physical or psychological examinations or tests”.

Exempt Categories

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
3. 1. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
      1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
      2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
      3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
   2. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
   3. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
   1. The identifiable private information or identifiable biospecimens are publicly available;
   2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
   4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
   1. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
6. Taste and food quality evaluation and consumer acceptance studies:
   1. If wholesome foods without additives are consumed, or
   2. If 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 and Inspection Service of the U.S. Department of Agriculture.
7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
8. Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
   1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d) (See Section VIII of these Policies);
   2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
   3. An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Expedited Categories

1. [NOT PERMITTED AT NWU] Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
   1. [NOT PERMITTED AT NWU] 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.)
   2. [NOT PERMITTED AT NWU] 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.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
   1. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
   2. 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 8 week period and collection may not occur more frequently than 2 times per week.

3. Prospective collection of biological specimens for research purposes by noninvasive means.

   Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

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: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch 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 listing refers only to research that is not exempt.)
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research 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 listing refers only to research that is not exempt.)
8. Continuing review of research previously approved by the convened IRB as follows:
   1. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
   2. where no subjects have been enrolled and no additional risks have been identified; or
   3. where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

CITI Training

IRB applications require a copy of a certificate demonstrating the completion of “protection of human subjects training” for all project personnel, including students and faculty sponsors, through the Collaborative Institutional Training Initiative (CITI). Certificates from other training providers for the protection of human subjects will NOT be accepted. NWU provides access to CITI for campus members free of charge. Training must be renewed every three years.

NOTE: Training certificates issued through the old NIH training that were issued prior to October 1, 2018, and have not yet reached the three-year expiration date, may be grandfathered in at the Chair’s discretion.

Campus members can register for a CITI account. Applicants must select one training course from “Human Subjects Research” (question 1) in the CITI curriculum for their certification. Directions and addition support for registering an account are provided through the CITI customer support portal

Application Form

All projects subject to NWU-IRB review must complete the application form and include all relevant supporting material as found on the checklist on the final page of the application. Faculty sponsoring student research are responsible for ensuring the accuracy, consistency and overall quality of the NWU-IRB application. Please complete the application in accordance with the instructions below. Please save all documents as a single pdf and submit the completed application to irb [at] 132072.com (irb[at]nebrwesleyan[dot]edu).

Cover Page: Please be sure to fill in all of the information for your study on this page. This is a reference page with important information for identifying your study and for our records. It is also important that all investigators – principal investigator, co-investigators, and faculty sponsors – sign the application.

1. Background: Please provide a brief summary of your research project, including review of relevant academic studies, rationale, objectives/purposes, and/or major hypothesis(es). Please include a list of academic references as an attachment. NOTE: Please try to keep your description to 1-2 single-spaced pages. Also please write it with the layperson in mind. This is of particular importance when the research concerns medical or other natural scientific projects. It should also be consistent with the description provided in the informed consent document.
2. Sample Studied – Sample Selection Process: Describe the population to be studied and information on selecting of your sample. Explain how participants will be recruited into your study. Include copies of any recruitment emails, letters, etc. as an appendix.

3. Procedures for Data Collection: Provide information on the nature of the participants’ involvement, their time commitment, etc., include a copy of your data collection instrument(s) as an appendix.

   Site Permission: If you are collecting data at a place of business/organization, you must also include a signed and dated site permission letter on organization letterhead indicating that you are allowed to conduct research at/with members of that business/organization. This does not include informal meetings with research participants in public places such as coffee shops, etc.

4. Risks to Research Participants: Provide information on any physical, social, or psychological risks that could be experienced by the research participants in this study. Describe any special arrangements to protect their safety, including protecting their privacy and confidentiality.

   Storage and Protection of Data: Specify where and how both physical/paper and electronic data will be stored and protected so as to ensure participants’ privacy and confidentiality. NWU policy requires that all data be kept in a secure location for a minimum of three years after study completion.

5. Describe Benefits to Participants: Provide information on any direct benefits, such as payments, gift cards, reimbursement for travel, etc., and any indirect benefits that may result from participating in the study. This does not include benefits to the larger research community, outside agencies, etc. This question is in regard to benefits to the participant.
6. Informed Consent Procedures: Describe how informed consent is to be obtained and documented. If your research takes place in the state of Nebraska, then prospective participants must be 19 years of age or older to provide informed consent. If prospective participants are 18 years of age or younger, then parental consent and youth assent forms must be used. However, if the research is being conducted outside Nebraska, then the local laws governing age of consent will apply. You should follow the instructions found in Section VIII of NWU-IRB Policies and on the Informed Consent template below.

NWU-IRB Review Process

1. Complete Application: Complete the application described above and attached below. Be sure that the principal investigator, all co-investigators, and all faculty sponsors sign the form. Also make sure that the application is accompanied by all required appendices, and that the application and the materials in the appendices are consistent. Please submit your application in one PDF document to irb [at] 132072.com (irb[at]nebrwesleyan[dot]edu).
2. IRB Coordinator Review: The IRB Coordinator will review your application for completeness. If the application is found to be incomplete, it will be sent back to the applicant with a list of what still needs to be included. Once the application is complete, the IRB Coordinator will process the application and pass it on to the IRB for review.
3. IRB Review: Applications are submitted under one of three categories: Exempt, Expedited, and Full Board Review. Exempt applications are reviewed by the IRB Chair. Other NWU-IRB members may review Exempt applications at the discretion of the chair. Expedited applications are reviewed by two IRB members. The Chair, however, is ultimately responsible for confirming the findings of other IRB members for exempt and expedited review. Applications requiring full board review will be reviewed by all IRB members at a convened meeting. In this case, the decision is based on a majority vote.

4. IRB Decision: Upon review, applications will receive a memo indicating one of the following decisions: approval/certification as exempt, conditional approval, revise and resubmit, or disapproval. NOTE: Projects must receive IRB certification as exempt or approved (as defined below) before they may begin. The NWU-IRB does not issue retroactive approvals.

   Certification as Exempt/Approval: Applications that have been certified as exempt do not require IRB oversight. Applicants will receive a memo to this effect and will include an NUW-IRB reference number.

   All approvals for those studies processed through expedited or full board review require IRB oversight and are good for one year. If a study exceeds one year, then the approval must be renewed. All renewals require full board review. Finally, all approved projects are subject to NWU-IRB audit at the chair’s discretion.

   Applicants should keep their certification/approval memo for their records and use their NWU-IRB reference number in further correspondence with the NWU-IRB. The NWU-IRB will also keep a copy of the memo in its files.

   Conditional Approval: An application is conditionally approved when there are minor changes necessary to approve the study. Once the changes are made, the application will be approved and a memo with an NWU-IRB reference number will be issued.

   Revise and Resubmit: An application will be sent back for revision when it needs significant changes. Once the changes are made, the application may be resubmitted for further review.

   Disapproval: A study that is found not to meet ethical standards for research and cannot be modified to do so will not receive approval. It is important to bear in mind, however, that disapproval of a study must result from a full board review.

5. Project Completion: Once a study is complete, the principle investigator and faculty sponsor (when applicable) must complete a Research Completion Notification form by the assigned end date and submit it to the NWU-IRB coordinator at irb [at] 132072.com (irb[at]nebrwesleyan[dot]edu).
6. Amending a Study: Sometimes studies take an unexpected turn such that the research protocol, e.g. sample selection, data collection, and/or informed consent processes, need to change in order for the project to continue. In this case, the NWU-IRB must be notified of the change and an Application Amendment form must be submitted for IRB review. The project cannot continue until the amendment(s) receive NWU-IRB approval.

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