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The process of obtaining approval to conduct a research study varies among clinical settings. Many organizations have a nursing research committee (Pintz et al., 2018) that promotes the integration and acculturation of evidence-based practice (EBP) generating nursing research. The research proposals are then submitted to the institutional review board (IRB) or the hospital nursing research committee to examine issues related to the protection of participants from the risks of participating in research. At institutions without a nursing research committee, research proposals may go to the director of nursing research or the institution’s nurse scientist, if there is one, but generally go directly to the IRB for review with all of the other research protocols.

■ REVIEW COMMITTEES

Whether a nursing research committee review in addition to IRB approval is needed, the research investigator must also consider the following:

■Frequency of the committee meetings. Some organizations schedule meetings on an as-needed basis if the volume of clinical studies is small. If both a nursing research committee and an IRB exist, the institution’s policies state whether a proposal for review can be submitted to both simultaneously or whether one must approve the proposal before it can be submitted to the other for review. It is important to know the structure and timeline of your institution’s review process so that the investigator can factor this into the timeline of the study.

366■Composition of the review committees. It cannot be assumed that all review committees include a member who is familiar with nursing research. Therefore, it is important to write the proposal in lay terms for readers who may not have expertise in that particular content area and may not be familiar with nursing research. Advanced practice registered nurses (APRNs) are valuable members of research review committees. Active participation in these meetings provides APRNs a service scholarship opportunity.

■The presence of site-specific idiosyncrasies. Some institutions require that an employee or physician be listed as principal investigator (PI) in a submission. This may require that the researcher set up collaborations in advance. IRBs require the PI and other research team members to complete initial training in research ethics before a protocol can be submitted. The Collaborative Institutional Training Initiative (CITI) provides online training for participating institutions and may be transferable; however, keep in mind that research training requirements are not the same at all institutions. Although these issues may seem trivial, such things can delay the process of approval while the committees seek additional information. By dealing directly and proactively with these issues, the investigator establishes credibility and demonstrates professionalism. Contact the site IRB to find out what research training requirements are needed to conduct the study.

Nursing Research Committees

Nursing research committees were initiated for the review of (a) scientific merit of a proposal for which an investigator is seeking support from nursing services, and (b) the nature and magnitude of the resources required of nursing services to implement the proposed research (Albert, 2016).

The nature and magnitude of resource consumption can range from minimal (e.g., a request merely to access participants for the study) to significant (e.g., an expectation that nursing staff will both implement various elements of an intervention and collect data regarding the feasibility and efficacy of the intervention).

Nursing research committees should be composed of members who have sufficient education and training in research to be able to examine the scientific merit of the study. Many institutions have PhD-prepared nurses lead these committees. APRNs leading or collaborating research teams, who are expert clinicians, are often valuable committee members. Committee membership may include those with a spectrum of experience from novice to expert (Albert, 2016). A goal of these committees would be to advance nursing science and, where possible, provide the research team with feedback that will improve the study (Parkosewich, 2013).

Institutional Review Boards

IRBs, also called human subject review committees, exist to provide fair and impartial review of research proposals and are responsible for the critical oversight of the research conducted on human subjects to protect them from any unnecessary risks associated with participation in research. In the United States, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS), specifically the Office for Human Research Protections (OHRP), regulations have empowered federally funded IRBs to approve, modify planned research prior to approval, or disapprove research. Institutions may not have a formal review structure if they do not receive federal funding, are small, or produce a limited volume of research. However, they can negotiate an agreement with a larger institution or external review committee to provide the required oversight.

367In organizations in which a large volume of research is conducted, there may be more than one IRB committee (e.g., biomedical, social-behavioral, and/or biobehavioral). In the absence of federal funding and a formal review structure, the review may be done informally by an administrator of the institution. However, in this instance, the investigator should obtain a review from an external human subjects committee to document that the researcher has adhered to federal guidelines concerning the protection of human subjects from risk. Several independent IRBs can be found on the internet. Having approval from some type of IRB may be a journal or organizational requirement for dissemination and publication of the results. Also, IRB approved research studies are required for Magnet® recognition.

Guidelines for Review

IRBs usually have a set of guidelines or principles that govern their procedures and reviews. Institutions that receive federal funding must follow the 45 CFR 46. This section of the Code of Federal Regulations, the Common Rule, was recently revised and became effective in January 2019 and can be obtained at www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.

Some small IRBs may use the principles set forth in the Belmont Report, which can be accessed at www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. The Belmont Report, published in 1979, was commissioned by the federal government to develop a set of principles that would offer guidance for the conduct of biomedical research and forms the basis for regulations and requirements imposed on IRBs. International review committees tend to use principles from the World Medical Association codified in the Declaration of Helsinki, found at www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects. It is important to have an understanding of the principles in the Declaration of Helsinki for any research conducted, in whole or in part, outside the United States.

The Code of Federal Regulations stipulates the composition of the IRB (OHRP, DHHS, 2019a, 45 CFR 46.107). An IRB must consist of a minimum of five members with varying backgrounds to ensure a complete and adequate review of the research activities commonly conducted by the institution. Furthermore, by regulation, an IRB may not consist entirely of members of one profession, gender, or racial group. Collectively, the IRB must be sufficiently qualified through the experience and expertise of its membership to have knowledge of and sensitivity to prevailing attitudes. If the particular IRB routinely reviews research involving vulnerable participants, then the composition of the board must include one or more individuals knowledgeable about and experienced in working with these vulnerable populations. Also, the IRB must include at least one member whose primary concerns are in nonscientific areas and one who is not otherwise affiliated with the institution. One of the members should be able to discuss issues emanating from the perspective of the community and its values. No IRB member shall participate in the review if that person has a conflict of interest affiliated with the project. Lastly, an IRB may invite additional individuals with special areas of expertise to participate in the review and discussion of research proposals to enable the IRB to fulfill its purpose. Please see the regulations at 45 CFR 46.107 for complete information on all of the required qualifications to properly compose an IRB.

Jurisdiction of an IRB

The jurisdiction of an IRB is determined by answering two fundamental questions: “Is the activity research?” and “Does the activity involve human subjects?” For healthcare professionals, the first question may not be so easily answered because the distinction between research and therapy is 368not always readily apparent. Federal policy defines research as a “systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalized knowledge” (OHRP, DHHS, 2019a, 45 CFR 46.102). Furthermore, research itself is not inherently therapeutic in that the therapeutic benefits of experimental interventions are unknown or may prove to be ineffective. If the focus of the proposed activity is currently accepted as standardized methods of care or if the research addresses institutional or patient-specific case issues, then the activity is generally not considered research and consequently may not require IRB reporting and review. However, if there is any uncertainty as to whether the activity is research, the activity should be treated as research and reported to the IRB. An activity is research if the answers to the following two questions are “yes”: “Does the activity employ a systematic approach involving predetermined methods for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing a theory?” and “Is the activity intended to contribute to generalizable knowledge by extending the results (e.g., publication of presentation) beyond a single individual or internal unit?” (OHRP, DHHS, 2019a, 45 CFR 46.102). It is ultimately up the IRB to determine if an activity is research.

There is one caveat. If the activity is to be disseminated (i.e., reported in a publication or presentation), the general practice has been to report it to the IRB for review. An activity that causes great confusion as to whether or not it constitutes research is continuous quality improvement (QI). QI is considered an essential component of responsible professional healthcare and a means for improving the processes, efficiencies, safety, and quality of care while preventing substandard care (Ogrinc et al., 2013). However, QI activities frequently consist of methods traditionally associated with randomized clinical trials, blurring the distinction between QI activities and research (Whicher et al., 2015). Some suggest that all activities should be reviewed by the IRB to ensure that the activity, research, or QI does not compromise patient autonomy or safety (Szanton et al., 2013). Those who advocate the review of all activities contend that once the activity receives IRB approval, it is sanctioned, thereby ensuring that the activity complies with commonly accepted ethical practices and involves a minimal level of risk for all participating parties, the human subjects, investigators, and the institution. However, many in the healthcare community believe that review of all activities would stall the research enterprise. According Ogrinc et al. (2013), if any of the following applies to the activity, it should be considered research and submitted to the IRB for review:

■Results are to be disseminated

■Results contribute to generalized knowledge

■Conditions are systematically assigned to patients

■Conditions are other than a standard of care

■Risks are explained in informed consent and may be minimal

■Information collected goes beyond routine patient care

■Risks to privacy and confidentiality exist

There is no consensus about universal criteria for making such a distinction between projects requiring IRB approval and those that are exempt (Whicher et al., 2015). However, the results of QI projects are often of interest to audiences outside the particular institution and dissemination of the results would be expected, and would not necessarily indicate that the QI project is research requiring IRB review (Gregory, 2015). Oermann et al. (2014) provide guidelines for writing QI and research manuscripts. To meet publication criteria, some institutions have separate processes in place that acknowledging the project as QI (Stausmire, 2014).

369To determine if a project is a QI initiative that does not generally require IRB review, it is useful to contrast the aims and methods of research with those of QI projects. The federal regulation governing IRBs defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (OHRP, DHHS, 2019a, 45 CFR 46.102). In contrast, “the goal of QI is to analyze data to improve systems related to processes and outcomes (i.e., cost, productivity, quality)” (Gregory, 2015, p. 101). Several useful tools have been developed to assist researchers in differentiating research from QI and helping them determine if IRB review is required (Ogrinc et al., 2013; Stausmire, 2014).

Once the activity has been deemed research, the investigator should ask whether the research activity involves human subjects. A human subject is a living individual about whom an investigator obtains data or biospecimens through intervention or interaction with the individual or obtains identifiable private information (OHRP, DHHS, 2019a, 45 CFR 46.102). For example, an investigator whose research activities involve accessing health records of only patients who have died is not conducting research with human subjects.

■ LEVELS OF REVIEW

Once it has been established that the activity falls within the jurisdiction of the IRB, the level of IRB reporting and review must be identified. There are three levels of review, determined on the basis of the degree of risks inherent in the proposed research. Risk is the likelihood of harm or injury, whether it is physical or psychological, that occurs as a result of participation in research and can range from minimal to significant. The three levels of review are exempt, expedited, and full. It is important to determine which level of review is required because the extent of information required, the forms to be completed, and the time necessary for the review are determined by the type of review. For any questions about the level of review or the submission process you should consult your IRB.

The 2019 Common Rule revisions impacted all constituencies involved in human research protection programs. The intention was to reduce administrative burden and better protect the human subjects by making the informed consents more meaningful and focusing IRBs on higher risk research.

Exempt From Review

Research activities that are exempt from review by the IRB are those that pose minimal risks to participants, have no means by which a participant can be identified, and use human subjects who are capable of freely consenting to participate (OHRP, DHHS, 2019a, 45 CFR 46.104). Even though a research activity falls into the exempt category, it still must be submitted to the IRB for affirmation. Examples of activities that are exempt from review are listed in Exhibit 19.1.

Copies of surveys, interview guides, or questionnaires and the exact introductory remarks and consent forms to be used must be submitted to the IRB when requesting exempt status. If advertisements for participants are used, copies of the text for the planned advertisement must also be submitted. Although these materials may or may not be formally reviewed in the committee, a member of the IRB will assess the materials to verify that the activity meets the stipulations for exemption. The investigator will receive a document from the IRB indicating the exact criteria used 370to judge whether the activity does or does not meet the requirements for an exemption. If the IRB assessment determines that the activity does not fulfill the requirements for exemption, the investigator may be asked to submit additional justification or appropriate materials for IRB review.

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