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Nurses as members of institutional review boards
Clinical Methods
Nurses as M e m b e r s of Institutional Review Boards Annette DeVito Dabbs and Marie T. Nolan
NCREASINGLY, nurses serve as members of institutional review boards (IRBs), committees whose charge is to review whether the benefits of proposed institutional research outweigh the risks and to ensure that investigators have explained the protocol sufficiently to allow subjects to give informed consent. Understanding the roles of the nurse as a member of a hospital's IRB can provide valuable insight for nurses who are appointed to serve on this committee, for directors of nursing who need to quantify the nursing resources used to support the research mission of the hospital, and for nurse investigators seeking IRB approval. The nurse IRB member may represent the hospital's nursing department, a school of nursing affiliated with the hospital, or a hospital department other than nursing. For the purpose of this report, the roles of the nurse who represents the nursing department will be explored. The authors, who are nursing department representatives on the IRBs of two academic medical centers, will provide a brief review of the literature concerning the role of IRBs and nurses who serve on these committees. The responsibilities of the nurse as an IRB member and as a representative of a nursing department will be discussed.
I
BACKGROUND History of Institutional Review Boards
Proclamation of the Nuremberg Code in 1949 and the World Medical Association's adoption of the Declaration of Helsinki in 1964 (Annas & Grodin, 1992) raised the public's awareness of abuse in human experimentation and compelled officials charged with the administration of governmental funds to regulate research (Edgar & Rothman, 1995). The U.S. Public Health Service issued guidelines for the protection of human subjects in 1966, and later the U.S. Congress established the National Commission for the Protection of Human Subjects. In 1974, The National Research Act was Applied Nursing Research,Vol. 10, No. 2 (May), 1997: pp 101-107
enacted by Congress, directing the Secretary of Health, Education, and Welfare to require all recipients of departmental research funds to establish IRBs (Rogers, 1992). The National Institutes of Health (NIH) and the Food and Drug Administration (FDA), subsidiaries of the Department of Health and Human Services, were specifically charged with supervising the ethical aspects of research involving human subjects. The NIH maintains an Office for the Protection from Research Risks and, in conjunction with the FDA, published revised regulations in 1981 (Code of Federal Regulations, 1981) and the Health Research Extension Act in 1985 (United States Congress, 1985). These have been amended periodically to provide additional protection to special groups, such as children, mentally disabled individuals, pregnant women, fetuses, and prisoners, culminating in the most recent regulations regarding the review of proposals for research (Code of Federal Regulations, 1991). Through these regulations, the govemment has delegated the protection of the rights of human subjects in inpatient and outpatient settings to local IRBs regardless of study funding source. The IRBs have been granted the authority to review and monitor the conduct of research to ensure that the following requirements are satisfied: risks to subjects are minimized, risks are reasonable in relation to expected benefits, selection of subjects is equi-
From the Department of lnterventional Cardiology, Penn State's Hershey Medical Center, Hershey, PA; and the Department of Nursing, The Johns Hopkins Hospital, Baltimore, MD. Annette DeVito Dabbs, MN, RN: Clinical Nurse Specialist, Cardiology, Penn State's Hershey Medical Center, Hershey, PA; Marie T. Nolan, DNSc, RN: Nurse Researcher, Department of Nursing, The Johns Hopkins Hospital, Baltimore, MD. Address reprint requests to Annette DeVito Dabbs, MN, RN, Cardiology C1517, Penn State's Hershey Medical Center, 500 University Dr, Hershey, PA 17033. Copyright © 1997by W.B. Saunders Company 0897-1897/97/1002-000755.00/0 101
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table, informed consent is obtained and appropriately documented, and provision for monitoring the safety and privacy of subjects is adequate (Iber, Riley, & Murray, 1987). Federal guidelines do not dictate the selection process for IRB members. Regulations mandate that the committee comprise at least five persons with varied backgrounds and that members possess the competency to review research, the diversity to promote respect for the welfare of human subjects, and the ability to ascertain the acceptability of the research in terms of institutional commitments and standards of professional practice (Code of Federal Regulations, 1991). Although nurses are not explicitly included on IRBs, nurses are eligible because they possess the expertise to fulfill the membership requirements. Nurses Serving on Institutional R e v i e w Boards
Literature regarding nurses and IRBs is scarce. In 1975, the American Nurses Association (ANA) published Human Rights Guidelines for Nurses in Clinical and Other Research. In this document, the ANA noted the need for professional nurses on IRBs to protect the rights of nurses who were expected to work on medical clinical trials without prior consultation. The ANA contended that nurse membership on IRBs would add another perspective to patient advocacy in human rights research. Spross, Kilpack, and Marchewka (1981) described problems such as overuse of nursing personnel and resources that occurred when nurses were called on to assist in study enrollments and data collection without warning before the start of studies. In accordance with the ANA guidelines, they resolved the issues by developing a nursing research committee and seeking nursing representation on their IRB. These investigators described monitoring research projects approved by the IRB to protect the rights of prospective subjects and to prevent overuse of nursing personnel. Fuhs and Moore (1981) described the development of a nursing research program in a tertiary care setting. These investigators attributed the establishment of a Committee on Clinical Nursing Research and the appointment of nurses to the university IRB as instrumental in achieving their research program goals. Robb (1981) reported concerns about the role of nurses in research that existed within the Veteran's Administration Nursing Service before nurse representation on the IRB. Some concerns were that
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nurses were being used to collect data, were excluded from proposal development, and were not oriented to protocols or informed of study results. Robb stressed that in spite of the time commitment required to serve on IRBs, nurses met the requirements for membership and made a unique contribution. They assisted in determining the impact of protocols on nursing services, communicated nursing's contribution to health care to other disciplines, provided an alternative professional view for the protection of human subjects, increased appreciation of behavioral research as a legitimate approach to problems in the delivery of health care, and encouraged nurses' participation with researchers from other disciplines. Cassidy and Oddi (1993) investigated the extent of nurses' participation on IRBs by surveying nursing administrators of hospitals in a midwestern state. Approximately one third of the hospitals (n = 45) reported having an IRB, but nursing representation tended to be low overall, with approximately one nurse on each IRB. The nature of nurses' participation on the IRBs was determined by surveying the nurse members. Most nurse members were appointed to the committee, had advanced degrees, held administrative or management positions, completed a research course, participated in ethics seminars, and attended continuing education programs related to research. In spite of these credentials, which were thought to enhance the nurses' abilities to function as active participants in IRB deliberations, the survey revealed that only 50% of the nurses reported "always" contributing to discussions; 60% reported that their input was only sought "seldom" or "sometimes." Cassidy and Oddi speculated that low nurse representation on IRBs indicated that nurses were viewed as "token" members rather than valued professionals with unique ideas, preparation, and perspectives who shared in deliberations about the protection of patients as subjects of research. RESPONSIBILITIES OF THE NURSE AS A MEMBER OF AN INSTITUTIONAL REVIEW BOARD
Nurse IRB members in hospitals are responsible to the institution for protecting human subjects and providing scholarly review of the research protocols submitted. They are also responsible to the department of nursing for ensuring that research protocols do not impede nursing care delivery. Finally, they facilitate the department of nursing
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research program by providing consultation in the research approval process. Drawing on their own experiences as nurse IRB members, the authors will discuss preparing to be an IRB member, providing clinical and scientific review, evaluating the impact of protocols on patient care delivery, and promoting the research program within a nursing department. Preparing to be an Institutional Review Board Member
All members of the IRB contribute unique areas of expertise to the committee's deliberations. Up to date knowledge of one's discipline as well as any special area of expertise is required to accurately evaluate the risks and benefits of proposed protocols. Innovations in drugs, diagnostic technology, or behavioral therapy can change the risk-benefit ratio of a particular protocol from one year to the next. Regularly reading the literature in one's area of expertise, attending regional and national conferences, and remaining clinically active are ways to maintain current information in one's field. Shrinking professional development budgets for nurses serve as a barrier to nurses on IRBs who are seeking to maintain their expertise. However, this disadvantage may be offset by accessing information on practice innovations via automated literature searches and from sources on the Internet. Maintaining knowledge of current federal IRB guidelines is also necessary to be an effective IRB member. The Belmont Report (Department of Health Education and Welfare, 1979), the Federal Policy for the Protection of Human Subjects (NIH, 1991), and the NIH Guidelines on the Inclusion of
Women and Minorities as Subjects in Clinical Research (NIH, 1994) are primers for any new IRB member. Also informative is the journal, IRB: A Review of Human Subjects Research, published by the Hastings Center, which is devoted to the analysis of IRB-related issues. Additionally, the NIH and the FDA periodically offer conferences about IRB issues, such as "Current Issues in Human Subject Protection: an FDA Perspective" (FDA; September 13, 1996), free of charge. Finally, the nurse member of the IRB is involved in an endeavor that deals with scientific and ethical issues. Although most nursing undergraduate programs now include an overview of ethical frameworks, little time is spent resolving ethical conflicts commonly encountered by IRB members. Genetics research has created a myriad of ethical conflicts to
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be dealt with by IRBs. For example, should beneficial information be released to family members of a subject during the study of the genetics of a deadly disease without the subject's permission? Should it be released after the subject dies? Nurses on the IRB and other committee members must be able to make distinctions between right and wrong actions in research and be able to justify their reasoning with a sound ethical framework. Public Responsibility in Medicine and Research, a national nonprofit organization, is dedicated to providing a multidisciplinary forum for addressing biomedical and bioethical issues. It provides conferences about the ethical, legal, and policy dimensions of research and clinical care. An affiliated organization, Applied Research Ethics National Association, comprising IRB administrators and representatives, researchers, patient advocacy representatives, clinical and legal professionals, and others interested in bioethics, was formally organized in 1986. Membership in organizations such as Applied Research Ethics National Association keeps IRB members aware of national and regional meetings that review and shape research policy and health care standards, provides access to current information about research ethics issues, and promotes opportunities for networking among members. Providing Clinical and Scientific Review of Research Protocols
The Federal Policy for the Protection of Human Subjects (NIH, 1991) provides for prospective and ongoing review of research by IRBs. Nurses, like other clinicians on the IRB, call on their clinical experience and knowledge of the literature in their practice area to evaluate the patient risks associated with each research protocol. For example, a cardiovascular clinical nurse specialist who knows the morbidity and mortality of a cardiac catheterization can use this knowledge when evaluating a protocol that calls for more frequent use of this procedure than would normally be required in the course of treatment. A nurse practitioner with an expertise in patient adherence to medication regimens can evaluate the risks associated with a tuberculosis study that is dependent on a high level of adherence to achieve a safe outcome. Evaluating the scientific integrity of study protocols is also undertaken by the IRB. Although it is not the federal charge of the IRB to redesign protocols to conform to the methodological prefer-
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ences of IRB members, a protocol may be rejected as an unwarranted risk for subjects if the method is viewed as insufficient to produce reliable data. Nurse researchers with their methodologic expertise may focus on these issues. For example, a nurse researcher with an expertise in pain management can recommend valid and reliable instruments for pain measurement to an investigator whose protocol was weak in this area. Nnrsing's traditional emphasis on patient education makes the nurse IRB member especially proficient in evaluating the readability of consent forms. In a study of 146 patients who were enrolled in clinical trials, investigators examined patients' understanding of phrases used in the consent forms. The words "efficacy," "lesion," "protocol," and "nonsteroidal anti-inflammatory drugs" were incompletely understood by more than 50% of respondents (Lawson & Adamson, 1995). In a study of oncology patients participating in clinical trials, investigators found that consent forms were written at an educational level too difficult for most patients to read (Grossman, Piantadosi, & Covahey, 1994). Nurses' close contact with patients keeps them attuned to patients' views of research and enables them to reduce the ambiguities of the informed consent process (Robb, 1981). Another area in which nursing knowledge about patient education is useful is in evaluating the language used to inform women of a protocol's potential for fetal harm. Guidelines recently adopted by the NIH and FDA call for the inclusion of women as subjects in clinical research (NIH, 1994). Previously, women were often excluded from clinical trials due to the unknown teratogenic effects of study drugs. In the wake of the mandatory inclusion guidelines, confusion has been reported among investigators regarding their responsibility to prevent fetal harm. Institutional Review Boards are struggling to ensure that women are provided adequate information to evaluate the risks to their future fertility or to their child should they become pregnant during the study (Rothenberg, Hayunga, Rudick, & Pinn, 1996). Multiple studies and clinical reports in the oncology nursing literature address similar issues. Bandyk and Gilmore (1995) described the concerns of women regarding the impact of cancer treatment on pregnancy. The effects of cancer treatment on sexual functioning (Lamb, 1995) and the impact of breast cancer treatment on fetal outcomes (Preftakes, 1994) were also described as patient concerns. The nurse
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member of the IRB can draw on this literature to help set standards of informed consent for women with childbearing potential who are candidates for clinical trials. RESPONSIBILITIES AS A DEPARTMENT OF NURSING REPRESENTATIVE Evaluating the Impact of Research Protocols on Patent Care Delivery
Issues about the impact of research activities on nursing services and resources have arisen, particulaxly in medical centers where scientific investigation is a prominent element of the institutions' mission. Two decades after the ANA made the appointment of nurses to IRBs a priority, nurse representation is still not universal (Cassidy & Oddi, 1993). Changing care models using fewer nurses require that the data collection activities of nurses be more closely scrutinized for their impact on patient care. Another responsibility of IRBs is to ascertain the acceptability of proposed research in terms of institutional commitments (Code of Federal Regulations, 1991). Involvement in clinical research often involves a change in routine patient care and because nurses comprise the largest cohort of care providers in the institution, nursing service administrators need a way to determine the volume of research that is planned or in progress. This is essential to ensure that patient care is not compromised. The IRB nursing representative should assist nurse managers to track the research conducted on their units. Some institutions require the investigators to secure the signatures of managers of departments affected by their proposed studies. In spite of this requirement, the impact of studies on the department of nursing is often overlooked. This may be because parts of the research protocol involve standard nursing interventions, such as administering medications, obtaining blood and urine samples, and recording vital signs. It is sometimes difficult to quantify the additional burden created by a study. Nevertheless, nurses on a unit where several studies are taking place can quickly be overwhelmed by the demands of studies requiring additional routine nursing interventions. All proposals that the nurse reviews as a member of the IRB should be scrutinized to determine the extent to which nursing units will be affected and whether the nurse manager is aware of the protocol. This can be accomplished by reviewing the proposals before the IRB meeting and discussing the
NURSES AS MEMBERS OF IRBS
potential impact with the appropriate nurse managers or by asking the investigators during the IRB meeting if an impact on patient care is foreseen. Regardless of the approach used, if an impact on patient care is anticipated, the investigator and the study unit nurse manager should agree on the degree of nursing involvement required. The ability of nurses to provide quality care for research subjects is intricately linked to the degree of involvement they have had in the research process. Investigator expectations of nurses can range in intensity from simply identifying patients as potential research subjects to participating in the design and conduct of studies. To ensure quality patient care, at a minimum, the nursing staff needs to know the identity of principal investigators and the purpose of studies being conducted on their units. Nurses must be prepared to answer patients' and families' questions about studies and treatments or to forward patients' concerns to the investigators. Patients receiving experimental drugs often require more frequent and more intensive nursing observation. When nurses are asked to administer experimental drugs, they must have information about the drug's action, dose, route, potential side effects, and the monitoring needed to ensure patient safety. When study subjects require hospitalization as part of the protocol, the census on a particular unit may increase, creating a need for increased staffing. When the nursing requirements of a study clearly go beyond routine patient care, compensation for this involvement should be written into the study budget. The nursing department representative to the IRB can assist investigators by reviewing protocols and providing cost estimates for nursing time and personnel. Compensation to a nursing unit for research activities need not always be financial. Nurse managers may provide increased nursing care hours for research, if investigators agree to compensate the nursing staff in ways that help them develop their research skills and grow professionally. Investigators should always be expected to communicate the findings of their study to the nurses involved in collecting data for the study. In certain cases, allowing nursing staff to add clinical questions to an existing study or providing nurses with secondary access to study data may help to compensate the nurses for additional research responsibilities. Investigators can be encouraged to involve nurses who have similar interest and expertise in future studies. Investigators who involve nurses in the design,
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conduct, and publication of the study provide an excellent opportunity for nurses to be mentored as researchers.
Promoting Research Within the Department of Nursing Although Cassidy and Oddi (1993) called for the study of the impact of IRB nursing members on the quality of nursing research conducted in the hospital, there has been little written about this topic. The great variability in models for supporting nursing research in tertiary care settings and the diversity in institutional roles of nurse IRB members make it impossible to define a single structure that would enable the nurse IRB member to positively influence the quality of research in the nursing department. Two institutional structures that allow the nurse IRB member to support the research program within a hospital department of nursing are described. At Pennsylvania State's Milton S. Hershey Medical Center, a cardiology clinical nurse specialist represents the Department of Nursing on the IRB and is also a member of the Research Committee of the Nursing Department. The Director for the Center for Nursing Research, a doctorally prepared nurse researcher, is the alternate member. The IRB of this institution expects protocols to be reviewed for acceptability and support within the investigators' departments before being submitted to the IRB for approval. This model holds the originating departments responsible for preliminary scrutiny and refinement and the IRB responsible for final approval of protocols. Research proposed by nursing students and members of the nursing department are reviewed for scientific integrity and feasibility by at least two members of the Nursing Research Committee before being submitted to the IRB. To ensure that patient populations are not overstudied and that nursing resources are available, nurse investigators must seek the approval of nurse managers of the units where the studies will be conducted. This model provides feedback to nurse researchers from at least two committee members so that theoretical, methodologic, human subject protection, and resource utilization issues can be addressed before IRB approval is sought. The Center for Nursing Research, which is fully supported by the Department of Nursing, has two doctorally prepared nurse researchers, a master's prepared research assistant, a data quality analyst, and a research data writer.
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These personnel are available full time to help staff nurses with the research process, from computerization through dissemination. At The Johns Hopkins Hospital, a doctorally prepared nurse researcher is the nursing department's representative on the IRB. She is also a member of the Research Committee for the Department of Nursing. Although nurses conducting research are free to submit their protocols simultaneously to the IRB and the Department of Nursing for approval without prior consultation, the majority of nurse investigators on staff at the hospital seek consultation with one of the three doctorally prepared nurse researchers in the department of nursing. Each protocol must be approved by the clinical director of nursing in the department where the study will take place to ensure that the proposed study sample is available and that the use of any nursing resources in the study is acceptable. The protocol is then reviewed by the Director of Nursing Systems and Research and finally by the Vice-President for Nursing for approval. Through the consultation process, the nurse researchers continually assess the learning needs of nurse investigators from the hospital regarding the research process. This information and information obtained from learning needs surveys conducted by the Nursing Research Committee are considered by the committee whose charge is to provide educational and material support to nursing staff who seek to conduct research. Examples of this support include the provision of a list of internal consultants to provide clinical or methodologic expertise, written materials, and educational seminars describing the research process. In summary, the nurse IRB member in this model influences the quality of research protocols in the department of nursing by providing individual consultation and by working with the Nursing Research Committee to develop ways to support nursing research in the department. In both models, the nurse IRB member functions
as a liaison between the IRB and the Nursing Research Committee. As a liaison, the nurse IRB member can communicate common problems that nurse researchers encounter during the IRB review process and work through the Nursing Research Committee to resolve these issues. For example, if there is confusion about the distinction between a research protocol requiring IRB approval and a quality improvement project that might not require this approval, the nurse IRB member can discuss this with the IRB chairperson and communicate the chairperson's response to the Nursing Research Committee. Likewise in both models, the nurse IRB member functions as a consultant to nurse investigators in the hospital regarding the IRB review process. Consultation may be sought on a variety of topics, such as when to seek expedited review or how to comply with protection of special subject groups. As a department-wide consultant, the IRB nurse member is in a unique position to identify patterns and trends in the nursing research process and provide feedback to the Vice-President of Nursing, Director of Nursing Research, Nursing Research Committee, and IRB so research processes can be continually improved. CONCLUSION
This report presented the views of a clinical nurse specialist and a nurse researcher regarding the role of nurses as members of an IRB. The role of the nurse representing the Department of Nursing on an institutional review board is multifaceted and challenging. There are variations among institutions in the way the role is fulfilled. The influence of nurses on the protection of human subjects and on the quality of research protocols approved by the IRB requires further investigation. In addition, the impact of research protocols on patient care delivery requires further quantification.
REFERENCES
American Nurses Association. (1975). Human rights guidelinesfor nurses in clinical and other research. KansasCity,MO: Author. Annas, G., & Grodin, M. (1992). The Nazi doctors and the Nuremberg code: Human rights in human experimentation.
New York, NY: Oxford University Press. (Original work published 1948.) Bandyk, E.A., & Gilmore, M.A. (1995). Perceivedconcerns of pregnant womenwith breast cancer treated with chemotherapy. Oncology Nursing Form, 22, 975-977. Cassidy, V.R., & Oddi, L.E (1993). Nurses on hospital IRBs:
A critical voicein protectinghuman subjects. Nursing Connections, 6(1), 31-38. Code of Federal Regulations Title 45, Part 46. (1981). Protectionof HumanSubjects. Federal Register, 8386-8391. Code of Federal Regulations Title 45, Part 46. (1991). Protectionof HumanSubjects, 1-8.Federal Register, 4-17. Departmentof HealthEducationandWelfare(1979).Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Bethesda, MD: National Commis-
sion for the Protection of Human Subjects of Biomedical and BehavioralResearch.
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Edgar, H., & Rothman, D.J. (1995). The institutional review board and beyond: Future challenges to the ethics of human experimentation. The Milbank Quarterly. 73, 489-506. Fuhs, M.E, & Moore, K. (1981). Research program development in a tertiary care setting. Nursing Research, 30, 24-27. Grossman, S.A., Piantadosi, S., & Covahey, C. (1994). Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? Journal of Clinical Oncology, 12, 2211-2215. Iber, EL., Riley, W.A., & Murray, EJ. (1987). Conducting clinical trials. New York: Plenum Medical. Lamb, M.A. (1995). Effects of cancer on the sexuality and fertility of women. Seminars in Oncology Nursing, 11, 120-127. Lawson, S.L., & Adamson, H.M. (1995). Informed consent readability: Subject understanding of 15 common consent form phrases. IRB: A Review of Human Subjects Research, 17, 16-19. National Institutes of Health (1991). Federal policy for the protection of human subjects. (ET. 34; K.W. 1014006, 0783005). Bethesda, MD: Author.
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National Institutes of Health (1994). NIH guidelines on the inclusion of women and minorities as subjects in clinical research. NIH Guide, (ET. 34, vol. 23, No. 10). Bethesda, MD: Author. Preftakes, D.K. (1994). Breast cancer and pregnancy: Implications for perinatal care and fetal outcomes. Journal of Perinatal and Neonatal Nursing, 7, 31-41. Robb, S.S. (1981). Nurse involvement in institutional review boards: The service perspective. Nursing Research, 30, 27-28. Rogers, B. (1992). Protecting human subjects in research: The role of the IRB. American Association of Occupational Health Nursing, 40, 500-501. Rothenberg, K.H., Hayunga, E.G., Rndick, J.E., & Pinn, V.W. (1996). The NIH inclusion guidelines: Challenges for the future. IRB: A Review of Human Subjects Research, 18, 1-4. Spross, J.A., Kilpack, V., & Marchewka, A.E. (1981). Committee evolution in a medical center. Nursing Research, 30, 30-31. United States Congress. (1985). House health research extension act of 1985: Conference report, pp. 99-309. Washington, DC: U.S. Government Printing Office.
Nurses as M e m b e r s of Institutional Review Boards Annette DeVito Dabbs and Marie T. Nolan
NCREASINGLY, nurses serve as members of institutional review boards (IRBs), committees whose charge is to review whether the benefits of proposed institutional research outweigh the risks and to ensure that investigators have explained the protocol sufficiently to allow subjects to give informed consent. Understanding the roles of the nurse as a member of a hospital's IRB can provide valuable insight for nurses who are appointed to serve on this committee, for directors of nursing who need to quantify the nursing resources used to support the research mission of the hospital, and for nurse investigators seeking IRB approval. The nurse IRB member may represent the hospital's nursing department, a school of nursing affiliated with the hospital, or a hospital department other than nursing. For the purpose of this report, the roles of the nurse who represents the nursing department will be explored. The authors, who are nursing department representatives on the IRBs of two academic medical centers, will provide a brief review of the literature concerning the role of IRBs and nurses who serve on these committees. The responsibilities of the nurse as an IRB member and as a representative of a nursing department will be discussed.
I
BACKGROUND History of Institutional Review Boards
Proclamation of the Nuremberg Code in 1949 and the World Medical Association's adoption of the Declaration of Helsinki in 1964 (Annas & Grodin, 1992) raised the public's awareness of abuse in human experimentation and compelled officials charged with the administration of governmental funds to regulate research (Edgar & Rothman, 1995). The U.S. Public Health Service issued guidelines for the protection of human subjects in 1966, and later the U.S. Congress established the National Commission for the Protection of Human Subjects. In 1974, The National Research Act was Applied Nursing Research,Vol. 10, No. 2 (May), 1997: pp 101-107
enacted by Congress, directing the Secretary of Health, Education, and Welfare to require all recipients of departmental research funds to establish IRBs (Rogers, 1992). The National Institutes of Health (NIH) and the Food and Drug Administration (FDA), subsidiaries of the Department of Health and Human Services, were specifically charged with supervising the ethical aspects of research involving human subjects. The NIH maintains an Office for the Protection from Research Risks and, in conjunction with the FDA, published revised regulations in 1981 (Code of Federal Regulations, 1981) and the Health Research Extension Act in 1985 (United States Congress, 1985). These have been amended periodically to provide additional protection to special groups, such as children, mentally disabled individuals, pregnant women, fetuses, and prisoners, culminating in the most recent regulations regarding the review of proposals for research (Code of Federal Regulations, 1991). Through these regulations, the govemment has delegated the protection of the rights of human subjects in inpatient and outpatient settings to local IRBs regardless of study funding source. The IRBs have been granted the authority to review and monitor the conduct of research to ensure that the following requirements are satisfied: risks to subjects are minimized, risks are reasonable in relation to expected benefits, selection of subjects is equi-
From the Department of lnterventional Cardiology, Penn State's Hershey Medical Center, Hershey, PA; and the Department of Nursing, The Johns Hopkins Hospital, Baltimore, MD. Annette DeVito Dabbs, MN, RN: Clinical Nurse Specialist, Cardiology, Penn State's Hershey Medical Center, Hershey, PA; Marie T. Nolan, DNSc, RN: Nurse Researcher, Department of Nursing, The Johns Hopkins Hospital, Baltimore, MD. Address reprint requests to Annette DeVito Dabbs, MN, RN, Cardiology C1517, Penn State's Hershey Medical Center, 500 University Dr, Hershey, PA 17033. Copyright © 1997by W.B. Saunders Company 0897-1897/97/1002-000755.00/0 101
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table, informed consent is obtained and appropriately documented, and provision for monitoring the safety and privacy of subjects is adequate (Iber, Riley, & Murray, 1987). Federal guidelines do not dictate the selection process for IRB members. Regulations mandate that the committee comprise at least five persons with varied backgrounds and that members possess the competency to review research, the diversity to promote respect for the welfare of human subjects, and the ability to ascertain the acceptability of the research in terms of institutional commitments and standards of professional practice (Code of Federal Regulations, 1991). Although nurses are not explicitly included on IRBs, nurses are eligible because they possess the expertise to fulfill the membership requirements. Nurses Serving on Institutional R e v i e w Boards
Literature regarding nurses and IRBs is scarce. In 1975, the American Nurses Association (ANA) published Human Rights Guidelines for Nurses in Clinical and Other Research. In this document, the ANA noted the need for professional nurses on IRBs to protect the rights of nurses who were expected to work on medical clinical trials without prior consultation. The ANA contended that nurse membership on IRBs would add another perspective to patient advocacy in human rights research. Spross, Kilpack, and Marchewka (1981) described problems such as overuse of nursing personnel and resources that occurred when nurses were called on to assist in study enrollments and data collection without warning before the start of studies. In accordance with the ANA guidelines, they resolved the issues by developing a nursing research committee and seeking nursing representation on their IRB. These investigators described monitoring research projects approved by the IRB to protect the rights of prospective subjects and to prevent overuse of nursing personnel. Fuhs and Moore (1981) described the development of a nursing research program in a tertiary care setting. These investigators attributed the establishment of a Committee on Clinical Nursing Research and the appointment of nurses to the university IRB as instrumental in achieving their research program goals. Robb (1981) reported concerns about the role of nurses in research that existed within the Veteran's Administration Nursing Service before nurse representation on the IRB. Some concerns were that
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nurses were being used to collect data, were excluded from proposal development, and were not oriented to protocols or informed of study results. Robb stressed that in spite of the time commitment required to serve on IRBs, nurses met the requirements for membership and made a unique contribution. They assisted in determining the impact of protocols on nursing services, communicated nursing's contribution to health care to other disciplines, provided an alternative professional view for the protection of human subjects, increased appreciation of behavioral research as a legitimate approach to problems in the delivery of health care, and encouraged nurses' participation with researchers from other disciplines. Cassidy and Oddi (1993) investigated the extent of nurses' participation on IRBs by surveying nursing administrators of hospitals in a midwestern state. Approximately one third of the hospitals (n = 45) reported having an IRB, but nursing representation tended to be low overall, with approximately one nurse on each IRB. The nature of nurses' participation on the IRBs was determined by surveying the nurse members. Most nurse members were appointed to the committee, had advanced degrees, held administrative or management positions, completed a research course, participated in ethics seminars, and attended continuing education programs related to research. In spite of these credentials, which were thought to enhance the nurses' abilities to function as active participants in IRB deliberations, the survey revealed that only 50% of the nurses reported "always" contributing to discussions; 60% reported that their input was only sought "seldom" or "sometimes." Cassidy and Oddi speculated that low nurse representation on IRBs indicated that nurses were viewed as "token" members rather than valued professionals with unique ideas, preparation, and perspectives who shared in deliberations about the protection of patients as subjects of research. RESPONSIBILITIES OF THE NURSE AS A MEMBER OF AN INSTITUTIONAL REVIEW BOARD
Nurse IRB members in hospitals are responsible to the institution for protecting human subjects and providing scholarly review of the research protocols submitted. They are also responsible to the department of nursing for ensuring that research protocols do not impede nursing care delivery. Finally, they facilitate the department of nursing
NURSES AS MEMBERS OF IRBS
research program by providing consultation in the research approval process. Drawing on their own experiences as nurse IRB members, the authors will discuss preparing to be an IRB member, providing clinical and scientific review, evaluating the impact of protocols on patient care delivery, and promoting the research program within a nursing department. Preparing to be an Institutional Review Board Member
All members of the IRB contribute unique areas of expertise to the committee's deliberations. Up to date knowledge of one's discipline as well as any special area of expertise is required to accurately evaluate the risks and benefits of proposed protocols. Innovations in drugs, diagnostic technology, or behavioral therapy can change the risk-benefit ratio of a particular protocol from one year to the next. Regularly reading the literature in one's area of expertise, attending regional and national conferences, and remaining clinically active are ways to maintain current information in one's field. Shrinking professional development budgets for nurses serve as a barrier to nurses on IRBs who are seeking to maintain their expertise. However, this disadvantage may be offset by accessing information on practice innovations via automated literature searches and from sources on the Internet. Maintaining knowledge of current federal IRB guidelines is also necessary to be an effective IRB member. The Belmont Report (Department of Health Education and Welfare, 1979), the Federal Policy for the Protection of Human Subjects (NIH, 1991), and the NIH Guidelines on the Inclusion of
Women and Minorities as Subjects in Clinical Research (NIH, 1994) are primers for any new IRB member. Also informative is the journal, IRB: A Review of Human Subjects Research, published by the Hastings Center, which is devoted to the analysis of IRB-related issues. Additionally, the NIH and the FDA periodically offer conferences about IRB issues, such as "Current Issues in Human Subject Protection: an FDA Perspective" (FDA; September 13, 1996), free of charge. Finally, the nurse member of the IRB is involved in an endeavor that deals with scientific and ethical issues. Although most nursing undergraduate programs now include an overview of ethical frameworks, little time is spent resolving ethical conflicts commonly encountered by IRB members. Genetics research has created a myriad of ethical conflicts to
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be dealt with by IRBs. For example, should beneficial information be released to family members of a subject during the study of the genetics of a deadly disease without the subject's permission? Should it be released after the subject dies? Nurses on the IRB and other committee members must be able to make distinctions between right and wrong actions in research and be able to justify their reasoning with a sound ethical framework. Public Responsibility in Medicine and Research, a national nonprofit organization, is dedicated to providing a multidisciplinary forum for addressing biomedical and bioethical issues. It provides conferences about the ethical, legal, and policy dimensions of research and clinical care. An affiliated organization, Applied Research Ethics National Association, comprising IRB administrators and representatives, researchers, patient advocacy representatives, clinical and legal professionals, and others interested in bioethics, was formally organized in 1986. Membership in organizations such as Applied Research Ethics National Association keeps IRB members aware of national and regional meetings that review and shape research policy and health care standards, provides access to current information about research ethics issues, and promotes opportunities for networking among members. Providing Clinical and Scientific Review of Research Protocols
The Federal Policy for the Protection of Human Subjects (NIH, 1991) provides for prospective and ongoing review of research by IRBs. Nurses, like other clinicians on the IRB, call on their clinical experience and knowledge of the literature in their practice area to evaluate the patient risks associated with each research protocol. For example, a cardiovascular clinical nurse specialist who knows the morbidity and mortality of a cardiac catheterization can use this knowledge when evaluating a protocol that calls for more frequent use of this procedure than would normally be required in the course of treatment. A nurse practitioner with an expertise in patient adherence to medication regimens can evaluate the risks associated with a tuberculosis study that is dependent on a high level of adherence to achieve a safe outcome. Evaluating the scientific integrity of study protocols is also undertaken by the IRB. Although it is not the federal charge of the IRB to redesign protocols to conform to the methodological prefer-
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ences of IRB members, a protocol may be rejected as an unwarranted risk for subjects if the method is viewed as insufficient to produce reliable data. Nurse researchers with their methodologic expertise may focus on these issues. For example, a nurse researcher with an expertise in pain management can recommend valid and reliable instruments for pain measurement to an investigator whose protocol was weak in this area. Nnrsing's traditional emphasis on patient education makes the nurse IRB member especially proficient in evaluating the readability of consent forms. In a study of 146 patients who were enrolled in clinical trials, investigators examined patients' understanding of phrases used in the consent forms. The words "efficacy," "lesion," "protocol," and "nonsteroidal anti-inflammatory drugs" were incompletely understood by more than 50% of respondents (Lawson & Adamson, 1995). In a study of oncology patients participating in clinical trials, investigators found that consent forms were written at an educational level too difficult for most patients to read (Grossman, Piantadosi, & Covahey, 1994). Nurses' close contact with patients keeps them attuned to patients' views of research and enables them to reduce the ambiguities of the informed consent process (Robb, 1981). Another area in which nursing knowledge about patient education is useful is in evaluating the language used to inform women of a protocol's potential for fetal harm. Guidelines recently adopted by the NIH and FDA call for the inclusion of women as subjects in clinical research (NIH, 1994). Previously, women were often excluded from clinical trials due to the unknown teratogenic effects of study drugs. In the wake of the mandatory inclusion guidelines, confusion has been reported among investigators regarding their responsibility to prevent fetal harm. Institutional Review Boards are struggling to ensure that women are provided adequate information to evaluate the risks to their future fertility or to their child should they become pregnant during the study (Rothenberg, Hayunga, Rudick, & Pinn, 1996). Multiple studies and clinical reports in the oncology nursing literature address similar issues. Bandyk and Gilmore (1995) described the concerns of women regarding the impact of cancer treatment on pregnancy. The effects of cancer treatment on sexual functioning (Lamb, 1995) and the impact of breast cancer treatment on fetal outcomes (Preftakes, 1994) were also described as patient concerns. The nurse
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member of the IRB can draw on this literature to help set standards of informed consent for women with childbearing potential who are candidates for clinical trials. RESPONSIBILITIES AS A DEPARTMENT OF NURSING REPRESENTATIVE Evaluating the Impact of Research Protocols on Patent Care Delivery
Issues about the impact of research activities on nursing services and resources have arisen, particulaxly in medical centers where scientific investigation is a prominent element of the institutions' mission. Two decades after the ANA made the appointment of nurses to IRBs a priority, nurse representation is still not universal (Cassidy & Oddi, 1993). Changing care models using fewer nurses require that the data collection activities of nurses be more closely scrutinized for their impact on patient care. Another responsibility of IRBs is to ascertain the acceptability of proposed research in terms of institutional commitments (Code of Federal Regulations, 1991). Involvement in clinical research often involves a change in routine patient care and because nurses comprise the largest cohort of care providers in the institution, nursing service administrators need a way to determine the volume of research that is planned or in progress. This is essential to ensure that patient care is not compromised. The IRB nursing representative should assist nurse managers to track the research conducted on their units. Some institutions require the investigators to secure the signatures of managers of departments affected by their proposed studies. In spite of this requirement, the impact of studies on the department of nursing is often overlooked. This may be because parts of the research protocol involve standard nursing interventions, such as administering medications, obtaining blood and urine samples, and recording vital signs. It is sometimes difficult to quantify the additional burden created by a study. Nevertheless, nurses on a unit where several studies are taking place can quickly be overwhelmed by the demands of studies requiring additional routine nursing interventions. All proposals that the nurse reviews as a member of the IRB should be scrutinized to determine the extent to which nursing units will be affected and whether the nurse manager is aware of the protocol. This can be accomplished by reviewing the proposals before the IRB meeting and discussing the
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potential impact with the appropriate nurse managers or by asking the investigators during the IRB meeting if an impact on patient care is foreseen. Regardless of the approach used, if an impact on patient care is anticipated, the investigator and the study unit nurse manager should agree on the degree of nursing involvement required. The ability of nurses to provide quality care for research subjects is intricately linked to the degree of involvement they have had in the research process. Investigator expectations of nurses can range in intensity from simply identifying patients as potential research subjects to participating in the design and conduct of studies. To ensure quality patient care, at a minimum, the nursing staff needs to know the identity of principal investigators and the purpose of studies being conducted on their units. Nurses must be prepared to answer patients' and families' questions about studies and treatments or to forward patients' concerns to the investigators. Patients receiving experimental drugs often require more frequent and more intensive nursing observation. When nurses are asked to administer experimental drugs, they must have information about the drug's action, dose, route, potential side effects, and the monitoring needed to ensure patient safety. When study subjects require hospitalization as part of the protocol, the census on a particular unit may increase, creating a need for increased staffing. When the nursing requirements of a study clearly go beyond routine patient care, compensation for this involvement should be written into the study budget. The nursing department representative to the IRB can assist investigators by reviewing protocols and providing cost estimates for nursing time and personnel. Compensation to a nursing unit for research activities need not always be financial. Nurse managers may provide increased nursing care hours for research, if investigators agree to compensate the nursing staff in ways that help them develop their research skills and grow professionally. Investigators should always be expected to communicate the findings of their study to the nurses involved in collecting data for the study. In certain cases, allowing nursing staff to add clinical questions to an existing study or providing nurses with secondary access to study data may help to compensate the nurses for additional research responsibilities. Investigators can be encouraged to involve nurses who have similar interest and expertise in future studies. Investigators who involve nurses in the design,
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conduct, and publication of the study provide an excellent opportunity for nurses to be mentored as researchers.
Promoting Research Within the Department of Nursing Although Cassidy and Oddi (1993) called for the study of the impact of IRB nursing members on the quality of nursing research conducted in the hospital, there has been little written about this topic. The great variability in models for supporting nursing research in tertiary care settings and the diversity in institutional roles of nurse IRB members make it impossible to define a single structure that would enable the nurse IRB member to positively influence the quality of research in the nursing department. Two institutional structures that allow the nurse IRB member to support the research program within a hospital department of nursing are described. At Pennsylvania State's Milton S. Hershey Medical Center, a cardiology clinical nurse specialist represents the Department of Nursing on the IRB and is also a member of the Research Committee of the Nursing Department. The Director for the Center for Nursing Research, a doctorally prepared nurse researcher, is the alternate member. The IRB of this institution expects protocols to be reviewed for acceptability and support within the investigators' departments before being submitted to the IRB for approval. This model holds the originating departments responsible for preliminary scrutiny and refinement and the IRB responsible for final approval of protocols. Research proposed by nursing students and members of the nursing department are reviewed for scientific integrity and feasibility by at least two members of the Nursing Research Committee before being submitted to the IRB. To ensure that patient populations are not overstudied and that nursing resources are available, nurse investigators must seek the approval of nurse managers of the units where the studies will be conducted. This model provides feedback to nurse researchers from at least two committee members so that theoretical, methodologic, human subject protection, and resource utilization issues can be addressed before IRB approval is sought. The Center for Nursing Research, which is fully supported by the Department of Nursing, has two doctorally prepared nurse researchers, a master's prepared research assistant, a data quality analyst, and a research data writer.
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These personnel are available full time to help staff nurses with the research process, from computerization through dissemination. At The Johns Hopkins Hospital, a doctorally prepared nurse researcher is the nursing department's representative on the IRB. She is also a member of the Research Committee for the Department of Nursing. Although nurses conducting research are free to submit their protocols simultaneously to the IRB and the Department of Nursing for approval without prior consultation, the majority of nurse investigators on staff at the hospital seek consultation with one of the three doctorally prepared nurse researchers in the department of nursing. Each protocol must be approved by the clinical director of nursing in the department where the study will take place to ensure that the proposed study sample is available and that the use of any nursing resources in the study is acceptable. The protocol is then reviewed by the Director of Nursing Systems and Research and finally by the Vice-President for Nursing for approval. Through the consultation process, the nurse researchers continually assess the learning needs of nurse investigators from the hospital regarding the research process. This information and information obtained from learning needs surveys conducted by the Nursing Research Committee are considered by the committee whose charge is to provide educational and material support to nursing staff who seek to conduct research. Examples of this support include the provision of a list of internal consultants to provide clinical or methodologic expertise, written materials, and educational seminars describing the research process. In summary, the nurse IRB member in this model influences the quality of research protocols in the department of nursing by providing individual consultation and by working with the Nursing Research Committee to develop ways to support nursing research in the department. In both models, the nurse IRB member functions
as a liaison between the IRB and the Nursing Research Committee. As a liaison, the nurse IRB member can communicate common problems that nurse researchers encounter during the IRB review process and work through the Nursing Research Committee to resolve these issues. For example, if there is confusion about the distinction between a research protocol requiring IRB approval and a quality improvement project that might not require this approval, the nurse IRB member can discuss this with the IRB chairperson and communicate the chairperson's response to the Nursing Research Committee. Likewise in both models, the nurse IRB member functions as a consultant to nurse investigators in the hospital regarding the IRB review process. Consultation may be sought on a variety of topics, such as when to seek expedited review or how to comply with protection of special subject groups. As a department-wide consultant, the IRB nurse member is in a unique position to identify patterns and trends in the nursing research process and provide feedback to the Vice-President of Nursing, Director of Nursing Research, Nursing Research Committee, and IRB so research processes can be continually improved. CONCLUSION
This report presented the views of a clinical nurse specialist and a nurse researcher regarding the role of nurses as members of an IRB. The role of the nurse representing the Department of Nursing on an institutional review board is multifaceted and challenging. There are variations among institutions in the way the role is fulfilled. The influence of nurses on the protection of human subjects and on the quality of research protocols approved by the IRB requires further investigation. In addition, the impact of research protocols on patient care delivery requires further quantification.
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