- Email: [email protected]
The nurse's role in the informed consent process
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S e m i n a r s in O n t o l o g y Nursing, Vol 15, No 2 (May), 1999: pp 116-123
OBJECTIVES: To review the informed consent process in relation to oneology nursing roles and responsibilities, patient comprehension, cultural sensitivity, and qualitative methodologies.
Scientific and review articles, regulatory documents, and texts relating to informed consent. CONCLUSIONS: Nursing is involved in almost every aspect of the informed consent process. To be effective, nurses must be knowledgeable about fundamental concepts associated with informed consent and corresponding responsibilities and willing to address the complexities of the informed consent process.
Situations related to informed consent provide challenges and opportunities for professional growth. Keeping abreast of the evolving standards and concepts of informed consent enhances the essential roles that nurses play in clinically based research.
From the Clinical Investigations Core, University of Colorado Comprehensive Cancer Center. Denver. CO: and the School of Nursing, University of Colorado Health
Ccrpyrig,ht © 1999 by W.B. Saunders Company 0749-2081/99/1502-0006[J10.00/0
THE NURSE'S ROLE IN THE INFORMED CONSENT PROCESS P A M E L A A . R O S S E A N D L I N D A U. K R E B S
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HE role of the nurse in the informed consent process has expanded as the health eare environment and the nature of health care-related research and research methodologies have changed. Before the 1990s, the primary focus for clinically based medical research was the use of therapeutic elinieal trials in which quantitative methodologies were used to describe specific outcomes for various treatments of a partieular disease, symptom, or process. However, since the early 1990s, there has been a proliferation of new areas for elinieal trials and additionally, the resurgence, or in many cases the initiation, of research using qualitative methodologies. Today, in addition to treatment, clinieal trims investigate diagnostics, prevention, symptom management, quality of life, psyehosocial responses and interventions, and a myriad of other topics using a variety of research methodologies. Additionally, nurses now assume the roles of principle investigator or collaborative partner as well as the more traditional role of supporting clinical research being conducted. In concert with the expanded focus of clinically based research, the integration of quantitative and qualitative research methodologies, and the development of the nurse as researcher as well as clinician and educator, the nurse's roles and responsibilities in the informed consent process have evolved. A review of recent literature suggests that the history and basic tenets regarding informed eonsent have remained relatively unchanged in the last few decades. 1,2 However, other events surrounding the informed eonsent process have changed. Both Gadow 3 and Oddi 4 point out that since the 1970s, the prineiple of patient autonomy has become more important than the principle of beneficence in health care settings. Thus, the importance of addressing the rights of patients participating in clinical trials
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seems to have taken precedence over the concept of "doing good" as the means of benefiting the patient. This shift seems to be part of a general movement in health care that is reflected in the emergence of living wills, durable power for medical affairs, a variety of professional codes, and federal regulations, including the Patient SelfDetermination Act.S-7 Other dramatic changes involving informed consent have resulted predominately because of changing situations in which informed consent occurs. Many of these situations refleet the rapid medical advancements and technologic developments present in today's society, including the evaluation of gene therapies, the movement to outpatient settings for surgery and complex therapies, and an increasingly vast array of drug formulations and combinations. Additionally, the expansion of qualitative nursing research presents new issues that previously were not as extensive. Finally, another factor strongly influencing the nurse's role in informed consent is the continually developing roles of nursing itself, resulting from expansion of responsibilities and increased accountability, s As nursing practice changes, new roles and responsibilities relevant to informed consent will continue to emerge. ROLES AND RESPONSIBILITIES he informed consent process has been standardized by federal regulations resulting in several elements that must be present in all consents in order for them to receive approval from an officially designated investigational review board (IRB). With each element, eorresponding nursing roles and responsibilities become evident (Table 1). In reviewing Table 1, the educational responsibilities of nurses stand out because they are so pervasive. If educating patients is one of the most salient responsibilities of nurses during the consent process, it follows that nurses, particularly in the clinical setting, need to have a clear understanding of the critical components essential to this process.
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ELEMENTS OF THE INFORMED CONSENT PROCESS
Element 1: Purpose of the Study Element 1 requires a statement clearly indicating that the individual is being asked to participate
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T A B L E 1. Nursing Roles Relative to Informed Consent Elements
Eight Elements of Informed Consent* Study background
Nursing Roles/ Responsibilities
Risks and discomforts
Education, coordination, patient identification, initial assessment Education, problem-solving
Description of benefits
Education~clarification,
Alternative therapies Confidentiality Injury compensation Contact referral Voluntary participation/ consent withdrawal
patient advocate Education, patient advocate, coordination Patient advocate, education Education Education, coordination Education, patient advocate, ongoing assessment
*Comprehensive Working Group on Informed Consent in Cancer Clinical, National Cancer Institute.
in a research study. A thorough description of the study, along with details of the processes, procedures, and therapies involved, is needed. The duration of expected participation and rationale for the study also must be provided. Because nurses are usually familiar with the specific processes involved in a study, they can explain procedures/therapies and provide rationale for those therapies. They can discuss the logistics of how study expectations would be fulfilled with regard to the patient's schedule. For example, a calendar tailored for each patient that provides detailed information, including what to do or not do before coming in for a subsequent visit, could be developed. While many studies are therapeutic and involve treatment for disease or treatment related to symptom management, nurses are increasingly employed in settings that have a strong preventive focus. Therefore, it may be advantageous to have nurses educated in early detection, prevention, screening, and genetie counseling to discuss informed consent issues pertaining to these modalities. Additionally, trials involving medical devices or new diagnostic procedures will necessitate education, potentially at both a basic and more advanced level, in relation to the science underlying these new technologies.
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Element 2: Risks and Discomforts Element 2 requires that a description of risks and discomforts be disclosed. Nurses are well aware of the risks associated with the therapies that they help deliver and the regimens in which patients participate. They see patients firsthand and often share the responsibility for documenting toxieities of treatments. At the same time, they possess a great deal of knowledge and experience in symptom management. There is an abundance of nurse-authored contributions devoted to symptom assessment and management. These efforts provide a wealth of information regarding such side effects as nausea, vomiting, and fatigue. As a result, nurses may provide patients with extensive information of how discomforts associated with therapy might be ameliorated. With this information, patients may be in a better position to evaluate the significance of potential toxieities. Element 3. Benefits Element 3 stipulates that a description of the benefits associated with the study be provided. It is common practice for most informed consent forms to be very factual in stating the benefits that may be derived from the study/therapy in question. A recent recommendation from the National Cancer Institute regarding wording for this element incorporates the following phrase: " . . . t h e r e may or may not be direct medical benefit to you ''9 for, phase I and phase II clinical trials. Because more information is known about a therapy by the time it is tested in a phase III trial, the recommendation for phase III studies reads, "The possible benefits of taking part in the study are the same as receiving [standard drug/intervention] without being in the study. ''9 This information should serve as a reminder to the health professional of the ongoing need for clarification and reiteration to the patient that positive outcomes cannot, in any way, be assumed. As a set of the life-threatening diseases, cancer may make individuals especially vulnerable when presented with a therapy that seems to offer at least some degree of hope. Gadow 3 discusses how health care professionals may take advantage of this vulnerability, either explicitly or inadvertently. Referring to increasing medical advancements, particularly in the field of oncology, Gadow states "health care professionals may become personally involved as well as professionally invested in keeping a patient alive as long as possible. ''3 In relating this to informed consent and clinical research, a nurse need not continually
remind patients that a new therapy may not work, but neither should the nurse be a proponent of false expectations. It is important to keep the risks to b e n e f t s ratio in perspective even once therapy has commenced. It is equally important for nurses to realize their own biases regarding the therapies under investigation. Personal preferences are often based on personal experience. However, these experiences may be unique to a particular group of nurses, patients, settings, or other eireumstanees. Similarly, although studies with an observational (no treatment) arm are rarely conducted, sueh observational studies undoubtedly may become more prevalent as chemoprevention therapies are explored. However, "studies that compare therapy with no therapy [observation] are particularly challenging. It is often difficult to do nothing when a patient is faced with the diagnosis of cancer. In such eases it may be beneficial to remember that many investigational cancer therapies ultimately have been deemed ineffeetive, and many are associated with numerous and significant toxicities. ''1°
Element 4: Alternative Treatment Element 4 addresses the need to disclose alternative procedures or treatments. Before signing any informed consent form that involves a treatment or therapy, the patient, family, and health care team should thoroughly discuss appropriate alternatives, including no treatment. Prentice et allJ stress the importance of recognizing that therapies being compared in an oneology clinical trial may include standard therapy for the disease. Patients often are more interested in investigational therapies and may not value participating in a study using standard therapy. Thus, a patient may prefer to seek out only investigational therapies or to receive standard therapy off-study (ie, without having to adhere to the requirements of a study). The possibility of being randomized to standard therapy or placebo should be made clear. Even in instances in which a patient has been made aware of the potential for being randomized to the standard of care arm, research nurses, data managers, and research pharmacists can cite cases in which patients have dropped out of studies shortly after being randomized to the standard of care in hope of finding an acceptable novel regimen. Alternative therapy may also include complementary and nontraditional approaches that are available. This is not to suggest that nurses should
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be endorsing unconventional or unsafe therapies. However, approaches such as acupuncture, stress management, symptom management, healthy dietary regimens, and positive lifestyle changes might potentially augment an oneology treatment regimen and could be discussed following patient/ family request. With or without input from health care providers, patients may prefer to pursue these options alone. As new therapies have become popularized, informed consent and ethical considerations in relation to these alternative and/or complementary modalities have become as relevant as those related to conventional medicine. "Patients cannot make informed decisions about proposed therapies unless the potential benefits, possible harms and the therapy itself is explained and discussed. This highlights the need for research-based information about complementary therapies in practice; systemic inquiry should determine those patients who will benefit from a particular therapy and those who might be at risk."12 On the other hand, if a patient chooses no treatment, it may be especially necessary for the nurse to help patients to verbalize and support an end of life choice to other members of the team and even to the patient's family. Arranging for palliative care may be a direct responsibility of the nurse and facilitating discussions about theses issues may enhance quality of life for the patient and family as the end of life nears.
Element 5: Confidentiality Element 5 describes conditions of patient confidentiality that will be maintained. Clearly, patients need to feel protected from employment and insurance discrimination. There are additional fears that information related to a cancer diagnosis may adversely affect patients' credit rating. 13 Added to these concerns are issues that have emerged with the expansion of genetic research and tissue banking. 14 In situations in which an individual tests positive for a cancerlinked gene, the findings may have far-reaching effects on a number of family members as well as the individual who was tested, is For whatever reasons, patients may not want genetic results, or any other medical information, divulged to anyone, including family members. Remember, too, that previous unknown or undisclosed parentage may become evident. The informed consent should clearly identify the parties that will have access to the information related to the consent, study, procedures, etc.
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Typically, there is also a statement that speaks to the time frame in which information can be accessed. In some eases, the time frame may be for the duration of the patient's life. Despite the best of intentions of element 5, nurses and patients should be aware that the potential for inadvertent disclosure is real and that confidentiality in the oncology setting becomes more of a concern with the increasing number of agencies or individuals involved in the care of a specific patient.
Elements 6 and 7: Compensation and Contact Persons Elements 6 and 7 stipulate conditions regarding compensation for injury and the medical treatment available if injury occurs in relation to the procedures being offered in the informed consent. Nurses arc not frequently involved directly in these aspects of informed consent, but they should understand the language of the informed consent and be able to clarify its meaning to the patient. In addition, the nurse can reiterate the names and numbers of people who are available to further discuss the study as well as a person who can provide additional information about the patient's rights as a participant. People frequently listed as contacts are the primary investigator(s) of the study and a representative of the local IRB that has approved the study.
Element 8: Voluntary Participation Element 8 requires a statement that elearly conveys to the subject that participation is voluntary and that if the subject decides not to participate, he or she will in no way be penalized. The concern for voluntariness is rooted, among other things, in the human experimentation that occurred during World War II under the Nazi regime. Those atrocities combined with other studies, such as the Tuskegee Study involving black prisoners with syphilis, have prompted codes, guidelines, and regulations to ensure that each participant's rights are not violated. In modern times, obvious coercion can occur. More frequently, however, there are subtle influences that may sway patients into participating (or not participating) in a study. This fact leads experts to question how often study participation is truly voluntary. Previous investigators have eoneluded that one of the primary reasons individuals participate in a particular treatment or study is because of an overriding trust in physieian judgement. 16 Alderson's 17 review indieates that some physicians
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believe patients prefer for their physicians to make health care decisions. Elderly patients m a y be particularly at risk because of their propensity to please health care providers, is Similarly, the vulnerability of patients with a c a n c e r diagnosis associated with a poor prognosis has already been discussed. 3 As with the seven prior elements, the nurse can assist in the initial education about this patient right that requires the promotion of participant autonomy. This activity is emphasized by the statement, "while institutional or legal criteria m a y be fulfilled, an autonomy-based model of informed consent requires more than a p e r f u n c t o r y explanation of risks and benefits associated with procedures. ''4 F u r t h e r m o r e , it is the ongoing nature of the consent process that should be r e m e m b e r e d . 19 Nurses can provide updated assessments to determine w h e t h e r patients continue to be satisfied with their initial decisions. When appropriate, the nurse can remind patients that participation m a y be discontinued at any time. This, in particular, m a y be a difficult decision with which patients have to struggle. Once a decision has been made, w h e t h e r or not t r e a t m e n t has occurred, a feeling of being compelled to carry it through to the end, despite a desire to terminate participation, m a y result. Patients m a y fear that family, friends, or the health care team will be disappointed. 3,1~ Patients also m a y feel that they are ruining the study or letting other patients "down." Furthermore, if a patient has participated to some degree and then decides to stop, he or she m a y w o n d e r if the previous involvement was a waste of time and effort. While it is not desirable from a study perspective for patients to discontinue participation (and perhaps this would be true from a medical t r e a t m e n t perspective as well), the nurse m a y be instrumental in helping patients to identify their c u r r e n t feelings about therapy, to verbalize those feelings, and to feel comfortable with their decision to withdraw from a trial. Nurses m a y play a significant role in conveying the patient's wishes to others.
have just recently learned of their illness. Others have had multiple therapies that have failed. In both instances, the patients are trying to determine the impact this information will have. Often, specific measures are used to ensure that patients have an adequate opportunity to u n d e r s t a n d the information that has been imparted. For example, some IRBs stipulate that the c o n s e n t should be written at the sixth-grade level; the National Cancer Institute r e c o m m e n d s an eighth-grade level or lower. 9 Print size, format, voice tense, informational pamphlets, and the like are all thought to contribute to the enhancing comprehensibility of a consent. 9 Some IRBs require the c o n s e n t to state that the patient has at least 24 hours and possibly up to 2 weeks to decide about participation. This stipulation gives c r e d e n c e to the importance of timing and allowing for synthesis to occur. Additionally, some investigators assess patient c o m p r e h e n s i o n by actually providing a n o n t h r e a t e n i n g "test" that reviews the i m p o r t a n t c o m p o n e n t s p r e s e n t e d in the consent. 11 While not always feasible, these kind of guidelines help to ensure that the process is a facilitated one.
Cultural Factors Other factors, such as the patient's age and cultural variations, speak to the individual needs of each patient. ~s,2°,21 Cultural issues t r a n s c e n d all aspects of clinical trials participation and the informed consent process. Previous experience with research, both from a personal and historical perspective, m a y influence one's future enrollment. Belief in providers as ethical individuals m a y influence initial and continued participation. Cultural and religious norms m a y affect an individual's ability to participate in some required aspects of a trial, potentially influencing retention. In addition to assuring that the informed consent process is u n d e r t a k e n in an individualized, culturally relevant manner, nurses have the responsibility to provide culturally sensitive and c o m p e t e n t care. This includes taking into a c c o u n t specific patient and family values, beliefs, and mores that m a y impact participation in clinical research.
ADDITIONAL ELEMENTS
Patient Comprehension After reviewing the elements of informed consent it is apparent that being able to assess a patient's ability to c o m p r e h e n d is crucial to validating the process. Many patients c o n f r o n t e d with informed consent in the oncology setting
INFORMED CONSENT IN QUALITATIVE METHODOLOGIES he use of qualitative methodologies adds a new perspective to the informed c o n s e n t process. Consisting primarily of methods such as grounded
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theory, ethnography, phenomenology, qualitative ethology, and ethnoseienee, "qualitative research enables us to make sense of reality, to deseribe and explain the social world, and to develop explanatory models and theories. ''22 As opposed to quantitative methods in whieh the expected outeome is identifleation of objeetive information or data, in a qualitative study the researcher is looking for the meaning of an experience, process, or event. Qualitative research is faee to faee and often personal, the data analysis is ongoing, and the researcher not only often stays in the research setting for an extended period of time, but often becomes or is the instrument of research. 23 Methods for data collection often are partieipatory and may include foeus groups, interviews, and participant observation. In addition, findings often are shared with participants for validation before writing the final report. 22,24,25 The very nature of qualitative research offers some dilemmas in the informed consent process. Robley26 states that ethical issues often arise in qualitative research because as data emerge, the foeus of the study may shift. In addition, the closeness and trust that develops between researeher and partieipant and the evolving content of questions developed for data collection require a eontinual process for informed consent. The use of participant observation as a technique to gather data is of notable concern as the role of the researcher may not be fully understood by participants. This may be particularly true if the researeher is taking part in the aetivity under observation and has not made clear his or her role in the research process. 2s A potential source of confliet in the informed consent proeess lies in the reality that the researcher, data eolleetor, and data analyst are often the same individual. Erlandson et a127stated that informed eonsent in qualitative studies must be an ongoing process, noting that the original research plan may not remain constant as the the context of the research changes. They added that integrity and sensitivity in the evolving informed eonsent proeess is essential. Munhall 2s coined the term p r o c e s s c o n s e n t and noted that the informed eonsent process in qualitative studies should be negotiated between researeher and partieipant. She further commented that the proeess consent must be individualized based on the planned researeh, should be developed collaboratively between researeher and partieipant, and ought to be continually and eonsistently evaluated and validated.
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Unfortunately, while the use of the proeess consent may be most appropriate for qualitative research participants, it may be difficult for IRBs to accept this type of eonsent process. In her article on institutional review of qualitative research proposals, Munhal125 believes that three issues may prevail whieh could potentially create challenges to IRB approval. These include a laek of knowledge about qualitative research methodologies, a belief that these methods are similar to tabloid-type journalism, and a perspective that research should include "an action, an intervention, and a eonerete observable task with a measurable outcome. ''2s In addition to the roles and responsibilities deseribed with the elements of informed consent (Table 1), the use of the process consent has further implications for nursing praetiee, particularly if the nurse is both clinician and researeher (Table 2). The collaborative nature of the consent requires an ongoing relationship with the participant and the continual negotiation of how and when data are collected, how field work will be undertaken and what it will consist of, how information will be shared with participants and the public at large, what methods will be taken to assure that information as portrayed is aecurate, what will happen to information related to findings that are unanticipated, and issues of confidentiality. In securing IRB approval, the nurse may facilitate discussion of and provide educational interventions for IRB members to learn about qualitative methodologies. In particular, it may be necessary for the nurse researcher to provide to IRB members and others an appreciation for the
T A B L E 2. Nursing Roles Relevant to Process Consent Elements
Elements of Process Consent
Nursing Roles/ Responsibilities
Definition of parameters for field work Description of information sharing
Discussion, individual negotiation Discussion, negotiation, education, problemsolving Discussion, negotiation, patient advocate, education Discussion, negotiation, patient advocate Discussion, negotiation, patient advocate
Confidentiality Issues related to findings Publication/presentation of findings
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n e e d to u n d e r s t a n d t h e m e a n i n g of e x p e r i e n c e s and events and how related knowledge can impact t h e h e a l t h a n d w e l l - b e i n g of t h e i n d i v i d u a l . F u r t h e r m o r e , t h e n u r s e as r e s e a r c h e r m u s t g e n e r a t e t r u s t a n d a m e l i o r a t e fears t h a t t h e s e m e t h o d ologies may generate within institutions. Finally, in a d d i t i o n to t h e r o l e s of n e g o t i a t o r , e d u c a t o r , a n d f a c i l i t a t o r , t h e r o l e of t h e n u r s e as p a t i e n t a d v o c a t e is p a r a m o u n t t h r o u g h o u t t h e e n t i r e p r o c e s s . CONCLUSION l d e r s o n 7 r e v i e w s s o m e of t h e d i l e m m a s f a c e d y n u r s e s w h e n r e s e a r c h i n v o l v i n g p a t i e n t s is b e i n g e o n d u e t e d . E x a m p l e s i n c l u d e s i t u a t i o n s in w h i c h t h e r e is a g a p b e t w e e n w h a t a p h y s i c i a n w a n t s t h e p a t i e n t to k n o w a n d w h a t a n u r s e b e l i e v e s t h e p a t i e n t s h o u l d k n o w . A n o t h e r exa m p l e r e f e r s to d e a l i n g w i t h t h e n u r s e ' s c o n c e r n a b o u t s t u d i e s t h a t s h e o r h e m a y p e r c e i v e as u s e l e s s o r h a r m f u l . T h e s e t y p e s of d i l e m m a s c h a l l e n g e n u r s e s in fulfilling t h e i r r o l e s d u r i n g t h e informed consent process. Although not an easy task, ethical decision-making models provide an a v e n u e for d e v e l o p i n g v i a b l e a p p r o a c h e s for t h e m a j o r i t y of t h e s e d i l e m m a s . T a c k l i n g t h e m is a n i n h e r e n t p a r t of t h e n u r s e ' s r e s p o n s i b i l i t i e s r e l a t e d to t h e a d v o c a c y role. S i m i l a r l y , n u r s e s h a v e l o n g
a d d r e s s e d t h e n e e d for p a t i e n t c o m p r e h e n s i o n w i t h r e g a r d to p a t i e n t e d u c a t i o n a n d s h o u l d a p p l y t h i s r e q u i r e m e n t to i n f o r m e d c o n s e n t . I n a d d i t i o n , cultural and religious sensitivity must always be p a r t of t h e n u r s e ' s role, n o m a t t e r w h e t h e r it is r e l a t e d to t h e i n f o r m e d c o n s e n t p r o c e s s . H o w e v e r , a n o t h e r i s s u e r e m a i n s s a l i e n t : if n u r s e s a r e to h e l p p a t i e n t s m a k e i n f o r m e d d e c i sions, t h e y t h e m s e l v e s m u s t first b e i n f o r m e d . This means having comprehensive knowledge about the procedures and the studies presented; a n u n d e r s t a n d i n g of f u n d a m e n t a l c o n c e p t s s u c h as equipoise, beneficence, and autonomy; and an a p p r e c i a t i o n for t h e d i v e r s i t y of m e t h o d o l o g i e s . W i t h o u t t h e s e , it is difficult for n u r s e s to c o m p e tently and successfully support the patient and family through the informed consent process and t h e c o m p l e t i o n of a c l i n i c a l trial. R e s e a r c h fills a v i t a l a n d i m p o r t a n t r o l e in s o c i e t y . I n f o r m e d c o n s e n t , d e f i n e d as a p r o c e s s rather than merely a one-time contractual agreem e n t , 28 p l a y s a n e s s e n t i a l r o l e in c l i n i c a l l y b a s e d r e s e a r c h . T h e r o l e of t h e n u r s e in a s s u r i n g t h a t a p o t e n t i a l p a r t i c i p a n t is fully i n f o r m e d a n d willing to e n r o l l o r r e m a i n in a c l i n i c a l t r i a l is p i v o t a l to g a i n i n g t h e r e q u i s i t e k n o w l e d g e to m o v e s c i e n c e f o r w a r d a n d to u l t i m a t e l y i d e n t i f y a n d i n f l u e n c e health care outcomes.
REFERENCES 1. Winters G, Glass E, 8akurai C: Ethical issues in oneology nursing practice: An overview of topies and strategies. Oneol Nurs Forum 20:21-34, 1993 (suppl) 2. Tabak N: Informed consent: The nurse's dilemma. Med Law 15:7-16, 1996 3. Gadow S: An ethical ease for patient self-determination. Sem Oneol Nurs 5:99-101, 1989 4. Oddi LF: Enhancing patients' autonomy. Dimens Crit Care Nurs 13:60-68, 1994 5. American Nurses Society and Ontology Nursing Society: Standards of Oneology Nursing Practice. Kansas City, MO, Ameriean Nurses Association, 1996 6. Food and Drug Administration Office of the Associate Commissioner for Health Affairs: Information Sheets for Institutional Review Boards and Clinical Investigators. Rockville, MD, Food and Drug Administration, 1996 7. The US Patient Self Determination Aet of 1991 8. Trott MC: Legal issues for nurse managers. Nurs Manage 29:38-42, 1998 9. Comprehensive Working Group on Informed Consent in Cancer Clinical Trials: Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials. Publ. no. 98-4355. Roekville, MD, National Cancer Institute, 1998 10. Rosse PA, Garcia MT: Clinieal trials, in Gates R, Fink R (eds): Secrets in Ontology Nursing. Philadelphia, PA, Hanley & Belsus, 1997, pp 81-84
11. Prentice ED, Gordon BG, Okui GSF, et al: Informed eonsent in ontology clinical trials. Caneer Manage 6-10, 1997 12. Norton L: Complimentary therapies in praetiee: The ethical issues. J Clin Nurs 4:343-348, 1995 13. Selwitz AS: Informed eonsent in genetic researeh, in Ethieal Researeh in an Ethical Soeiety: Principles, Praetices and Politics. Proceedings of the Public Responsibility in Medieine and Researeh Annual Conference, Boston, MA, 1997, pp 111-114. 14. Springarn ND, Chasen NH: Working with your doetor and hospital system: Becoming a wise consumer, in Hoffman B (ed): A Cancer Survivor's Almanae: Charting Your Journey. Minneapolis, MN, Chronimed Publishing, 1996, pp 75-86 15. Loescher LJ: DNA testing for cancer predisposition. Oncol Nurs Forum 25:1317-1327, 1998 16. Jassak PF, Ryan MP: Ethieal issues in elinieal research. Semin Oncol Nurs 5:102-108, 1989 17. Alderson P: Consent to research: The role of the nurse. Nurs Standard 9:28-31, 1995 18. Alt&Vhite AC: Obtaining "informed" consent from the elderly. West J Nurs Res 17:700-705, 1995 19. Berry DL, Dodd IvlJ, Hinds PS, et al: Informed consent: Process and elinical issues. Oncol Nurs Forum 23:507-512, 1996 20. Behi R, Nolan M: Ethical issues in research. Br J Nurs 4:712-716, 1995
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21. Brennan M: A concept analysis of consent. J Adv Nurs 25:477-484, 1997 22. Morse JM, Field PA: Qualitative Researeh Methods for Health Professionals (ed 2). Thousand Oaks, CA, Sage Publications, 1995 23. Janesiek VJ: The dance of qualitative research designs: Metaphor, methodolatry and meaning, in Denzin NK, Lincoln YS (eds): Handbook of Qualitative Research. Thousand Oaks, CA, Sage Publieations, 1994, pp 209-219 24. Lipson JG: Ethical issues in ethnography, in Morse JM (ed): Critieal Issues in Qualitative Research Methods. Thousand Oaks, CA, Sage Publieations, 1994, pp 333-355
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25. Munhall PL: Institutional review of qualitative research proposals: A task of no small consequence, in Morse J (ed): Qualitative Nursing Research: A Contemporary Dialogue. Thousand Oaks, CA, Sage Publications, 1991, pp 258-271 26. Robley LR: The ethics of qualitative nursing research, d ProfNurs 11:45-48, 1995 27. Erlandson DA, Harris EL, Skipper BL, et al: Doing Naturalistic Inquiry: A Guide to Methods. Newbury Park, CA, Sage Publications, 1993 28. Woods NF, Catanzano M: Nursing Research: Theory and Praetiee. St Louis, MO, Mosby, 1988
S e m i n a r s in O n t o l o g y Nursing, Vol 15, No 2 (May), 1999: pp 116-123
OBJECTIVES: To review the informed consent process in relation to oneology nursing roles and responsibilities, patient comprehension, cultural sensitivity, and qualitative methodologies.
Scientific and review articles, regulatory documents, and texts relating to informed consent. CONCLUSIONS: Nursing is involved in almost every aspect of the informed consent process. To be effective, nurses must be knowledgeable about fundamental concepts associated with informed consent and corresponding responsibilities and willing to address the complexities of the informed consent process.
Situations related to informed consent provide challenges and opportunities for professional growth. Keeping abreast of the evolving standards and concepts of informed consent enhances the essential roles that nurses play in clinically based research.
From the Clinical Investigations Core, University of Colorado Comprehensive Cancer Center. Denver. CO: and the School of Nursing, University of Colorado Health
Ccrpyrig,ht © 1999 by W.B. Saunders Company 0749-2081/99/1502-0006[J10.00/0
THE NURSE'S ROLE IN THE INFORMED CONSENT PROCESS P A M E L A A . R O S S E A N D L I N D A U. K R E B S
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HE role of the nurse in the informed consent process has expanded as the health eare environment and the nature of health care-related research and research methodologies have changed. Before the 1990s, the primary focus for clinically based medical research was the use of therapeutic elinieal trials in which quantitative methodologies were used to describe specific outcomes for various treatments of a partieular disease, symptom, or process. However, since the early 1990s, there has been a proliferation of new areas for elinieal trials and additionally, the resurgence, or in many cases the initiation, of research using qualitative methodologies. Today, in addition to treatment, clinieal trims investigate diagnostics, prevention, symptom management, quality of life, psyehosocial responses and interventions, and a myriad of other topics using a variety of research methodologies. Additionally, nurses now assume the roles of principle investigator or collaborative partner as well as the more traditional role of supporting clinical research being conducted. In concert with the expanded focus of clinically based research, the integration of quantitative and qualitative research methodologies, and the development of the nurse as researcher as well as clinician and educator, the nurse's roles and responsibilities in the informed consent process have evolved. A review of recent literature suggests that the history and basic tenets regarding informed eonsent have remained relatively unchanged in the last few decades. 1,2 However, other events surrounding the informed eonsent process have changed. Both Gadow 3 and Oddi 4 point out that since the 1970s, the prineiple of patient autonomy has become more important than the principle of beneficence in health care settings. Thus, the importance of addressing the rights of patients participating in clinical trials
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seems to have taken precedence over the concept of "doing good" as the means of benefiting the patient. This shift seems to be part of a general movement in health care that is reflected in the emergence of living wills, durable power for medical affairs, a variety of professional codes, and federal regulations, including the Patient SelfDetermination Act.S-7 Other dramatic changes involving informed consent have resulted predominately because of changing situations in which informed consent occurs. Many of these situations refleet the rapid medical advancements and technologic developments present in today's society, including the evaluation of gene therapies, the movement to outpatient settings for surgery and complex therapies, and an increasingly vast array of drug formulations and combinations. Additionally, the expansion of qualitative nursing research presents new issues that previously were not as extensive. Finally, another factor strongly influencing the nurse's role in informed consent is the continually developing roles of nursing itself, resulting from expansion of responsibilities and increased accountability, s As nursing practice changes, new roles and responsibilities relevant to informed consent will continue to emerge. ROLES AND RESPONSIBILITIES he informed consent process has been standardized by federal regulations resulting in several elements that must be present in all consents in order for them to receive approval from an officially designated investigational review board (IRB). With each element, eorresponding nursing roles and responsibilities become evident (Table 1). In reviewing Table 1, the educational responsibilities of nurses stand out because they are so pervasive. If educating patients is one of the most salient responsibilities of nurses during the consent process, it follows that nurses, particularly in the clinical setting, need to have a clear understanding of the critical components essential to this process.
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ELEMENTS OF THE INFORMED CONSENT PROCESS
Element 1: Purpose of the Study Element 1 requires a statement clearly indicating that the individual is being asked to participate
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T A B L E 1. Nursing Roles Relative to Informed Consent Elements
Eight Elements of Informed Consent* Study background
Nursing Roles/ Responsibilities
Risks and discomforts
Education, coordination, patient identification, initial assessment Education, problem-solving
Description of benefits
Education~clarification,
Alternative therapies Confidentiality Injury compensation Contact referral Voluntary participation/ consent withdrawal
patient advocate Education, patient advocate, coordination Patient advocate, education Education Education, coordination Education, patient advocate, ongoing assessment
*Comprehensive Working Group on Informed Consent in Cancer Clinical, National Cancer Institute.
in a research study. A thorough description of the study, along with details of the processes, procedures, and therapies involved, is needed. The duration of expected participation and rationale for the study also must be provided. Because nurses are usually familiar with the specific processes involved in a study, they can explain procedures/therapies and provide rationale for those therapies. They can discuss the logistics of how study expectations would be fulfilled with regard to the patient's schedule. For example, a calendar tailored for each patient that provides detailed information, including what to do or not do before coming in for a subsequent visit, could be developed. While many studies are therapeutic and involve treatment for disease or treatment related to symptom management, nurses are increasingly employed in settings that have a strong preventive focus. Therefore, it may be advantageous to have nurses educated in early detection, prevention, screening, and genetie counseling to discuss informed consent issues pertaining to these modalities. Additionally, trials involving medical devices or new diagnostic procedures will necessitate education, potentially at both a basic and more advanced level, in relation to the science underlying these new technologies.
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Element 2: Risks and Discomforts Element 2 requires that a description of risks and discomforts be disclosed. Nurses are well aware of the risks associated with the therapies that they help deliver and the regimens in which patients participate. They see patients firsthand and often share the responsibility for documenting toxieities of treatments. At the same time, they possess a great deal of knowledge and experience in symptom management. There is an abundance of nurse-authored contributions devoted to symptom assessment and management. These efforts provide a wealth of information regarding such side effects as nausea, vomiting, and fatigue. As a result, nurses may provide patients with extensive information of how discomforts associated with therapy might be ameliorated. With this information, patients may be in a better position to evaluate the significance of potential toxieities. Element 3. Benefits Element 3 stipulates that a description of the benefits associated with the study be provided. It is common practice for most informed consent forms to be very factual in stating the benefits that may be derived from the study/therapy in question. A recent recommendation from the National Cancer Institute regarding wording for this element incorporates the following phrase: " . . . t h e r e may or may not be direct medical benefit to you ''9 for, phase I and phase II clinical trials. Because more information is known about a therapy by the time it is tested in a phase III trial, the recommendation for phase III studies reads, "The possible benefits of taking part in the study are the same as receiving [standard drug/intervention] without being in the study. ''9 This information should serve as a reminder to the health professional of the ongoing need for clarification and reiteration to the patient that positive outcomes cannot, in any way, be assumed. As a set of the life-threatening diseases, cancer may make individuals especially vulnerable when presented with a therapy that seems to offer at least some degree of hope. Gadow 3 discusses how health care professionals may take advantage of this vulnerability, either explicitly or inadvertently. Referring to increasing medical advancements, particularly in the field of oncology, Gadow states "health care professionals may become personally involved as well as professionally invested in keeping a patient alive as long as possible. ''3 In relating this to informed consent and clinical research, a nurse need not continually
remind patients that a new therapy may not work, but neither should the nurse be a proponent of false expectations. It is important to keep the risks to b e n e f t s ratio in perspective even once therapy has commenced. It is equally important for nurses to realize their own biases regarding the therapies under investigation. Personal preferences are often based on personal experience. However, these experiences may be unique to a particular group of nurses, patients, settings, or other eireumstanees. Similarly, although studies with an observational (no treatment) arm are rarely conducted, sueh observational studies undoubtedly may become more prevalent as chemoprevention therapies are explored. However, "studies that compare therapy with no therapy [observation] are particularly challenging. It is often difficult to do nothing when a patient is faced with the diagnosis of cancer. In such eases it may be beneficial to remember that many investigational cancer therapies ultimately have been deemed ineffeetive, and many are associated with numerous and significant toxicities. ''1°
Element 4: Alternative Treatment Element 4 addresses the need to disclose alternative procedures or treatments. Before signing any informed consent form that involves a treatment or therapy, the patient, family, and health care team should thoroughly discuss appropriate alternatives, including no treatment. Prentice et allJ stress the importance of recognizing that therapies being compared in an oneology clinical trial may include standard therapy for the disease. Patients often are more interested in investigational therapies and may not value participating in a study using standard therapy. Thus, a patient may prefer to seek out only investigational therapies or to receive standard therapy off-study (ie, without having to adhere to the requirements of a study). The possibility of being randomized to standard therapy or placebo should be made clear. Even in instances in which a patient has been made aware of the potential for being randomized to the standard of care arm, research nurses, data managers, and research pharmacists can cite cases in which patients have dropped out of studies shortly after being randomized to the standard of care in hope of finding an acceptable novel regimen. Alternative therapy may also include complementary and nontraditional approaches that are available. This is not to suggest that nurses should
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be endorsing unconventional or unsafe therapies. However, approaches such as acupuncture, stress management, symptom management, healthy dietary regimens, and positive lifestyle changes might potentially augment an oneology treatment regimen and could be discussed following patient/ family request. With or without input from health care providers, patients may prefer to pursue these options alone. As new therapies have become popularized, informed consent and ethical considerations in relation to these alternative and/or complementary modalities have become as relevant as those related to conventional medicine. "Patients cannot make informed decisions about proposed therapies unless the potential benefits, possible harms and the therapy itself is explained and discussed. This highlights the need for research-based information about complementary therapies in practice; systemic inquiry should determine those patients who will benefit from a particular therapy and those who might be at risk."12 On the other hand, if a patient chooses no treatment, it may be especially necessary for the nurse to help patients to verbalize and support an end of life choice to other members of the team and even to the patient's family. Arranging for palliative care may be a direct responsibility of the nurse and facilitating discussions about theses issues may enhance quality of life for the patient and family as the end of life nears.
Element 5: Confidentiality Element 5 describes conditions of patient confidentiality that will be maintained. Clearly, patients need to feel protected from employment and insurance discrimination. There are additional fears that information related to a cancer diagnosis may adversely affect patients' credit rating. 13 Added to these concerns are issues that have emerged with the expansion of genetic research and tissue banking. 14 In situations in which an individual tests positive for a cancerlinked gene, the findings may have far-reaching effects on a number of family members as well as the individual who was tested, is For whatever reasons, patients may not want genetic results, or any other medical information, divulged to anyone, including family members. Remember, too, that previous unknown or undisclosed parentage may become evident. The informed consent should clearly identify the parties that will have access to the information related to the consent, study, procedures, etc.
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Typically, there is also a statement that speaks to the time frame in which information can be accessed. In some eases, the time frame may be for the duration of the patient's life. Despite the best of intentions of element 5, nurses and patients should be aware that the potential for inadvertent disclosure is real and that confidentiality in the oncology setting becomes more of a concern with the increasing number of agencies or individuals involved in the care of a specific patient.
Elements 6 and 7: Compensation and Contact Persons Elements 6 and 7 stipulate conditions regarding compensation for injury and the medical treatment available if injury occurs in relation to the procedures being offered in the informed consent. Nurses arc not frequently involved directly in these aspects of informed consent, but they should understand the language of the informed consent and be able to clarify its meaning to the patient. In addition, the nurse can reiterate the names and numbers of people who are available to further discuss the study as well as a person who can provide additional information about the patient's rights as a participant. People frequently listed as contacts are the primary investigator(s) of the study and a representative of the local IRB that has approved the study.
Element 8: Voluntary Participation Element 8 requires a statement that elearly conveys to the subject that participation is voluntary and that if the subject decides not to participate, he or she will in no way be penalized. The concern for voluntariness is rooted, among other things, in the human experimentation that occurred during World War II under the Nazi regime. Those atrocities combined with other studies, such as the Tuskegee Study involving black prisoners with syphilis, have prompted codes, guidelines, and regulations to ensure that each participant's rights are not violated. In modern times, obvious coercion can occur. More frequently, however, there are subtle influences that may sway patients into participating (or not participating) in a study. This fact leads experts to question how often study participation is truly voluntary. Previous investigators have eoneluded that one of the primary reasons individuals participate in a particular treatment or study is because of an overriding trust in physieian judgement. 16 Alderson's 17 review indieates that some physicians
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believe patients prefer for their physicians to make health care decisions. Elderly patients m a y be particularly at risk because of their propensity to please health care providers, is Similarly, the vulnerability of patients with a c a n c e r diagnosis associated with a poor prognosis has already been discussed. 3 As with the seven prior elements, the nurse can assist in the initial education about this patient right that requires the promotion of participant autonomy. This activity is emphasized by the statement, "while institutional or legal criteria m a y be fulfilled, an autonomy-based model of informed consent requires more than a p e r f u n c t o r y explanation of risks and benefits associated with procedures. ''4 F u r t h e r m o r e , it is the ongoing nature of the consent process that should be r e m e m b e r e d . 19 Nurses can provide updated assessments to determine w h e t h e r patients continue to be satisfied with their initial decisions. When appropriate, the nurse can remind patients that participation m a y be discontinued at any time. This, in particular, m a y be a difficult decision with which patients have to struggle. Once a decision has been made, w h e t h e r or not t r e a t m e n t has occurred, a feeling of being compelled to carry it through to the end, despite a desire to terminate participation, m a y result. Patients m a y fear that family, friends, or the health care team will be disappointed. 3,1~ Patients also m a y feel that they are ruining the study or letting other patients "down." Furthermore, if a patient has participated to some degree and then decides to stop, he or she m a y w o n d e r if the previous involvement was a waste of time and effort. While it is not desirable from a study perspective for patients to discontinue participation (and perhaps this would be true from a medical t r e a t m e n t perspective as well), the nurse m a y be instrumental in helping patients to identify their c u r r e n t feelings about therapy, to verbalize those feelings, and to feel comfortable with their decision to withdraw from a trial. Nurses m a y play a significant role in conveying the patient's wishes to others.
have just recently learned of their illness. Others have had multiple therapies that have failed. In both instances, the patients are trying to determine the impact this information will have. Often, specific measures are used to ensure that patients have an adequate opportunity to u n d e r s t a n d the information that has been imparted. For example, some IRBs stipulate that the c o n s e n t should be written at the sixth-grade level; the National Cancer Institute r e c o m m e n d s an eighth-grade level or lower. 9 Print size, format, voice tense, informational pamphlets, and the like are all thought to contribute to the enhancing comprehensibility of a consent. 9 Some IRBs require the c o n s e n t to state that the patient has at least 24 hours and possibly up to 2 weeks to decide about participation. This stipulation gives c r e d e n c e to the importance of timing and allowing for synthesis to occur. Additionally, some investigators assess patient c o m p r e h e n s i o n by actually providing a n o n t h r e a t e n i n g "test" that reviews the i m p o r t a n t c o m p o n e n t s p r e s e n t e d in the consent. 11 While not always feasible, these kind of guidelines help to ensure that the process is a facilitated one.
Cultural Factors Other factors, such as the patient's age and cultural variations, speak to the individual needs of each patient. ~s,2°,21 Cultural issues t r a n s c e n d all aspects of clinical trials participation and the informed consent process. Previous experience with research, both from a personal and historical perspective, m a y influence one's future enrollment. Belief in providers as ethical individuals m a y influence initial and continued participation. Cultural and religious norms m a y affect an individual's ability to participate in some required aspects of a trial, potentially influencing retention. In addition to assuring that the informed consent process is u n d e r t a k e n in an individualized, culturally relevant manner, nurses have the responsibility to provide culturally sensitive and c o m p e t e n t care. This includes taking into a c c o u n t specific patient and family values, beliefs, and mores that m a y impact participation in clinical research.
ADDITIONAL ELEMENTS
Patient Comprehension After reviewing the elements of informed consent it is apparent that being able to assess a patient's ability to c o m p r e h e n d is crucial to validating the process. Many patients c o n f r o n t e d with informed consent in the oncology setting
INFORMED CONSENT IN QUALITATIVE METHODOLOGIES he use of qualitative methodologies adds a new perspective to the informed c o n s e n t process. Consisting primarily of methods such as grounded
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theory, ethnography, phenomenology, qualitative ethology, and ethnoseienee, "qualitative research enables us to make sense of reality, to deseribe and explain the social world, and to develop explanatory models and theories. ''22 As opposed to quantitative methods in whieh the expected outeome is identifleation of objeetive information or data, in a qualitative study the researcher is looking for the meaning of an experience, process, or event. Qualitative research is faee to faee and often personal, the data analysis is ongoing, and the researcher not only often stays in the research setting for an extended period of time, but often becomes or is the instrument of research. 23 Methods for data collection often are partieipatory and may include foeus groups, interviews, and participant observation. In addition, findings often are shared with participants for validation before writing the final report. 22,24,25 The very nature of qualitative research offers some dilemmas in the informed consent process. Robley26 states that ethical issues often arise in qualitative research because as data emerge, the foeus of the study may shift. In addition, the closeness and trust that develops between researeher and partieipant and the evolving content of questions developed for data collection require a eontinual process for informed consent. The use of participant observation as a technique to gather data is of notable concern as the role of the researcher may not be fully understood by participants. This may be particularly true if the researeher is taking part in the aetivity under observation and has not made clear his or her role in the research process. 2s A potential source of confliet in the informed consent proeess lies in the reality that the researcher, data eolleetor, and data analyst are often the same individual. Erlandson et a127stated that informed eonsent in qualitative studies must be an ongoing process, noting that the original research plan may not remain constant as the the context of the research changes. They added that integrity and sensitivity in the evolving informed eonsent proeess is essential. Munhall 2s coined the term p r o c e s s c o n s e n t and noted that the informed eonsent process in qualitative studies should be negotiated between researeher and partieipant. She further commented that the proeess consent must be individualized based on the planned researeh, should be developed collaboratively between researeher and partieipant, and ought to be continually and eonsistently evaluated and validated.
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Unfortunately, while the use of the proeess consent may be most appropriate for qualitative research participants, it may be difficult for IRBs to accept this type of eonsent process. In her article on institutional review of qualitative research proposals, Munhal125 believes that three issues may prevail whieh could potentially create challenges to IRB approval. These include a laek of knowledge about qualitative research methodologies, a belief that these methods are similar to tabloid-type journalism, and a perspective that research should include "an action, an intervention, and a eonerete observable task with a measurable outcome. ''2s In addition to the roles and responsibilities deseribed with the elements of informed consent (Table 1), the use of the process consent has further implications for nursing praetiee, particularly if the nurse is both clinician and researeher (Table 2). The collaborative nature of the consent requires an ongoing relationship with the participant and the continual negotiation of how and when data are collected, how field work will be undertaken and what it will consist of, how information will be shared with participants and the public at large, what methods will be taken to assure that information as portrayed is aecurate, what will happen to information related to findings that are unanticipated, and issues of confidentiality. In securing IRB approval, the nurse may facilitate discussion of and provide educational interventions for IRB members to learn about qualitative methodologies. In particular, it may be necessary for the nurse researcher to provide to IRB members and others an appreciation for the
T A B L E 2. Nursing Roles Relevant to Process Consent Elements
Elements of Process Consent
Nursing Roles/ Responsibilities
Definition of parameters for field work Description of information sharing
Discussion, individual negotiation Discussion, negotiation, education, problemsolving Discussion, negotiation, patient advocate, education Discussion, negotiation, patient advocate Discussion, negotiation, patient advocate
Confidentiality Issues related to findings Publication/presentation of findings
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n e e d to u n d e r s t a n d t h e m e a n i n g of e x p e r i e n c e s and events and how related knowledge can impact t h e h e a l t h a n d w e l l - b e i n g of t h e i n d i v i d u a l . F u r t h e r m o r e , t h e n u r s e as r e s e a r c h e r m u s t g e n e r a t e t r u s t a n d a m e l i o r a t e fears t h a t t h e s e m e t h o d ologies may generate within institutions. Finally, in a d d i t i o n to t h e r o l e s of n e g o t i a t o r , e d u c a t o r , a n d f a c i l i t a t o r , t h e r o l e of t h e n u r s e as p a t i e n t a d v o c a t e is p a r a m o u n t t h r o u g h o u t t h e e n t i r e p r o c e s s . CONCLUSION l d e r s o n 7 r e v i e w s s o m e of t h e d i l e m m a s f a c e d y n u r s e s w h e n r e s e a r c h i n v o l v i n g p a t i e n t s is b e i n g e o n d u e t e d . E x a m p l e s i n c l u d e s i t u a t i o n s in w h i c h t h e r e is a g a p b e t w e e n w h a t a p h y s i c i a n w a n t s t h e p a t i e n t to k n o w a n d w h a t a n u r s e b e l i e v e s t h e p a t i e n t s h o u l d k n o w . A n o t h e r exa m p l e r e f e r s to d e a l i n g w i t h t h e n u r s e ' s c o n c e r n a b o u t s t u d i e s t h a t s h e o r h e m a y p e r c e i v e as u s e l e s s o r h a r m f u l . T h e s e t y p e s of d i l e m m a s c h a l l e n g e n u r s e s in fulfilling t h e i r r o l e s d u r i n g t h e informed consent process. Although not an easy task, ethical decision-making models provide an a v e n u e for d e v e l o p i n g v i a b l e a p p r o a c h e s for t h e m a j o r i t y of t h e s e d i l e m m a s . T a c k l i n g t h e m is a n i n h e r e n t p a r t of t h e n u r s e ' s r e s p o n s i b i l i t i e s r e l a t e d to t h e a d v o c a c y role. S i m i l a r l y , n u r s e s h a v e l o n g
a d d r e s s e d t h e n e e d for p a t i e n t c o m p r e h e n s i o n w i t h r e g a r d to p a t i e n t e d u c a t i o n a n d s h o u l d a p p l y t h i s r e q u i r e m e n t to i n f o r m e d c o n s e n t . I n a d d i t i o n , cultural and religious sensitivity must always be p a r t of t h e n u r s e ' s role, n o m a t t e r w h e t h e r it is r e l a t e d to t h e i n f o r m e d c o n s e n t p r o c e s s . H o w e v e r , a n o t h e r i s s u e r e m a i n s s a l i e n t : if n u r s e s a r e to h e l p p a t i e n t s m a k e i n f o r m e d d e c i sions, t h e y t h e m s e l v e s m u s t first b e i n f o r m e d . This means having comprehensive knowledge about the procedures and the studies presented; a n u n d e r s t a n d i n g of f u n d a m e n t a l c o n c e p t s s u c h as equipoise, beneficence, and autonomy; and an a p p r e c i a t i o n for t h e d i v e r s i t y of m e t h o d o l o g i e s . W i t h o u t t h e s e , it is difficult for n u r s e s to c o m p e tently and successfully support the patient and family through the informed consent process and t h e c o m p l e t i o n of a c l i n i c a l trial. R e s e a r c h fills a v i t a l a n d i m p o r t a n t r o l e in s o c i e t y . I n f o r m e d c o n s e n t , d e f i n e d as a p r o c e s s rather than merely a one-time contractual agreem e n t , 28 p l a y s a n e s s e n t i a l r o l e in c l i n i c a l l y b a s e d r e s e a r c h . T h e r o l e of t h e n u r s e in a s s u r i n g t h a t a p o t e n t i a l p a r t i c i p a n t is fully i n f o r m e d a n d willing to e n r o l l o r r e m a i n in a c l i n i c a l t r i a l is p i v o t a l to g a i n i n g t h e r e q u i s i t e k n o w l e d g e to m o v e s c i e n c e f o r w a r d a n d to u l t i m a t e l y i d e n t i f y a n d i n f l u e n c e health care outcomes.
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21. Brennan M: A concept analysis of consent. J Adv Nurs 25:477-484, 1997 22. Morse JM, Field PA: Qualitative Researeh Methods for Health Professionals (ed 2). Thousand Oaks, CA, Sage Publications, 1995 23. Janesiek VJ: The dance of qualitative research designs: Metaphor, methodolatry and meaning, in Denzin NK, Lincoln YS (eds): Handbook of Qualitative Research. Thousand Oaks, CA, Sage Publieations, 1994, pp 209-219 24. Lipson JG: Ethical issues in ethnography, in Morse JM (ed): Critieal Issues in Qualitative Research Methods. Thousand Oaks, CA, Sage Publieations, 1994, pp 333-355
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25. Munhall PL: Institutional review of qualitative research proposals: A task of no small consequence, in Morse J (ed): Qualitative Nursing Research: A Contemporary Dialogue. Thousand Oaks, CA, Sage Publications, 1991, pp 258-271 26. Robley LR: The ethics of qualitative nursing research, d ProfNurs 11:45-48, 1995 27. Erlandson DA, Harris EL, Skipper BL, et al: Doing Naturalistic Inquiry: A Guide to Methods. Newbury Park, CA, Sage Publications, 1993 28. Woods NF, Catanzano M: Nursing Research: Theory and Praetiee. St Louis, MO, Mosby, 1988