Ethical Issues, Evidenced Based Practice, Future Research

NURSING RESEARCHIntroduction to Nursing Research

UNIT I

SOURCES OF NURSING KNOWLEDGE

• Nurses have relied on several sources of knowledge to guide nursing practice.

• Great storehouse of knowledge for nurses has been tradition.

• Tradition involves the handing down of knowledge from one generation to another and leads to actions that occur because “we’ve always done it that way.”

• Another source of knowledge for nurses has been found in authority or clinical experience/expertise.

• Experts or authorities in a given field often provide knowledge for other people (eg. authors of text books)

• In the past, nurses looked to physicians for a great deal of their practice knowledge.

• It has only been in recent years that nurses have begun to build a unique body of nursing knowledge.

• Clinical Experience and Trial and Error - Nurses have also used trial and error as a means of discovering knowledge.

• If one approach did not work, another one was used.

Lecture III

PRIORITIES FOR FUTURE NURSING RESEARCH

• Professional nursing organizations and individual nurse leaders are united in identifying the need for research that will help build a scientific knowledge base for nursing practice.

• In 1980 the ANA Commission on Nursing Research identified priorities for nursing research.

• These priorities included research concerned with health promotion and preventive health practices for all age groups, health care needs of high-risk groups, life satisfaction of individuals and families, and the development of cost effective health care systems.

10 priority areas for future research:

• These included (a) promote health, well-being, and the ability to care for oneself among all age, social, and cultural groups

• (b) minimize or prevent behaviorally and environmentally induced health problems that compromise the quality of life and reduce productivity

• (c) minimize the negative effects of new health

technologies on the adaptive abilities of individuals and families experiencing acute or chronic health problems.

• (d) Mental health, Alzheimer's, and Oncology

• Brown, Tanner, and Padrick (1984) wrote that research regarding nurse characteristics, nursing education, and nursing administration should not be abandoned because these factors affect the care that nurses provide.

• Fitzpatrick (1999) contended that nursing education research should receive the same recognition as clinical research.

• She mentioned the pressure in recent years to transform nursing educational programs to meet changing health care needs and contended that any changes should be based on research

• Tucker-Allen (2003) wrote an editorial in which she bemoaned the fact that nursing education research is not always respected.

• She called for nurse educators to conduct research on both clinical issues and educational issues.

• She expressed the hope that funding would increase for educational research.

• Replication studies should be a high priority for nursing research.

• Replication studies involve repeating a study with all the essential elements of the original study held intact.

• Different samples and settings may be used.

• Replication studies in nursing have not been numerous, and the lack of these studies has hindered the development of a cumulative body of nursing knowledge.

• This type of study is of particular importance in clinical nursing research, since it provides validity.

• Because of the small nonrandom samples used in many studies, nurses need to conduct many similar studies on the same topic to allow for generalization of findings.

• It is rare that the results of a single study provide enough evidence for making decisions about nursing practice.

Evidenced Based Practice

Objectives

At the end of the interactive session students will be able to:

• Define evidenced based practice (EBP) as cited by

• State the components of EBP

• Discuss the steps utilized in EBP

• Identify the significant databases utilized in EBP

• It is now widely recognized throughout the globe that evidence-based practice (EBP) is key to delivering the highest quality of healthcare and ensuring the best patient outcomes.

• Findings from numerous studies have indicated that an evidence-based approach to practice versus the implementation of clinical care that is steeped in tradition or based upon outdated policies results in a multitude of improved health, safety, and cost outcomes, including a decrease in patient morbidity and mortality

(McGinty & Anderson, 2008; Williams, 2004).

• When clinicians know how to find, critically appraise, and use the best evidence in clinical practice, and when patients are confident that their healthcare providers are using evidence-based care, optimal outcomes are achieved for all.

(Melnyck & Fineout-Overholt, 2011)

Components of Evidence-Based Practice• Although evidence from systematic reviews of RCTs has been

regarded as the strongest level of evidence (i.e., Level 1 evidence) on which to base practice decisions about treatments to achieve a desired outcome, evidence from descriptive and qualitative studies as well as from opinion leaders should be factored into clinical decisions when RCTs are not available.

• Evidence-based theories (i.e., theories that are empirically supported through well-designed studies) also should be included as evidence.

• In addition, patient preferences, values, and concerns should be incorporated into the evidence-based approach to decision making along with a clinician’s expertise.

• These includes (a) clinical judgment (i.e., the ability to think about, understand, and use research evidence; the ability to assess a patient’s condition through subjective history taking, thorough physical examination findings, and laboratory reports), (b) internal evidence generated from quality improvement or outcomes management projects, (c) clinical reasoning (i.e., the ability to apply the above information to a clinical issue), and (d) evaluation and use of available healthcare resources needed to implement the chosen treatment(s) and achieve the expected outcome.


• Clinicians often ask how much and what type of evidence is needed to change practice.

• A good rule of thumb to answer this question is that there needs to be strong enough evidence to make a practice change.

• Specifically, the level of evidence plus the quality of evidence equals the strength of the evidence, which provides clinicians the confidence that is needed to change clinical practice.


Components of Evidenced Based Practice (EBP)

Clinical Expertise (i.e., internal evidencegenerated from outcomes managementor quality improvement projects,a thorough patient assessmentand evaluation, and use of available resources)

External Evidence from Research,Evidence-Based Theories,Opinion of Leaders, and Expert Panels

Patient Preferencesand Values

Evidence-BasedClinical Decision

Making

Quality client outcomes

The Steps of Evidence-Based Practice

The seven critical steps of EBP include:

0. Cultivate a spirit of inquiry

1. Ask the burning clinical question in the format that will yield the most relevant and best evidence (PICOT)

2. Search for and collect the most relevant and best evidence to answer the clinical question (e.g., searching for systematic reviews, including meta-analyses)

3. Critically appraise the evidence that has been collected for its validity,

reliability, and applicability, then synthesize that evidence

4. Integrate the evidence with one’s clinical expertise and the patient’s

preferences and values to implement a clinical decision

5. Evaluate outcomes of the practice decision or change based on

evidence

6. Disseminate the outcomes of the EBP decision or change(Melnyck & Fineout-Overholt, 2011)

Cultivating the Spirit of Inquiry

• Before embarking on the well-known steps of EBP, it is critical to cultivate a spirit of inquiry (i.e., a consistently questioning attitude toward practice) so that clinicians are comfortable with and excited about asking questions regarding their patients’ care as well as challenging current institutional or unit-based practices.

• Without a culture that is supportive of a spirit of inquiry and EBP, individual and organizational EBP change efforts are not likely to succeed and sustain

(Fineout-Overholt, Melnyk, & Schultz, 2005; Rycroft-Malone, 2008).

Step 1: Formulate the Burning Clinical PICOT Question

• In step 1 of EBP, clinical questions are asked in PICOT format (i.e., Patient population, Intervention or Issue of interest, Comparison intervention or group, Outcome, and Time frame) to yield the most relevant and best evidence.

• For example, a well-designed PICOT question would be: In teenagers (the patient population), how does cognitive-behavioral skills building (the experimental intervention) compared to yoga (the comparison intervention) affect anxiety (the outcome) after 6 weeks of treatment (the time frame)?

• When questions are asked in a PICOT format, it results in an effective search that yields the best, relevant information and saves an inordinate amount of time (Fineout-Overholt & Johnston, 2005; Melnyk & Fineout-Overholt, 2002a, Melnyk & Fineout-Overholt, 2011).

• In contrast, an inappropriately formed question (e.g., What is the best type of intervention to use with teenagers who are anxious?) would lead to a search outcome that would likely include hundreds of non-usable abstracts and irrelevant information.

(Melnyck & Fineholt-Overholt, 2011)

• For other clinical questions that are not intervention focused, the meaning of the letter I can be “issue of interest” instead of “intervention.”

• An example of a non-intervention PICOT question would be: How do new mothers who have breast-related complications perceive their ability to breast-feed past the first 3 months after their infants’ birth? In this question, the population is new breast-feeding mothers, the issue of interest is breast-feeding complications, there is no appropriate comparison group, the outcome is their perception of their ability to continue breast-feeding, and the time is the 3 months after their infants’ birth.

• When a clinical problem generates multiple clinical questions, priority should be given to those questions with the most important consequences or those that occur most frequently

(Melnyck & Fineholt-Overholt, 2011)

Step 2: Search for the Best Evidence

• The search for best evidence should first begin by considering the elements of the PICOT question.

• Each of the key words from the PICOT question should be used to begin the search.

• The type of study that would provide the best answer to an intervention or treatment question would be systematic reviews or meta-analyses, which are regarded as the strongest level of evidence on which to base treatment decisions

(Guyatt & Rennie, 2002).

• There are different levels of evidence for each kind of PICOT question

• Although there are many hierarchies of evidence available in the literature to answer intervention PICOT questions we have chosen to present a hierarchy of evidence to address these questions that encompasses a broad range of evidence, including systematic reviews of qualitative evidence, also referred to as meta-syntheses


PICOT: Components of an answerable, searchable question

Patient population/disease The patient population or disease of interest, for example: Age, Gender, Ethnicity, With certain disorder (e.g., hepatitis)

Intervention or issue of interest

The intervention or range of interventions of interest, for example: Therapy, Exposure to disease,, Risk behavior (e.g., smoking)

Comparison intervention orissue of interest

What you want to compare the intervention or issue against, for example: Alternative therapy, placebo, or no intervention/therapy, No disease, Absence of risk factor (e.g., nonsmoking)

Outcome Outcome of interest, for example: Outcome expected from therapy (e.g., pressure ulcers), Risk of disease, Accuracy of diagnosis, Rate of occurrence of adverse outcome (e.g., death)

Time The time involved to demonstrate an outcome,for example: The time it takes for the intervention to achieve the outcome, The time over which populations are observed for theoutcome (e.g., quality of life) to occur, given a certaincondition (e.g., prostate cancer)

Hierarchy of Evidence for Intervention/Treatment Questions

Level I: Evidence from a systematic review or meta-analysis of all relevant RCTsLevel II: Evidence obtained from well-designed RCTsLevel III: Evidence obtained from well-designed controlled trials without randomizationLevel IV: Evidence from well-designed case-control and cohort studiesLevel V: Evidence from systematic reviews of descriptive and qualitative studiesLevel VI: Evidence from single descriptive or qualitative studiesLevel VII: Evidence from the opinion of authorities and/or reports of expert committees

Levels/Hierarchy of Evidence

• Systematic Review - is a summary of evidence on a particular topic, typically conducted by an expert or expert panel that uses a rigorous process for identifying, appraising, and synthesizing studies to answer a specific clinical question.

• Conclusions are then drawn about the data gathered through this process (e.g., In adult women with arthritis, how does massage compared to pharmacologic agents reduce pain after 2 weeks of treatment? In women, what factors predict heart disease in older adulthood?).

• Using a rigorous process of well-defined, preset criteria to select studies for inclusion in the review as well as stringent criteria to assess quality, bias is overcome and results are more credible.

• Population health stands a better chance for improvement when there is effective integration of scientific evidence through systematic reviews that are made available to influence policy makers’ decisions

(Sweet & Moynihan, 2007).

• Many systematic reviews incorporate quantitative methods to summarize the results from multiple studies - these reviews are called meta-analyses.

• A meta-analysis generates an overall summary statistic that represents the effect of the intervention across multiple studies.

• Because a meta-analysis can combine the samples of each study included in the review to create one larger study, the summary statistic is more precise than the individual findings from any one of the contributing studies alone

(Ciliska, Cullum, & Marks, 2001).

• Thus, systematic reviews and meta-analyses yield the strongest level of evidence on which to base practice decisions.

• Caution must be used when searching for systematic reviews as some evidence reviews or narrative reviews may be labeled systematic reviews; however, they lack the rigorous process that is required of true systematic reviews

(Fineout-Overholt, O’Mathúna, & Kent, 2008; Newhouse, 2008).

• If syntheses (e.g., systematic reviews, meta-analyses) are not available to answer a clinical practice treatment question, the next step should be a search for original RCTs that are found in databases such as MEDLINE or CINAHL (Cumulative Index of Nursing and Allied Health Literature).

• If RCTs are not available, the search process should then include other types of studies that generate evidence to guide clinical decision making (e.g., nonrandomized, descriptive, or qualitative studies).

(Melnyck & Fineout Overholt, 2011)

Choosing the Right Database

• Of the many databases that index healthcare literature, some are available through several vendors at a cost, some are free of charge, and some are available both free of charge and through a vendor for a fee.

• For example, as noted previously, depending on the search options desired, MEDLINE can be accessed free of charge through the NLM’s PubMed or obtained for a cost through other providers (e.g., Ovid).


This lecture focuses primarily on the following databases:

• Cochrane Databases

• NGC

• MEDLINE

• CINAHL

• Excerpta Medica Online (EMBASE)

• PsycINFO

• PUBMED


• MEDLINE and CINAHL are among the best-known comprehensive databases and can arguably be described as representing the scientific knowledge base of healthcare.

• However, the amount of information in healthcare exceeds the capacity of either of these databases.

• In addition to MEDLINE and CINAHL, there are other databases available, some of which are highly specialized, and their numbers are growing in response to the desire for more readily available information (e.g., Up-to-Date, Clinical Evidence).


Cochrane Databases• Classified as an international not-for-profit organization, The

Cochrane Collaboration represents the efforts of a global network of dedicated volunteer researchers, healthcare professionals, and consumers who prepare, maintain, and promote access to The Cochrane Library’s six databases:

• Cochrane Database of Systematic Reviews (CDSR), Database of Reviews of Effectiveness (DARE), Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Methodology Register, Health Technology Assessment Database, and NHS Economic Evaluation Database (Melnyck & Fineout Overholt, 2011)

• The Cochrane Library’s “gold standard” database is the CDSR.

• It contains Cochrane full-text systematic reviews and should be searched first to answer intervention questions.

• The databases produced by The Cochrane Collaboration can be accessed via http://www.cochrane.org.

• National Guideline Clearinghouse

• The NGC is a comprehensive database of evidence-based clinical practice guidelines and related documents that provide physicians, nurses, and other healthcare professionals and stakeholders with detailed information on the latest management and maintenance of particular health issues, along with how the guideline was developed, tested, and should be used (Melnyck & Fineout Overholt, 2011)

http://www.cochrane.org/

• The NGC is a government-supported database that was initiated by the Agency for Healthcare Research and Quality (AHRQ) within the U.S. Department of Health and Human Services.

• The agency has a mission to improve the quality, safety, efficiency, effectiveness, and cost effectiveness of health

• The NGC can be found at http://www.guideline.gov.


• MEDLINE

• MEDLINE is one of the world’s largest searchable bibliographic databases covering medicine, health, and the biomedical sciences, and it is available 24 hours a day on any computer in the world with Internet access. The NLM also leases the MEDLINE data to vendors.

• These types of companies load the database into their own user interfaces with unique features and sell subscriptions to libraries and others.

• It is important to acknowledge that the original file of indexed citations is the same MEDLINE product in PubMed as in any of these other vendors’ versions of the file.

• It contains citations from more than 5,200 biomedical journals in medicine, nursing, pharmacy, dentistry, and allied health.

• The database is updated daily and has abstracts for over 52% of its articles, with 80% of its citations in English.

• The MEDLINE database is available free of charge through PubMed at http://www.ncbi.nlm.nih.gov/pubmed


http://www.ncbi.nlm.nih.gov/pubmed



• CINAHL

• The Cumulative Index of Nursing & Allied Health Literature (CINAHL) database is produced by Cinahl Information Systems and contains article citations with abstracts, when available, from 13 nursing and allied health disciplines. Articles are retrieved from journals, books, drug monographs, dissertations, and images that are sometimes difficult to locate in other databases.

• The CINAHL database is usually accessed through libraries but can be accessed through a personal CINAHL direct subscription via the Cinahl Information Systems website (http://www.ebscohost. com/cinahl/).

http://www.ebscohost/

http://www.ebscohost/

• The CINAHL database includes more than 3 million journal articles from 1982 to present. About 70% of the citations in CINAHL also appear in the MEDLINE database.

• The CINAHL database also has a controlled vocabulary.

• It is an English language database and available through various vendors.


• EMBASE

• Excerpta Medica Online (EMBASE) is the major European biomedical and pharmaceutical database indexing in the fields of drug research, pharmacology, pharmaceutics, toxicology, clinical and experimental human medicine, health policy and management, public health, occupational health, environmental health, drug dependence and abuse, psychiatry, forensic medicine, and biomedical engineering/instrumentation.

• The EMBASE database currently has more than 19 million indexed records from more than 7,000 peer-reviewed journals.

• Yearly, EMBASE adds more than 600,000 articles to the database, 80% of which have full abstracts. EMBASE requires a subscription to access its indexed articles.

• The EMBASE database is available at http://www.embase.com/.


http://www.embase.com/

http://www.embase.com/

• PsycINFO

• PyscINFO is a bibliographic database that indexes publications from the late 1800s to present.

• This database of scholarly literature in psychology, behavioral sciences, and mental health contains more than 2 million citations, 7% of which are books and 11% dissertations.

• Professionals in psychology and related fields such as psychiatry, education, neuroscience, nursing, and other healthcare disciplines can find relevant evidence in this database to answer specific clinical questions. PsycINFO is available at http://www.apa.org/psycinfo/.


http://www.apa.org/psycinfo/

http://www.apa.org/psycinfo/

Step 3: Critical Appraisal of Evidence

• This step is vital, in that it involves critical appraisal of the evidence obtained from the search process.

• Although healthcare professionals may view critical appraisal as an exhaustive, time-consuming process, the first steps of critical appraisal can be efficiently accomplished by answering three key questions as part of a rapid critical appraisal process in which studies are evaluated for their validity, reliability, and applicability to answer the posed clinical question

• Are the results of the study valid? (Validity) That is, are the results as close to the truth as possible? Did the researchers conduct the study using the best research methods possible?

• For example, in intervention trials, it would be important to determine whether the subjects were randomly assigned to treatment or control groups and whether they were equal on key characteristics prior to the treatment.

• What are the results? (Reliability) For example, in an intervention trial, this includes (a) whether the intervention worked, (b) how large a treatment effect was obtained, and (c) whether clinicians could expect similar results if they implemented the intervention in their own clinical practice setting (i.e., the preciseness of the intervention effect).

• In qualitative studies, this includes evaluating whether the research approach fits the purpose of the study, along with evaluating other aspects of the study.

• Will the results help me in caring for my patients? (Applicability) - This third critical appraisal question includes asking whether (a) the subjects in the study are similar to the patients for whom care is being delivered, (b) the benefits are greater than the risks of treatment (i.e., potential for harm), (c) the treatment is feasible to implement in the practice setting, and (d) the patient desires the treatment.

• The answers to these questions ensure relevance and transferability of the evidence to the specific population for whom the clinician provides care.


• Step 4: Integrate the Evidence With Clinical Expertise and

Patient Preferences to Make the Best Clinical Decision

• The next key step in EBP is integrating the best evidence found from the literature with the healthcare provider’s expertise and patient preferences and values to implement a decision.

• Consumers of healthcare services want to participate in the clinical decision-making process, and it is the ethical responsibility of the healthcare provider to involve patients in treatment decisions

• Even if the evidence from a rigorous search and critical appraisal strongly supports that a certain treatment is beneficial (e.g., HRT to prevent osteoporosis in a very high-risk woman), a discussion with the patient may reveal her intense fear of developing breast cancer while taking HRT or other reasons that the treatment is not acceptable.

• Moreover, as part of the history-taking process or physical examination, a comorbidity or contraindication may be found that increases the risks of HRT (e.g., prior history of stroke).

• Therefore, despite compelling evidence to support the benefits of HRT in preventing osteoporosis in high-risk women, a decision against its use may be made after a thorough assessment of the individual patient and a discussion of the risks and benefits of treatment (Melnyk & Fineout-Overholt, 2011).

• Step 5: Evaluate the Outcomes of the Practice Change Based on Evidence

• Step 5 in EBP is evaluating the evidence-based initiative in terms of how the change affected patient outcomes or how effective the clinical decision was with a particular patient or practice setting.

(Melnyk & Fineout-Overholt, 2011).

• This type of evaluation is essential in determining whether the change based on evidence resulted in the expected outcomes when implemented in the real-world clinical practice setting.

• Measurement of outcomes is important to determine and document the impact of the EBP change on healthcare quality and/or patient outcomes.

• If a change in practice based on evidence did not produce the same findings as demonstrated in rigorous research, clinicians should ask themselves a variety of questions (e.g., Was the treatment administered in exactly the same way that it was delivered in the study? Were the patients in the clinical setting similar to those in the studies?) (Melnyk & Fineout-Overholt, 2011).

• Step 6: Disseminate the Outcomes of the Evidence-Based Practice Change

• The last step in EBP is disseminating the outcomes of the EBP change.

• All too often, clinicians achieve many positive outcomes through making changes in their care based upon evidence, but those outcomes are not shared with others, even colleagues within their same institution.

• As a result, others do not learn about the outcomes and clinicians as well as patients in other settings do not benefit from them.

• It is so important for clinicians to disseminate outcomes of their practice changes based on evidence through such venues as oral and poster presentations at local, regional, and national conferences; EBP rounds within their own institutions; journal and newsletter publications; and lay publications (Melnyk & Fineout-Overholt, 2011).

Lecture VI

ETHICAL ISSUES IN NURSING RESEARCH

Objectives

At the end of this interactive session students will be able to:

• Discuss the historical background that led to the creation of various codes of ethics

• Understand the potential for ethical dilemmas stemming from conflicts between ethics and research demands

• Identify the three primary ethical principles articulated in the Belmont Report and the important dimensions encompassed by each

• Identify procedures for adhering to ethical principles and protecting study participants

• evaluate the ethical dimensions of a research report

HISTORICAL BACKGROUND (I)

• In any research with human beings or animals, researchers must address ethical issues.

• Ethical concerns are especially prominent in nursing research because the line between what constitutes the expected practice of nursing and the collection of research data sometimes gets blurred.

• We might like to think that violations of moral principles among researchers occurred centuries ago rather than recently, but this is not the case.

(Nieswiadomy, 2011)

• The Nazi medical experiments of the1930s and 1940s are the most famous example of recent disregard for ethical conduct.

• The Nazi program of research involved using prisoners of war and racial “enemies” in experiments designed to test human endurance and reactions to untested drugs.

• The studies were unethical not only because they exposed people to harm and even death, but because subjects could not refuse participation.

• Similar wartime experiments that raised ethical concerns were conducted in Japan and Australia.

(Nieswiadomy, 2011)

• There are more recent examples. For instance, between 1932 and 1972, the Tuskegee Syphilis Study, sponsored by the U.S. Public Health Service, investigated the effects of syphilis among 400 poor African-American men.

• Medical treatment was deliberately withheld to study the

course of the untreated disease.

• Similarly, Dr. Herbert Green in Auckland, New Zealand, studied women with cervical cancer in the 1980s; patients with carcinoma in situ were not given treatment so that researchers could study the natural progression of the disease.

• Other examples of studies with ethical transgressions have emerged to give ethical concerns the high visibility they have today (Nieswiadomy, 2011)

CODE OF ETHICS

• In response to human rights violations, various codes of ethics have been developed.

• One of the first international set of ethical standards was the Nuremberg Code, developed in 1949 in response to the Nazi atrocities.

• Several other international standards have subsequently been developed, including the Declaration of Helsinki, which was adopted in 1964 by the World Medical Association and most recently revised in 2008.

• Most disciplines, such as medicine and psychology, have established their own code of ethics.

• Nurses also have developed ethical guidelines In the United States, the American

• Nurses Association (ANA) issued Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research in 1995 (Silva, 1995).

• ANA (2001) also published a revised Code of Ethics for Nurses with Interpretive Statements, a document that covers ethical issues for practicing nurses primarily but also includes principles that apply to nurse researchers.

• In Canada, the Canadian Nurses Association published its Ethical Research Guidelines for Registered Nurses in 2002. And, the International Council of Nurses (ICN) has developed the ICN Code of Ethics for Nurses, which was most recently updated in 2006.

(Polit & Beck, 2014; Rebar et al, 2011)

Ethical Dilemmas in Conducting Research (II)

• Research that violates ethical principles typically occurs out of a researcher’s conviction that knowledge is potentially life-saving or beneficial in the long run.

• There are research problems in which participants’ rights and study demands are put in direct conflict, posing ethical dilemmas for researchers.

• Here is an example of research problems in which the desire for rigor conflicts with ethical considerations:

• Research question: Are nurses equally empathic in their treatment of ICU patients from different ethnic backgrounds?

• Ethical dilemma: Ethics require that participants be informed of their role in a study.

• Yet if the researcher tells participating nurses that their degree of empathy in treating different patients will be scrutinized, will their behavior be “normal?”

• If the nurses’ usual behavior is altered because of the presence of research observers, then the findings will not be valid.

(Polit & Beck, 2014)

• As this example suggest, researchers are sometimes in a bind.

• Their goal is develop high-quality evidence for practice, but they must also adhere to rules for protecting human rights.

• Another type of dilemma may arise if nurse researchers face conflict of- interest situations, in which their expected behavior as nurses conflicts with standard research behavior (e.g., deviating from a research protocol to assist a patient).

• It is precisely because of such dilemmas that codes of ethics have been developed to guide researchers’ efforts


ETHICAL PRINCIPLES FOR PROTECTING PARTICIPANTS

• The Belmont Report articulated three primary ethical principles on which standards of ethical research conduct are based: beneficence, respect for human dignity, and justice.

• It is a code of ethics issued in 1978 In the United States, and adopted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

• It provided a model for many guidelines adopted by disciplinary organizations worldwide (Polit & Beck, 2014).

Beneficence

• A fundamental ethical principle in research is that of beneficence, the duty to minimize harm and maximize benefits.

• Human research should produce benefits for participants themselves or—a situation that is more common—for other individuals or society as a whole.

• The Right to Freedom From Harm and Discomfort - Researchers have an obligation to prevent or minimize harm in studies with humans.

(Polit & Beck, 2014).

• Participants must not be subjected to unnecessary risks of harm or discomfort, and their participation in research must be essential to achieving societally important aims.

• In research with humans, harm and discomfort can be physical (e.g., injury), emotional (e.g., stress), social (e.g., loss of social support), or financial (e.g., loss of wages).

• Ethical researchers must use strategies to minimize all types of harms and discomforts, even ones that are temporary.

• The Right to Protection From Exploitation - Involvement in a study should not place participants at a disadvantage.

• Participants need to be assured that their participation, or information they provide, will not be used against them in any way.

• For example, people describing their economic situation should not risk loss of public health benefits; people reporting drug abuse should not fear exposure to criminal authorities.

(Polit & Beck, 2014).

• Study participants enter into a special relationship with researchers, and this relationship should not be exploited.

• Exploitation may be overt and malicious (e.g., sexual exploitation), but it might also be more subtle (e.g., getting people to complete a 1-year follow-up interview, without having warned them of this possibility at the outset).

• Because nurse researchers may have a nurse–patient (in addition to a researcher–participant) relationship, special care may be needed to avoid exploiting that bond.

• Patients’ consent to participate in a study may result from their understanding of the researcher’s role as nurse, not as researcher


Respect for Human Dignity

• Respect for human dignity is the second ethical principle articulated in the Belmont Report.

• This principle includes the right to self-determination and the right to full disclosure.

• The Right to Self-Determination - The principle of self-determination means that prospective participants have the right to decide voluntarily whether to participate in a study, without risking penalty or prejudicial treatment.

(Polit & Beck, 2014; Burns & 2010)

• It also means that people have the right to ask questions, to refuse to give information, and to withdraw from the study.

• A person’s right to self-determination includes freedom from coercion.

• Coercion involves explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate


• The Right to Full Disclosure - Respect for human dignity encompasses people’s right to make informed, voluntary decisions about study participation, which requires full disclosure.

• Full disclosure means that the researcher has fully described the study, the person’s right to refuse participation, and possible risks and benefits.

• The right to self-determination and the right to full disclosure are the two major elements on which informed consent are based

• Full disclosure maybe problematic is issue being studied is sensitive


Justice III

• The third broad principle articulated in the Belmont Report concerns justice, which includes participants’ right to fair treatment and their right to privacy.

• The Right to Fair Treatment

• One aspect of justice concerns the equitable distribution of benefits and burdens of research.

• The selection of participants should be based on research requirements and not on people’s vulnerabilities.

(Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011)

• Historically, subject selection has been a key ethical concern, with many

researchers selecting groups deemed to have lower social standing

(e.g., poor people, prisoners, the mentally disabled) as study

participants.

• The principle of justice imposes particular obligations toward individuals

who are unable to protect their own interests (e.g., dying patients) to

ensure that they are not exploited for the advancement of knowledge.

• The right to fair treatment encompasses other obligations. (Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011)

• For example, researchers must treat people who decline to participate in a study or who withdraw from it in a non-prejudicial manner; they must honor all agreements made with participants; they must show respect for the beliefs and lifestyles of people from different backgrounds; and they must treat participants courteously and tactfully at all times

• The Right to Privacy - Virtually all research with humans involves intruding into personal lives.

• Researchers should ensure that their research is not more intrusive than it needs to be and that privacy is maintained.

• Participants have the right to expect that any data they provide will be kept in strict confidence.


INFORMED CONSENT

• An important procedure for safeguarding participants involves obtaining their informed consent.

• Informed consent means that participants have

adequate information about the study, comprehend the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily.

• Researchers usually document informed consent by having participants sign a consent form.


• The consent includes information about the study purpose, specific expectations regarding participation (e.g., how much time will be required), the voluntary nature of participation, and potential costs and benefits.

• Researchers may not obtain written informed consent when data collection is through self administered questionnaires.

• Researchers often assume implied consent (i.e., the return of a completed questionnaire reflects the person’s voluntary consent to participate).


ELEMENTS OF INFORMED CONSENT IN RESEARCH

• Show copy of informed consent with various elements

ISSUES RELATING TO CONFIDENTIALITY• Study participants have the right to expect that any data they

provide will be kept in strict confidence (disclosed unwittingly).

• Participants’ right to privacy is protected through confidentiality procedures.

• Anonymity - the most secure means of protecting confidentiality, occurs when the researcher cannot link participants to their data.

• For example, if questionnaires were distributed to a group of nursing home residents and were returned without any identifying information, responses would be anonymous


• Treatment of Vulnerable Groups

• Adherence to ethical standards is often straightforward.

• The rights of special vulnerable groups, however, may need extra protections.

• Vulnerable populations may be incapable of giving fully informed consent (e.g., developmentally delayed people) or may be at high risk of unintended side effects (e.g., pregnant women).

• Attention should be payed to the ethical dimensions of a study when people who are vulnerable are involved.

• Among the groups that should be considered as being vulnerable are the following:

• Children - Legally and ethically, children do not have the competence to give informed consent and so the consent of children’s parents or guardians should be obtained.


• Mentally or emotionally disabled people - Individuals whose disability makes it impossible for them to make informed decisions (e.g., people affected by cognitive impairment, coma, and so on) also cannot legally provide informed consent.

• In such cases, researchers should obtain the written consent of a legal guardian.

• Severely ill or physically disabled people - For patients who are very ill or undergoing certain treatments (e.g., mechanical ventilation), it might be necessary to assess their ability to make reasoned decisions about study participation.

• For certain disabilities, special consent procedures may be required.

• For example, with people who cannot read or who have a physical impairment preventing them from writing, alternative procedures for documenting informed consent (e.g., videotaping) should be used.


• Terminally ill - Terminally ill people can seldom expect to benefit personally from research, and thus the risk/benefit ratio needs to be carefully assessed.

• Institutionalized people - Nurses often conduct studies with hospitalized or institutionalized people who might feel that their care would be jeopardized by failure to cooperate.

• Inmates of prisons and correctional facilities may similarly feel constrained in their ability to give free consent.

• Researchers studying institutionalized groups need to emphasize the voluntary nature of participation.

CRITIQUING THE ETHICAL ASPECTS OF A STUDY

• Members of an Internal Review Board (IRB) or human subjects or ethics committee are provided with sufficient information to answer all these questions, but research articles do not always include detailed information about ethics because of space constraints in journals.

• Thus, it may be difficult to critique researchers’ adherence to ethical guidelines.

• Nevertheless, we offer a few suggestions for considering ethical issues.

• Many research reports do acknowledge that the study procedures were reviewed by an IRB or human subjects committee.

• When a report mentions a formal review, it is usually safe to assume that a panel of concerned people thoroughly reviewed ethical issues raised by the study.

• Was the study approved and monitored by an Institutional Review Board, Research Ethics Board, or other similar ethics review committee?

• Were study participants subjected to any physical harm, discomfort, or psychological distress? Did the researchers take appropriate steps to remove or prevent harm?

• Did the benefits to participants outweigh any potential risks or actual discomfort they experienced? Did the benefits to society outweigh the costs to participants?

• Was any type of coercion or undue influence used to recruit participants? Did they have the right to refuse to participate or to withdraw without penalty?

• Were participants deceived in any way? Were they fully aware of participating in a study and did they understand the purpose and nature of the research?

• Were appropriate informed consent procedures used with all participants? If not, were the reasons valid and justifiable?

• Were adequate steps taken to safeguard participants’ privacy? How was confidentiality maintained? Was a Certificate of Confidentiality obtained—and, if not, should one have been obtained?

• Were vulnerable groups involved in the research? If yes, were special precautions instituted because of their vulnerable status?

• Were groups omitted from the inquiry without a justifiable rationale, such as women (or men), or minorities?

• A person could come to some conclusions based on a description of the study methods.

• There may be sufficient information to judge, for example, whether study participants were subjected to harm or discomfort.

• Reports do not always state whether informed consent was secured, but you should be alert to situations in which the data could not have been gathered as described if participation were purely voluntary (e.g., if data were gathered unobtrusively).

• In thinking about the ethical aspects of a study, you should also consider who the study participants were.

• For example, if the study involves vulnerable groups, there should be more information about protective procedures.

• You might also need to attend to who the study participants were not.

• For example, there has been considerable concern about the omission of certain groups (e.g., minorities) from clinical research

Nieswiadomy R. Foundations of nursing research (2011). Prentice Hall. New Jersey

Documents

Ethical Issues, Evidenced Based Practice, Future Research