reflect on the concept of scientific merit.

  • Describe the aspects of the study you chose for your Scientific  Merit Paper course project that exemplify each of the three dimensions  of scientific merit (advances the knowledge base, contributes to theory,  and meets hallmarks of good research).
  • Identify an area of scientific merit that could be improved in your chosen study, and explain how it could be improved.
  • List the persistent link for your chosen article.
  • Cite all sources in APA style and provide an APA-formatted reference list at the end of your post.

Reference

Gwyn, P. G., & Colin, J. M. (2010). Research with the doubly vulnerable population of individuals who abuse alcohol. Journal of Psychosocial Nursing and Mental Health Services, 48(2), 38-43. doi:10.3928/02793695-20100108-01

Earn

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AbstrAct

Individuals who have maladaptive patterns of drinking alcohol fall into the category of vul- nerable research participants for many reasons, not the least of which includes the stigma of- ten placed on individuals who abuse alcohol. Vulnerable subgroups within the population of people who abuse alcohol include women; older adults; incarcerated, socioeconomically disadvantaged, and mentally ill individuals; as well as people from racial minorities. Thus, as research participants, individuals who abuse

alcohol can be labeled a doubly vulnerable pop- ulation. Belonging to more than one popula- tion simultaneously can lead to a compromised ability to protect one’s own interests or greater susceptibility to harm related to participating in research studies. Arguments against including people who abuse alcohol as research partici- pants will be presented, followed by the argu- ment for including these individuals, which is suggested as the more ethically sound of the two points of view.

Priscilla Gage Gwyn, PhD, ArNP-bc, OcN; and Jessie M. colin, PhD, rN

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In any research effort, it is cru-cial that the participants in-volved are not harmed in the process. This is particularly im- portant when the research partici- pants are considered vulnerable. An assumption made by many re- searchers when discussing vulner- able populations is that “certain categories of people are presumed to be more likely than others to be misled, mistreated or otherwise taken advantage of as participants in research” (Levine et al., 2004, p. 44). The Council for International Organizations of Medical Sciences (CIOMS) defines vulnerable peo- ple as “those who are relatively (or absolutely) incapable of protect- ing their own interests [because] they may have insufficient power, intelligence, education, resources, strength, or other needed attri- butes to protect their own inter- ests” (Commentary on Guideline 13 section). In this article, we will demonstrate that a population may be doubly vulnerable because they experience more than one of these problems. Research with these in- dividuals necessitates that extraor- dinary care be taken to avoid tak-

ing advantage of or harming them in any way.

Research is essential to advance knowledge and science; however, the drive for new knowledge must not be allowed to take precedence over the welfare of research partici- pants (U.S. Department of Health and Human Services, 2005). Be- cause of these constraints, the challenges related to studying people addicted to alcohol pres- ents ethical concerns that could discourage any research at all. We contend that the challenges inher- ent in such research simply make ethically conducted research more challenging, not impossible, and that people who abuse alcohol should be afforded the same oppor- tunities as people who do not abuse alcohol in being able to participate in research studies.

the POPulAtiON Of iNDiviDuAls whO Abuse AlcOhOl

Regardless of setting, nurses will find themselves responsible for the care of people who experience al- cohol dependence, abuse, or addic- tion. In the United States, alcohol

abuse is reported to be one of the most prevalent addictive problems in the nation, if not the number one addictive disease experienced by Americans (Compton, 2002). Alcohol-related injuries and ill- nesses contribute to a large per- centage of patient hospitalizations; some estimates for hospitalizations related to alcoholism are as high as one fifth of all admissions (Comp- ton, 2002).

Because health care provid- ers care for people with a broad spectrum of maladaptive drinking patterns, it is important to under- stand that identification of alcohol abuse or dependence is based on behavioral indicators of addictive disease, not on a set volume of alcohol consumed or frequency of consumption (Compton, 2002). Compton (2002) defines alcohol abuse as “harmful and recurrent alcohol use despite social, occupa- tional, or legal consequences” (p. 59); alcohol dependence includes the additional criteria of “being unable to cut down or control alcohol use, being physically dependent on alcohol, and being tolerant to alcohol” (p. 59). In addition, the

Journal of Psychosocial nursing • Vol. 48, no. 2, 2010 39

fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 1994) specified that if a person experiences three or more of the following seven criteria within a 12-month period, he or she meets the criteria for alcohol dependence:

l Tolerance, defined as a need for increased amounts of alcohol to achieve the desired effect.

l Withdrawal symptoms or drinking alcohol to avoid with- drawal symptoms.

l Drinking alcohol in larger amounts than intended.

l Unsuccessful attempts at cutting down on alcohol use.

l Excessive time related to ob- taining, using, and recovering from alcohol use.

l Social, occupational, or recreational activities curtailed or ceased due to alcohol use.

l Continued use of alcohol, despite negative psychological or physical consequences.

Many people feel that alcohol- ism is a weakness manifesting from a “character flaw” and that people who have maladaptive patterns of drinking alcohol could drink “in moderation” if they wanted to control their alcohol consumption. In the past several decades, a sig- nificant body of both national and international scientific research has delineated that there are ge- netic factors, in addition to envi- ronmental factors, that increase a person’s risk of both alcohol abuse and dependence (Dick et al., 2006; Edenberg & Foroud, 2006; Williams & Lu, 2008). Research- ers have found that up to 50% to 60% of the risk for developing al- cohol abuse and dependence is ge- netic (Prescott & Kendler, 1999). Because health care providers’ personal beliefs about people who have maladaptive patterns of drinking alcohol continue to vary widely, more research is needed with this population.

vulNerAbility Having outlined how preva-

lent consumers of alcohol are in health care arenas, expanding further what constitutes a vulner- able population is important, as it supports the viewpoint that many individuals who abuse alcohol are doubly vulnerable. Vulnerability is a common human experience that has taken on an expanded meaning in the field of research. Vulnerable populations are those who have a greater predisposition or suscepti- bility to harm than other individu- als (Levine et al., 2004; Moore &

Miller, 1999; Rhodes, 2005; Rog- ers, 2005). Other definitions of vul- nerable populations include those with diminished autonomy and de- creased decision-making capacity, although Quest and Marco (2003) indicated that this definition is evolving. Quest and Marco (2003) have expanded their view of vul- nerability to include six areas:

l Those with cognitive im- pairment who cannot make ade- quate decisions about participating in research.

l Those who are institutional- ized and are at risk for feeling they must participate and do not have a choice to participate in research.

l Those who are deferentially vulnerable. This area also refers to individuals who feel they must participate and do not have a choice to do so due to subtle co- ercion; the difference from those who are institutionalized is that informal authority causes this group to feel their choice to par- ticipate is removed.

l Medically vulnerable indi- viduals with acute or chronic ill- nesses for which no satisfactory standard of treatment exists.

l Economically vulnerable in- dividuals.

l Socially vulnerable individ- uals are those belonging to a group that is undervalued, such as people who are homeless or addicted to substances.

It follows that individuals who abuse alcohol could be categorized as socially vulnerable. Simultane- ously, while belonging to a group that is socially vulnerable, indi-

viduals who abuse alcohol often belong to other vulnerable groups as well and, therefore, could be de- scribed as doubly at risk for harm than other individuals, or more simply, doubly vulnerable.

ethicAl GuiDeliNes fOr huMAN reseArch

Several professional organiza- tions have published documents that outline ethical research con- ducted with human participants, and many address additional efforts that should be taken to protect vul- nerable populations. These include the Declaration of Helsinki (World Medical Association, 2008), the Nuremberg Code (1949), The Belmont Report (National Com- mission for the Protection of Hu- man Subjects of Biomedical and Behavioral Research, 1979), and International Ethical Guidelines for Biomedical Research Involving Hu- man Subjects (CIOMS, 2002).

Because of the widespread be- lief that those who abuse alcohol

The most common ethical breaches related to research are coercion, therapeutic misconception, undue influence, and manipulation leading to study enrollment.

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can be “in control” of their drink- ing, stigma surrounds those with this disease, and this stigma often extends to those who are in re- covery. Consequently, many are secretive about having this disease, which supports categorizing people who abuse alcohol as a vulnerable population. Because vulnerable populations may have difficulty protecting their own interests and may experience decreased ability to make decisions, these individu- als have an increased propensity for having their rights violated. The most common ethical breach- es related to research are coercion, therapeutic misconception, undue influence, and manipulation lead- ing to study enrollment.

Coercion is using the threat of harm or force to “push” individuals to enroll in a research study, over- riding their right to choose not to participate (Israel & Hay, 2006; Rhodes, 2005; Rogers, 2005). Therapeutic misconception is the be- lief that the benefits of participat- ing in a research study are greater than they actually are (Steinke, 2004). Undue influence is exerted when people in positions of power or respect encourage individuals to participate, even when enrolling in the study may not be in the partici- pant’s best interest (Rogers, 2005). Finally, manipulation is deliberately changing the environment or the information to lead others to make decisions they otherwise would not have made (Israel & Hay, 2006; Rogers, 2005).

Using these tactics in accumu- lating research study participants violates the ethical principles of beneficence (doing good acts and avoiding evil), nonmalefi- cence (doing no harm), autonomy (choosing for oneself), distributive justice (benefits and burdens should be shared equally by all people in an identical manner regardless of social status, race, religion, or other grouping), and informed consent (Israel & Hay, 2006; Quest &

Marco, 2003; Rhodes, 2005; Stein- ke, 2004). Informed consent has four essential parts: adequate and truthful disclosure of information, freedom of choice in participation, comprehension of the information, and adequate capacity for deci- sion making (Israel & Hay, 2006; Rhodes, 2005).

ArGuMeNt AGAiNst cONDuctiNG reseArch with iNDiviDuAls whO Abuse AlcOhOl

The argument against research with vulnerable populations re- lates to ethical compromises that can occur at different levels of the research study. Issues with consent might not be overcome by indi- viduals who abuse alcohol; there- fore, it could be unethical to enroll this population in research studies, meaning they should be excluded for their own protection. Ethical standards need to be upheld when conducting studies of any kind so the participants’ rights, whether or not they are doubly vulnerable, are not violated.

The first point to be made against conducting research with vulnerable or doubly vulnerable populations is that their enroll- ment will always cause problems with upholding ethical standards related to the four essential parts of informed consent. Being edu- cationally and economically dis- advantaged may place individuals who abuse alcohol at risk for being unable to fully comprehend the study protocol and the research consent.

Second, individuals who abuse alcohol may have an erro- neous belief that they will expe- rience benefits if they choose to participate in a study (i.e., thera- peutic misconception). It can be argued that it would not be pos- sible to eliminate the potential for coercion or therapeutic mis- conception and ensure adequate comprehension and decision-

making capacity of people who abuse alcohol. Thus, appropriate safeguards that ensure informed consent and maintain confiden- tiality, as well as the participants’ dignity, may be difficult at best.

A third argument is that a great number of individuals who abuse alcohol are socio- economically and education- ally disadvantaged. This could easily make them susceptible to coercion to enroll in a research study. Also, many of those who abuse alcohol are doubly vul- nerable, placing them at higher risk for harm if unethical meth- ods are used to boost study en- rollment.

Finally, participants may erro- neously believe they may receive the medical care they need by participating in the study. Allow- ing this therapeutic misconcep- tion among participants is a more subtle form of manipulation. The argument is that unless all indi- viduals in the country have equal access to care, research with vul- nerable individuals (who do not have equal access to medical care due to socioeconomic barriers) should not be conducted. The drive for new knowledge should not take precedence over partici- pants’ welfare.

In discussing ethical issues related to the research design itself, deontology lends support to a final argument for not con- ducting research with people who abuse alcohol. Deontology is the ethical philosophy in which individuals are treated as an end themselves, not simply as a means to an end (Israel & Hay, 2006). Many research trials col- lect information that may not directly benefit those enrolled in a study but that could help indi- viduals in the future. Consistent with deontology, only research directly benefiting individu- als who abuse alcohol would be ethically acceptable.

Journal of Psychosocial nursing • Vol. 48, no. 2, 2010 41

ArGuMeNt fOr cONDuctiNG reseArch with iNDiviDuAls whO Abuse AlcOhOl

The first point to be made in support of research with doubly vulnerable individuals is guided by justice-based ethics. The founda- tion of justice-based ethics is that benefits and burdens should be distributed among all in ways that are fair and just. When benefits or burdens are distributed unequally, there is a strong presumption that this should be remedied. Under- represented concerns and special health care needs of vulnerable groups may never be addressed if research studies are not open to them. To exclude them would counter the belief that research is essential to improve knowledge and understanding and to advance science; limited decision-making ability should not prevent individ- uals from participating in research nor impede researchers’ ability to gain new knowledge.

Not allowing doubly vulner- able individuals to participate in research could also create an ethical dilemma (Steinke, 2004). Moore and Miller (1999) argued that “only when vulnerable groups receive the appropriate research attention can their care and qual- ity of life be enhanced” (p. 1040). Therefore, research should be con- ducted with individuals who abuse alcohol to afford them the same

attention and life-improving re- search to which those who are not vulnerable have access, as it is not fair or just to exclude doubly vul- nerable groups.

Further support for conduct- ing research with this population is related to a rights-based ethi- cal approach, which stems from the belief that all human beings have rights and the ability to choose freely what they do with their lives. Ethical actions should be those that best protect and respect the moral rights of those affected and promote individuals’ ability to choose freely (Rhodes, 2005). To say the population of those who abuse alcohol can- not make voluntary and non- coerced decisions about whether they would like to participate in research is paternalistic and a breach of rights-based ethics (Rhodes, 2005). Rhodes (2005) also stated that this paternalism “denies people the opportunity to evaluate the costs and benefits of research participation in light of their own priorities, their own goals, and their own values” (p. 12). Rights-based ethics supports the argument that the doubly vulnerable population being dis- cussed can and should be permit- ted to evaluate for themselves and freely choose whether they would like to participate in research studies and should have the same rights as nonvulnerable popula-

tions and not be barred from tak- ing part in research studies.

Support to conduct research with people who have maladap- tive patterns of drinking alcohol is based on researchers’ ability to minimize ethical breaches of the four essential parts of informed con- sent and their ability to institute appropriate safeguards to protect participants’ confidentiality and dignity. Researchers must provide adequate and truthful disclosure of information at a level that allows comprehension on the part of the participant. The study’s inclusion and exclusion criteria should be clear enough so that those who meet the inclusion criteria are able to fairly and equitably participate in the study. Researchers must be objective and nonjudgmental. The design and study protocol must be unambiguous. Allowing self- disclosure as an inclusion criterion allows participants the freedom to choose to participate and dimin- ishes the potential for issues such as coercion.

While it is possible to ensure adequate protection of individu- als who are doubly vulnerable, it is important for institutional review boards and researchers to establish additional safeguards and use great- er scrutiny when working with this population. Individuals who are doubly vulnerable have the right to participate in research, and the outcomes of those studies are im- portant to the understanding of and ability to design effective treat- ment for these conditions.

suMMAry: A MOre ethicAlly sOuND viewPOiNt

Research with individuals who abuse alcohol—regardless of their classification as vulnerable or dou- bly vulnerable—should be con- ducted. This viewpoint depends on the premise that all research should be designed to ensure that participants are protected, risks to

1. Rigorous ethical standards must be upheld in conducting research, and attention should be given to vulnerable populations when they are used as research participants.

2. Some individuals fall into more than one vulnerable population, causing them to be doubly vulnerable.

3. People who have maladaptive patterns of drinking should be afforded the same research rights as others.

Do you agree with this article? Disagree? Have a comment or questions? Send an e-mail to the Journal, at jpn@slackinc.com.

we’re waiting to hear from you!

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the participants are minimized, and safeguards to protect the par- ticipants are implemented.

In addition, classifying indi- viduals with maladaptive patterns of drinking alcohol as vulner- able fails to distinguish between “individuals in the group who indeed might have special char- acteristics that need to be taken into account and those who do not” (Levine et al., 2004, p. 47). This could lead to excluding en- tire groups from participating in research studies simply because of a label that implies that “one size fits all,” as it is not applicable to all within the group labeled vulnerable. Excluding entire groups who might be vulnerable is discriminatory, and health care providers and researchers should take care to examine their be- liefs about people who abuse alcohol. Stereotyping from nar- row-minded belief systems could lead to the exclusion of doubly vulnerable groups from research that is needed to provide the very growth in scientific knowl- edge that allows nurses and other health care workers to step out of preconceived beliefs. Such re- search will enhance the delivery of care in response to the unique needs of vulnerable groups, who- ever they might be.

The number of groups becom- ing officially deemed vulnerable continues to expand, making virtually everyone vulnerable for some reason. If arguments for not conducting research with vulner- able populations were to prevail, the advancement of the body of scientific knowledge could eas- ily be halted. Such an outcome clearly would not be in anyone’s best interest.

If ethical guidelines are held to the highest possible standards, research with every population will be ethical, and all popula- tions can be included, which will allow all individuals to reap

the benefits of ongoing research. This contributes to the health of all people, expansion of the body of nursing knowledge, and im- proved human existence.

refereNces American Psychiatric Association.

(1994). Diagnostic and statistical manu- al of mental disorders (4th ed.). Wash- ington, DC: Author.

Compton, P. (2002). Caring for an al- cohol-dependent patient. Nursing, 32(12), 58-63.

Council for International Organizations of Medical Sciences. (2002). Inter- national ethical guidelines for biomedi- cal research involving human subjects. Retrieved from http://www.cioms.ch/ frame_guidelines_nov_2002.htm

Dick, D.M., Jones, K., Saccone, N., Hin- richs, A., Wang, J.C., Goate, A., et al. (2006). Endophenotypes successfully lead to gene identification: Results from the collaborative study on the genetics of alcoholism. Behavior Ge- netics, 36, 112-126.

Edenberg, H.J., & Foroud, T. (2006). The genetics of alcoholics: Identifying specific genes through family studies. Addiction Biology, 11, 386-396.

Israel, M., & Hay, I. (2006). Research eth- ics for social scientists. London, UK: Sage.

Levine, C., Faden, R., Grady, C., Ham- merschmidt, D., Eckenwiler, L., & Sugarmen, J. (2004). The limitations of “vulnerability” as a protection for human research participants. The American Journal of Bioethics, 4(3), 44-49.

Moore, L.W., & Miller, M. (1999). Ini- tiating research with doubly vulner- able populations. Journal of Advanced Nursing, 30, 1034-1040.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved from the National Institutes of Health website: http://ohsr.od.nih.gov/guidelines/ belmont.html

Nuremberg code. (1949). In Trials of war criminals before the Nuremberg military tribunals under control council law (No. 10, Vol. 2, pp. 181-182). Re- trieved from the National Institutes of Health website: http://ohsr.od.nih. gov/guidelines/nuremberg.html

Prescott, C.A., & Kendler, K.S. (1999). Genetic and environmental contri- butions to alcohol abuse and depen-

dence in a population-based sample of male twins. American Journal of Psychiatry, 156, 34-39.

Quest, T., & Marco, C.A. (2003). Ethics seminars: Vulnerable populations in emergency medicine research. Aca- demic Emergency Medicine, 10, 1294- 1298.

Rhodes, R. (2005). Rethinking research ethics. The American Journal of Bioeth- ics, 5(1), 7-28.

Rogers, B. (2005). Research with pro- tected populations: Vulnerable par- ticipants. AAOHN Journal, 53, 156- 157.

Steinke, E.E. (2004). Research ethics, informed consent, and participant recruitment. Clinical Nurse Specialist, 18, 88-95.

U.S. Department of Health and Human Services. (2005). Public welfare: Pro- tection of human subjects, 45 C.F.R. § 46. Retrieved from http://www.hhs. gov/ohrp/humansubjects/guidance/ 45cfr46.htm

Williams, R.W., & Lu, L. (2008). Inte- grative genetic analysis of alcohol dependence using the genetwork web resources. Technologies from the Field, 31, 275-277.

World Medical Association. (2008). Declaration of Helsinki—Ethical prin- ciples for medical research involving human subjects. Retrieved from http:// www.wma.net/en/30publications/ 10policies/b3/index.html

Dr. Gwyn is Assistant Professor, De- partment of Nursing, Florida Hospital College of Health Sciences, Orlando, and Dr. Colin is Professor and Director, Nursing PhD, Nursing Administration, and Nursing Education Programs, Barry University, Division of Nursing, Miami Shores, Florida.

The authors disclose that they have no significant financial interests in any product or class of products discussed directly or indirectly in this activity, including research support. The authors acknowledge Rev. Lewis R. Gwyn, III, and Barry University’s Writing Center for their guidance and editorial support in preparing the manuscript.

Address correspondence to Priscilla Gage Gwyn, PhD, ARNP-BC, OCN, Assistant Professor, Department of Nursing, Florida Hospital College of Health Sciences, 671 Winyah Drive, Orlando, FL 32803; e-mail: gage. gwyn@fhchs.edu.

Received: March 22, 2009 Accepted: October 5, 2009 Posted: January 22, 2010

doi:10.3928/02793695-20100108-01

Journal of Psychosocial nursing • Vol. 48, no. 2, 2010 43

Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.

 
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