Guidelines for critiquing the ethical aspects of a study are presented in Box 5.2.
Members of an IRB or human subjects committee should be provided with suffi- cient information to answer all these questions. Research articles, however, do not
1. Was the study approved and monitored by an Institutional Review Board, Research Ethics Board, or other similar ethics review committee?
2. Were study participants subjected to any physical harm, discomfort, or psychological distress? Did the researchers take appropriate steps to remove or prevent harm?
3. Did the benefits to participants outweigh any potential risks or actual discomfort they experienced? Did the benefits to society outweigh the costs to participants?
4. 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?
5. 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?
6. Were appropriate informed consent procedures used with all participants? If not, were there valid and justifiable reasons?
7. Were adequate steps taken to safeguard the privacy of participants? How were data kept anonymous or confidential? Were Privacy Rule procedures followed (if applicable)?
Was a Certificate of Confidentiality obtained?
8. Were vulnerable groups involved in the research? If yes, were special precautions instituted because of their vulnerable status?
9. Were groups omitted from the inquiry without a justifiable rationale (e.g., women, minorities)?
BOX 5.2 GUIDELINES FOR CRITIQUING THE ETHICAL ASPECTS OF A STUDY
always include detailed information about ethical procedures because of space con- straints in journals. Thus, it may not always be possible to critique researchers’
adherence to ethical guidelines. Nevertheless, we offer a few suggestions for con- sidering ethical issues in a study.
Many research reports do acknowledge that the study procedures were reviewed by an IRB or human subjects committee of the institution with which the researchers are affiliated. When a report specifically mentions a formal external review, it is generally safe to assume that a panel of concerned people thoroughly reviewed the ethical issues raised by the study.
You can also 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 physical or psychological harm or discomfort.
Reports do not always specifically 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 unob- trusively).
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.
Abstracts for a quantitative and a qualitative nursing study are presented below, followed by some questions to guide critical thinking about the ethical aspects of a study.
EXAMPLE 1 ■ Quantitative Research Study
Health status in an invisible population: Carnival and migrant worker children (Kilanowski &
Ryan-Wenger, 2007).
Study Purpose
The purpose of the study was to examine indicators of the health status of children of itiner- ant carnival workers and migrant farm workers in the United States.
Research Methods
A total of 97 boys and girls younger than 13 years were recruited into the study. Parents com- pleted questionnaires about their children’s health and health care, and most brought health records from which information about immunizations was obtained. All children received an oral health screening and were measured for height and weight.
R E S E A R C H E X A M P L E S A N D C R I T I C A L T H I N K I N G A C T I V I T I E S
Ethics-related Procedures
The families were recruited through the cooperation of gatekeepers at farms and carnival communities in seven states. Parents were asked to complete informed consent forms, which were available in both English and Spanish. Children who were older than 9 years were also asked whether they would like to participate, and they gave verbal assent. Confidentiality was a major concern to both the families and the gatekeepers, and the researchers needed to assure all parties that the data would be confidential and not used against families or facilities. Data were gathered in locations and time periods that had been suggested by the carnival managers and farm owners, so that parents did not need to forfeit work hours to par- ticipate in the study. Migrant farm workers were often eager to participate, and often waited in line to sign the consent forms. At the conclusion of the encounter, the researchers gave the parents a written report of the children’s growth parameters and recommendations for follow- up. In appreciation of the parents’ time, $10 was given to the parents, and the child was given an age-appropriate nonviolent toy (worth about $10) of their choice. Children were also given a new toothbrush. The IRB of the Ohio State University approved this study.
Key Findings
Carnival children were less likely than migrant children to have regularly scheduled well-child examinations and to have seen a dentist in the previous year. Among children ages 6 to 11, the itinerant children in both groups were substantially more likely to be overweight than same-aged children nationally.
CRITICAL THINKING SUGGESTIONS*:
*See the Student Resource CD-ROM for a discussion of these questions.
1. Answer the relevant questions from Box 5.2 regarding this study.
2. Also, consider the following targeted questions, which may further assist you in assessing the ethical aspects of the study:
a.Could the data for this study have been collected anonymously?
b.Why might a Certificate of Confidentiality have been helpful in this study?
3. If the results of this study are valid and generalizable, what might be some of the uses to which the findings could be put in clinical practice?
EXAMPLE 2 ■ Qualitative Research Study
Perinatal violence assessment: Teenagers’ rationale for denying violence when asked (Renker, 2006).
Study Purpose
The purpose of the study was to describe teenagers’ experiences with violence assessments from health care and social service providers, and to explore their reasons for failing to disclose violence.
Study Methods
Renker recruited 20 teenagers (18 and 19 years of age) who were no longer pregnant but who had experienced physical or sexual abuse in the year before or during a pregnancy. All women were interviewed in person and asked in-depth questions about their experiences relating to violence.
Ethics-related Procedures
Renker recruited teenagers primarily at two outpatient gynecologic clinics. Teenagers who were deemed eligible for the study were invited to schedule an interview at a location of their choice. All but one of the young women who volunteered chose a public library or a university office rather than their own homes. Teens were offered a $50 stipend to partially compensate them for the time spent in the interview (30–90 minutes). Before beginning the interview, informed consent issues were discussed, including the researcher’s responsibility to report child abuse and harm to third parties. Study participants were told that no specific questions would be asked about either of these reportable issues, but that the researcher would assist them in reporting any abuse situations if they so desired. To protect their confi- dentiality, Renker encouraged each teenager to make up a name for herself, the perpetrator, and other family members. Each interview was assigned an ID number, and the data files contained no information that could identify participants or the locale of their recruitment.
Interviews were conducted in a private setting without the presence of the teenagers’
partners, parents, or children aged 2 or older. At the end of the interview, Renker provided the teenagers with information designed to promote their safety (e.g., danger assessments, review of legal options, list of local community resources). Renker received IRB approval from her university and from the medical systems of the two clinics from which participants were recruited.
Key Findings
The teenagers reported a range of violent experiences from their current and previous
intimate partners, their parents, and gangs. Their reasons for not disclosing violence to health care providers fell into categories that corresponded to four continua: Power/Powerlessness;
Fear/Hope; Trust/Mistrust; and Action/Inertia.
CRITICAL THINKING SUGGESTIONS:
1. Answer the relevant questions from Box 5.2 regarding this study.
2. Also, consider the following targeted questions, which may further assist you in assessing the ethical aspects of the study:
a.Renker paid participants a $50 stipend—was this ethically appropriate?
b.What dilemma would Renker face if participants told her that they had abused their own children?
c.What ethical principle(s) did Renker seek to address in providing participants with information to keep them safe?
d.Did the teenagers’ creation of a pseudonym result in anonymity?
e.Might Renker have benefited from obtaining a Certificate of Confidentiality for this research?
f. If you had a teenaged friend or family member who had been abused during pregnancy, how would you feel about her participating in the study?
3. If the results of this study are trustworthy and transferable, what might be some of the uses to which the findings could be put in clinical practice?
EXAMPLE 3 ■ Quantitative Study in Appendix A
1. Read the method section from Howell and colleagues’ (2007) study (“Anxiety, anger, and blood pressure in children”) in Appendix A of this book, and then answer relevant ques- tions in Box 5.2.
2. Also consider the following targeted questions, which may further assist you in assessing the ethical aspects of the study:
a.Where was information about ethical issues located in this report?
b.What additional information regarding the ethical aspects of their study could the researchers have included in this article?
c. If you had a school-aged sibling or child of your own, how would you feel about him or her participating in the study?
EXAMPLE 4 ■ Qualitative Study in Appendix B
1. Read the method section from Beck’s (2006) study (“Anniversary of birth trauma”) in Appendix B of this book and then answer relevant questions in Box 5.2.
2. Also, consider the following targeted questions, which may further assist you in assessing the ethical aspects of the study:
a.Where was information about the ethical aspects of this study located in the report?
b.What additional information regarding the ethical aspects of Beck’s study could the researcher have included in this article?
CHAPTER REVIEW
Key new terms introduced in the chapter, together with a summary of major points, are presented in this section. Chapter 5 of the accompanying Study Guide for Essen- tials of Nursing Research,7th edition also offers exercises and study suggestions for reinforcing the concepts presented in this chapter. For additional review, see self- study questions on the CD-ROM provided with this book.
Key New Terms
Anonymity Assent
Belmont Report Beneficence Certificate of
Confidentiality Code of ethics Consent form
Confidentiality Debriefing Ethical dilemma Full disclosure Implied consent Informed consent Institutional Review
Board (IRB)
Minimal risk Process consent Research misconduct Risk–benefit assessment Stipend
Vulnerable subjects
Summary Points
* Because research has not always been conducted ethically, and because of gen- uine ethical dilemmasthat researchers often face in designing studies that are
both ethical and methodologically rigorous, codes of ethics have been devel- oped to guide researchers.
* Three major ethical principles from the Belmont Report are incorporated into most guidelines: beneficence, respect for human dignity, and justice.
* Beneficenceinvolves the performance of some good and the protection of partic- ipants from physical and psychological harm and exploitation (nonmaleficence).
* Respect for human dignity involves the participants’ right to self-determination, which means participants have the freedom to control their own activities, including their voluntary participation in the study.
* Full disclosuremeans that researchers have fully described to prospective par- ticipants their rights and the costs and benefits of the study. When full disclo- sure poses the risk of biased results, researchers sometimes use covert data col- lection or concealment (the collection of information without the participants’
knowledge or consent) or deception (either withholding information from par- ticipants or providing false information).
* Justice includes the right to fair equitable treatment and the right to privacy. In the United States, privacy has become a major issue because of the Privacy Rule regulations that resulted from the Health Insurance Portability and Account- ability Act (HIPAA).
* Various procedures have been developed to safeguard study participants rights, including the performance of a risk–benefit assessment, the implementation of informed consent procedures, and taking steps to safeguard participants’ confi- dentiality.
* In a risk–benefit assessment, the potential benefits of the study to individual participants and to society are weighed against the costs to individuals.
* Informed consentprocedures, which provide prospective participants with infor- mation needed to make a reasoned decision about participation, normally involve signing a consent form to document voluntary and informed participation.
* In qualitative studies, consent may need to be continually renegotiated with par- ticipants as the study evolves, through process consent procedures.
* Privacy can be maintained through anonymity(wherein not even researchers know participants’ identities) or through formal confidentiality procedures that safeguard the information participants provide.
* In some studies, it may be advantageous for U.S. researchers to obtain a Cer- tificate of Confidentiality that protects them against the forced disclosure of confidential information through a court order or other administrative process.
* Researchers sometimes offer debriefing sessions after data collection to provide participants with more information or an opportunity to air complaints.
* Vulnerable subjects require additional protection. These people may be vul- nerable because they are not able to make a truly informed decision about study participation (e.g., children), because of diminished autonomy (e.g., prisoners), or because their circumstances heighten the risk of physical or psychological harm (e.g., pregnant women, the terminally ill).
* External review of the ethical aspects of a study by a human subjects commit- tee, Research Ethics Board (REB), or Institutional Review Board (IRB) is highly desirable and is often required by universities and organizations from which participants are recruited.
* Ethical conduct in research involves not only protecting the rights of human and animal subjects, but also efforts to maintain high standards of integrity and avoid such forms of research misconductas plagiarism, fabrication of results, or falsification of data.