The Right to Freedom from Harm and Discomfort

The Right to Freedom from Harm and Discomfort

Researchers have an obligation to avoid, prevent, or minimize harm (nonmaleficence) in studies with humans. Participants should not be subjected to unnecessary risks of harm or discomfort, and their participation must be essential to achieving societally important aims that could not otherwise be realized. In research with humans, harm and discomfort can be physical (e.g., injury, fatigue), emotional (e.g., stress, fear), 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.

Research should be conducted only by qualified people, especially if potentially dangerous equipment or specialized procedures are used. Ethical researchers must be prepared to terminate a study if they suspect that continuation would result in injury, death, or undue distress to participants. When a new medical procedure or drug is being tested, prior experimentation with animals or tissue cultures is often advisable. (Guidelines for the ethical treatment of animals are discussed later in this chapter).

Protecting human beings from physical harm may be straightforward, but the psychological consequences of study participation are usually subtle and require sensitivity. For example, participants may be asked questions about their personal views, weaknesses, or fears. Such queries might lead people to reveal highly personal information. The point is not that researchers should refrain from asking questions but that they need to be aware of the intrusion on people’s psyches.

The need for sensitivity may be greater in qualitative studies, which often involve in-depth exploration on personal topics. In-depth probing may expose deep-seated fears that study participants had previously repressed. Qualitative researchers, regardless of the underlying research tradition, must be especially vigilant in anticipating complications.

The Right to Protection from Exploitation

Study involvement should not place participants at a disadvantage or expose them to damages. Participants need to be assured that their participation, or information they might provide, will not be used against them. For example, people describing their finances to a researcher should not be exposed to the risk of losing public health care benefits; those divulging illegal drug use should not fear exposure to criminal authorities.

Study participants enter into a special relationship with researchers, and this relationship should never be exploited. Exploitation may be overt and malicious (e.g., sexual exploitation, use of donated blood for a commercial product) but might also be more elusive. For example, suppose people agreed to participate in a study requiring 30 minutes of their time but the time commitment was actually much longer (e.g., 90 minutes). In such a situation, the researcher might be accused of exploiting the researcher–participant relationship.

Because nurse researchers may have a nurse–patient (in addition to a researcher–participant) relationship, special care may be required 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.

In qualitative research, psychological distance between researchers and participants often declines as the study progresses. The emergence of a pseudotherapeutic relationship is not uncommon, which can heighten the risk that exploitation could occur inadvertently (Eide & Kahn, 2008). On the other hand, qualitative researchers often are in a better position than quantitative researchers to do good, rather than just to avoid doing harm, because of the relationships they often develop with participants. Munhall (2012) has argued that qualitative nurse researchers have the responsibility of ensuring that, if there is a conflict, the clinical and therapeutic imperative of nursing takes precedence over the research imperative of advancing knowledge.

Example of Therapeutic Research Experiences: In their study on secondary traumatic stress among certified nurse-midwives, Beck and colleagues (2015) were told by some participants that it was therapeutic for them to write about traumatic births they had attended. One participant wrote,

· “I think it’s fascinating how little respect our patients and coworkers give to the traumatic experiences we suffer. It is healing to be able to write out my experiences in this study and actually have researchers interested in studying this topic.”

Respect for Human Dignity

Respect for human dignity is the second ethical principle in the Belmont Report. This principle includes the right to self-determination and the right to full disclosure.

The Right to Self-Determination

Humans should be treated as autonomous agents, capable of controlling their actions. Self-determination means that prospective participants can voluntarily decide whether to take part in a study, without risk of prejudicial treatment. 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 , which involves threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate. Protecting people from coercion requires careful thought when the researcher is in a position of authority or influence over potential participants, as is often the case in a nurse–patient relationship. The issue of coercion may require scrutiny even when there is not a preestablished relationship. For example, a generous monetary incentive (or stipend ) offered to encourage participation among an economically disadvantaged group (e.g., the homeless) might be considered mildly coercive because such incentives might pressure prospective participants into cooperation.

The Right to Full Disclosure

People’s right to make informed, voluntary decisions about study participation requires full disclosure. Full disclosure means that the researcher has fully described the study, the person’s right to refuse participation, the researcher’s responsibilities, and likely risks and benefits. The right to self-determination and the right to full disclosure are the two major elements on which informed consent—discussed later in this chapter—is based.

Full disclosure is not always straightforward because it can create biases and sample recruitment problems. Suppose we were testing the hypothesis that high school students with a high rate of absenteeism are more likely to be substance abusers than students with good attendance. If we approached potential participants and fully explained the study purpose, some students likely would refuse to participate, and nonparticipation would be selective; those least likely to volunteer might well be substance-abusing students—the group of primary interest. Moreover, by knowing the research question, those who do participate might not give candid responses. In such a situation, full disclosure could undermine the study.

A technique that is sometimes used in such situations is covert data collection ( concealment ), which is the collection of data without participants’ knowledge and consent. This might happen, for example, if a researcher wanted to observe people’s behavior in real-world settings and worried that doing so openly would affect the behavior of interest. Researchers might choose to obtain the information through concealed methods, such as by videotaping with hidden equipment or observing while pretending to be engaged in other activities. Covert data collection may in some cases be acceptable if risks are negligible and participants’ right to privacy has not been violated. Covert data collection is least likely to be ethically tolerable if the study is focused on sensitive aspects of people’s behavior, such as drug use or sexual conduct.

A more controversial technique is the use of deception , which involves deliberately withholding information about the study or providing participants with false information. For example, in studying high school students’ use of drugs, we might describe the research as a study of students’ health practices, which is a mild form of misinformation.

Deception and concealment are problematic ethically because they interfere with people’s right to make informed decisions about personal costs and benefits of participation. Some people argue that deception is never justified. Others, however, believe that if the study involves minimal risk to participants and if there are anticipated benefits to society, then deception may be justified to enhance the validity of the findings.

Another issue that has emerged in this era of electronic communication concerns data collection over the Internet. For example, some researchers analyze the content of messages posted to blogs, listservs, or social media sites. The issue is whether such messages can be treated as research data without permission and informed consent. Some researchers believe that messages posted electronically are in the public domain and can be used without consent for research purposes. Others, however, feel that standard ethical rules should apply in cyberspace research and that researchers must carefully protect the rights of those who participate in “virtual” communities. Guidance for the ethical conduct of health research on the Internet has been developed by such writers as Ellett et al. (2004) and Holmes (2009).


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. Participant selection should be based on study requirements and not on a group’s vulnerability. Participant selection has been a key ethical issue historically, with researchers sometimes selecting groups with lower social standing (e.g., poor people, prisoners) as 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.

Distributive justice also imposes duties to neither neglect nor discriminate against individuals or groups who may benefit from research. During the 1980s and 1990s, it became evident that women and minorities were being unfairly excluded from many clinical studies in the United States. This led to the promulgation of regulations requiring that researchers who seek funding from the National Institutes of Health (NIH) include women and minorities as participants. The regulations also require researchers to examine whether clinical interventions have differential effects (e.g., whether benefits are different for men than for women), although this provision has had limited adherence (Polit & Beck, 2009, 2013).

The fair treatment principle covers issues other than participant selection. The right to fair treatment means that researchers must treat people who decline to participate (or who withdraw from the study after initial agreement) in a nonprejudicial manner; that they must honor all agreements made with participants (including payment of any promised stipends); that they demonstrate respect for the beliefs, habits, and lifestyles of people from different backgrounds or cultures; that they give participants access to research staff for desired clarification; and that they afford participants courteous and tactful treatment at all times.

The Right to Privacy

Research with humans involves intrusions into personal lives. Researchers should ensure that their research is not more intrusive than it needs to be and that participants’ privacy is maintained. Participants have the right to expect that their data will be kept in strictest confidence.

Privacy issues have become especially salient in the U.S. health care community since the passage

of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which articulates federal standards to protect patients’ health information. In response to the HIPAA legislation, the U.S. Department of Health and Human Services issued the regulations Standards for Privacy of Individually Identifiable Health Information. For most health care providers who transmit health information electronically, compliance with these regulations, known as the Privacy Rule, was required as of April 14, 2003.

TIP: Some information relevant to HIPAA compliance is presented in this chapter, but you should confer with organizations that are involved in your research (if they are covered entities) regarding their practices and policies relating to HIPAA provisions. Websites that provide information about the implications of HIPAA for health research include and .


Now that you are familiar with fundamental ethical principles in research, you need to understand procedures that researchers use to adhere to them.

Risk/Benefit Assessments

One strategy that researchers can use to protect participants is to conduct a risk/benefit assessment. Such an assessment is designed to evaluate whether the benefits of participating in a study are in line with the costs, be they financial, physical, emotional, or social—that is, whether the risk/benefit ratio is acceptable. A summary of risks and benefits should be communicated to recruited individuals so that they can evaluate whether it is in their best interest to participate. Box 7.1 summarizes major costs and benefits of research participation.

BOX 7.1: Potential Benefits and Risks of Research to Participants


· Access to a potentially beneficial intervention that might otherwise be unavailable

· Comfort in being able to discuss their situation or problem with a friendly, impartial person

· Increased knowledge about themselves or their conditions, either through opportunity for introspection and self-reflection or through direct interaction with researchers

· Escape from normal routine

· Satisfaction that information they provide may help others with similar conditions

· Direct monetary or material gains through stipends or other incentives


· Physical harm, including unanticipated side effects

· Physical discomfort, fatigue, or boredom

· Emotional distress resulting from self-disclosure, introspection, fear of the unknown, discomfort with strangers, fear of repercussions, anger or embarrassment at the questions being asked

· Social risks, such as the risk of stigma, adverse effects on personal relationships, loss of status

· Loss of privacy

· Loss of time

· Monetary costs (e.g., for transportation, child care, time lost from work)

TIP: The Toolkit in the accompanying Resource Manual includes a Word document with the factors in Box 7.1 arranged in worksheet form for you to complete in doing a risk/benefit assessment. By completing the worksheet, it may be easier for you to envision opportunities for “doing good” and to avoid possibilities of doing harm.

The risk/benefit ratio should take into consideration whether risks to participants are commensurate with benefits to society. A broad guideline is that the degree of risk by participants should never exceed the potential humanitarian benefits of the knowledge to be gained. Thus, the selection of a significant topic that has the potential to improve patient care is the first step in ensuring that research is ethical. Gennaro (2014) has written eloquently about this issue.

All research involves some risks, but risk is sometimes minimal. Minimal risk is defined as risks no greater than those ordinarily encountered in daily life or during routine tests or procedures. When the risks are not minimal, researchers must proceed with caution, taking every step possible to diminish risks and maximize benefits. If expected risks to participants outweigh the anticipated benefits of the study, the research should be redesigned.

In quantitative studies, most details of the study usually are spelled out in advance, and so a reasonably accurate risk/benefit ratio assessment can be developed. Qualitative studies, however, usually evolve as data are gathered, and so it may be more difficult to assess all risks at the outset. Qualitative researchers must remain sensitive to potential risks throughout the study.

Example of Ongoing Risk/Benefit Assessment: Carlsson and colleagues (2007) discussed ethical issues relating to the conduct of interviews with people who have brain damage. The researchers noted the need for ongoing vigilance and attention to cues about risks and benefits. For example, one interview had to be interrupted because the participant displayed signs of distress. Afterward, however, the participant expressed gratitude for the opportunity to discuss his experience.

One potential benefit to participants is monetary. Stipends offered to prospective participants are rarely viewed as an opportunity for financial gain, but there is ample evidence that stipends are useful incentives to participant recruitment and retention (Edwards et al., 2009). Financial incentives are especially effective when the group under study is difficult to recruit, when the study is time-consuming or tedious, or when participants incur study-related costs (e.g., for childcare or transportation). Stipends range from $1 to hundreds of dollars, but many are in the $20 to $30 range.

TIP: In evaluating the anticipated risk/benefit ratio of a study design, you might want to consider how comfortable you would feel about being a study participant.

Informed Consent and Participant Authorization

A particularly important procedure for safeguarding participants is to obtain their informed consent. Informed consent means that participants have adequate information about the research, comprehend that information, and have the ability to consent to or decline participation voluntarily. This section discusses procedures for obtaining informed consent and for complying with HIPAA rules regarding accessing patients’ health information.

The Content of Informed Consent

Fully informed consent involves communicating the following pieces of information to participants:

· 1. Participant status. Prospective participants need to understand the distinction between research and treatment. They should be told which health care activities are routine and which are implemented specifically for the study. They also should be informed that data they provide will be used for research purposes.

· 2. Study goals. The overall goals of the research should be stated in lay rather than technical terms. The use to which the data will be put should be described.

· 3. Type of data. Prospective participants should be told what type of data (e.g., self-report, laboratory tests) will be collected.

· 4. Procedures. Prospective participants should be given a description of the data collection procedures and of procedures to be used in any innovative treatment.

· 5. Nature of the commitment. Participants should be told the expected time commitment at each point of contact and the number of contacts within a given time frame.

· 6. Sponsorship. Information on who is sponsoring or funding the study should be noted; if the research is part of an academic requirement, this information should be shared.

· 7. Participant selection. Prospective participants should be told how they were selected for recruitment and how many people will be participating.

· 8. Potential risks. Foreseeable risks (physical, psychological, social, or economic) or discomforts should be communicated as well as efforts that will be made to minimize risks. The possibility of unforeseeable risks should also be discussed, if appropriate. If injury or damage is possible, treatments that will be made available to participants should be described. When risks are more than minimal, prospective participants should be encouraged to seek advice before consenting.

· 9. Potential benefits. Specific benefits to participants, if any, should be described as well as possible benefits to others.

· 10. Alternatives. If appropriate, participants should be told about alternative procedures or treatments that might be advantageous to them.

· 11. Compensation. If stipends or reimbursements are to be paid (or if treatments are offered without any fee), these arrangements should be discussed.

· 12. Confidentiality pledge. Prospective participants should be assured that their privacy will at all times be protected. If anonymity can be guaranteed, this should be stated.

· 13. Voluntary consent. Researchers should indicate that participation is strictly voluntary and that failure to volunteer will not result in any penalty or loss of benefits.

· 14. Right to withdraw and withhold information. Prospective participants should be told that, after consenting, they have the right to withdraw from the study or to withhold any specific piece of information. Researchers may need to describe circumstances under which researchers would terminate the study.

· 15. Contact information. The researcher should tell participants whom they could contact in the event of further questions, comments, or complaints.

In qualitative studies, especially those requiring repeated contact with participants, it may be difficult to obtain meaningful informed consent at the outset. Qualitative researchers do not always know in advance how the study will evolve. Because the research design emerges during data collection, researchers may not know the exact nature of the data to be collected, what the risks and benefits to participants will be, or how much of a time commitment they will be expected to make. Thus, in a qualitative study, consent is often viewed as an ongoing, transactional process, sometimes called process consent . In process consent, the researcher continually renegotiates the consent, allowing participants to play a collaborative role in making decisions about ongoing participation.

Example of Process Consent: Darcy and colleagues (2014) studied the process of striving for an “ordinary, everyday life” among young children with cancer. In-depth interviews were conducted with children and their parents at 6 months and 1 year after diagnosis. Informed consent was obtained from parents, and verbal assent was obtained from children, at the first interview and confirmed at the second interview.

Comprehension of Informed Consent

Consent information is typically presented to prospective participants while they are being recruited, either orally or in writing. Written notices should not, however, take the place of spoken explanations, which provide opportunities for elaboration and for participants to question and “screen” the researchers.

Because informed consent is based on a person’s evaluation of the potential risks and benefits of participation, the information must not only be communicated but understood. Researchers may have to play a “teacher” role in communicating consent information. They should be careful to use simple language and to avoid jargon and technical terms whenever possible; they should also avoid language that might unduly influence the person’s decision to participate. Written statements should be consistent with the participants’ reading levels and educational attainment. For participants from a general population (e.g., patients in a hospital), the statement should be written at about the 7th or 8th grade reading level.

TIP: Innovations to improve understanding of consent are being developed (e.g., Yates et al., 2009). Nishimura and colleagues (2013) have undertaken a systematic review of 54 of them.

For some studies, especially those involving more than minimal risk, researchers need to ensure that prospective participants understand what participation will entail. In some cases, this might involve testing participants for their comprehension of the informed consent material before deeming them eligible. Such efforts are especially warranted with participants whose native tongue is not English or who have cognitive impairments (Simpson, 2010).

Example of Evaluating Comprehension in Informed Consent: Horgas and colleagues (2008) studied the relationship between pain and functional disability in older adults. Prospective participants had to demonstrate ability to provide informed consent:

· “Ability to consent was ascertained by explaining the study to potential participants, who were then asked to describe the study” (p. 344). All written materials for the study, including consent forms, were at the 8th grade reading level and printed in 14-point font.

Documentation of Informed Consent

Researchers usually document informed consent by having participants sign a consent form . In the United States, federal regulations for studies funded by the government require written consent of participants except under certain circumstances. When the study does not involve an intervention and data are collected anonymously—or when existing data from records or specimens are used without linking identifying information to the data—regulations requiring written informed consent do not apply. HIPAA legislation is explicit about the type of information that must be eliminated from patient records for the data to be considered de-identified.

The consent form should contain all the information essential to informed consent. Prospective participants (or a legally authorized representative) should have ample time to review the document before signing it. The consent form should also be signed by the researcher, and a copy should be retained by both parties.

An example of a written consent form used in a study of one of the authors is presented in Figure 7.1 . The numbers in the margins of this figure correspond to the types of information for informed consent outlined earlier. (The form does not indicate how people were selected; prospective participants were aware of recruitment through a particular support group.)

TIP: In developing a consent form, the following suggestions might prove helpful:

· 1. Organize the form coherently so that prospective participants can follow the logic of what is being communicated. If the form is complex, use headings as an organizational aid.

· 2. Use a large enough font so that the form can be easily read, and use spacing that avoids making the document appear too dense. Make the form attractive and inviting.

· 3. In general, simplify. Avoid technical terms if possible. If technical terms are needed, include definitions. Some suggestions are offered in the Toolkit.

· 4. Assess the form’s reading level by using a readability formula to ensure an appropriate level for the group under study. There are several such formulas, including the Flesch Reading Ease score and Flesch-Kincaid Grade Level score (Flesch, 1948). Microsoft Word provides Flesch readability statistics.

· 5. Test the form with people similar to those who will be recruited, and ask for feedback.

In certain circumstances (e.g., with non-English-speaking participants), researchers have the option of presenting the full information orally and then summarizing essential information in a short form. If a short form is used, however, the oral presentation must be witnessed by a third party, and the witness’s signature must appear on the short consent form. The signature of a third-party witness is also advisable in studies involving more than minimal risk, even when a comprehensive consent form is used.

When the primary means of data collection is through a self-administered questionnaire, some researchers do not obtain written informed consent because they assume implied consent (i.e., that the return of the completed questionnaire reflects voluntary consent to participate). This assumption, however, may not always be warranted (e.g., if patients feel that their treatment might be affected by failure to cooperate with the researcher).

TIP: The Toolkit in the accompanying Resource Manual includes several informed consent forms as Word documents that can be adapted for your use. (Many universities offer templates for consent forms.) The Toolkit also includes several other resources designed to help you with the ethical aspects of a study.

Authorization to Access Private Health Information

Under HIPAA regulations in the United States, a covered entity such as a hospital can disclose individually identifiable health information (IIHI) from its records if the patient signs an authorization. The authorization can be incorporated into the consent form, or it can be a separate document. Using a separate authorization form may be advantageous to protect the patients’ confidentiality because the form does not need to provide detailed information about the study purpose. If the research purpose is not sensitive, or if the entity is already cognizant of the study purpose, an integrated form may suffice.

The authorization, whether obtained separately or as part of the consent form, must include the following: (1) who will receive the information, (2) what type of information will be disclosed, and (3) what further disclosures the researcher anticipates. Patient authorization to access IIHI can be waived only under certain circumstances. Patient authorization usually must be obtained for data that are created as part of the research as well as for information already maintained in institutional records (Olsen, 2003).

Confidentiality Procedures

Study participants have the right to expect that data they provide will be kept in strict confidence. Participants’ right to privacy is protected through various 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. As another example, if a researcher reviewed hospital records from which all identifying information had been expunged, anonymity would again protect participants’ right to privacy. Whenever it is possible to achieve anonymity, researchers should strive to do so.

Example of Anonymity: Johnson and McRee (2015) studied health-risk behavior among high school athletes. The data for the study were collected via questionnaires, completed anonymously by nearly 50,000 student athletes in the state of Minnesota.

Confidentiality in the Absence of Anonymity

When anonymity is not possible, other confidentiality procedures are needed. A promise of confidentiality is a pledge that any information participants provide will not be publicly reported in a manner that identifies them and will not be accessible to others. This means that research information should not be shared with strangers nor with people known to participants (e.g., relatives, doctors, other nurses), unless participants give explicit permission to do so.

Researchers can take a number of steps to ensure that a breach of confidentiality does not occur, including the following:

· Obtain identifying information (e.g., name, address) from participants only when essential.

· Assign an identification (ID) number to each participant and attach the ID number rather than other identifiers to the actual data.

· Maintain identifying information in a locked file.

· Restrict access to identifying information to only a few people on a need-to-know basis.

· Enter no identifying information onto computer files.

· Destroy identifying information as quickly as practical.

· Make research personnel sign confidentiality pledges if they have access to data or identifying information.

· Report research information in the aggregate; if information for an individual is reported, disguise the person’s identity, such as through the use of a fictitious name.

TIP: Researchers who plan to collect data from participants multiple times (or who use multiple forms that need to be linked) do not have to forego anonymity. A technique that has been successful is to have participants themselves generate an ID number. They might be instructed, for example, to use their birth year and the first three letters of their mother’s maiden names as their ID code (e.g., 1946CRU). This code would be put on every form so that forms could be linked, but researchers would not know participants’ identities.

Qualitative researchers may need to take extra steps to safeguard participants’ privacy. Anonymity is rarely possible in qualitative studies because researchers typically become closely involved with participants. Moreover, because of the in-depth nature of qualitative studies, there may be a greater invasion of privacy than is true in quantitative research. Researchers who spend time in the home of a participant may, for example, have difficulty segregating the public behaviors that the participant is willing to share from private behaviors that unfold during data collection. A final issue is adequately disguising participants in reports. Because the number of participants is small, qualitative researchers may need to take extra precautions to safeguard identities. This may mean more than simply using a fictitious name. Qualitative researchers may have to slightly distort identifying information or provide only general descriptions. For example, a 49-year-old antique dealer with ovarian cancer might be described as “a middle-aged cancer patient who worked in sales” to avoid identification that could occur with the more detailed description.

Example of Confidentiality Procedures in a Qualitative Study: Dale and colleagues (2015) explored factors that contribute to poor attendance in cardiac rehabilitation programs among men with coronary heart disease and type 2 diabetes, including factors relating to the men’s masculinity and perceptions about gender roles. Potential participants were provided with an informational packet and then informed consent procedures were initiated, including assurances of confidentiality. To further protect confidentiality, the study team assigned pseudonyms to all participants.

Certificates of Confidentiality

There are situations in which confidentiality can create tensions between researchers and legal or other authorities, especially if participants engage in criminal or dangerous activity (e.g., substance abuse). To avoid the possibility of forced, involuntary disclosure of sensitive research information (e.g., through a court order or subpoena), researchers in the United States can apply for a Certificate of Confidentiality from the National Institutes of Health (Lutz et al., 2000; Wolf et al., 2012). Any research that involves the collection of personally identifiable, sensitive information is potentially eligible for a Certificate, even if the study is not federally funded. Information is considered sensitive if its release might damage participants’ financial standing, employability, or reputation or might lead to discrimination; information about a person’s mental health, as well as genetic information, is also considered sensitive. A Certificate allows researchers to refuse to disclose identifying information on study participants in any civil, criminal, administrative, or legislative proceeding at the federal, state, or local level.

A Certificate of Confidentiality helps researchers to achieve their research objectives without threat of involuntary disclosure and can be helpful in recruiting participants. Researchers who obtain a Certificate should alert prospective participants about this valuable protection in the consent form and should note any planned exceptions to those protections. For example, a researcher might decide to voluntarily comply with state child abuse reporting laws even though the Certificate would prevent authorities from punishing researchers who chose not to comply.

Example of Obtaining a Certificate of Confidentiality: Mallory and Hesson-McInnis (2013) pilot tested an HIV prevention intervention with incarcerated and other high-risk women. The women were asked about various sensitive topics, and so the researchers obtained a Certificate of Confidentiality.

Debriefings, Communications, and Referrals

Researchers can show their respect—and proactively minimize emotional risks—by carefully attending to the nature of their interactions with participants. For example, researchers should always be gracious and polite, should phrase questions tactfully, and should be considerate with regard to cultural and linguistic diversity.

Researchers can also use more formal strategies to communicate respect and concern for participants’ well-being. For example, it is sometimes useful to offer debriefing sessions after data collection is completed to permit participants to ask questions or air complaints. Debriefing is especially important when the data collection has been stressful or when ethical guidelines had to be “bent” (e.g., if any deception was used in explaining the study).

Example of Debriefing: Payne (2013) evaluated the effectiveness of a diabetes support group for indigenous women in Australia. Information was obtained before and after implementing the support group. At the end of the study,

· “a final group debriefing was implemented for ethical closure” (p. 41).

It is also thoughtful to communicate with participants after the study is completed to let them know that their participation was appreciated. Researchers sometimes demonstrate their interest in study participants by offering to share study findings with them once the data have been analyzed (e.g., by mailing them a summary or advising them of an appropriate website).

Finally, in some situations, researchers may need to assist study participants by making referrals to appropriate health, social, or psychological services.

Example of Referrals: Simwaka and colleagues (2014) studied the perceptions of women living in villages in Malawi regarding the caring behaviors of nurse-midwives during perinatal loss. To minimize psychological distress, participants were told that a qualified community nurse and her students would be available in the community from time to time to provide professional support as they grieved their loss.

Treatment of Vulnerable Groups

Adherence to ethical standards is often straightforward, but additional procedures may be required to protect the rights of special vulnerable groups . Vulnerable populations may be incapable of giving fully informed consent (e.g., cognitively impaired people) or may be at risk of unintended side effects because of their circumstances (e.g., pregnant women). Researchers interested in studying high-risk groups should understand guidelines governing informed consent, risk/benefit assessments, and acceptable research procedures for such groups. Research with vulnerable groups should be undertaken only when the risk/benefit ratio is low or when there is no alternative (e.g., studies of childhood development require child participants).

Among the groups that nurse researchers should consider vulnerable are the following:

· Children. Legally and ethically, children do not have competence to give informed consent, so the informed consent of their parents or legal guardians must be obtained. It is appropriate, however—especially if the child is at least 7 years old—to obtain the child’s assent as well. Assent refers to the child’s agreement to participate. If the child is mature enough to understand basic informed consent information (e.g., a 12-year-old), it is advisable to obtain written consent from the child as well, as evidence of respect for the child’s right to self-determination. Kanner and colleagues (2004) and Lambert and Glacken (2011) provide some guidance on children’s assent and consent to participate in research. The U.S. government has issued special regulations (Code of Federal Regulations, 2009, Subpart D) for additional protections of children as study participants.

· Mentally or emotionally disabled people. Individuals whose disability makes it impossible for them to weigh the risks and benefits of participation (e.g., people affected by cognitive impairment or coma) also cannot legally or ethically provide informed consent. In such cases, researchers should obtain the written consent of a legal guardian. To the extent possible, informed consent or assent from participants themselves should be sought as a supplement to a guardian’s consent. NIH guidelines note that studies involving people whose autonomy is compromised by disability should focus in a direct way on their condition.

· Severely ill or physically disabled people. For patients who are very ill or undergoing certain treatments, it might be prudent to assess their ability to make reasoned decisions about study participation. For certain disabilities, special procedures for obtaining consent may be required. For example, with deaf participants, the entire consent process may need to be in writing. For people who have a physical impairment preventing them from writing or for participants who cannot read and write, alternative procedures for documenting informed consent (e.g., videorecording consent proceedings) should be used.

· The terminally ill. Terminally ill people who participate in studies seldom expect to benefit personally from the research, and so the risk/benefit ratio needs to be carefully assessed. Researchers must take steps to ensure that the health care and comfort of terminally ill participants are not compromised.

· Institutionalized people. Particular care is required in recruiting institutionalized people because they depend on health care personnel and may feel pressured into participating or may believe that their treatment would be jeopardized by failure to cooperate. Inmates of prisons and other correctional facilities, who have lost their autonomy in many spheres of activity, may similarly feel constrained in their ability to withhold consent. The U.S. government has issued specific regulations for the protection of prisoners as study participants (see Code of Federal Regulations, 2009, Subpart C). Researchers studying institutionalized groups need to emphasize the voluntary nature of participation.

· Pregnant women. The U.S. government has issued additional requirements governing research with pregnant women and fetuses (Code of Federal Regulations, 2009, Subpart B). These requirements reflect a desire to safeguard both the pregnant woman, who may be at heightened physical and psychological risk, and the fetus, who cannot give informed consent. The regulations stipulate that a pregnant woman cannot be involved in a study unless its purpose is to meet the health needs of the pregnant woman, and risks to her and the fetus are minimized or there is only a minimal risk to the fetus.

Example of Research with a Vulnerable Group: Nyamathi and colleagues (2012) studied the impact of a nursing intervention on decreasing substance use among homeless youth. The participants were recruited from a drop-in agency in California. A community advisory board contributed to the design of the intervention. Research staff met with homeless youth who were interested in the study to assist them in reading and understanding informed consent. Participants completed two consent forms—one prior to screening for eligibility and the second prior to actual participation in one of two programs.

It should go without saying that researchers need to proceed with great caution in conducting research with people who might fall into two or more vulnerable categories (e.g., incarcerated youth).

External Reviews and the Protection of Human Rights

Researchers, who often have a strong commitment to their research, may not be objective in their risk/benefit assessments or in their procedures to protect participants’ rights. Because of the possibility of a biased self-evaluation, the ethical dimensions of a study should normally be subjected to external review.

Most institutions where research is conducted have formal committees for reviewing proposed research plans. These committees are sometimes called human subjects committees, ethical advisory boards, or research ethics committees. In the United States, the committee usually is called an Institutional Review Board (IRB) , whereas in Canada, it is called a Research Ethics Board (REB).

TIP: You should find out early what an institution’s requirements are regarding ethics, in terms of its forms, procedures, and review schedules. It is wise to allow a generous amount of time for negotiating with IRBs, which may require procedural modifications and re-review.

Qualitative researchers in various countries have expressed concerns that standard ethical review procedures are not sensitive to special issues and circumstances faced in qualitative research. There is concern that regulations were “… created for quantitative work, and can actually impede or interrupt work that is not hypothesis-driven ‘hard science’” (van den Hoonaard, 2002, p. i). Qualitative researchers may need to take care to explain their methods, rationales, and approaches to review board members unfamiliar with qualitative research.

Institutional Review Boards

In the United States, federally sponsored studies are subject to strict guidelines for evaluating the treatment of human participants. (Guidance on human subject’s issues in grant applications is provided in Chapter 31 .) Before undertaking such a study, researchers must submit research plans to the IRB and must also go through a formal training on ethical conduct and a certification process that can be completed online.

The duty of the IRB is to ensure that the proposed plans meet federal requirements for ethical research. An IRB can approve the proposed plans, require modifications, or disapprove the plans. The main requirements governing IRB decisions may be summarized as follows (Code of Federal Regulations, 2009, §46.111):

· Risks to participants are minimized.

· Risks to participants are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result.

· Selection of participants is equitable.

· Informed consent will be sought, as required, and appropriately documented.

· Adequate provision is made for monitoring the research to ensure participants’ safety.

· Appropriate provisions are made to protect participants’ privacy and confidentiality of the data.

· When vulnerable groups are involved, appropriate additional safeguards are included to protect their rights and welfare.

Example of IRB Approval: Deitrick and co-researchers (2015) compared the effectiveness of two different doses of promethazine for the treatment of postoperative nausea and vomiting in an American teaching hospital. Approval to conduct the study was obtained from the university’s Institutional Review Board.

Many studies require a full IRB review at a meeting with a majority of IRB members present. An IRB must have five or more members, at least one of whom is not a researcher (e.g., a member of the clergy or a lawyer may be appropriate). One IRB member must be a person who is not affiliated with the institution and is not a family member of an affiliated person. To protect against potential biases, the IRB cannot comprise entirely men, women, or members from a single profession.

For certain research involving no more than minimal risk, the IRB can use expedited review procedures, which do not require a meeting. In an expedited review, a single IRB member (usually the IRB chairperson) carries out the review. An example of research that qualifies for an expedited IRB review is minimal-risk research “… employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies” (Code of Federal Regulations, 2009, §46.110).

Federal regulations also allow certain types of research in which there are no apparent risk to participants to be exempt from IRB review. The website of the Office for Human Research Protections, in its policy guidance section, includes decision charts designed to clarify whether a study is exempt.

TIP: Researchers seeking a Certificate of Confidentiality must first obtain IRB approval because such approval is a prerequisite for the Certificate. Applications for the Certificate should be submitted at least 3 months before participants are expected to enroll in the study.

Data and Safety Monitoring Boards

In addition to IRBs, researchers in the United States may have to communicate information about ethical aspects of their studies to other groups. For example, some institutions have established separate Privacy Boards to review researchers’ compliance with provisions in HIPAA, including review of authorization forms and requests for waivers.

For researchers evaluating interventions in clinical trials, NIH also requires review by a data and safety monitoring board (DSMB). The purpose of a DSMB is to oversee the safety of participants, to promote data integrity, and to review accumulated outcome data on a regular basis to determine whether study protocols should be altered, or the study stopped altogether. Members of a DSMB are selected based on their clinical, statistical, and methodologic expertise. The degree of monitoring by the DSMB should be proportionate to the degree of risk involved. Slimmer and Andersen (2004) offer suggestions on developing a DSM plan. Artinian and colleagues (2004) provided good descriptions of their data and safety monitoring plan for a study of a nurse-managed telemonitoring intervention and discussed how IRBs and DSMBs differ.

Building Ethics into the Design of the Study

Researchers need to give thought to ethical requirements while planning a study and should ask themselves whether intended safeguards for protecting humans are sufficient. They must continue their vigilance throughout the course of the study as well because unforeseen ethical dilemmas may arise. Of course, first steps in doing ethical research include ensuring that the research question is clinically significant and designing the study to yield sound evidence—it can be construed as unethical to do weakly designed research because it would be a poor use of people’s time.

The remaining chapters of the book offer advice on how to design studies that yield high-quality evidence for practice. Methodologic decisions about rigor, however, must be made within the context of ethical requirements. Box 7.2 presents some examples of the kinds of questions that might be posed in thinking about ethical aspects of study design.

BOX 7.2: Examples of Questions for Building Ethics into a Study Design


· Will participants get allocated fairly to different treatment groups?

· Will steps to reduce bias or enhance integrity add to the risks participants will incur?

· Will the setting for the study protect against participant discomfort?


· Is the intervention designed to maximize good and minimize harm?

· Under what conditions might a treatment be withdrawn or altered?


· Is the population defined so as to unwittingly and unnecessarily exclude important segments of people (e.g., women or minorities)?

· Will potential participants be recruited into the study equitably?


· Will data be collected in such a way as to minimize respondent burden?

· Will procedures for ensuring confidentiality of data be adequate?

· Will data collection staff be appropriately trained to be sensitive and courteous?


· Will participants’ identities be adequately protected?

TIP: After study procedures have been developed, researchers should undertake a self-evaluation of those procedures to determine if they meet ethical requirements. Box 7.3 later in this chapter provides some guidelines that can be used for such a self-evaluation.

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