SEPTEMBER 2001, VOL 74, NO 3 R E S E A R C H C O R N E R

The concept of informed consent

in qualitative research erioperative nurses are knowl- edgeable about informed con- P sent related to surgical proce-

dures. It is incumbent upon sur- geons to inform their patients about the risks, benefits, altema- tive treatments, and potential com- plications of an impending proce- dure. Nurses, however, may ques- tion whether patients were informed adequately. Often, it is nurses who advocate for patients and demand that surgeons spend time communicating all the risks, complications, and outcomes with their patients. In research, partici- pants or subjects also need to be informed regarding the purpose and procedures, as well as the risks and benefits, before study initiation. This article describes the background of informed con- sent and human rights. Some dif- ferences between quantitative and qualitative studies related to informed consent are explained, as researchers must consider and address these issues.

HISTORICAL BACKGROUND OF INFORMED CONSENT

Violations in the ethical treat- ment of humans have resulted in the development of ethical codes and regulations that affect research protocols.’ Two famous unethical studies are the Nazi experiments conducted during World War I1 and the Tuskegee syphilis study. The Third Reich committed unethical and atrocious activities in the 1930s and 1940s, including human sterilization and euthanasia, as well as numerous

medical experiments, such as exposing participants to high alti- tudes, freezing temperatures, poi- sons, and malaria. Prisoners who could not refhe participation were subjected to surgical proce- dures. Unfortunately, this type of research was not performed in isolated cases but was planned and supported by high-ranking officials in the Nazi party.

In the United States, unethical research and scientific misconduct was documented in the Tuskegee syphilis study, which began in 1932. This study continued for 40 years with the purpose of docu- menting the natural course of syphilis in adult African- American men. Racism and class- ism were embedded in this study, and participants were not in- formed about the purpose or pro- cedures of the research. Even though the death rate of partici- pants with syphilis was twice as high for participants in the control group, the researchers did not treat them, despite the fact that penicillin was determined to be an effective cure. Numerous physi- cians, nurses, medical founda- tions, and national medical organ- izations were aware of this re- search and, for three generations, failed to stop this investigation. In 1972, the study was halted when it was reported in a newspaper and deemed ethically unjustified.

RESEARCH AND HUMAN RIGHTS These two cases of unethical

studies are famous, but they are not the only examples of studies that

risk the health and lives of partici- pants. Knowledge is power and power can corrupt, hence codes for the protection of human rights (eg, the Nuremberg Code, the Declara- tion of Helsinki) have been devel- oped by various organizations.2 The Department of Health, Education and Welfare; the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; and many other professional organizations have identified procedures for the protection of human subjects. Specifically, people have the right to self-determination, privacy, anonymity or confidentiality, fair treatment, and protection from dis- comfort and harm.

Self-determination supports people’s right to choose and con- trol their own destiny. Participants have the right to choose whether to participate in a study and the right to withdraw at any time. Deception or coercion by the researcher violates this right. “Privacy refers to the rights of individuals to decide how infor- mation about them is to be com- municated to others.”’ Privacy is violated if data are collected or disseminated without participants’ knowledge. A researcher can pro- tect research participants’ privacy by ensuring anonymity or confi- dentiality. Anonymity exists when participants’ identities cannot be linked, even by the researcher, to their actual data or responses! Confidentiality is the management of data to prevent participants’ identities from being linked to

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their responses. The right to fair treatment is based on the principle of justice. The right to protection from discomfort and harm sug- gests that the benefits of a re- search study should outweigh the risks or harm to people participat- ing in the study.

essential information for informed consent in research is

Based on these principles, the

introduction of research activities, statement of research purpose, selection of research subjects, explanation of procedures, description of risks and discomforts, description of benefits, disclosure of alternatives, assurance of anonymity or confidentiality, offer to answer questions, noncoercive disclaimer, option to withdraw, and consent to incomplete disclosure.’

DIFFERENCES BETWEEN QUANTITATIVE AND QUALITATIVE INFORMED CONSENT

In quantitative research, it is common for research participants to sign an informed consent form that contains the aforementioned information. When researchers use paper and pencil tools, the com- pletion of the survey or instrument connotes that participants agree to be involved in the study. When interviewing, the researcher may want to capture the discussion of informed consent, as well as par- ticipants’ verbal consent, on audiotape or videotape.

Ongoing Consent. The term informed consent infers the past tense or a completed process. This term suggests that all information is known and described before ini- tiation of a study, which com-

monly is done in quantitative re- search studies. In some qualitative studies, however, data collection and analysis will evolve, and some mformation may not be known before the initiation of a study.6

For example, if a qualitative

Qualitative research supports an

ongoing negotiation related to study

participation and informed consent.

researcher interviews participants regarding their compliance with taking antihypertensive medica- tion, it may be only after a few initial interviews that the researcher identifies the need to investigate sexuality. Sexual dys- function is a common adverse effect of these medications and may contribute to noncompliance among patients taking antihyper- tensives. In this example, the researcher initially may not have deemed this private information important. Data collection, howev- er, may have led the researcher to this major category of research findings. Some participants may choose not to disclose this infor- mation and, hence, refuse to par- ticipate in the study. The dynamic aspects of qualitative research, therefore, support an ongoing negotiation related to study partic- ipation and informed consent.’

Protecting paniclpants. In most qualitative studies, the potential for harm is related to

social or psychological harm as opposed to physical harm, as often is the case in quantitative studies. The researcher must iden- tify when the anticipated or col- lected data may induce stress for participants. Information regard- ing participants’ sexuality, intelli- gence, personality traits, or beliefs related to social, political, or reli- gious values must be protected, as divulging such information may induce mental or emotional stress. Qualitative researchers, therefore, must take precautions to safe- guard this information with strate- gies such as using pseudonyms, changing facts or descriptors to protect participants, or transcrib- ing transcripts personally.

divulge confidential or private information. For example, if a researcher used a convenience sample of male nurses in a certain hospital system, people with inside information, such as knowing if participants are married, their age, or the unit where they are employed, easily could identify those participants. Demographics, therefore, may need to be reported in a very generalized summary.

For the researcher, interview- ing people he or she works with, cares for, or teaches also can put the ethics of privacy, confiden- tiality, and anonymity at risk. In addition, the ethics of self-deter- mination could be violated if a teacher asks a student or a super- visor asks a subordinate to par- ticipate in his or her study. When the researcher is in an authority position, potential participants may feel some coercion to par- ticipate in the study. Too often, convenience samples are chosen because of the researcher’s ease of access. The ethics and find- ings of these studies should be

Sample descriptions also could

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evaluated cautiously. Terminology. Another differ-

ence is that qualitative research reports may use different termi- nology from quantitative research reports. The term subject connotes a power differential in which the researcher subjects a person to research variables. In many types of qualitative research, however, the person providing the data is considered a research participant. The term participant is more egal- itarian and suggests that the per- son involved is more than just a

source of data. Researchers who truly desire an egalitarian relation- ship often will involve partici- pants in analysis and procedures that contribute to the theory. Some qualitative researchers provide services, such as educational pro- grams or materials, to research participants to further enhance a democratic relationship.

SUMMARY Informed consent is an essen-

tial part of all research endeavors that involve human participants.

NOTES

Research: Conduct, Critique & Utilization, second ed (Philadelphia: W B Saunders, 1993) 89-118.

2. Ibid. 3. J J Shaughnessy, E B Zechmeister, J S

1. N Bums, S K Grove, The Practice of Nursing

Zechmeister, Research Methods in Psycholog, fifth ed (Boston: McGraw-Hill, 2000) 41-81.

4. Bums, Grove, The Practice of Nursing Research:

The human rights of research participants must be protected. It is incumbent upon the qualitative researcher to provide a dynamic informed consent when study outcomes change. The violation of privacy is more apt to occur with in-depth interviews, which has implications for researchers to protect human rights through- out data collection, analysis, and dissemination.

MICHELLE BYRNE RN, MS, PHD, CNOR

NURSING RESEARCH COMMIITEE

Conduct, Critique & Utilization, second ed, 89- 11 8. 5. Ibid; Shaughnessy, Zechmeister, Zechmeister,

Research Methods in Psycholoa, fifth ed, 41-81, 6. D Erlandson, Doing Naturalistic Inquiiy: A

Guide to Methods (Newbury Park, Calif: Sage, 1993)

7. P L Munhall, C 0 Boyd, Nursing Research: A Qualitative Perspective, second ed (New York: National League for Nursing Press, 1993) 395-408.

155-1 60.

New Evidence About Improving Patient Safety Released The Agency for Healthcare Research and Quality (AHRQ) has released new evidence about practices that could improve patient safety, according to a July 17, 200 I , news release from the agency. Researchers reviewed evidence on 79 patient safety practices, identifying 73 that are likely to improve patient safety and 1 1 that are considered highly proven to improve safety but that are not performed routinely in US hospitals and nursing homes.

The report, Making Health Care Safer: A Critical Analysis of Patient Safety Practices, is the result of a comprehensive review of the literature from medicine, aviation, and other relevant fields. Researchers focused on issues relevant to care deliv- ered in hospitals and on prevalent diseases and pro- cedures rather than on specific diagnoses.

are giving patients antibiotics immediately before surgery to prevent infections; using ultrasound to help guide the insertion of central IV lines and pre- vent punctured arteries and other complications; and administering beta blockers to patients to prevent

Among the 11 highly proven practices identified

heart attacks during or after surgical procedures. Some practices, such as the use of computerized order enhy systems, improved handwashing compli- ance, and changes in nurse staffing ratios, are not included in the 11 because they have not been stud- ied sufficiently. According to the release, more research is needed in these areas. Other practices are not included in the top 11 because they carry poten- tial risks. One such practice is increasing the use of antibiotics to prevent infections, which has the poten- tial to create antibiotic resistance.

The report is being provided to the National Forum for Health Care Quality Measurement and Reporting, which will use this information to devel- op a list of measures that patients can use to deter- mine the actions that health care facilities have taken to improve safety. The report is available on the AHRQ’s web site at http://www.ahrq.gov.

AHRQ Releases New Evidence on Proven Patient Safely Practices (news release, Rockville, Md: Agency for Heallhcare Research and Qualiiy, July 1 7, 200 I ) 1-2.

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