- Email: [email protected]
Legal considerations for nurse researchers
Janet R Southby, RN
Legal considerations for nurse researchers
Professional nurses have the right and responsibility to conduct research that will advance knowledge, develop nursing theory, and improve the practice of nursing. In nursing research, as in clinical practice, patient safety is a major concern. As a result, several codes have been developed for the ethical conduct of research with human subjects. These codes offer a basis for establishing standards for the conduct of such research. Adherence to ethical codes protects the interests of study subjects, the agency in which the research is conducted, and the investigators. Biomedical and behavioral researchers are legally liable for their performance. The first major effort of the law to cope with the problems of modern biomedical research occurred during the war crimes trials before the Nuremberg
Janet R Southby, RN, DNSc, is a major in the Army Nurse Corps. She is chief of the Nursing Research Service at the Walter Reed Army Medical Center,Washington,DC. Southby is a graduate of the Winchester (Va) Memorial Hospital School of Nursing. She received a BSN from the University of Pittsburgh, an M S N
from the University of Maryland, Baltimore, and a DNSc from The Catholic University of America, Washington, DC. The opinionsor assertionscontained herein are the private views of the author and are not to be construed as official or as reflecting the views of the Department of the Army or t h e Department of Defense.
1278
Military Tribunal. The Nuremberg Code identified certain basic moral, ethical, and legal principles for the conduct of acceptable experiments.' The Declaration of Helsenki, prepared by the World Medical Association in 1964 contained recommendations t o guide medical doctors in biomedical research involving human subjects. The declaration sets forth basic principles for the conduct of biomedical research, medical research combined with professional care, and nontherapeutic biomedical research involving human subjects. The American Medical Association (AMA) Ethical Guidelines for Clinical Investigation were written to aid physicians in fulfilling their ethical responsibilities when engaging in the clinical investigation of new drugs and procedures. The guidelines further delineate responsibilities for clinical investigations primarily for treatment and investigations for the accumulation of scientific knowledge. The Medical Malpractice Commission recommends t h a t physicians consider the Declaration of Helsenki and the AMA Guidelines for Clinical Investigation as minimal standards for the ethical conduct of clinical research. Creighton echoes this recommendation for nurses involved in research.2 Nurse researchers should be registered nurses who have achieved the educational and technical competence to perform the conceptualizing, super-
AORN Journal, June 1981, V o l 3 3 , No 7
Published guidelines on nursing ethics The American Nurses' Association (ANA) has published at least three pamphlets delineating the nursing profession's expectations and requirements in ethical matters. These ethical guidelines parallel those established by other professional codes. Code for Nurses (adopted in 1950 and revised periodically) The code provides a framework for nurses to use in making ethical decisions and discharging responsibilitiesto patients, the public, and other health care professionals.According to the code, nurses should participate in activities that contribute to the development of nursing's body of knowledge, as an investigator, a participant in research, or as a user of research results. General guidelines for participating in research, the protection of human rights, and the rights and responsibilitiesof the practitioner are presented as interpretive statements for the code. The Nurse in Research: ANA Guidelines on Ethical Values (approved in 1968) These guidelines were designed to
establish a broad context within which nurses could fulfill their research roles. They also provide a basis for the expectations placed on nurse investigators by members of other disciplines and the public. The guidelines also discuss individual rights valued by society and the profession, as well as the rights and responsibilitiesof nurses in relation to research. Human Rights Guidelines for Nurses in Clinical and Other Research (accepted in 1975 by the ANA Commission on Nursing Research) These guidelines are concerned with (1) the right of nurses with research preparationto engage in research and to have access to adequate resources and (2) the human rights of all recipients of health care or participants in research performed by investigatorswhose studies impinge on the patient care provided by nurses. Further explanation of the preparation necessary for nurse researchers is provided in the Preparation of Nurses for Participation in Research published by the ANA Commission on Nursing Research in 1976.
visory, collaborative, and e v a l u a t i v e functions i n h e r e n t in t h e investigative role. A nurse who represents herselfas a nurse researcher, whatever h e r credentials, i s h e l d to t h e standards expected o f a reasonable, prudent nurse researcher. As such, she is responsible f o r adhering t o e t h i c a l l y valid and s c i e n t i f i c a l l y s o u n d m e t h o d s and p r o c e d u r e s throughout t h e i n ~ e s t i g a t i o n . ~ I f y o u plan t o conduct research o r be part o f a researchteam, t h e protection o f human r i g h t s i s a value y o u m u s t h o l d inviolate. These r i g h t s include privacy; self-determination; conservation o f personal time, dignity, and m e n t a l energy; freedom f r o m m e n t a l o r physical harm; a n d freedom f r o m t h e i n t r i n s i c r i s k of
emotional o r physical injury. Individuals' participation as research subjects i s based o n t h e t r u s t that t h e i r r i g h t s w i l l b e respected. A c t i o n s t o protect subjects' r i g h t s should b e planned during t h e developm e n t of t h e research design and should be included in t h e study proposal. A complete description o f t h e proposed subject population and procedures for obtaining informed consent should b e reviewed and evaluated for t h e protect i o n o f human r i g h t s as w e l l as scientific merit. I f t h e design o f y o u r investigation calls for u s i n g children, pregnant women, fetuses, t h e m e n t a l l y disabled, prisoners, o r persons judged as incom-
AORN Journal, June 1981, Vol33, No 7
1279
ou must obtain consent to participate from each subject.
Y
petent to handle their own affairs, you must explain your rationale for using that population. Their use as research subjects can be justified only if there are potential benefits for them or for others of the same group in the future. You must obtain consent to participate in the research from each prospective subject or his legal representative, such as parents or a legal guardian. Children who are able to understand the implications of the proposed study should be asked to give their consent to supplement that of their parents or guardian, particularly if there is an element of risk. If a third party has a valid interest in the research procedures, such as the spouse of a patient, then consent should also be obtained from that person. If the proposed subjects are patients of other health care professionals, the researcher should discuss the proposed study with them and arrange their support. Free and informed consent incorporates several elements. These include an explanation of the study; the procedures to be followed and their purposes; the nature, extent, and possible consequences of participation; potential benefits t o the individual o r society from the research; the possible riskbenefit ratio; alternative treatment approaches available; and the methods to be used to protect privacy, such as confidentiality of the data and anonymity of the subjects. In addition to making
1280
specific information available in writing to the proposed subjects, the investigator should discuss or answer any additional questions. The subject must give his consent voluntarily and be told he is free to withdraw his consent at any time during the study. It is generally understood that potential subjects for an experimental study must be informed before they are placed in the sample and assigned t o a study group. In some studies, however, disclosing the true purpose or methodology would invalidate the study. It may then be acceptable to provide for subsequent disclosure of the nature of the concealment and the rationale for it to the participants. Arrangements should already be made for this when you obtain their consent. When discussing confidentiality, it may be advisable for you to tell the patient that if you feel your observations need t o be told to the attending physician or nurse for the patient’s welfare, you will first inform the patient and discuss this with him. Despite the importance of confidentiality to the patient and the investigation, patient welfare and safety must take precedence for the nurse.4 In many instances, the easiest way of assuring privacy is by not recording the subject’s name or any other identifying information on the d a t a collection forms. If a variety of forms that will need to be correlated are going to be used with the same subject, a code
AORN Journal, June 1981, VoE 33, No 7
number or unit number may be used. If names are necessary for follow-up, a master list of names could be kept securely in another location. The investigator may arrange to use a control desk for distribution and follow-up of questionnaires and not have personal access to the subjects’ names. If a subject’s identity is revealed on the data collection forms, a signed consent form protects both the subjects and the investigator. As the investigator, you are responsible for obtaining the informed consent of all research subjects. This responsibility cannot be delegated. In hospitals, a copy of the signed consent form should be attached to the patient’s record so staff members will be aware that research is in progress and the patient is a subject.5 If the research design requires participation by the hospital staff, you should ensure these persons are informed about the procedures and activities expected of them. For example, a staff nurse must be sufficiently informed about the research design to enable her to participate in an ethical manner. For this, the nurse must ascertain that the study design has been approved by an appropriate body; obtain information about the intent and nature of the research; and determine whether the research is consistent with professional goals.6 Bowie presented a discussion of research ethics for the clinical nurse earlier in this ~ e r i e sUlti.~ mately, the clinical nurse is responsible for giving quality nursing care to patients in the research setting.8 The investigator must adhere to the oral or written agreement made with each subject. In studies where subjects surrender one or more of their rights, it is advisable to obtain written consent. This is also true when data are collected on such media as tapes or films. When data are obtained through observation
or interviews, and the subject’s identity is not recorded or cannot be ascertained, written consent may not be necessary. Consent is usually not needed for anonymous questionnaires. Directions for completing a questionnaire often state the information will be held confidential. If a questionnaire is signed, it is usual to consider that the information was freely given. For some investigations in which the nature of the data and its use present no risk, subjects’ consent is rarely required. This applies largely t o studies seeking group characteristics using data from records o r clinical observations. The identity of each individual is lost in the analysis and interpretation of the group data, and there is no potential harm for the subjects in the data or the findings. In general, only the investigator and the research staff have access t o the raw data. If the research advisors, statisticians, or others need the raw data, it should be coded or otherwise disguised. The raw data, including signed consent forms, should be retained for a period of time after publication of the research results. Agency policy, the type of study, and statutory limitation periods will influence the time requirement. Regardless of the procedures used for protection of privacy, it is expected that research reports will not contain the identification of individual subjects. Reports should reflect a consideration of human dignity and autonomy. A disclosure t h a t would permit subjects or agencies to be identified, with potential embarrassment or psychological harm, should be sufficient to cause the investigator to desist from publi~ation.~ The research design you select will be influenced by your principles of research ethics. To assure compliance with ethical values, you should evaluate your methodology from the choice of study population through the
AORN Journal, June 1981, Vol33, No 7
1285
nstitutions differ widely in dealing with legal and ethical responsibilities.
I
plans for data collection, analysis, and publication. You must ask whether your research will be ethically acceptable while meeting scientific research goals. Informal and formal peer review can provide assistance in answering this question. Peer review is valuable for many reasons. MacKay and Soule say that peer review can be used to identify weaknesses in design or methodology; to contribute thinking directed toward the central theory or clinical question being examined; to reveal potential ethical questions, even legal problems; and, most importantly, to give expert judgment on whether the study is scientifically sound and able to answer the questions it asks. To attempt a study when the plan has obvious weaknesses is a disservice to the community and to the profession and is, therefore, unethical.l0 Informal peer review of your protocol could begin by asking a trusted colleague for comments on the ethical acceptability, quality of experimental design, and scientific merit. You may even want to set up a consulting relationship with a colleague experienced in research, a lawyer, or another health care professional. An advisory committee may be identified for a particular study. A group of colleagues with diverse backgrounds and interests can generate ideas, identify and suggest solutions to
1288
problems, and help find resources. One of the committee's most important functions though is looking at the ethical features of your proposal. The committee examines particular ethical and legal considerations and helps you weigh the possible risks against the expected gains. You should seek a formal review of your protocol before the study is begun. A review by a committee of peers is a marked asset in any research. It provides additional ethical protection to the subjects, investigator, practitioners working in the research setting, and the sponsoring institution or agency. Institutions differ widely in their requirements, structure, and operational procedures for dealing with their legal and ethical responsibilities to research subjects. In some universities, a large committee acts on all research; in other settings, there may be separate research committees for medical, behavioral, and nursing research. No institution may receive federal funds for research unless it has an institutional review board (IRB) responsible for protecting the rights of the subjects of biomedical and behavioral research, For the IRB to have the approval of the US Department of Health and Human Services, it must have qualified researchers from various fields of study and other representatives such as consumers, lawyers, members of the clergy, and members of both sexes. The ANA
AORN Journal, June 1981, Vol33, No 7
publicly supports the inclusion of nurses as members of IRBs. Nurse representation is particularly important when nursing research is being reviewed or when the research would have a n effect on nursing practice. Specific guidelines under which IRBs function are presented in proposed regulations amending basic Department of Health and Human Services policy for protection of human research subjects.’l In addition, the IRB at a particular agency will have a set of instructions for potential investigators to follow when preparing protocols for review. Diers maintains that IRBs should be responsible only for the protection of human subjects.12 In many settings, however, clearance for use of human subjects also means the researcher is automatically granted access to clinical facilities. The kinds of clearance or approval necessary for conducting research tend to become mixed, as there are some inevitable overlaps. When and where possible, it is useful to keep the various aspects of research clearance separate. The four kinds of clearance are: 1. Protection of human subjectswith consideration for the human subject’s rights. 2. Acknowledgement of scientific merit-with consideration of the rigor of the design and the methodology of the study. 3. Access to patients or subjects-with consideration of the extent to which the agency can accommodate the study, the burden it will put on staff and patients, and the priority the agency gives to the research. 4. Provision of funding-with consideration of the appropriateness of Editor’s note: This is the 19th article in a series on nursing research. Next month in the final article in the series, ElizabethA Rimm, RN, will discuss funding for nursing research.
1290
the amount of funding requested and the priority for funding the research. Nurse researchers have been troubled by the lack of distinction among the kinds of clearance necessary. For example, Diers notes there can be vast disagreement among disciplines about what constitutes a ttg~od’7 study.13 A study may be good in that it has more than adequate procedures for protection of human subjects, but it may not be approved by a clinical agency that has other priorities. Before submitting your proposal for consideration, determine which clearances or approvals are required. This will help clarify the approval process and may yield a n indica0 tion of the time needed. Notes 1. Trials of War Criminalsbefore the Nuremberg Military Tribunals under Control Council Law No 10, Vol II (Nurernberg, Germany, October 1946-April 1949). 2. Helen Creighton, “Legal concerns of nursing research,” Nursing Research 26 (SepternberOctober 1977) 337-341. 3. The Nurse in Research: ANA Guidelines on Ethical Values (New York: American Nurses’ Association, 1968). 4. R Ellis, “The nurse as investigator and member of the research team,” Annals of the New York Academy of Sciences 169 (Jan 21, 1970) 435-441. 5. Human Rights Guidelines for Nurses in Clinical and Other Research (Kansas City: American Nurses’ Association, 1975) 1. 6. Code for Nurses with Interpretive Statements (Kansas City: American Nurses’Association,1979). 7. R B Bowie, “Research ethics for the clinical nurse,” AORN Journal 31 (May 1980) 1016-1018. 8. The Nurse in Research: ANA Guidelines. 9. Sr Bernadette Arminger, “Ethics of nursing research,” Nursing Research 26 (SepternberOctober 1977) 330-336. 10. Ruth C MacKay, John A Soule, ”Nurses as investigators: Some ethical and legal issues,” The Canadian Nurse 71 (September 1975) 29. 11. U S Department of Health, Education, and Welfare, “Proposed regulations amending basic HEW policy for protection of human research subjects,” Federal Register 44 (Aug 14, 1979) 47,68847,729. 12. D Diers, Research in Nursing Practice (Philadelphia: J 6 Lippincott, 1979) 264-271. 13. Ibid.
AORN Journal, June 1981, Vol33, No 7
Legal considerations for nurse researchers
Professional nurses have the right and responsibility to conduct research that will advance knowledge, develop nursing theory, and improve the practice of nursing. In nursing research, as in clinical practice, patient safety is a major concern. As a result, several codes have been developed for the ethical conduct of research with human subjects. These codes offer a basis for establishing standards for the conduct of such research. Adherence to ethical codes protects the interests of study subjects, the agency in which the research is conducted, and the investigators. Biomedical and behavioral researchers are legally liable for their performance. The first major effort of the law to cope with the problems of modern biomedical research occurred during the war crimes trials before the Nuremberg
Janet R Southby, RN, DNSc, is a major in the Army Nurse Corps. She is chief of the Nursing Research Service at the Walter Reed Army Medical Center,Washington,DC. Southby is a graduate of the Winchester (Va) Memorial Hospital School of Nursing. She received a BSN from the University of Pittsburgh, an M S N
from the University of Maryland, Baltimore, and a DNSc from The Catholic University of America, Washington, DC. The opinionsor assertionscontained herein are the private views of the author and are not to be construed as official or as reflecting the views of the Department of the Army or t h e Department of Defense.
1278
Military Tribunal. The Nuremberg Code identified certain basic moral, ethical, and legal principles for the conduct of acceptable experiments.' The Declaration of Helsenki, prepared by the World Medical Association in 1964 contained recommendations t o guide medical doctors in biomedical research involving human subjects. The declaration sets forth basic principles for the conduct of biomedical research, medical research combined with professional care, and nontherapeutic biomedical research involving human subjects. The American Medical Association (AMA) Ethical Guidelines for Clinical Investigation were written to aid physicians in fulfilling their ethical responsibilities when engaging in the clinical investigation of new drugs and procedures. The guidelines further delineate responsibilities for clinical investigations primarily for treatment and investigations for the accumulation of scientific knowledge. The Medical Malpractice Commission recommends t h a t physicians consider the Declaration of Helsenki and the AMA Guidelines for Clinical Investigation as minimal standards for the ethical conduct of clinical research. Creighton echoes this recommendation for nurses involved in research.2 Nurse researchers should be registered nurses who have achieved the educational and technical competence to perform the conceptualizing, super-
AORN Journal, June 1981, V o l 3 3 , No 7
Published guidelines on nursing ethics The American Nurses' Association (ANA) has published at least three pamphlets delineating the nursing profession's expectations and requirements in ethical matters. These ethical guidelines parallel those established by other professional codes. Code for Nurses (adopted in 1950 and revised periodically) The code provides a framework for nurses to use in making ethical decisions and discharging responsibilitiesto patients, the public, and other health care professionals.According to the code, nurses should participate in activities that contribute to the development of nursing's body of knowledge, as an investigator, a participant in research, or as a user of research results. General guidelines for participating in research, the protection of human rights, and the rights and responsibilitiesof the practitioner are presented as interpretive statements for the code. The Nurse in Research: ANA Guidelines on Ethical Values (approved in 1968) These guidelines were designed to
establish a broad context within which nurses could fulfill their research roles. They also provide a basis for the expectations placed on nurse investigators by members of other disciplines and the public. The guidelines also discuss individual rights valued by society and the profession, as well as the rights and responsibilitiesof nurses in relation to research. Human Rights Guidelines for Nurses in Clinical and Other Research (accepted in 1975 by the ANA Commission on Nursing Research) These guidelines are concerned with (1) the right of nurses with research preparationto engage in research and to have access to adequate resources and (2) the human rights of all recipients of health care or participants in research performed by investigatorswhose studies impinge on the patient care provided by nurses. Further explanation of the preparation necessary for nurse researchers is provided in the Preparation of Nurses for Participation in Research published by the ANA Commission on Nursing Research in 1976.
visory, collaborative, and e v a l u a t i v e functions i n h e r e n t in t h e investigative role. A nurse who represents herselfas a nurse researcher, whatever h e r credentials, i s h e l d to t h e standards expected o f a reasonable, prudent nurse researcher. As such, she is responsible f o r adhering t o e t h i c a l l y valid and s c i e n t i f i c a l l y s o u n d m e t h o d s and p r o c e d u r e s throughout t h e i n ~ e s t i g a t i o n . ~ I f y o u plan t o conduct research o r be part o f a researchteam, t h e protection o f human r i g h t s i s a value y o u m u s t h o l d inviolate. These r i g h t s include privacy; self-determination; conservation o f personal time, dignity, and m e n t a l energy; freedom f r o m m e n t a l o r physical harm; a n d freedom f r o m t h e i n t r i n s i c r i s k of
emotional o r physical injury. Individuals' participation as research subjects i s based o n t h e t r u s t that t h e i r r i g h t s w i l l b e respected. A c t i o n s t o protect subjects' r i g h t s should b e planned during t h e developm e n t of t h e research design and should be included in t h e study proposal. A complete description o f t h e proposed subject population and procedures for obtaining informed consent should b e reviewed and evaluated for t h e protect i o n o f human r i g h t s as w e l l as scientific merit. I f t h e design o f y o u r investigation calls for u s i n g children, pregnant women, fetuses, t h e m e n t a l l y disabled, prisoners, o r persons judged as incom-
AORN Journal, June 1981, Vol33, No 7
1279
ou must obtain consent to participate from each subject.
Y
petent to handle their own affairs, you must explain your rationale for using that population. Their use as research subjects can be justified only if there are potential benefits for them or for others of the same group in the future. You must obtain consent to participate in the research from each prospective subject or his legal representative, such as parents or a legal guardian. Children who are able to understand the implications of the proposed study should be asked to give their consent to supplement that of their parents or guardian, particularly if there is an element of risk. If a third party has a valid interest in the research procedures, such as the spouse of a patient, then consent should also be obtained from that person. If the proposed subjects are patients of other health care professionals, the researcher should discuss the proposed study with them and arrange their support. Free and informed consent incorporates several elements. These include an explanation of the study; the procedures to be followed and their purposes; the nature, extent, and possible consequences of participation; potential benefits t o the individual o r society from the research; the possible riskbenefit ratio; alternative treatment approaches available; and the methods to be used to protect privacy, such as confidentiality of the data and anonymity of the subjects. In addition to making
1280
specific information available in writing to the proposed subjects, the investigator should discuss or answer any additional questions. The subject must give his consent voluntarily and be told he is free to withdraw his consent at any time during the study. It is generally understood that potential subjects for an experimental study must be informed before they are placed in the sample and assigned t o a study group. In some studies, however, disclosing the true purpose or methodology would invalidate the study. It may then be acceptable to provide for subsequent disclosure of the nature of the concealment and the rationale for it to the participants. Arrangements should already be made for this when you obtain their consent. When discussing confidentiality, it may be advisable for you to tell the patient that if you feel your observations need t o be told to the attending physician or nurse for the patient’s welfare, you will first inform the patient and discuss this with him. Despite the importance of confidentiality to the patient and the investigation, patient welfare and safety must take precedence for the nurse.4 In many instances, the easiest way of assuring privacy is by not recording the subject’s name or any other identifying information on the d a t a collection forms. If a variety of forms that will need to be correlated are going to be used with the same subject, a code
AORN Journal, June 1981, VoE 33, No 7
number or unit number may be used. If names are necessary for follow-up, a master list of names could be kept securely in another location. The investigator may arrange to use a control desk for distribution and follow-up of questionnaires and not have personal access to the subjects’ names. If a subject’s identity is revealed on the data collection forms, a signed consent form protects both the subjects and the investigator. As the investigator, you are responsible for obtaining the informed consent of all research subjects. This responsibility cannot be delegated. In hospitals, a copy of the signed consent form should be attached to the patient’s record so staff members will be aware that research is in progress and the patient is a subject.5 If the research design requires participation by the hospital staff, you should ensure these persons are informed about the procedures and activities expected of them. For example, a staff nurse must be sufficiently informed about the research design to enable her to participate in an ethical manner. For this, the nurse must ascertain that the study design has been approved by an appropriate body; obtain information about the intent and nature of the research; and determine whether the research is consistent with professional goals.6 Bowie presented a discussion of research ethics for the clinical nurse earlier in this ~ e r i e sUlti.~ mately, the clinical nurse is responsible for giving quality nursing care to patients in the research setting.8 The investigator must adhere to the oral or written agreement made with each subject. In studies where subjects surrender one or more of their rights, it is advisable to obtain written consent. This is also true when data are collected on such media as tapes or films. When data are obtained through observation
or interviews, and the subject’s identity is not recorded or cannot be ascertained, written consent may not be necessary. Consent is usually not needed for anonymous questionnaires. Directions for completing a questionnaire often state the information will be held confidential. If a questionnaire is signed, it is usual to consider that the information was freely given. For some investigations in which the nature of the data and its use present no risk, subjects’ consent is rarely required. This applies largely t o studies seeking group characteristics using data from records o r clinical observations. The identity of each individual is lost in the analysis and interpretation of the group data, and there is no potential harm for the subjects in the data or the findings. In general, only the investigator and the research staff have access t o the raw data. If the research advisors, statisticians, or others need the raw data, it should be coded or otherwise disguised. The raw data, including signed consent forms, should be retained for a period of time after publication of the research results. Agency policy, the type of study, and statutory limitation periods will influence the time requirement. Regardless of the procedures used for protection of privacy, it is expected that research reports will not contain the identification of individual subjects. Reports should reflect a consideration of human dignity and autonomy. A disclosure t h a t would permit subjects or agencies to be identified, with potential embarrassment or psychological harm, should be sufficient to cause the investigator to desist from publi~ation.~ The research design you select will be influenced by your principles of research ethics. To assure compliance with ethical values, you should evaluate your methodology from the choice of study population through the
AORN Journal, June 1981, Vol33, No 7
1285
nstitutions differ widely in dealing with legal and ethical responsibilities.
I
plans for data collection, analysis, and publication. You must ask whether your research will be ethically acceptable while meeting scientific research goals. Informal and formal peer review can provide assistance in answering this question. Peer review is valuable for many reasons. MacKay and Soule say that peer review can be used to identify weaknesses in design or methodology; to contribute thinking directed toward the central theory or clinical question being examined; to reveal potential ethical questions, even legal problems; and, most importantly, to give expert judgment on whether the study is scientifically sound and able to answer the questions it asks. To attempt a study when the plan has obvious weaknesses is a disservice to the community and to the profession and is, therefore, unethical.l0 Informal peer review of your protocol could begin by asking a trusted colleague for comments on the ethical acceptability, quality of experimental design, and scientific merit. You may even want to set up a consulting relationship with a colleague experienced in research, a lawyer, or another health care professional. An advisory committee may be identified for a particular study. A group of colleagues with diverse backgrounds and interests can generate ideas, identify and suggest solutions to
1288
problems, and help find resources. One of the committee's most important functions though is looking at the ethical features of your proposal. The committee examines particular ethical and legal considerations and helps you weigh the possible risks against the expected gains. You should seek a formal review of your protocol before the study is begun. A review by a committee of peers is a marked asset in any research. It provides additional ethical protection to the subjects, investigator, practitioners working in the research setting, and the sponsoring institution or agency. Institutions differ widely in their requirements, structure, and operational procedures for dealing with their legal and ethical responsibilities to research subjects. In some universities, a large committee acts on all research; in other settings, there may be separate research committees for medical, behavioral, and nursing research. No institution may receive federal funds for research unless it has an institutional review board (IRB) responsible for protecting the rights of the subjects of biomedical and behavioral research, For the IRB to have the approval of the US Department of Health and Human Services, it must have qualified researchers from various fields of study and other representatives such as consumers, lawyers, members of the clergy, and members of both sexes. The ANA
AORN Journal, June 1981, Vol33, No 7
publicly supports the inclusion of nurses as members of IRBs. Nurse representation is particularly important when nursing research is being reviewed or when the research would have a n effect on nursing practice. Specific guidelines under which IRBs function are presented in proposed regulations amending basic Department of Health and Human Services policy for protection of human research subjects.’l In addition, the IRB at a particular agency will have a set of instructions for potential investigators to follow when preparing protocols for review. Diers maintains that IRBs should be responsible only for the protection of human subjects.12 In many settings, however, clearance for use of human subjects also means the researcher is automatically granted access to clinical facilities. The kinds of clearance or approval necessary for conducting research tend to become mixed, as there are some inevitable overlaps. When and where possible, it is useful to keep the various aspects of research clearance separate. The four kinds of clearance are: 1. Protection of human subjectswith consideration for the human subject’s rights. 2. Acknowledgement of scientific merit-with consideration of the rigor of the design and the methodology of the study. 3. Access to patients or subjects-with consideration of the extent to which the agency can accommodate the study, the burden it will put on staff and patients, and the priority the agency gives to the research. 4. Provision of funding-with consideration of the appropriateness of Editor’s note: This is the 19th article in a series on nursing research. Next month in the final article in the series, ElizabethA Rimm, RN, will discuss funding for nursing research.
1290
the amount of funding requested and the priority for funding the research. Nurse researchers have been troubled by the lack of distinction among the kinds of clearance necessary. For example, Diers notes there can be vast disagreement among disciplines about what constitutes a ttg~od’7 study.13 A study may be good in that it has more than adequate procedures for protection of human subjects, but it may not be approved by a clinical agency that has other priorities. Before submitting your proposal for consideration, determine which clearances or approvals are required. This will help clarify the approval process and may yield a n indica0 tion of the time needed. Notes 1. Trials of War Criminalsbefore the Nuremberg Military Tribunals under Control Council Law No 10, Vol II (Nurernberg, Germany, October 1946-April 1949). 2. Helen Creighton, “Legal concerns of nursing research,” Nursing Research 26 (SepternberOctober 1977) 337-341. 3. The Nurse in Research: ANA Guidelines on Ethical Values (New York: American Nurses’ Association, 1968). 4. R Ellis, “The nurse as investigator and member of the research team,” Annals of the New York Academy of Sciences 169 (Jan 21, 1970) 435-441. 5. Human Rights Guidelines for Nurses in Clinical and Other Research (Kansas City: American Nurses’ Association, 1975) 1. 6. Code for Nurses with Interpretive Statements (Kansas City: American Nurses’Association,1979). 7. R B Bowie, “Research ethics for the clinical nurse,” AORN Journal 31 (May 1980) 1016-1018. 8. The Nurse in Research: ANA Guidelines. 9. Sr Bernadette Arminger, “Ethics of nursing research,” Nursing Research 26 (SepternberOctober 1977) 330-336. 10. Ruth C MacKay, John A Soule, ”Nurses as investigators: Some ethical and legal issues,” The Canadian Nurse 71 (September 1975) 29. 11. U S Department of Health, Education, and Welfare, “Proposed regulations amending basic HEW policy for protection of human research subjects,” Federal Register 44 (Aug 14, 1979) 47,68847,729. 12. D Diers, Research in Nursing Practice (Philadelphia: J 6 Lippincott, 1979) 264-271. 13. Ibid.
AORN Journal, June 1981, Vol33, No 7