1. Was the study approved by an Institutional Review Board (IRB)? 2. Was informed consent obtained from the subjects?
3. Is there information about provisions for anonymity or confidentiality? 4. Were vulnerable subjects used?
5. Does it appear that subjects might have been coerced into acting as subjects?
6. Is it evident that the benefits of participation in the study outweighed the risks involved?
7. Were subjects provided the opportunity to ask questions about the study and told how to contact the researcher if other questions arose?
8. Were the subjects told how they could obtain the results of the study?
SUMMARY
Many unethical studies were conducted during World War II, particularly in the prison camps in Germany. Unethical research studies have also been revealed here in the United States.
Because of the public outcry against the atrocities committed in Germany in the 1940s, the Nuremberg Code was developed in 1947. This code calls for voluntary subjects and quali- fied researchers. Other ethical codes have been
formulated since World War II. Many professional groups have developed codes for their members.
The federal government developed research guidelines in the early 1970s, and these guidelines have been revised several times. The original guidelines called for the creation of institutional review boards (IRBs) to be established in all agen- cies that receive federal money for research. IRBs review research proposals and set standards for research conducted in their agencies.
In 1968 the American Nurses Association de- veloped a set of guidelines for nursing research. These guidelines, Human Rights Guidelines for
Nurses in Clinical and Other Research, were revised in
1975 and 1985. The American Nurses Association published another set of guidelines in 1995,
Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research.
The principal means for ensuring the rights of research subjects is through informed consent.
Informed consent means that subjects agree to participate in studies about which they have complete understanding before the study begins. The major elements of informed consent concern
the researcher’s qualifications, subject selection process, purpose of the study, study procedures, potential risks and benefits to subjects, compen- sation, alternative procedures, anonymity and confidentiality, right to refuse to participate, offer to answer questions, and means of obtaining study results. Debriefing involves a meeting with research participants after the study is com- pleted. The purpose is to ensure subjects’ under- standing of the reasons and the justification for the procedures used in the study.
Anonymity means that no one can identify the subjects in a study. Confidentiality means that the researcher will protect the subjects’ identities.
The nurse researcher must act as a patient ad- vocate, particularly in clinical trials. This advo- cacy involves protecting patients’ privacy and dignity and ensuring that there are no undue physical or psychological risks to subjects. Particular attention should be given to the rights of certain vulnerable groups, such as children, geriatric clients, prisoners, and unconscious or se- dated patients. If a child is older than 7 years, the child must give assent to participate in a study.
NURSING RESEARCH
ON THE WEB
For additional online resources, research activi- ties, and exercises, go to www.mynursingkit.
com. Select Chapter 2 from the drop-down menu.
GET INVOLVED ACTIVITIES
1. Prior to your next class, peruse the newspa- pers or periodicals to see if there is any re- port of an unethical study.
2. Ask your colleagues at work or your family or friends to tell you about some unethical research that they have seen or heard about.
3. Imagine that you are trying to obtain a 10- year-old child’s assent to participate in a study. Outline a procedure that would en- sure the child was making his or her own decision to participate.
4. Read the following explanation of a study and try to determine if all of the elements of informed consent are present. Use the 12 ele- ments of informed consent presented in this chapter as your criteria.
Students,
You are being invited to participate in a re- search project concerning assertiveness levels and locus of control. Participation in this proj- ect is strictly voluntary, and your grade in this class will not be influenced by your failure to participate in this study. You may choose to write a short research paper to earn the equiva- lent class credit.
Your participation in this study will require approximately 30 minutes of class time and will involve completion of two questionnaires. There are no risks involved in this study other than the uncomfortable feelings that may arise when reading the questions. There are several poten- tial benefits of participating in this study. You may learn more about yourself and also learn
about the research process. Additionally, the knowledge gained from this study will help nurse educators to predict assertiveness levels and locus of control levels of nursing students in the future.
Answers will remain anonymous. Please do not put your name or any identifying informa- tion on the questionnaires. If you have any ques- tions, please feel free to ask them. Results will be available on completion of the study.
SELF-TEST
Circle the letter before the best answer.
1. A questionnaire is being used to gather data on the study sample. Identification numbers on the corner of the questionnaires corre- spond to the researcher’s master list of names and numbers. Respondents are assured that this information will not be shared with any- one. The researcher is trying to ensure A. informed consent.
B. anonymity. C. data security. D. confidentiality.
2. Study participants are asked to complete a questionnaire before and after a relaxation session. One potential participant asks how confidentiality will be assured. The re- searcher states:
A. Participants will place only their first names on the questionnaires.
B. An identification number will be placed on the questionnaire that corresponds to the researcher’s master list of names and numbers.
C. It is very difficult to assure confidentiality in research involving questionnaires, but an effort will be made to assure confidentiality. D. Participants will be asked to place their
names on the questionnaire, but only the researcher will have access to the ques- tionnaires.
3. If an individual volunteers to participate in a study, he or she is always guaranteed that which of the following will be done?
A. Anonymity will be provided. B. Confidentiality will be provided. C. Informed consent will be obtained. D. Protection from psychological stress will
be assured.
4. An institutional review board is required in which type of agency or institution?
A. all agencies and institutions
B. all agencies and institutions that receive federal money for research
C. federal agencies
D. health care agencies and institutions
5. Which of the following is “least” likely to be provided for subjects?
A. informed consent B. anonymity C. confidentiality D. privacy
6. What is the name of the process used to ob- tain a child’s agreement for participation in a study?
A. assent
B. consent of a minor C. minor agreement D. informed consent
7. A friend of yours has agreed to participate in a research study. However, she is upset that she has to contact the researcher to ob- tain a copy of the study results. She thinks she should automatically be sent a copy. You tell her:
A. The researcher should automatically send a copy of the study results to all participants.
B. Researchers are required, by federal guidelines, to send a copy of the study re- sults to all participants.
C. Study participants should be provided with information that will allow them to contact the researcher if a copy of the study results is desired.
D. A copy of the study abstract should be mailed to all participants within 6 weeks of completion of the study.
Write T (True) or F (False) beside the following statements:
____ 8. Once a subject signs an informed con- sent form, he or she is agreeing to re- main in the study until it is completed. ____ 9. All study subjects must be guaranteed
anonymity.
____10. Access to the results of a study in which they have participated is the right of all participants.
____11. In a study in which confidentiality is guaranteed, anonymity is usually guar- anteed also.
____12. Debriefing means that the researchers meet and discuss problems that oc- curred in a study.
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