ch 13

A person gives consent to participate in a study, is assigned to an intervention group, and is expected to remain in the study for 1 year. What ethical principle is violated if after 6 months the subjects in the treatment group have more problems than the control subjects, and the nurse researcher does not allow the members of the treatment group to stop treatment? a. Justice b. Beneficence c. Confidentiality d. respect for persons

ANS: A Justice is an ethical principle that preserves a participant's right to fair treatment. Participants should be able to withdraw without recrimination from the researcher. They can choose to withdraw from a study at any time. Beneficence refers to benefitting others. Confidentiality refers to privacy. Respect for persons refers to self-determination.

What basic human right exists when subjects have the right to withdraw from a study without penalty? Right to self-determination Right to anonymity and confidentiality Right to fair treatment Right to protection from discomfort and harm

ANS: A The right to self-determination exists when subjects have the right to withdraw from a study without penalty. This does not describe the right to anonymity and confidentiality. This does not describe right to fair treatment. This does not describe the right to protection from discomfort and harm.

What are ethical principles that are illustrated by obtaining IRB approval? (Select all that apply.) a. Respect b. Beneficence c. Trust d. Justice e. Anonymity f. Confidentiality

ANS: A, B, D

The five human rights that are outlined in ANA guidelines include: (Select all that apply.) a. right to self-determination. b. right to privacy and dignity. c. right to legal consultation. d. right to anonymity and confidentiality. e. right to fair treatment. f. right to protection from discomfort and harm. g. right to comprehensive medical care.

ANS: A, B, D, E, F

Which statements are accurate regarding the assent process for pediatric research? (Select all that apply.) a. A parental signature is required for a child to participate in a study. b. The study protocol is reviewed with the parent and not the child. c. The child should be able to express a preference for participation. d. A child older than age 16 does not require a parent's signature for consent. e. The child should understand the purpose of the study.

ANS: A, C, E

What factors might influence whether it is ethical to require an older adult to participate in a research study? (Select all that apply.) a. The relevance of the research to issues important to older adults b. The ethnic background of the potential participant c. The age of the potential participant d. The cognitive capacity of the potential participant e. The degree of risk associated with the study

ANS: A, D, E

All the following statements appear in a study's informed consent form. Which statement violates the Code of Federal Regulations? "I understand that I may feel discomfort during the study when blood is drawn." "I understand that the researcher is not responsible for negligence-caused injury." "I understand that I will not be compensated for participating in this study." "I understand that participating in the study will not immediately benefit me."

ANS: B Consent should inform a participant of potential discomfort. Consent does not release researchers from negligence. Issues of compensation should be addressed. Consent should include issues related to the presence of or lack of benefits for participants.

The nurse researcher is planning a research study that will use human subjects and their choice to participate in a specific treatment. The ethical principle guiding the research study that describes the nurse researcher's obligation to benefit others is: justice. beneficence. confidentiality. respect for persons

ANS: B Justice refers to fair treatment. Beneficence refers to benefitting others. Confidentiality refers to anonymity and privacy. Respect for persons refers to the right to self-determination.

A patient newly diagnosed with breast cancer is asked to participate in a clinical trial for a new chemotherapy agent. This patient's freedom to participate or not participate in the study exercises protection of which of her human rights? Right to fair treatment Right to self-determination Right to privacy and dignity Right to anonymity and confidentiality

ANS: B Right to fair treatment protects a participant from coercion or undue influence as it relates to decisions related to participation in studies. Freedom to participate or not participate is the right to self-determination. Refers to a participant's right to privacy. Refers to a participant's right to privacy.

What is the basic human right that exists when the subject's identity cannot be linked, even by the researcher, with his or her individual responses? Right to self-determination Right to anonymity and confidentiality Right to fair treatment Right to protection from discomfort and harm

ANS: B This does not describe the right to self-determination. The right to anonymity and confidentiality exists when the subject's identity cannot be linked, even by the researcher, with his or her individual responses. This does not describe the right to fair treatment. This does not describe the right to protection from discomfort and harm.

An adult participant receives an informed consent form to participate in a study on breast cancer in women younger than the age of 35. The study's informed consent process should include: (Select all that apply.) a. the participants meeting the IRB members who approved the study. b. the participants being informed of risks associated with the study. c. the participants being informed of the study protocol. d. the participants being given the right to decline participation at any time. e. the participants being assured that her confidentiality will be maintained.

ANS: B, C, D, E

The role of an IRB includes: (Select all that apply.) a. assisting researchers in maintaining rigor during the data analysis phase of a study. b. ensuring that human subjects are protected from undue risks. c. providing approval for studies to be conducted at an institution. d. interviewing subjects for the informed consent process. e. ensuring that HIPAA privacy rules are maintained in a study.

ANS: B, C, E

Which is considered an essential element of the informed consent form for a research study? a. The witnessing signature of an authorized party b. The listing of members of the agency's IRB c. Explanation of whom to contact regarding any area of the study d. List of subject's assignment to intervention group or control group

ANS: C A witnessing signature is not required. Members of the IRB do not need to be listed on the consent form. Consent forms must include identification of investigators. Consent forms do not indicate in what group a participant will be placed.

A staff nurse overhears a health care professional use coercion to make a patient agree to participate in a research study. what should the staff nurse do? a. Confront the researcher with concerns. b. Document suspicions in the patient's medical record. c. Contact the hospital's institutional review board. d. Secretly tape-record the researcher's interaction with a potential subject.

ANS: C Confronting the researcher is not appropriate. Documenting in the medical record is not appropriate. Concerns regarding unethical conduct by a researcher should be directed to the IRB. Tape-recording the researcher is not appropriate.

Which statement regarding informed consent is most accurate? a. Informed consent needs to be sought only if the risks outweigh the benefits. b. Informed consent is required if there are physical risks but not if there are psychological risks. c. Researchers must obtain voluntary participation of subjects after informing them of possible risks and benefits. d. A researcher is not obligated to seek informed consent if the details of the study could upset the subject and potentially affect the study outcome.

ANS: C Informed consent should be obtained regardless of the risk-benefit ratio. Informed consent should be obtained whether risks are physical or psychological. Informed consent is required to inform participants of risks and benefits. Informed consent is especially important if participation in the study can result in the participant's experiencing emotional distress.

What is the basic human right that is violated when a nurse researcher allows an unauthorized person access to study data containing information about subject identity and responses? a. Justice b. beneficence c. confidentiality d. respect for persons

ANS: C Justice refers to fair treatment. Beneficence refers to benefitting others.P articipants should be assured of anonymity and confidentiality. The ethical principle of confidentiality is being violated. Respect for persons refers to self-determination.

What basic human right is considered to be equitable selection of subjects and their treatment during the research study? Right to self-determination Right to anonymity and confidentiality Right to fair treatment Right to protection from discomfort and harm

ANS: C This does not describe the right to self-determination. This does not describe the right to anonymity and confidentiality. The right to fair treatment is being honored when there is equitable selection of subjects and their treatment during the research study. This does not describe the right to protection from discomfort and harm

What is the ethical principle that is violated if doctors inject aged and senile patients with their cancer cells to study their rejection responses? Justice Beneficence Confidentiality Respect for persons

ANS: D Justice refers to fair treatment. Beneficence refers to benefitting others. Confidentiality refers to maintaining privacy. Participants have a right to decide whether they receive a treatment or not. Injecting senile patients with a medication without their expressed consent violates the ethical principle of respect for persons.

The nurse researcher is planning a research study that will use human subjects and their choice to participate in a specific treatment. The ethical principle that describes a prospective subject's freedom to choose whether or not to participate in the research study is: justice. beneficence. confidentiality. respect for persons.

ANS: D Justice refers to fair treatment. Beneficence refers to benefitting others. Confidentiality refers to anonymity and privacy. Respect for persons refers to the right to self-determination.

The issue of personal privacy may be more difficult for nurse researchers to protect in qualitative studies than it is in quantitative studies because: participants may be related to each other. the researcher meets face to face with most participants. participants are not asked to sign an informed consent statement. verbatim quotations from participants may reveal personal information.

ANS: D Participants are usually not related to each other. Meeting face to face with participants occurs in qualitative and quantitative research and is not an issue of personal privacy unique to qualitative research. Participants do provide informed consent for qualitative studies. ANS: Verbatim quotes regarding personal situations could inadvertently reveal a participant's identity. Qualitative researchers will not use a participant's real name in a study report in an attempt to maintain a participant's anonymity.

What is the next step after an informed consent form is completed and signed? a. It is turned over to the agency's institutional review board (IRB) for safekeeping. b. It is sent to the National Institutes of Health Office of Research Integrity. c. It is filed in a locked filing cabinet, separate from data generated by the study. d. It is copied, with one given to the participant and the other held by the researcher.

ANS: D The IRB does not hold records of informed consent. The National Institutes of Health (NIH) does not hold informed consent documents. All materials from a study should be secured in the same location. The participant and researcher should both receive a copy of the informed consent document.