Question 1

Summarize the background and purpose of the Nuremberg Code.

Accepted Answer

In the aftermath of World War II, trials involving war criminals brought to light numerous critical concerns about research-related ethical and legal considerations. The American Medical Association was asked to develop a code of ethics for research that would provide standards for judging the crimes committed by physicians who conducted experiments on prisoners in concentration camps. This request resulted in the Nuremberg Code, which defined the terms voluntary, legal capacity, sufficient understanding, and enlightened decision.

Question 2

Which provision is afforded by way of ensuring research participants' autonomy?&#10;A) Acting in the best interest of research participants&#10;B) Selecting research participants from a variety of groups&#10;C) Obtaining informed consent from research participants&#10;D) Providing research participants with protection from harm

Accepted Answer

Autonomy is the ethical principle related to informed consent, which provides a person with the right to make an informed decision about whether to participate in a research study. Beneficence guides healthcare providers to act in the best interest of the research participant and provides participants with protection from harm. Justice governs recruitment of research subjects and mandates that research participants are selected from multiple groups rather than only from a pool of those most likely to be coerced, such as subjects with severe physical or mental illness or those who are economically disadvantaged.

Question 3

Discuss the main implications of informed consent.

Accepted Answer

Informed consent ultimately implies that the potential participant's ratio of risk to benefits is clearly identified and understood. Informed consent is given when a person with the capacity to make decisions exercises the power to make a choice without force, fraud, deceit, or any type of coercion. Such an individual is usually an adult with decision-making capacity, although in some states a legally emancipated minor who makes decisions for himself or herself can provide informed consent. If the individual is not capable of providing informed consent, the person's family member or legal representative can provide informed consent for the person.

Question 4

Which method of data collection is least likely to raise challenges related to informed consent?&#10;A) Administering surveys to members of a nursing team&#10;B) Monitoring use of standard precautions by physicians&#10;C) Observing routine hand hygiene practices among nursing students&#10;D) Implementing a field experiment among same-day surgery patients

Accepted Answer

The Code of Federal Regulations does not require written consent for surveys unless the information collected is recorded in a manner that allows identification of participants, and disclosure of the information could damage the participants' reputation or lead to criminal or civil liability. Research that involves conducting field experiments or observing participants in a covert manner presents the greatest challenge to the researcher regarding informed consent. In both of these types of studies, the researcher's need to observe participants in spontaneous behavior is incompatible with the provision of informed consent. The researcher is cautioned that implementing these types of research studies could result in the primary investigator being labeled as engaging in unethical research practices.

Question 5

Differentiate between the concepts of privacy and confidentiality.

Accepted Answer

The answer of Differentiate between the concepts of privacy and...

Question 6

The DNP researcher wishes to collect data from participants' hospital medical records. In addition to ensuring informed consent and confidentiality, permission to access medical records must be granted by which organization?

A) The American Nurses Association (ANA)
B) The American Medical Association (AMA)
C) The hospital's institutional review board (IRB)
D) The hospital's utilization review (UR) committee

Accepted Answer

A researcher can gain access to medical records only through a privacy review conducted by an institutional review board (IRB). The Privacy Rule, which was implemented in 2004 as the first phase of HIPAA (Health Insurance Portability and Accountability Act of 1996), defined patient rights regarding individual health information and established protection for access to and release of a patient's medical records. HIPAA also mandates the creation of privacy boards whose sole authority is to review individual privacy rights. The AMA, ANA, and hospital UR committee are not authorized to grant access to medical records to researchers.

Question 7

Identify 10 examples of specific data elements cannot be released during the course of a research project without prior authorization from the subject in question.

Accepted Answer

The answer of Identify 10 examples of specific data elements...

Question 8

When evaluating a research proposal, which condition is not assessed by an organization's IRB?&#10;A) Equitable selection of human subjects&#10;B) Minimal identified risks to human subjects&#10;C) Provision for ensuring confidentiality of data&#10;D) Availability of funding for the research project

Accepted Answer

An IRB does not assess availability of funding for the research project. However, in addition to the federal requirement for an IRB to be in place in order for funding to be awarded, many private funding agencies and most biomedical journals require an IRB to approve research that is conducted. Prior to approval of a research proposal, an IRB ensures compliance with conditions such as equitable selection of human subjects; minimal identified risks to human subjects; provision for ensuring privacy of human subjects and confidentiality of data gathered; appropriate documentation of informed consent from all participants; and appropriate monitoring of data to ensure safety of subjects.

Question 9

Under what condition is a research proposal eligible for being awarded an expedited review by a facility's IRB?

Accepted Answer

The answer of Under what condition is a research proposal...

Question 10

Which research proposal is most likely to be exempt from IRB review?&#10;A) Studying existing hospital patient data related to hypertension&#10;B) Compiling publicly available data related to university enrollment&#10;C) Reviewing recorded diagnostic data related to patient chest X-rays&#10;D) Collecting perspiration samples from members of the healthcare team

Accepted Answer

Five categories of research may qualify as being exempt from IRB review, including (1) research projects in educational settings such as universities; (2) research involving collection of existing data if sources are either publicly available or have already been deidentified; (3) research involving surveys and tests in which the participant cannot be identified; (4) research conducted by or subject to approval by federal agencies, with the agencies overseeing the good of the general public; and (5) research related to the taste and quality of food. Expedited review may be granted by an IRB for research that involves studying existing patient data or collection of excreta and external secretions, including perspiration.

Deck 4: Ethics in Clinical Research