Legal and Ethical issues in Nursing Research

 

Uma Perwal1, Sunita Lawrence2

1PhD Scholar, Pragyan College of Nursing, Bhopal.

2Principal, Pragyan College of Nursing, Bhopal.

*Corresponding Author E-mail: perwaluma@gmail.com

 

ABSTRACT:

Introduction: In contemporary scientific and clinical research, legal and ethical issues pertaining to subjects and researchers, subject dignity preservation, and research publication play a significant role. Nonetheless, when nurses engage in research, they must navigate three distinct value systems: nursing, science, and society. These systems may clash with the values of the research subjects, communities, and cultures, leading to conflicts and challenges within the nursing profession. Definition: The definition of ethics in nursing research is "the act of moral principles that the researcher has to follow while conducting nursing research is to ensure the right and welfare of individuals, groups, or communities under study, as well as the extent of confidentiality of study and medical records." Ethics in Nursing Research Is Important. Keep the other research participants and the vulnerable group safe from the negative impacts of the experimental interventions. Prevent researchers from taking advantage of the subjects. The following are the rights of patients: emergency care, information, records, and reports; informed consent; confidentiality; and another opinion. The Ethical Obligations of a Nurse Investigator: makes ensuring that study participants' autonomy is respected when giving their agreement to engage in research and makes sure that the necessary safeguards are in place to keep them safe. In order to provide the best possible protection for the vulnerable groups included in the study—children, the elderly, pregnant women, mentally ill patients, people with physical disabilities, people who are terminally ill, and institutions—it is necessary to minimize potential risks and maximize potential benefits for each and every subject. The study's risks and rewards must be split equally between preserving the promised level of proficiency in the designated research methodologies.

 

KEYWORDS: Confidentiality, ethics, Informed consent, Legal issues, Plagiarism, Professional misconduct, Scientific research, Clinical research.

 

 


INTRODUCTION:

In contemporary scientific as well as the clinical research, legal and ethical issues that pertain to the subjects and researchers, subject dignity preservation, and research publication play a significant role. Nonetheless, when nurses engage in research, they must navigate three distinct value systems: nursing, science, and society. These systems may clash with the values of research subjects, communities, and cultures, leading to conflicts and challenges within the nursing profession.

Ethics defined:

 

The definition of ethics in nursing research is "the act of moral principles that the researcher has to follow while conducting nursing research is to ensure the right and welfare of individuals, groups, or communities under study, as well as the extent of confidentiality of study and medical records."         

 

The following are the main reasons that ethics are important in nursing research:

·       Prevent adverse consequences from the experimental interventions on the vulnerable group and other study participants.

·       Prevent researchers from abusing the participants.

·       Determine the research participants' risk-benefit ratio.

·       Assure decency and respect. confidentiality, information sharing, and treating research participants fairly.

·       Enhance the subjects' ability to provide informed or written consent for research study involvement, as well as the ability to accept or refuse study participation.   

 

ICMR Guidelines for Biomedical Ethics in Research:

I.       Principles of essentiality, which state that any research involving human subjects must do so in order to further our understanding of the topic, benefit all members of the human species, and improve the planet's ecological and environmental well-being.

II.     Community consensus, informed consent, and voluntariness principles: It acknowledges that people are only sufficiently equipped to make an informed decision about whether or not to participate in a research study if they have been given enough information about it and have understood it. Research subjects are fully told about the nature of the study, its implications, and the risks involved.

III.    The Principles of Non-exploitation, which state that research volunteers should always get compensation for their participation in studies or experiments, regardless of their social or economic background.

IV.   Principles of privacy and confidentiality, which state that, to the greatest extent feasible, the identity and records of human participants in the research or experiments are kept private and that no information about those participants that could lead to their identity disclosure is shared without legitimate scientific and legal justification.

V.     Principles of precaution and risk minimization, which entail taking care and caution at every stage of the experiment and research to guarantee that professional and ethical reviews are conducted at the proper times to establish further, detailed guidelines and provide the necessary instructions regarding the conduct of the experiment or research.

VI.   The standards of professional competence, which state that only competent, qualified professionals acting impartially and with the utmost honesty should conduct the research. If at all possible, these people have also received training to make sure they are aware of the ethical issues that need to be taken into account when carrying out such studies or experiments.

VII. Principles of accountability and transparency: All parties involved in the experiment or research shall be fully disclosed, and it will be conducted in a fair, honest, unbiased and transparent manner.

VIII. The principles of distributive justice and public interest maximization, which direct research or experimentation and their later application to benefit humanity, including the most disadvantaged members of society, research participants, and/or the community from which they are drawn.

IX. Principles of institutional arrangements: all study participants have a duty to guarantee that all institutional arrangements and protocols required for adhering to the research are in place.

X. Public interest domain principles: according to them, the research is in the public domain, as are any follow-up studies, examinations, or assessments. Subject to the rights that the researcher and study participants have under current legislation, this permits the research's findings to be widely shared through publications in academic journals and other media.

XI. The principles of totality of responsibility state that all parties, direct or indirect, who are engaged in research or experimentation have a professional and moral obligation to follow any norms, regulations, or recommendations made either generally or particularly in relation to the research or experiment under consideration.

XII. Principles of compliance, which stipulate that both the text and the spirit of these guidelines, along with any other standards, directives, and guidelines, must be adhered to by everyone conducting, associated with, or involved in any research involving the use of human subjects.

 

Recognized patients' bill of rights:

Patients have seventeen rights listed in the Charter of Patients' Bill of Rights:

·       Right to information: Every patient has a right to information about the nature of their illness, how it progressed, whether their diagnosis is confirmed or provisional, and the estimated cost of their projected course of care. Service providers should also explain this to patients in a way that they can comprehend.

·       Right to reports and records: The patient is entitled to see their reports and records, including any investigative findings. Patients should have access to these from service providers once they have paid any necessary photocopy fees.

·       Right to emergency treatment: Patients, regardless of their financial condition, shall get emergency medical care in both public and private hospitals.

·       Right to informed consent: Before beginning potentially hazardous therapy, patients have the right to be questioned about their objectives. Doctors should only administer a treatment after getting the patient's signed consent that has been carefully considered and should clearly disclose any hazards.

·       Right to confidentiality, privacy, and dignity: Unless there is a possible risk to the public's health, medical personnel are expected to maintain patient medical records in absolute confidence. When a male doctor examines a female patient, the patient has the right to have a female companion with her at all times. Additionally, hospitals need to protect patient data from outside threats.

·       Right to a second opinion: Medical facilities are required to provide patients with whatever information or data that they require in order to exercise their right to a second opinion.

·       Service providers are prohibited from denying consumers access based on their age, sexual orientation, gender, caste, or social background under the right to be free from discrimination.

·       The ability to assign a rating at the approved rate for openness and, when appropriate, care received.

·       Essential medications, equipment, and implants should be billed in accordance with the National Pharmaceutical Pricing Authority's (NPPA) tariffs, and the hospital should make it obvious to the patient when payment is due and provide an itemized bill. Furthermore, as mentioned in the Charter, it is illegal to refuse medical care to a patient due to their health, including their status as HIV positive.

·       The right to safe and standard-compliant care: In order to offer their services, hospitals must maintain a clean, hygienic atmosphere.

·       The option to select from a variety of treatment options, should any be available: Alternative medical treatments are something that patients are free to think about and even reject.

·       The freedom to select where to get prescription medications or tests: Patients can get the required supplies and services from any licensed laboratory or pharmacy.

·       Right to appropriate referral and transfer, free from unjust commercial influence: Patients who are referred or transferred are entitled to an explanation of the transfer as well as a confirmation from the hospital that they accepted the transfer.

·       All guidelines set forth by the Directorate General of Health Services must be adhered to in clinical investigations. Participants in these trials are entitled to protection.

·       The right to participant protection in biomedical and health research: National Ethical Guidelines for Biomedical and Health Research Involving Human Participants must be followed by studies involving patients.

·       The right to receive a deceased patient's body from the hospital or to be released from it: Patients are not allowed to be held in a medical facility for official purposes, such as disagreements over bill amounts.

·       Right to Patient Education: In addition to information regarding their medical condition, patients have a right to know about public health services, insurance policies, and nonprofit hospitals.

·       Right to be heard and to seek remedies: Patients are entitled to voice their concerns and opinions to their healthcare practitioners, as well as to file complaints when appropriate. In addition, if someone's rights are violated, they are entitled to remedies.

 

The Ethical Obligations of a Nurse Investigator:

The following are some of a nurse researcher's primary ethical obligations, makes ensuring that study participants' autonomy is respected when giving their agreement to engage in research and makes sure that the necessary safeguards are in place to keep them safe. In order to provide the best possible protection for the vulnerable groups included in the study—children, the elderly, pregnant women, mentally ill patients, people with physical disabilities, people who are terminally ill, and institutions—it is necessary to minimize potential risks and maximize potential benefits for each and every subject. The study's risks and rewards must be split evenly between preserving the promised level of expertise in the designated research methods and the research that is protected during the area.        

 

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Received on 09.01.2024         Modified on 29.01.2024

Accepted on 13.02.2024       ©A&V Publications All right reserved

Int.  J. of Advances in Nur. Management. 2024; 12(1):47-49.

DOI: 10.52711/2454-2652.2024.00012