Learn — Research process, problem & ethics

5 notes · 15 questions on the topic

Research — meaning, purposes and the steps of the research process

Nursing research is the systematic, disciplined inquiry that develops, refines and extends the knowledge on which nursing practice, education and administration rest, using methods that let another person check how the answer was reached. It differs from problem solving on a ward, which settles one situation, in that it seeks knowledge that transfers to other patients and settings, and from audit, which measures practice against a standard already accepted.

The purposes of research are description, exploration, explanation, prediction and control; basic (pure) research adds to knowledge for its own sake and applied research solves a practice problem, and evidence-based practice is the use of the results, ranked on a hierarchy that puts systematic reviews and randomised trials at the top and expert opinion at the bottom.
Quantitative research measures variables as numbers, reasons deductively from theory to data, values objectivity and control and generalises from a sample; qualitative research collects words, reasons inductively from data to meaning, studies people in their natural setting and seeks depth rather than breadth; mixed methods combine the two in one study.
The research process runs in phases: the conceptual phase — identify and state the problem, review the literature, define the framework, formulate the question or hypothesis; the design and planning phase — choose the design, the population and sample, the tools, obtain ethics approval and run a pilot; the empirical phase — collect the data; the analytic phase — analyse and interpret; and the dissemination phase — report and use the findings.
The first step of the research process is to identify and state the research problem, before the literature is reviewed or a hypothesis written, and a pilot study is a small-scale trial run of the whole study on a few participants before the main study, done to test the tools, the procedure and the feasibility — not to produce a preliminary result.
Knowledge in nursing has come from tradition, authority, trial and error, personal experience, intuition and logical reasoning, and the scientific method — systematic, empirical, replicable and controlled — is the most reliable of these sources; a study's own characteristics are that it is systematic, logical, empirical and objective.
Florence Nightingale was the first nurse researcher — her Notes on Nursing of 1859 and her statistical charts of mortality in the Crimean War — the journal Nursing Research began in 1952, and in India the Nursing Research Society of India, founded in 1982, and the inclusion of research in the Indian Nursing Council's curricula carry the tradition.
A research report or proposal follows one order — title, abstract, introduction with the problem, purpose and hypotheses, review of literature, methodology, results, discussion, conclusion and references (the IMRAD form) — and dissemination by publication and presentation is the last step of the process, because research that is not communicated cannot change practice.

Research problem, purpose statement and research questions

A research problem is a perplexing or troubling condition that a study is designed to address, stated as a problem statement that says what is wrong or unknown and why it matters; from it come the purpose statement, which says what the study will do, and the research questions or hypotheses, which say what it will answer. The problem is the seed of the study, and every later choice of design, sample and tool must be traceable to it.

Problems come from clinical experience, from gaps and contradictions in the literature, from theory, from social and policy issues and from the priorities of funding bodies such as the ICMR, and a good one is judged by the FINER criteria — feasible, interesting, novel, ethical and relevant — together with its significance to nursing and the researcher's competence and resources.
A problem must be researchable: a question of value or policy — should nurses strike, should hospitals employ more nurses — cannot be answered by data, whereas a question about the relationship between measurable variables can, and the problem statement gives the problem, its background and significance, the gap in what is known and the purpose.
The purpose statement names what the study will do and its verb signals the approach — 'to test the effect of' points to an experiment, 'to describe' or 'to explore' to a descriptive or qualitative study, 'to compare' or 'to examine the relationship' to a comparative or correlational one; a clinical question is built as PICO — population, intervention, comparison, outcome — with T for time added when it matters.
A research question is used where prediction is impossible — descriptive and qualitative studies — and a hypothesis where a relationship can be predicted and tested: 'Does music reduce anxiety in patients waiting for surgery?' is a research question, 'patients who listen to music will report lower anxiety' is a hypothesis.
The proposal also states the delimitations (the boundaries the researcher sets — one hospital, adults only), the limitations (the weaknesses she cannot control — a convenience sample), the assumptions (taken as true without proof) and the operational definitions of every key term, and its title names the variables, the population and the setting in a dozen words or so.

Review of literature — sources, purposes and critique

A review of literature is the systematic search for, reading of and critical summary of what has already been published on a research problem, done before the study to shape it and again at the end to interpret its findings. Its purposes are to learn what is known and where the gaps are, to avoid unintended duplication, to borrow tested designs and tools, and to build the framework the study rests on.

A primary source is the original report written by the researcher who did the study — the journal article, the thesis — and a secondary source is someone else's account of it — a textbook, a review article; a review is built from primary sources, with peer-reviewed journals preferred and grey literature (reports, theses, conference papers) used with care.
The search runs through the databases — PubMed and MEDLINE, CINAHL (the nursing database), the Cochrane Library for systematic reviews, Scopus and Google Scholar — with keywords and MeSH terms joined by the Boolean operators AND, OR and NOT, inclusion and exclusion criteria set in advance, a search log kept and the reference lists of retrieved papers followed backwards.
The steps are to define the question and keywords, search, screen titles and abstracts, retrieve the full papers, read and appraise them, extract the findings into a matrix and synthesise them by theme — not study by study — and the written review moves from the broad to the specific and ends with the gap the study will fill.
Critical appraisal judges each study by its design and level of evidence, sample size and method, the reliability and validity of its tools, its analysis, its biases and how far it applies to the reader's setting; a systematic review with meta-analysis stands highest, and narrative, scoping and integrative reviews are the other forms.
The review is written in the researcher's own words with every source cited — using another's words or ideas without credit is plagiarism — in a recognised style such as APA (author and date), Vancouver (numbered, the medical journals' style) or Harvard, and the reference list holds only the works cited.

Research ethics — Nuremberg, Helsinki, Belmont and the ICMR 2017 guidelines

Research ethics is the set of principles and rules that protect the people who take part in research from harm, exploitation and deceit, and that keep the research itself honest; it was written in answer to abuses and is enforced through independent ethics committees and national guidelines. In India the governing document is the ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants, whose current edition is that of 2017.

The Nuremberg Code of 1947, written after the trial of the Nazi doctors, made the voluntary consent of the human subject essential; the Declaration of Helsinki of the World Medical Association (1964, revised many times since) is the physicians' code for research on humans and requires a favourable balance of benefit over risk and review by an independent committee; the Belmont Report of 1979 in the United States, written after the Tuskegee syphilis study, set out three principles — respect for persons, beneficence and justice.
Respect for persons means informed consent and extra protection for those with diminished autonomy, beneficence means minimising harm and maximising benefit through a risk–benefit assessment, and justice means the fair selection of participants so that the burdens and benefits of research are shared — the vulnerable are not used for research that benefits others.
The ICMR guidelines, first issued as a policy statement in 1980 and revised in 2000, 2006 and 2017, list twelve general principles — essentiality, voluntariness, non-exploitation, social responsibility, privacy and confidentiality, risk minimisation, professional competence, maximisation of benefit, institutional arrangements, transparency and accountability, totality of responsibility and environmental protection — and require every study involving human participants to be reviewed and approved by a registered institutional ethics committee before the first participant is approached.
An ethics committee under the ICMR guidelines has seven to fifteen members from several disciplines, with a chairperson from outside the institution, a member secretary, clinicians, a basic scientist, a legal expert, a social scientist or ethicist and a lay person, and a clinical trial of a drug additionally needs the approval of the Drugs Controller General of India under the New Drugs and Clinical Trials Rules of 2019 and registration in the Clinical Trials Registry – India.
Participants have the right to be informed, to consent and to withdraw at any time without penalty or loss of care, to privacy and confidentiality, to fair treatment and to protection from harm, and vulnerable groups — children, pregnant women, prisoners, the mentally ill, students and employees of the investigator, the economically or socially disadvantaged — need a justification for their inclusion and extra safeguards.
Research misconduct is fabrication (inventing data), falsification (altering data or results) and plagiarism, and honest research also means declaring conflicts of interest, giving authorship only for a real contribution, keeping the data for the required period, compensating research-related injury and never publishing the same study twice as if it were new.

Informed consent, assent, anonymity and confidentiality in research

Informed consent in research is the voluntary agreement of a person to take part in a study after being told, in a language he understands, what the study is, what it will ask of him, what risks and benefits it carries and that he may refuse or withdraw at any time without losing the care he would otherwise receive. Anonymity and confidentiality are the two ways his identity is protected afterwards, and the difference between them is the commonest examination question on research ethics.

The consent process under the ICMR guidelines gives the participant an information sheet and a consent form in his own language stating the purpose and procedures, the duration, the risks and discomforts, the benefits, the alternatives, how confidentiality will be kept, the compensation for research-related injury, the freedom to refuse or withdraw without penalty and whom to contact; it is signed and dated by the participant and a witness, a copy is given to him, a legally authorised representative signs for one who cannot, and consent is taken again when the protocol changes.
A child cannot consent, so the parent or guardian consents and the child gives assent in a form suited to his age — verbal assent from about seven years and written assent from twelve under the ICMR guidelines — and a child's refusal is respected even when the parent has agreed.
Withdrawal is a right exercised at any time, for any reason or none, without penalty and without any loss of the care the participant is entitled to; the investigator records it, never argues, and asks — without pressure — whether the data collected so far may be kept.
Anonymity means that no one, not even the researcher, can link a response to the person who gave it — questionnaires returned without names or codes; confidentiality means that the researcher can link the data to the person but promises not to reveal it — codes in place of names, the key kept separately under lock, data reported only in aggregate, records destroyed after the retention period; privacy is the person's own control over what is shared about him.
Consent must be free of coercion and undue influence: no excessive payment, no recruitment of subordinates by their superior, of students by their teacher or of patients by their treating doctor without safeguards, and deception or covert observation only with the ethics committee's approval and debriefing afterwards; anonymised record-based research may be granted a waiver of consent by the committee.
Vulnerable participants — children, pregnant women, prisoners, people with mental illness, the poor — need a justification for their inclusion, a legally authorised representative where they cannot decide and extra safeguards, and the ICMR guidelines add community consent for research in tribal populations and separate consent for the storage of samples and their use in future research.

Free today: the 10-question daily quiz · the NORCET 11 recall paper · what ₹999 unlocks — once, no auto-renewal.