Research

Question 1

Difference between research and clinical audit

Answer 1

Research:
The attempt to derive generalisable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them.
Quantitative research – designed to test a hypothesis
Addresses clearly defined questions, aims and objectives.
Needs a statistically valid sample size.
Extensive statistical analysis is required.
Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care
No built-in mechanism to require action on findings
Findings can have a wide influence on clinical practice.
Always requires ethics committee approval
Expectation that research findings are published.

Audit:
Produce information to inform delivery of best care
Designed to answer the q: ‘Does those service reach a predetermined standard?’
Measures against a standard
Does not necessarily need a statistically valid sample size
Basic statistical analysis usually suffices
Usually involves analysis of existing data, may include administration of simple interview or questionairre
Responsibility to act on findings through development of an action plan
Findings usually only influence practice within the area evaluated
Does not usually require ethics approval
Without ethics approval, audit results are not generally eligible for publication.

Question 2

Important aspects of research planning

Answer 2

type of study design, management of research bias, study power, timeframes to obtain ethics approval, publication goals (e.g. journal to submit to, mentioning publication in the ethics application and informed consent), rights and authorship (e.g. order of authors, substantial participation in the project), governance, leadership, support, having access to resources (e.g. time, data, and quality managers / statisticians), any opportunity costs, and utilisation / dissemination of the findings

Question 3

Approval for human research

Answer 3

All human research activities involving patients and / or staff must undergo ethical review and monitoring by a Human Research Ethics Committee (HREC). This review and monitoring is conducted in accordance with the relevant national human research legislation (e.g. The National Statement on Ethical Conduct in Human Research (2007) in Australia

Question 4

Goals of ethics committees

Answer 4

The underlying goals of ethics committees are to:
• protect patient rights;
• encourage shared decision making between patients (or substitute decision maker) and clinicians;
• promote fair policies and procedures that optimise the likelihood of achieving good, patient-centred outcomes;
• enhance the ethical environment for health professionals within healthcare organisations.

Question 5

Potential harms on participants

Answer 5

• ‘Harm’ to research participants may include physical harms (injury, illness, pain); psychological harms (feelings of worthlessness, distress, guilt, anger or fear related, for example, to disclosure of sensitive or embarrassing information, or learning about a genetic possibility of developing an untreatable disease); devaluation of personal worth (being humiliated, manipulated or in other ways treated disrespectfully or unjustly); social harms (damage to social networks or relationships with others; discrimination in access to benefits, services, employment or insurance; social stigmatisation; and findings of previously unknown paternity status); economic harms (discovery and prosecution of criminal conduct).
• ‘Low risk research’ describes research where the only foreseeable risk to participants is not more than one of ‘discomfort’, which can include minor side-effects of medication, the discomforts related to measuring blood pressure or doing exercise, or anxiety introduced by being interviewed. ‘Inconvenience’ may include such activities as filling in a form or participating in a street or phone survey, or simply giving up time to participate in research.
• Research into human genetics, pregnant women / human foetus, human stem cells, people highly dependent on medical care, people with intellectual or cognitive disability or severe mental illness usually require review by a full committee.

Question 6

Cultural aspects of research planning

Answer 6

The Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) has created the Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) to ensure that research with and about Aboriginal and Torres Strait Islander peoples follows a process of meaningful engagement and reciprocity between the researcher and the individuals and / or communities involved in the research. The GERAIS has 14 principles:
• Principle 1 - Recognition of the diversity and uniqueness of peoples, as well as of individuals, is essential.
• Principle 2 - The rights of Indigenous peoples to self‑determination must be recognised.
• Principle 3 - The rights of Indigenous peoples to their intangible heritage must be recognised.
• Principle 4 - Rights in the traditional knowledge and traditional cultural expressions of Indigenous peoples must be respected, protected and maintained.
• Principle 5 - Indigenous knowledge, practices and innovations must be respected, protected and maintained.
• Principle 6 - Consultation, negotiation and free, prior and informed consent are the foundations for research with or about Indigenous peoples.
• Principle 7 - Responsibility for consultation and negotiation is ongoing.
• Principle 8 - Consultation and negotiation should achieve mutual understanding about the proposed research.
• Principle 9 - Negotiation should result in a formal agreement for the conduct of a research project.
• Principle 10 - Indigenous people have the right to full participation appropriate to their skills and experiences in research projects and processes.
• Principle 11 - Indigenous people involved in research, or who may be affected by research, should benefit from, and not be disadvantaged by, the research project.
• Principle 12 - Research outcomes should include specific results that respond to the needs and interests of Indigenous people.
• Principle 13 - Plans should be agreed for managing use of, and access to, research results.
• Principle 14 - Research projects should include appropriate mechanisms and procedures for reporting on ethical aspects of the research and complying with these guidelines.

Question 7

Ethical principles for consideration

Answer 7

• Respect for autonomy - the patient has the right to refuse or choose their treatment (Voluntas aegroti suprema lex).
• Beneficence - a practitioner should act in the best interest of the patient (Salus aegroti suprema lex).
• Non-maleficence - “first, do no harm” (primum non nocere).
• Justice - the distribution of scarce health resources, and the decision of who gets what treatment (fairness and equality) (Iustitia).

Question 8

Informed consent in research

Answer 8

• Informed consent
o Researchers should obtain the prior informed consent of study participants. Informed consent has two basic components:
a) The decision is informed by adequate understanding of any information that is relevant to that decision.
b) The decision is voluntary, and is therefore free from undue influence such as manipulation or coercion.
o Information about the purpose of the study should be as specific as possible without compromising the validity of the study.
o When specific information cannot be provided at the outset, the researcher should offer to provide results to participants.
o When researchers collect information directly from individuals, or seek their consent to access records, they should inform them that supplying information is voluntary.
o The right of any person to decline to take part in a study or to withdraw from the study at any time must always be explained and respected. This includes the right to decline to answer all or any questions in a questionnaire.
• Justice
o Justice requires that, within a population, there is a fair distribution of the benefits and burdens of participation in a study, and for any participant, a balance of burdens and benefits.
o Accordingly, a researcher must:
a) avoid imposing on particular groups an unfair burden of participation in research; for example, vulnerable members of communities should not bear disproportionate burdens of studies from which other members of the community are intended to benefit
b) design studies so the inclusion and exclusion conditions for participants are fair
c) not discriminate in the selection and recruitment of participants by including or excluding them on the grounds of ethnicity, age, sex, disability or religious or spiritual beliefs, except when such exclusion or inclusion is essential to the purpose of the study.
• Beneficence and non-maleficence
o The risks of a study should be reasonable in the light of the expected benefits.
o Researchers should consider the features of a proposed study in the light of ethical considerations, and satisfactorily resolve ethical issues raised by the study. Not all ethical considerations weigh equally. A study may be assessed as ethically justifiable even if a usual ethical expectation, such as confidentiality of data, has not been comprehensively met, provided the potential benefits clearly outweigh the risks and the researchers can minimise the risks.
o A proportionate approach should be taken: the greater the risk of harm from the study, the greater should be the care in addressing the ethical issues raised.
o Above the threshold of minimal risk, a study warrants greater provision for the protection of participants. A study is within the range of minimal risk if potential participants can reasonably be expected to regard the probability and magnitude of possible harms from participation in the study as no greater than those encountered in those aspects of everyday life that relate to the study (for example, a clinical consultation with a health care provider).
• Integrity
A researcher’s commitment to the advancement of knowledge implies a duty to conduct honest and thoughtful inquiry and rigorous analysis, and to be accountable for her or his activities.
• Conflict of interest
Researchers should identify to co-researchers, sponsors, employers, participants and, where applicable, ethics committees any perceived, potential or actual conflict of interest he or she might have in relation to any others who are involved with the study. Such conflicts of interest can compromise the design or conduct of a study or the reliability of its results, thereby exposing study participants or others to needless risk or inconvenience