اخلاق در پژوهش های پزشکی
Ethical Issues in Medical Research
تاریخ : سه شنبه 23 خرداد 1391


Research underpins nursing's effectiveness and standing within the health services.  The following statement on the ethics of nursing research is intended to be read by all nurses who are in any way involved with research, extending from the initial project approval and funding stages through to the use of research findings as the basis for practice and education.  In short it its relevant to all nurses.  It has been framed particularly for nurses planning or doing research and those who teach research methods to nurses.  It assumes familiarity with other NZNO documents, particularly the Code of Ethics for Nurses and also the papers relating to social policy, research policy, and standards for practice and education; and legislation such as the Privacy Act and Human Rights Act, Code of Rights, Health & Disability Consumers, Health Commissioner Act and so needs to be understood in that broader context.

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All research makes demands on others and is likely to involve some invasion of privacy.  Hence the need for ethical guidelines.  Furthermore research is a creative process and like all creative acts is at risk of being driven by single mindedness and selfishness, which is all the more reason for its processes being subjected to ongoing scrutiny.  At base research ethics are not essentially different from any other kind of ethics, nor do the ethics of nursing research differ in principle from those applicable to all research.  However there are aspects of nursing research, as outlined below, which underline the need for ethical consciousness raising.


Some reasons why nurse researchers need to be particularly vigilant about ethics.

1. It is not only overtly vulnerable populations such as the very young, very old and mentally ill who need to be protected.  In most nursing research the data sources are human beings (whether they be called co-researchers, participants, or subjects) and are more than usually vulnerable in some way, since without actual or potential health impairment they would not fall within the ambit of nursing.

2. Because potential for physical harm resulting from nursing research is generally slight there is a tendency towards ethical naivety in underestimating and understating possibilities for other forms of risk.  Concern for safety must include prevention of psychological harm in even its most subtle forms.

3. Almost all research involving human beings is intrusive.  Information has to be elicited, things observed and recorded that might otherwise remain entirely private.  Because of the trust and intimacy inherent in the nurse-patient relationship nurses have privileged access to all kinds of information. It is all too easy to abuse that trust.

4. There is very strong pressure on nurses to engage in research, yet in New Zealand the pool of experienced nurse researchers is still relatively small, so adequate supervision is not always readily accessible.

5. The prevailing model associated with most health services and health care research is that of western science, so leaving researchers open to the risk of unintentionally applying a monocultural approach to issues and questions which are bicultural and multicultural in origin.

6. In the public arena the professional status of nursing has been ambiguous, and nursing research is still in the process of developing a distinct identity.  Hence there is no publicly recognised code of ethical practice for nurses and the public is not always clear about its expectations for nurses in the researcher role.

7. As a profession nursing in New Zealand is at the forefront of concern for human rights, consequently nurses may at times find themselves expressing ethical concerns that have not yet occurred to others.  In this frontier position nurses need to feel supported by a clear statement from their professional organisation.

8. Guidelines established for traditional scientific method are no longer adequate as, increasingly, qualitative approaches are favoured for nursing research.  In such studies it is often only in the doing and reflecting on the process that all the implications for research participants become apparent.  Therefore ethical guidelines for qualitative research are less prescriptive, so placing more responsibility on the researcher.  Ethical audit has to continue beyond initial review of the protocol.

9. Ethics and quality are inextricably linked.  The complexity of the questions which nurses research require innovative designs.  Nursing research is a purposeful activity geared directly or indirectly to the public good.  The necessary involvement of other people carries an obligation for the researcher to think about the worthiness of the project and to ensure both that it is worthwhile and that, as far as possible, the purpose is achieved.  Successful research relies on a sensitive blending of innovation, sound design, careful planning and execution, with meticulous attention to detail throughout the whole process.  Enthusiasm is important, but on its own is not a sufficient guarantee of either success or ethical soundness.

10. Research funding is increasingly competitive.  The future of nursing research depends upon its success in attracting funding.  The temptation is to adopt the strategies which have been successful for other disciplines, notably medicine, without thinking through what this means in terms of nursing's own aims, philosophy and values.


The rights of all persons to life, esteem, self determination, privacy, and protection from all forms of injury and manipulation are values which must govern researchers in their conduct towards those whom they involve as participants/subjects and co-researchers.

Competency boundaries

The first requirement for nurse researchers, just as it is for a clinician, is to work within their boundaries of competence, extending the latter as needed.  Research has its own body of knowledge and skills which are not subsumed under clinical competence.

Informed consent

The provision of information on which consent is to be based has to be nicely judged so that it does not overwhelm or confuse those whom it is intended to inform.  Valid consent to participate in research is dependent on full understanding and freedom from coercion and deception.  Usually the information to prospective participants/subjects needs to be presented both orally and in written form and should cover:

* the nature and extend of involvement expected of them

* the purpose of the research, particularly any benefits which are anticipated for the participants directly, and for the public more generally through increased knowledge

* the right to refuse and to withdraw at any point without prejudice to their care or welfare.

* ongoing opportunities for further discussion or clarification of any aspect of the study

* their rights with respect to any publication which comes out of the research

* any actual or potential risks.

Group consent does not replace individual consent, although in some cultural settings both may be required.  Generally no person can give consent for another except for those mentally incapable of giving consent for themselves, in which case a guardian may make the decision.

Consent should be written or recorded, and reconfirmed from time to time if the study extends over a long period, and there is doubt about a participant's memory.  Nurse researchers need to be particularly careful that captive populations such as students and patients are not exploited.  Consent is not open ended and refers only to the current project.  Qualitative research presents a major challenge to the principle of informed consent because the study may evolve in ways that could not be foreseen at the outset.


Confidentiality refers to what happens to the data.  It is an extension of the concept of privacy and as such is governed by the Privacy Act.  Having consented to an initial invasion of privacy by supplying information research participants have the right to maintain control over any further release of those data.  Participants/subjects should be able to trust that strict confidentiality will be maintained during the collection, storage and use of the data.  They should know who, if anyone other than the researcher, will have access to the data, and for what purposes.  The researcher needs to think through in advance the implications of guarantees given to participants, so as to be sure that these can be honoured.  Use of photographs should be specifically negotiated.

Anonymity refers to the protection given to individuals or organisations against them being identifiable in the data and the report.

Protection from risk and injury

Researchers have a responsibility to ensure that their participants/subjects are not directly or indirectly harmed in the course of the research.  Safety must encompass physical and non-physical wellbeing (psychological, cultural, social, financial and spiritual).  Qualitative research requires very careful monitoring in the respect.  Because the scope of open ended interviewing is not definable in advance the researcher is unable predict what painful experiences or memories may be triggered by the questioning.  When questioning in sensitive areas the researcher must set the limits for what is ethical.  Possible strategies for debriefing and providing additional support for participants should be rehearsed in case they are needed.

In clinical settings it should be the concern of caregivers, as well as the researcher, to ensure that services to non-participants are not diminished in anyway because of the demands of the research.


 To protect the public most organisations now have review committees to assess the ethical implications of research proposals with which they are in any way involved.  It is essential that there be a nurse member, as well as lay members, on all such committees reviewing nursing research.  Nurse researchers need to be self-monitoring also with respect to checking that their level of professional and technical competence is compatible with designing and undertaking good research of the type planned.  Implementation of poorly planned or designed research is unethical.

Where possible beginning researchers should work as part of a team.  In team research the principal researcher has responsibility for ensuring that others in the team are competent, and have the information they need in order to act in an ethical manner.  There should be inbuilt checks and balances.  Researchers who have to work alone should establish informal mentorship or supervision.  Even more experienced researchers should still use peer review regularly.

Often in nursing research the nature of the experiences being studied makes data collection stressful for the researcher as well as for the participant - so much so that their judgement could be impaired.  Researchers need to be forewarned of this possibility, vigilant for adverse effects, and ready to draw upon support and help if needed.

Publication and dissemination of findings

 This last phase of the research process also has ethical aspects.  First and foremost is the need for honesty in reporting.  The researcher has an obligation to publish both the process and the findings, so that the former can be subjected to peer scrutiny and the latter will add to the pool of nursing knowledge.  Prior to publication participants/subjects should be given an opportunity to confirm that they are faithfully represented in what is being published and, if anonymity has been promised, that this has been retained.  Any prior agreement with a supporting agency in relation to publication should be similarly honoured.  Responsibility extends beyond publication in so much as researchers have an obligation to.  Counter any misinterpretation or misuse of their research.


 Nursing research relies on collaboration and partnerships based on mutual trust.  When that trust is breached the damage is irreversible.  Honesty, openness, respect and sensitivity to others provide the cornerstones for ethical research.  It is important that all nursing research is undertaken from a clear ethical stance, with ethical concerns identified at the outset and agreed strategies for dealing with negotiated and renegotiated on an ongoing basis throughout the project.  Researchers' habits of critique and reflection provide one safeguard; external review is another.  Ethical concerns in research, particularly qualitatively research, often do not have straight forward solutions.  Nevertheless the quality of decision making is likely to be enhanced where the issues are freely discussed by all those who have a stake in the research process in conjunction with independent advisors.

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