Intensive and Critical Care Nursing (2004) 20, 313—315

Clinical research 2: legal and ethical issues inresearch

R. Endacott*

La Trobe University, PO Box 199, Bendigo, Vic. 3552, Australia

Accepted 30 April 2004

Introduction

Legal and ethical principles should be at the fore-front of any researcher’s mind when planning andconducting a study, and disseminating findings. Suchprinciples are not unique to research; much of thediscussion in this paper will strike a familiar chordfrom nursing practice. This paper seeks to identifyhow researchers can satisfy ethical and legal re-quirements without compromising the intent of thestudy.

Ethical principles

Under the Nuremberg code (1964) and the Helsinkideclaration (1989), all research studies should prop-erly consider and address the ethical implicationsthat may arise from their conduct. The three eth-ical principles of beneficence, respect and justiceunderpin the conduct of research; the manner inwhich they are addressed is discussed below:

1. Informed consent in full knowledge of the risksand benefits of the study: All participants shouldbe given an information sheet outlining the na-ture of the data collection and the purpose forwhich the data will be used. Any risks, steps

*Tel.: +61 3 5444 7814; fax: +61 3 5444 7977.E-mail address: r.endacott@latrobe.edu.au (R. Endacott).

taken to reduce risk, and benefits for the indi-vidual participant should bemade explicit on theparticipant information sheet. Consent shouldbe obtained from each participant. A key issuewith some critical care research studies relatesto who the participants are. For studies whereresearchers are observing and recording nursingactivities, rather than patient data, the nurseswould be viewed as the participants. However,in these circumstances, it is common practice toseek the verbal assent of patients/relatives tothe presence of the researcher.An issue over which ethics committees may

make differing decisions is the requirement forpatient/next of kin consent for activities where:(1) the intervention is standard ICU practice(e.g. the Saline versus Albumin (SAFE) study),or where (2) no intervention is undertaken. Forexample, patient records may be reviewed aspart of a study to determine factors influencingtime taken for spinal clearance. The positioncommonly adopted is for the participating hos-pital to give consent for data collection, withthe proviso that all data is de-identified beforeit leaves the hospital and, often, that data isde-identified by a member of the research teamnot involved in management of the patient.Ethics committees will frequently request detailof the de-identification procedures. However, itis not unknown for ethics committee to requirewritten consent from patients/next of kin.

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314 R. Endacott

Consent for critically ill patients is often ad-dressed as a specific issue (NHMRC, 2001, p. 155)with the requirement in Australia for an inde-pendent third party, such as a State Guardian-ship Board or person lawfully appointed to doso, to act on behalf of the potential partici-pant in giving, or refusing, consent to inclu-sion in a research project. However, this is acontentious area, with an EU Directive (EU Di-rective 2001/20/EC) further strengthening thelegislative requirement for consent with in-competent (including critically ill) participants.The difficulties this can sometimes cause areheightened in a recent paper by Annane et al.(2004) who contrast recruitment rates to a sep-sis study before and after the decision to waivepatient/next of kin consent for inclusion in thestudy. The authors and other commentators(Annane et al., 2004; Lemaire, 2004) argue thatin such time-critical studies (randomisation wasrequired within 3 hours of the onset of shock)it is often not possible to obtain next of kinconsent. The use of a rider such as an emer-gency situation arising in the intensive care unit(shock, cardiac arrest) is proposed as a rationalefor consent waiver (Lemaire, 2004).The ethical principles of honesty and trust are

implicit in the informed consent process. Simi-larly, the concept of ‘risk’ for both participantsand hospitals also includes potential for misuseof results.

2. Autonomy: It must be made clear to participantsthat they have the right to refuse or to with-draw from the project at any time without it af-fecting their/their relative’s care (or, where theparticipants are members of staff, their profes-sional development). With qualitative methods,it is considered good practice to seek verbal as-surance from participants immediately followingdata collection that their data can be includedin the study. This safeguards against use of infor-mation which may have been accidentally dis-closed.

3. Confidentiality and anonymity: All project datamust remain confidential to the research teamand no participant should be identifiable in thefinal report or any subsequent publications. Itis common practice to also assure that partici-pating hospitals are not identifiable although inpractice this is often inferred from membershipof the research team. Similarly, some hospitalsrequire acknowledgement of their role in thestudy.

A more detailed exploration of research ethics isprovided by Miles and Huberman (1994, p. 290).

Who judges whether research is‘ethical’?

In a formal manner, hospital and University ethicscommittees are appointed specifically for this pur-pose. However, those who allow access to theirsettings (unit managers) and consumers/the mediaalso comment on the ethical conduct of research.

Gaining ethics approval

The key concerns of ethics committees can begrouped under three headings:

(a) Is this ‘good science’? This issue is often de-bated by recipients of critical reports fromethics committees but a key ethical concern isthat participants shouldn’t waste their time onpoorly designed research. The competence ofthe researchers to undertake the study is alsoassessed by the ethics committee.

(b) What are the benefits, costs and risks for pa-tients/participants? It is generally accepted byparticipants that their input may not yield ben-efit for them personally. However, researchersshould bear in mind the balance of cost andbenefit. It may be appropriate to deliver aseminar to present and discuss findings in thesite where data collection was undertaken. It iscommon practice to identify what processes arein place for dealing with any potential harm,physical or psychological, that may result tothe patient. This usually requires identifyingthe trigger points for reporting or intervening ifbad practice is revealed through the researchdata collection (for example, if patient safetyis compromised). A useful strategy is to referany matters of concern through the hospitalclinical risk management processes. Drug tri-als have detailed procedures for reporting andmanaging any harm to participants.

(c) What are the benefits, costs and risks for thishospital/department? Costs to be consideredby ethics committees include the time to betaken for staff in providing data, or in attend-ing briefing sessions regarding the research. Inthe UK there are processes in place at NHS Trustlevel to identify all such ‘hidden’ costs. Ethicscommittees also seek to protect both staff andpatients from being ‘over-researched’.

The audit/research distinction is used by someethics committees to frame their role, with auditdescribed as evaluation of an existing service, withthe goal of improving the service, and research

Clinical research 2: legal and ethical issues in research 315

described as evaluation of a new service or inter-vention (The Alfred Hospital Research and EthicsUnit, 2000). However, depending on local arrange-ments for clinical governance, there may be arequirement for the Ethics Committee Chair to beinformed of all audit activity.

Access and gate-keeping in research

Any discussion regarding ethics would not be com-plete without consideration of the requirement tofully brief managers regarding research to be under-taken within their Unit. Managers are accountablefor allowing access to staff/patients for researchpurposes. This access does not negate the need forinformed consent but it does allow the manager toraise any issues that the ethics committee may havebeen unaware of.Recent developments have sought to stream-

line ethics approval processes and reduce duplica-tion for researchers (for example, the MREC andLREC model in place for some years in the UK).This model has recently been adapted to meetthe requirements of EU legislation (EU Directive2001/20/EC) and includes application to a CentralOffice of Research Ethics Committees (COREC) forclinical drug trials and studies undertaken in morethan one Strategic Health Authority. For fuller de-tails of the new process see www.corec.org.uk.In Australia, many hospital ethics committees usethe same application form. Whilst both of thesedevelopments can still result in researchers be-ing asked to refine their study in different waysby different ethics committees, this approach hasmoved the ethics approval process forward, andsimultaneously aided the accountability process.

Legal issues

Any breach of ethical principles has potential tobe a matter for litigation (e.g. breach of confiden-tiality); however, the more common legal concernswith research fall into three categories:

• Ownership of data/patents etc.: This can be aparticular thorny issue for research which is thesubject of a contract, and can also arise withcompetitive research grants.

• Professional indemnity: Academics are usuallycovered by their University professional indem-

nity insurance and nurses by the vicarious lia-bility held by their employer. However, where aresearcher is collecting research data in a fieldoutside of their place of employment, the issueof indemnity needs to be addressed. This is of-ten achieved through an honorary (i.e. unpaid!)contract between the hospital and the researc-her.

• Privacy legislation: Recent developments in pri-vacy legislation (NHMRC, 2000) have given rise tonew questions appearing on ethics forms. Specif-ically, ethics committees need to know how pa-tient datawill be kept confidential (de-identified)and how participants will be recruited. It is nolonger acceptable for the researcher to be givencontact details for potential research partici-pants. Recruitment processes thus require theresearcher to advertise the study and partici-pants to volunteer their involvement. Exceptionsto this would be: (1) recruitment of patients whomay be offered a new treatment as part of arandomised controlled trial, and (2) recruitmentof staff whose details are publicly available (e.g.via the internet).

In summary, ethical and legal issues have the po-tential to stop a research study in its tracks if notconsidered fully at all stages. The time taken forapproval by ethics committees, particularly if thereare a number involved (and if you have to apply toa Multi Centre Ethics Committee), can be consider-able. It is wise to allow at least three months forfull ethics approval.

References

Annane D, Outin H, Fisch C, Bellissant E. The effect of waiv-ing consent on enrolment in a sepsis trial. Intensive CareMedicine 2004;30(2):321—4.

Lemaire F. A waiver of consent for intensive care research?Intensive Care Medicine 2004;30(2):177—9.

Miles MB, Huberman AM. Qualitative data analysis. California:Sage Publications; 1994.

NHMRC. Guidelines under section 95 of the Privacy Act 1988.Canberra: NHMRC; 2000.

NHMRC. Human research ethics handbook: commentary on thenational statement on ethical conduct in research involvinghumans. Canberra: NHMRC; 2001.

The Alfred Hospital Research and Ethics Unit. The differencebetween audit/quality assurance (QA) and research. 2000,accessed on 19.03.04 via http://www.alfredresearch.org/ethics/qa.htm.