Gatekeeping is the process of allowing or denying another person access to someone or something (Holloway and Wheeler, 2002).  ABSTRACT VOL: 101, ISSUE: 32, PAGE NO: 36 Polly Lee, MSc, RSCN,

RGN, RM, DipN, ILTM, is lecturer in child health nursing, City University, St Bartholomew School of Nursing and Midwifery, London As well as occurring in health, it also occurs in health

care research. This article defines gatekeeping within naturalistic research in health care and discusses the different stages of a research project at which it is known to occur. It then

identifies issues that may arise with regard to gatekeeping in clinical research that can cause difficulties for the researcher. It is recognised that other disciplines such as social care

does not work on a particular afternoon. Although this is deliberate, the receptionist is protecting the GP from being presented with too many appointments. Gatekeeping also occurs within

research - particularly in the health care arena. This is deliberate, to ensure that vulnerable people such as patients or their families are protected. However, even health care

professionals can also be considered to be vulnerable if they are asked to participate in research. Therefore they too must be protected from some researchers who may not be scrupulous in

adhering to ethical principles. The gatekeeper within health care research therefore has some power and control - and responsibility - to protect potentially vulnerable people (Holloway and

Wheeler, 2002). THE PROCESS OF GATEKEEPING With health care research there is a process of gaining access to the proposed research site, and this is where the first gatekeepers are

encountered. Polit et al (2001) suggest that advanced planning is essential in order to gain this access. Gatekeeping can occur at other stages in the research process, and can cause

difficulties if it is done improperly. However, a number of strategies can be employed to avoid or at least minimise these potential difficulties. Mander (1992) recognises that the process

of gaining access to a research site presents not only some well-recognised challenges but also some positive benefits to researchers. The process has recently changed within England -

although permission has always been required from the potential research site this must now be requested by completing the relevant form (www.rdform.org.uk), which must then be submitted to

the relevant research ethics committee (www.rdform.org.uk/Info/RDform researcher guidance pack 280305.doc). ORGANISATIONAL AND PROFESSIONAL GATEKEEPERS In health care, researchers understand

that access to a research site, which may include patients, their families or health care professionals, is an important ethical issue within research proposals and therefore an element of

gatekeeping must be involved. Initially therefore they must identify the key gatekeepers concerned (Polit et al, 2001) and focus attention on gaining their support (Holloway and Wheeler,

2002). Benton and Cormack (2000) suggest that within health care the key gatekeepers are at both an organisational and a professional level. Within health care in England the organisational

gatekeeper is often the research and development coordinator for the NHS trust (or equivalent), while the professional gatekeeper(s) will be the director of nursing or nominated deputy if

access to nurses is required. However, if the involvement of patients and families is required then medical staff will also be professional gatekeepers. The organisational gatekeeper has a

duty to be aware of research taking place within the organisation so that the cumulative effect of all research projects currently under way may be monitored. The professional gatekeepers

will need to be convinced that the research is credible and that the researcher is competent (Benton and Cormack, 2000). There is often a layer of professional gatekeepers, and experienced

researchers will need to keep them all informed to obtain and maintain access to the proposed research site.  Initially researchers normally write to the key gatekeepers explaining the

purpose of their research and including a copy of the research proposal and letters of invitation to the research participants. It is a good idea to offer to meet the gatekeepers to explain

the research in more detail (Benton and Cormack, 2000). Such a meeting presents an excellent opportunity to gain their trust by demonstrating an interest in the research site (Polit and

Beck, 2004). Professional gatekeepers must be given sufficient information to enable them to make an informed decision as to whether to grant permission for the researcher to proceed to

their local research ethics committee (LREC) or, if the proposed research is being undertaken at a number of health care sites, a multi-centre research ethics committee (MREC). If they have

not fully understood the research permission may be withdrawn after the study commences. At this stage some of the positive benefits of gatekeeping can be identified (Mander, 1992). The key

gatekeepers may help to refine the project and may also suggest constructive restrictions. For example, they may stipulate that nurses may not be interviewed in work time. A meeting is

invaluable to discuss strategies such as how an agency nurse could be paid for by the researcher to cover nurses so that they can be released for an interview during working hours. The key

professional gatekeeper may also identify other informal gatekeepers such as ward managers or clinical nurse specialists who could be approached so that their cooperation may be obtained at

an early stage. As gatekeeping is an ongoing process it is vital that sufficient time and energy is devoted to the process when planning the project timetable. Inexperienced researchers

often fail to do this, as they do not understand the need to write letters to key gatekeepers then wait for a response and then for a convenient meeting date. However, at this stage the

gatekeeper may deny access for a variety of reasons, in which case the research will not be able to proceed. Holloway and Wheeler (2002) suggest that access may be denied because:  - The

gatekeeper sees the researcher as unsuitable because of age, gender or even a lack of credibility or trustworthiness; - It is feared that an observer might disturb the setting, as staff on

the ward may become conscious of having their ‘every movement watched’ thus creating an ‘observer effect’; - There is suspicion and fear of criticism, either from the researcher or even from

the findings of the research; - Sensitive issues are being investigated; - Potential participants in the research may be embarrassed or fearful. Again this may be with regard to the

research or the findings of the research. Access may also be denied because: - The gatekeeper has personal reasons for denying it - while this should not occur, it may be simply a lack of

interest in research, the topic to be studied or even deliberate non-cooperation because the gatekeeper dislikes the researcher; - The gatekeeper considers that a particular clinical area

has already been over-researched in recent months; - The gatekeeper believes that the research will not be of benefit; - The gatekeeper feels the research is unethical; - The proposed

research has already been undertaken by a different researcher or similar work has recently been published. Most of the reasons for denial can be eliminated or anticipated and therefore

minimised by an introductory letter to a gatekeeper or at a meeting with the gatekeeper. Alternatively, if similar research has already been undertaken the researcher may be able to explain

to the gatekeeper how the proposed research may use a different approach or methodology or the viewpoints or understandings of a different group of staff. However, before it is submitted to

the LREC, an independent reviewer must scrutinise the research proposal. If records and therefore confidential information need to be accessed within NHS institutions there is an additional

layer of gatekeeping to consider. The ‘Caldicott Guardian’ must approve the use of any confidential information as recommendation 3 of the Caldicott Report states that a senior person,

preferably a health professional, should be nominated in each health organisation to safeguard the confidentiality of patient information (DoH, 1998; Eckstein, 2003). RESEARCH ETHICS

COMMITTEES Assuming that the organisational and professionals gatekeepers are satisfied that the research can proceed each should write a relevant letter for the researcher to submit to the

LREC or MREC with the research proposal. The relevant committee must then approve the study. While the gatekeepers do not normally interfere with the research process the LREC or MREC may do

so (Holloway and Wheeler, 2002). The process of obtaining ethical approval has in the past been a challenge for some researchers planning to undertake a study within the naturalistic

paradigm and therefore to collect qualitative data, because not all committees include members who understand naturalistic research. However, LREC and MREC membership must include not only

health professionals but also a number of lay people (DoH, 2001). The committees must also approve letters of invitation to potential participants such as trust staff, patients or their

families and carers. This is to ensure participants are asked to opt in to a research project when they are invited to participate, rather than being expected to opt out if they do not wish

to participate (DoH, 2001).  Just as key gatekeepers may refuse permission to access the research site the LREC or MREC may do the same. However, a researcher may know one or more members of

a LREC or MREC, and sometimes these people may be willing to offer informal advice about a research proposal before it is formally submitted to the committee for approval. This does not

constitute trying to ‘gain entry via the back door’, it is simply trying to increase the chances of the project receiving ethical approval by ensuring it meets the committee’s ethical

requirements. However, all potential researchers should be able to seek some informal advice about the committee’s requirements from the LREC or MREC administrator. RESEARCH APPROVAL AND

FURTHER ISSUES Once ethical approval has been granted, the researcher has permission to conduct the study. However, this permission is granted only provided they adhere strictly to the

submitted research proposal and any conditions that may have been stipulated by the LREC or MREC. Another part of the understanding of ethical approval being granted is that the research and

the researcher may not be influenced by the personal views of others about issues such as who should and who should not participate in the research process. Even at this stage gatekeeping

may occur. In order to undertake the study the researcher will need to gain the cooperation of others, such as ward managers. Again it is beneficial to arrange to meet these gatekeepers to

explain the research project and answer any queries they may have (Polit and Beck, 2004). If they are reassured that their professional gatekeeper and the LREC or MREC have already given

permission for the project to proceed they are more likely to cooperate themselves. At all stages of a research project a cooperative gatekeeper can help to gain the cooperation of other key

people and therefore lead to a smooth path for the researcher (Holloway and Wheeler, 2002). Again even at this stage of the research process there may be possible benefits of ‘unofficial

gatekeeping’. For example, ward managers may be able to suggest creative ways of using agency staff to release nursing staff to be interviewed by the researcher. Conversely, such unofficial

gatekeepers may request that a particular member of staff should not be asked to participate for a range of reasons such as: - A perceived lack of knowledge or credibility of the potential

participant; - The potential participant is known by the ward manager to have a ‘problem’ that the manager considers may make it disadvantageous for her or him to participate in the research

project. Unless the ward manager’s request was followed, permission to continue to undertake the research project could be withdrawn. Such a ward manager may believe that the requested

restrictions ensure non-maleficence to the potential participant. On other occasions gatekeeping may be undertaken to ensure beneficence to the researcher in order to make sure that the best

possible data is obtained. Here the researcher must use strong interpersonal skills to explain the research methodology, the data collection tool and population and sampling methods. If

such advice had been given when initially gaining the cooperation of the director of nursing then the population or sampling criteria could have been altered. However, once the research

project has received ethical approval such a request from a ward manager would mean that unless the ward manager understands the nature of the ethical approval, the researcher would have to

return to the LREC to seek further advice. Alternatively, the professional gatekeeper may be able to offer some assistance. CONCLUSION Gatekeeping as part of a research project is a complex

ongoing process. It requires the researcher to have strong interpersonal skills, a sound understanding of ethical principles and knowledge of who can be approached for advice and when to do

so. By following these guidelines it is more likely that ethical research will be conducted and in the future research sites will probably be more likely to permit other researchers to enter

the research site. This article has been double-blind peer-reviewed. For related articles on this subject and links to relevant websites see www.nursingtimes.net