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Abstract

Whistle-blowing has played an important role in improving patient care. It has brought many cases of malpractice and research misconduct to light and contributed to nipping them in the bud. Indeed, patients’ interests have been generally improved due to the activities of whistle-blowers in medicine. However, a number of healthcare personnel consider whistle-blowing negatively because it might sabotage their professional careers. As such, whistle-blowers are sometimes dealt with in appalling manners. This entry discusses the development of whistle-blowing, how culprits in healthcare can be exposed, and the judicial support for whistle-blowers. The role of academia in shaping the way difﬁcult situations are handled and future strategies developed, to improve and protect whistle-blowers are also elaborated. The entry highlights the need to change policies into practice and assist healthcare personnel in coming forward to expose wrongdoers in the noble ﬁeld of medicine and for the ultimate good of humanity.

Introduction

Whistle-blowing (WB) embeds a message of caution. In recent times, one name that readily comes to mind in relation to WB, thanks to the efforts of the media, is Snowden. However, in bioethics, WB has manifold ramiﬁcations and may involve human life, death, and human rights. This entry highlights the development of WB and examines some of the conceptual grounds which warrant and justify it. Two broad outlets of WB are elaborated: the pure patient-doctor relationship setting of a clinic and a subject-researcher relationship with regard to clinical trials. Attempt is also made to explore ways of exposing culprits in healthcare globally and judicial support for whistle-blowers. Common responses of professional acquaintances to someone who dares to come forward, role of academia in shaping the way whistle-blowers are handled in today’s time, and future strategies to improve and protect whistle-blowers are also discussed.

Those who are in search of answers to deal with conﬂicting situations at their own work place should read further and equip themselves with the tools of how to tackle such a situation at your clinic or research facility. This chapter will also help policy makers and institutional board members who want to set up a fault proof institutional structure to report and prevent misconduct. After all, no institute sets out to have a scandal linked with its name when one of its staffs blows the whistle on another colleague.

History And Development

The use of the term WB is relatively new. In early 1970s, a US (United States) civic activist Ralph Nader devised the term to avoid the negativity associated with its synonyms such as informer or snitch (Vaughn 2014). Historically it has been used in the context of police ofﬁcers blowing their whistles to alert others of criminal activities and acquire help (Bolsin et al. 2011). United Kingdom (UK) is one of the ﬁrst countries where healthcare whistle-blowers came forward regarding cases of professional negligence. List of recommendations on how to deal with them also started coming from that part of the world. However, even till recent years, UK physicians are still putting forward recommendations to see real concrete support toward WB.

Professional negligence, scientiﬁc misconduct, and WB go together. There would be no need of reporting any misconduct if it is never done. Hence, WB came as a blessing in disguise for improved patient care. In a perfect world all physicians, nurses, paramedics, and researchers should follow the rules of ethics generally and as they relate to particular professions. There should never be the need to alert the public or fellow colleagues of any transgression. Reality has however proved otherwise as values and morals are not alike in all humans. The globe has varying personalities from Florence Nightingale to Dr. Jack Kevorkian. Perhaps, this is why there is a need to remind healthcare personnel about ethics in the ﬁeld of medicine to maintain an acceptable standard of care.

An informal need assessment of the situation shows that WB is still in its teething phase as much work needs to be done to improve it in the healthcare context. It is a reaction to actions of misconduct and has arisen due to the social need to devise an objective manner of identifying, reporting, and investigating wrongdoers. The idea that a wrongdoer gets exposed however implies the need to prevent injustice toward whistle-blowers. So preventing professional negligence and scientiﬁc misconduct will also contribute to WB. Self-reporting should be encouraged if the intention is not truly to hurt anyone. Also, there is a need to assist those who dare to come forward to alert fellow colleagues and patients. Even though developed countries generally have polices designed to assist whistleblowers, these are seldom applied. The situation is even worse in the developing countries where such policies hardly exist. Corruption and fraud is prevalent in many developing countries such as in Africa (Uys and Senekal 2008). Southeast Asia has a similar reputation as there are unenforced laws and trivial punishments for scientiﬁc misconduct (Silverman et al. 1990). Those who still come forward are often targeted and threatened. This contrasts with developed nations where usually WB only brings an end to a career.

Conceptual Clarification

WB is deﬁned as “reporting by an organizational member of illegal, immoral, or illegitimate practices under the control of their employer to person or organization that may be able to effect action” (Miceli et al. 2008). It involves raising alarm about bad behavior (Bolsin et al. 2011), and in the healthcare context, this plays a constructive part in documentation and compliance of poor patient care. Since good reporting is the cornerstone of good patient-centered care (Bolsin et al. 2011), deaths may be prevented if information about things negatively affecting patients is heard by the correct people and at the correct time.

Thus, the objective of WB is to stop any harmful behavior to patients and to prevent it in the future. Whistle-blowers deﬁnitely become target of great criticism themselves.

One common problem faced by whistleblowers is the deﬁnition of right or wrong. It is also debated as to who decides upon these deﬁnitions. Yet, WB remains an important tool through which wrongdoing may be exposed and stopped. Since one of bioethics’ thematic foci deals with professional negligence and research misconduct, WB clearly falls within its ambit. In this vein, professional negligence in the clinic or research setting involves healthcare providers who act against the basic pledge of serving, protecting, and healing other humans.

In the clinic setting, recognizing that standard patient care has been jeopardized, may provoke an act of WB. There are however situations which create an atmosphere for malpractice or negligence to thrive including systemic failure of trust, poor clinical outcome of departments, or an individual or a catastrophic event. The likelihood that a member of the staff may depart from the standard patient care increases when such practices prevail. In such contexts, the patient should be informed of what is being done against the standard patient care that they are entitled to receive, and senior administrative staff members should be involved (Bell et al. 2015). Transparency in clinical practice depends on physicians’ attitudes. Those who think that errors should be disclosed to patients included younger doctors, surgeons, and those who have had a previous positive experience of such reporting (Bell et al. 2015).

In the research setting, the race of getting published and greed to make ever more money drives many to lie and endanger patients’ lives. Although Institutional Review Boards (IRBs) have evolved to help keep research misconduct in check, these still occur partly from poor supervision of junior staff members by the principal investigator (PI) and from PI mental health problems (Klitzman 2011).

Ethical Dilemmas Of Whistle-Blowing

WB itself is not just a simple process of informing the authorities of any wrongdoing. Whistleblowers face the dilemma of weighing the obligation to care for the larger public compared to obligation of loyalty to their establishment (Uys and Senekal 2008; Macdougall 2014). Any particular incident of misconduct needs to be distinguished between universalism and particularism (Uys and Senekal 2008). Morality of principle and morality of loyalty can be subdivided according to the action of any responsible person (Uys and Senekal 2008). Depending on how one acts either in a way of conformity or deviance, these morals are helpful in deﬁning human actions. For example, if one is compliant with the morality of principle and morality of loyalty, then their action can be deﬁned as that following congruent morality (Uys and Senekal 2008). Likewise, WB is when one follows morality of principle but deviates from morality of loyalty. Actions can either be loyal to the society or to principles (Uys and Senekal 2008). Most institutes are harsh toward whistle-blowers due to this very reason. Whistles are blown in the clinics when an error is identiﬁed, and the concerned institute does not take any action to prevent it from reoccurring. Eventually whistle-blowers are themselves penalized for not being loyal to the institute or fellow colleagues. In reality whistle-blowers are compliant with morality of loyalty but just toward the general public not their peers or hospital.

Is There A Need To Blow The Whistle In Healthcare?

It has been discussed that bioethicists are driven by virtues and as such should be whistle-blowers. Bioethicists view this ethical dilemma from a different angle. The public is ﬁrst in their views and values. It helps one deal with the conﬂicting duties toward public and private employers (Macdougall 2014). In both the below mentioned examples, it was possible to put a stop to the malpractice only because of WB. Cases such as the Korean stem cell scandal could never have surfaced had it not been for the younger generation trying to ﬁnd answers (Chekara and Kitzingera 2007).

A real life example is that of a gastroenterologist ofﬁce in Nevada, USA (Leary and Diers 2013). A nursing staff, fresh out of school, identiﬁed numerous unethical practices. The physician and senior nurses were cutting corners by pre-charting patients’ vital signs and other information, documenting inaccurate time of procedures, and signing off on charting done by other nurses. The same center was responsible for exposing 63,000 patients to hepatitis C (Leary and Diers 2013). Other billing irregularities were also noted. Initially when the new nurse attempted to report the clinic’s activities to the Nevada State Board of Nursing, she was asked for speciﬁc full names of all those involved. As she had only worked at the center for a few days, before quitting she did not have the complete information. Seven months later the ofﬁce was scrutinized due to unsafe injection practices and lack of infection control that resulted in the death of a patient and nine nosocomial cases of hepatitis C (Leary and Diers 2013).

In the research context, a US investigator was identiﬁed by his fellow researcher in conducting unauthorized procedures on laboratory rats (Klitzman 2011). When brought in for questioning, the senior investigator was helped by bending the deﬁnition of what was perceived wrong by the young researcher as invalid. For the sake of convenience, the involved institute judged that no major harm was done and that the reported harm was minor. An IRB member justiﬁed the actions of investigators by explaining the importance of who decides what is scientiﬁc misconduct and what should be considered major or minor (Klitzman 2011). The IRB member elaborated that what seems major to a federal regulator is only minor for a local administrator, especially when someone’s career is at risk. Hence it is important that one needs to know that all objective assessments should come from common guidelines that should be followed by all. Minor problems are only those that do not involve harm to research subjects. In this particular case, the institution did not punish the PI but increased efforts within the institute to prevent the same from repeating in the future (Klitzman 2011). Hence it should be clear to all concerned parties of what misconduct is and what are the penalties involved in such behavior. The moral here is that even where rules and regulation exist to prevent scientiﬁc misconduct, people try to use them for their best interest. This case was observed at a well-reputed institute in a developed country.

Exposing The Culprit And Law Protection

Majority of the human race fails to raise their voices when they see any wrongdoing in their surroundings (King and Hermodson 2000). It is therefore not surprising that reporting wrongdoing even in health institutes hardly occurs, starting from a small doctors’ ofﬁce to larger corporate based university hospitals. Ironically, the way we humans act is based on balancing the greater risk against the beneﬁt. This sheds some insights into why many of us do not come headﬁrst. Rather, we become part of the delinquency by keeping it as a trade secret. Some questions that arise include how one will be treated at work after making an observation of misconduct publicly, what will be the institution’s response to it, even how to pay one’s bills, and ﬁnally fear of being ﬁred. Unfortunately, most of us ﬁnd the risks outweighing the beneﬁts, and we take the path of keeping our heads down and mouths closed.

There is no perfect way yet devised through which one can inform fellow colleagues of any wrongdoing in the medical ﬁeld, but professionals are devising foolproof methods of doing so with minimal damage and maximum beneﬁts. Reporting can be to senior administration within the organization or to regulatory bodies outside the concerned organization. It is better to resolve issues internally, but if there is no satisfactory response, then external regulatory bodies must be involved.

As concerned human beings, only few healthcare providers make the moral decision and take the step of blowing the whistle. Judicial support in protecting whistle-blowers is available in the developed countries. Some laws already exist while some are being formulated. In the USA, at President Lincoln’s request, The False Claims Act was endorsed in March of 1863.

Later its amendment in 1986 encourages WB provisions under the Act (Maynard et al. 1998). The amendment includes employment protection, reinstatement of status, special damages, and double back pay (Maynard et al. 1998). It should encourage people to come forward to testify. In UK, Public Interest Disclosure Act of 1998 was passed to assist WBs (Bolsin et al. 2011). In majority of the developing countries, laws still need to be made or malpractice has minimal penalties (Silverman et al. 1990).

Reporting In Clinical Practice

In the developed countries, corporate administration and senior board members are involved in WB. Professional bodies for various healthcare professions are the current method of reporting. In the UK physicians have had mixed experiences. If someone does report any wrongdoing, then it is a traumatic undertaking. Alternatively, if they fail to report poor care, their own registration is at stake. The British Medical Council has members who discourage WB, and elected members conﬂict with their voters when they empathize with any whistle-blower. The UK government has been asked to make Health Select Committee Review of Whistleblowing along with a National Whistleblowers Center like in the USA (Bolsin et al. 2011). In the UK, Public Interest Disclosure Act of 1998 tries to protect whistle-blowers. However it does not always work such in the case of the Bristol pediatric cardiac surgery scandal (Bolsin et al. 2011). In Australia, the role of nurses in reporting jeopardized patient safety and rights is well established. It is also accepted how WB affects the staff as an individual, their family, friends, colleagues, and overall policy and nursing practice (Ahern and McDonald 2002; Jackson et al. 2014). There are support groups and networks for whistle-blowers. In the USA, National Whistleblowing Center has an active website www.whistleblowers.org (Bolsin et al. 2011). However, these are corporate based and what are their standards to deal with healthcare-related cases are questionable. A study from Israel involving nurses and nursing students tried to design practical tools to assess preparedness to blow the whistle. It showed that those who had less professional experience could not distinguish the severity of harmful incidences. However, they had a greater tendency to reach out to internal and external authorities to report any wrongdoing. Age was also found to be a signiﬁcant factor (Mansbach et al. 2014). In situations when serious harm can hurt any patient, both nurses and nursing students expressed preparedness to report fellow colleagues or management involved to internal or external authorities (Mansbach et al. 2014).

In the developing countries, the roles of professional bodies exist but only to a limited extent. The print media and professional bodies can only advocate for a good cause but do not have any control on the actual institutes’ policies. Senior administrative members from the dean’s ofﬁce are involved. One institute even started a method of anonymous reporting through emails. However, employees were concerned if their unique email addresses would be really kept conﬁdential. A drop box at the human resource department was another idea but only few cases were taken up for investigation. Others were dismissed on grounds of being invalid concerns. Internationally accredited tertiary care institutes try to have a system of “incidence forms” that are submitted to the most senior administrative person on the medicine or surgical ﬂoor. The best practice evolved by reporting medical staff is to make three copies of such a document before submitting it. Submit one copy to the senior most administrative person such as the head nurse. Second copy should be submitted to the dean’s ofﬁce and one for your own record. If one tries to hush up the negligence report, others can question them. This method is simply an extension of how to deal with an unpleasant situation in the medical ﬁeld, i.e., involving multiple parties and not creating a scene at the patient’s bedside. By doing so, the whistle-blower does not give a chance for the culprit to get away, alert concerned personnel, and even keep a low proﬁle.

Reporting In Research

Success stories from previous cases include some similarities as to how one should report any research misconduct ﬁndings. IRBs are often approached by patients or study coordinators or other concerned study staff. They alert the IRBs without involving the PI. Here, we should also keep in mind that patients seldom come forward and often the junior staff does not have enough proof to provide a valid report. IRBs also learn of problems at various research sites through continuing review of the project, by PI self-reporting, and sometimes by simple good fortune. Poor informed consent and not submitting the protocol or its changes to the IRB are some points of error. The ongoing site study status report should also be submitted to the IRB in a timely manner. When IRBs identify a problem, several steps can be taken depending on the severity and type of incident. Education of the PI and staff, suspending the study, and involving federal agencies are advised.

Another method is audit. Audits include random audits and audits for cause. Either the monitor assisting the sponsors or the sponsors themselves or Food and Drug Administration (FDA) can take this action. Causes behind such audits are lack of PI oversight, neglect or lack of trained staff, lack of timely review of test results, improper documentation, backdating, or changing source documents by staff members (Klitzman 2011).

Common Responses To Whistle-Blowing

There are mixed responses to WB. While few whistle-blowers have been rewarded for coming forward, most are harassed and mistreated, while senior staff or PI are usually protected. This partly underscores why other potential whistle-blowers are discouraged. Another view of WB is how the concerned institute or public views the whistleblower. Whether one is treated as a saint or a sinner varies. Acts of WB have attracted penalties for breaking the law as they make internal patient matters public thereby breaching conﬁdentially. Some people argue that whistle-blowers should not be the one to decide what is wrong or correct at a given institute that they should rather let the leading institutional or professional bodies take action. However, such critics forget to notice that WB occurs when the leading bodies fail to fulﬁll their responsibilities or when the institutes have no road map for such issues.

Although there is increasing level of acceptance that they have important contributions toward patient safety, whistle-blowers are still subjected to severe punishment. In the UK, the General Medical Council of UK has prosecuted doctors when they raised concerns, consequently working against the public good (Bolsin et al. 2011). This has created a climate in which most whistle-blowers leave the workforce. Perhaps, one way to understand the lack of WB culture is to look at the institutional framework for it. In medicine-related training institutes throughout world, WB is part of a “hidden curriculum” (Bolsin et al. 2011). This informal teaching comes from senior physicians during clinical rotations when professors’ assumptions and values are passively transferred to students. Generally, however, healthcare professionals are reluctant in reporting ill actions, though how this plays out from context to context depends on one’s belief system. For instance, an Australian study involving nurses concluded that nurses’ responses to ethical dilemmas were based on different belief systems (Ahern and McDonald 2002). In the USA, 31 % of physicians remain reluctant in exposing their coworkers’ offenses. Of these, twelve percent fear reprisal for doing so (DesRoches et al. 2010; White 2004).

An example from one of the developing countries is most interesting to share here. The setting was an internationally renowned medical institute whose troublemaker was a professor of the department and a recipient of numerous international grants including one from World Health Organization. The whistle-blower was a senior instructor who had recently joined the same department with the zeal to bring about a change with fresh research ideas. The professor had regular meetings with his junior faculty members and enquired as to what research ideas the instructor would like to work on. The junior member conﬁdentially discussed one of his research ideas. After a few days, a faculty meeting was announced for the department, and the professor had written a list of research ideas on the board. He informed his junior faculty that these were his own ideas and that he is working on them. Also if anyone wanted to join him, they could do so with some limitations. The senior instructor was horriﬁed when he saw his own idea being called as the professor’s.

When he tried to discuss the matter with the professor in private, he was not given a chance to even make an appointment with him. So he went to the dean’s ofﬁce. An internal investigation was conducted to ﬁnd the professor was wrong and had done this many a times in the past. No one had the courage to come forward and report. The department’s other faculty members socially isolated the instructor, but the dean’s ofﬁce proved supportive for the whistle-blower. The professor took an early retirement after the incident became public.

Contrasting this example with the position of the UK Medical Council shows that those coming forward to identify transgression in healthcare should be ready to present themselves to authorities and accept the consequences of their actions. They should weigh the risks and be willing to put their own life on stake. While maltreatment and disrespect is not a mandatory consequence of WB, whistle-blowers have hardly received due regard or recognition for their bravery.

Future Strategies On Whistle-Blowing

Enough has been written to identify the issue of WB and problems behind it. The goal now is to ﬁnd some solution. This needs to begin with acknowledging the need for WB in private and public healthcare institutions and followed by the creation of methods for reporting professional negligence and scientiﬁc misconduct on all levels. Besides encouraging WB, success stories should be published in newsletters so that the fear of unknown can be minimized among the staff. Presented in this section are some points to ponder, though their application can vary on a case-to-case basis. Few of these recommendations are already used in some countries; however, we should universally apply these to achieve better patient care and protection for whistle-blowers.

At the level of regulatory bodies and international associations:

We must gather to design and test systems that would support WB through ways that one can objectively access and report any offense as well as allow the investigation of doubtful cases. In many institutes this is partly being done by IRBs; however, a subgroup within these committees should focus on monitoring and promoting events that support whistleblowers to come forward.
Whistle-blowers should report to more than one person within the institute. No one person should be responsible to get notiﬁed of any ill event in the institute. Nor should one person be responsible to investigate any situation. A subgroup of the IRB should have publicly elected and appointed professionals, patients, and community representatives. Such individuals should have no conﬂict of interest in dealing with reported cases of misconduct.
In collaboration with international healthcare organizations, regulatory bodies such as local and international medical councils should commission consultation groups (Bolsin et al. 2011). Whistle-blowers should be able to report poor patient care to them for further investigation.
Institutes with “red tapes” that hide wrongdoers and discourage WB need to be identiﬁed and kept in check so that on-paper policies are applied in practice.
Research misconduct penalties involving corporate executives rather than just companies should be implemented. Senior executives of pharmaceuticals should repay the bonuses when fraudulent behavior is conﬁrmed (Outterson 2012) as this will improve medication marketing strategies and research integrity in general.

At the level of medical institutes:

Public scrutiny should be encouraged. All staff members should have in mind that they are not above the general public and cannot get away with any wrongdoing. This will stop few if not most wrongdoers.
In addition concerns of whistle-blowers should be handled seriously, individually, and conﬁdentially. Anonymous reporting systems can be helpful in this regard.
Internal channels of reporting misconduct should be established in all registered institutes, and their existence should be made public to patients and employees.
Medical institutes should choose the most appropriate leaders as those who put others before their own interests. In times of WB, this will facilitate the necessary support based on innate moral orientation to support the correct cause and person(s). Unfortunately, this is difﬁcult as most appointments for higher posts in medical institutes are on basis of seniority and experience. Supporters within the institutes also play an important role. Some are themselves the perpetrators that need to be exposed.
Institutes should arrange for periodic training sessions and teach the staff of all categories regarding how to report malpractice or scientiﬁc misconduct cases.
The next point is already in play in most of the institutes as teachings of bioethics are being promoted. One message should be clear in all healthcare personnel: “patient ﬁrst.” This will assist in minimizing wrongdoings. The staff should be encouraged to think by putting themselves in any patient’s shoes and then making the best decision in difﬁcult situations.
Laws and institutional policies ﬁnally accepted by medical institutes should be posted on departmental notice boards and mailed to all employees. This will help spread the correct method of reporting incidences as well as prevent others from doing ill as they would have a higher probability of getting caught.

Conclusion

WB cannot only improve clinical performance but also improve patient safety. There are polices on paper in most major medical institutes around the globe. However, a successful way to implement these has not been achieved. It is time to sit together, brainstorm, and start supporting each other when faced with such dilemmas. It is also important to spread the message of such policies and cases where whistle-blowers are not penalized. This will both help healthcare personnel and researchers in coming forward to expose wrongdoers and serve the ultimate good of humanity.

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