Education Autonomy & Ethical Principles of Care Assignment

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Honesty So, understanding the importance of honesty is the most important outcome in any societies in the medical profession.

Advocacy for patient interest and welfare required the following competencies: Having a good practice Interpersonal skills Making the correct decision Avoiding mistakes

We need in our heart and soul to reassure the patient that procedures, diagnostic tests, and clinical pathways are of a high standard of care because we know our hospital or department can always perform a root cause analysis of any complication to try to prevent reoccurrence and a malpractice review. The problem is how often the cause analysis is used? How often are complications filtered out of any form of discussion, and openly discussed, without any possible backlash? That analysis activates the transparency ethic.

Patient Autonomy The patient should preserve their autonomy. They should have the last decision and words on their treatment, and they should be able to do their research. Requesting more information or a second opinion should be the norm and not the exception.

The watch is turning, swinging from the physician–health care worker decision to absolute patient autonomy, and the emphasis on the relationship and trust building is becoming more critical.

Patients seeking medical care place themselves in a precarious condition – to place their lives in the hand of somebody else is what the patient does by going to see a physician.

Therefore, they need to weigh and balance their understanding of the procedure and its consequences.

Patient autonomy is defined as the independence of choices and the availability of extra sources. This is informed consent.

From all these subjects we can extrapolate some conclusions and directions:

Medicare, Medicaid, and VA placed emphasis on the road justice and treatment of the patient. Many physicians practice day by day ethics more than anybody else probably in any profession. Honesty is the act of transferring medicine fairness in all human interaction.

The potential benefit of disclosing information outweighs the possible harmful consequences as they would increase emphasis on patient autonomy an equal partnership. The patient requires information to decide. It is challenging to keep the truth away from the patient in modern times because there is a lot all web information and basic knowledge available.

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In Europe and Latin America, the family can ask not to release information to protect the patient psychological event in case of terminal illness. This is something to discuss with the family with the power of attorney.

Patient autonomy strives toward equality in this partnership:

A significant change in law and medicine will change the relationship. The first was the requirement for a simple consent for the treatment of a specifically invasive procedure.

The landmark decision was reached in 1914 when Judge Benjamin Cardozo stated “every human being of adult years and sound mind has a right to determine what shall be done. No one has to perform any procedure without the patient consent.” This was part of a verdict in New York Hospital.

Global Trust Honesty, which is telling the truth and avoiding intentional false hope Confidentiality, which is a proper use of the sensitive information Global trust, which is the soul of confidence or aspect that combine elements from some or all of the other dimensions

Building Trust The central theme of building trust is honesty and trustworthiness brought on a professional organizational and an individual level. How can human pain relate to trust? The initial development of trust is the meeting between the physician and the patient ending by exposing all the issues that need to be presented, such as what it is natural, what the problem is, and what the future treatment will be. The trust means that you continue to talk to the family to be sure that everyone is on the same page. The initial step is based on the global and professional respect. Several studies have shown that the deciding factor for trust in the physician is the interpersonal relationship between the physician and the patient, which is usually established before surgery. The same approach applies to the nurse; the relationship is to be built in the first few hours of taking care of the patient. The physician and the nurse need to be present to explain any consent needed in detail.

Errors The error may not result in the adverse event but can still be troubling to the patient. The American Medical Association states that the physician should deal honestly and openly with the patient at all times. At the international level, there was a lot of initiative in Australia/United Kingdom on the ways to decrease the medical error to talk to the patient.

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In the United States in 2005, the same time as the campaign was launched in Australia and the United Kingdom, Senators Hillary Clinton and Barack Obama sponsored a bill – The National Medical Error Disclosing and Compensation Act.

Disclosure Disclosure would increase the likelihood of malpractice action. This concern has done much to impede the flow of information to patient and family. Despite this, it is now clear that the patient wants to know about all errors that cause them harm. Another study showed that the patient would be less likely to seek legal advice when the error was disclosed. Nurse leader–hospital administration need to be involved in the revealing process and offer the emotional support to patient and family should any necessary support should be needed. The patient should also be told what measure would be taken to assure the scenario does not occur in the future to another patient.

Legal The legal aspect of the medical profession every physician or health care practitioner are concerned with, to some degree, is to avoid involvement of medical malpractice lawsuit.

Protecting the patient from harm is no doubt a primary concern at the foundation of every medical practice of any professional. It should include a plan to reduce the risk by utilizing protocols standard, standard care, and best practice develop skills for effective patient – physician communication; this type of model can help reduce the number of medical errors or anticipated outcomes that occur in assisting the physician to efficiently manage this event.

Transparency Studies overwhelming show that apologies and transparent disclosure is the best risk management tool. The standard required health care organization to disclose unanticipated outcomes of care or treatment for their patient and, when appropriate, to their family with issues of concern, including unexpected results. A sense of compassion – an understanding of the pain after the apology. The physician needs to practice what they will say and not practice the same thing over and over again. Second, a responsible, independent practitioner knows always to explain the outcome of any treatment or procedure to the patient, and when appropriate, to the patient’s family. Whenever findings are significantly different from anticipated results, this can spark some controversies because not all adverse consequences are caused by medical error or negligence. The first step must be a collaborative effort with the family and the patient, and a structured plan of action can help assure complete and timely disclosure of the event. The standard does not require documentation of exposure but to avoid any doubt, a team approach of having more than one witness during the explanation. The AMA has similar ethics requirements as part of their code of ethics, and its fundamental ethics require that the physician should, at all times, be honest and open with their patient.

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Situations occasionally occur in which a patient suffers a significant medical complication. In the situation, the physician is ethically required to inform the patient of all facts necessary to ensure understanding of what has occurred. The independence that should be afforded to the patient or the amount of information required to make an informed health care decision.

Arrogance Arrogant, inattentive physicians are more likely to have a lawsuit filed against them not necessarily because of the outcome of a medical mix-up but because of an unsatisfactory feeling. Communication includes the consideration from disclosure; sympathetic concern and respect are things that everyone expects. One of the most effective forms of communication is apologizing. An apology needs to be an admission of fault or negligence but should also be a demonstration of compassion and understanding of what the apology is for. “I’m sorry” may be a standard phrase but it needs to be phrased in a way that means it. Physician’s ability to recognize, regret, take responsibility for, and remedy must always be visible when an apology is appropriate; so fear, frustration, or anger should be placed aside. An apology should be considered. Keep in mind that an excuse should not be reserved solely for the medical mix-up but is also appropriate for situations of less severity, such as a long wait before an appointment, behavior by staff, delay in returning a telephone call, or delay in answering when the nurses call into the room.

Suggested Reading 1.ABIM. 2018. ABIM Foundation Principles. Accessed at URL: http://abimfoundation.org/what-we-do/physician-charter. 2.Blendon, R. J., J. M. Benson, and J. O. Hero . 2014. Public Trust in Physicians — U.S. Medicine in International

Perspective, October 23. N Engl J Med 371: 1570–2. Accessed at URL: http://www.nejm.org/doi/full/10.1056/NEJMp1407373.

3.Hunt, M. 1989. Body and Mind; Patients’ Rights. March 5. Accessed at URL: http://www.nytimes.com/1989/03/05/magazine/body-and-mind-patients-rights.html.

4.Medical Professionalism Project: ABIM Foundation. 2002. Medical Professionalism in the New Millennium: A Physician Charter. Project of the ABIM Foundation, ACP–ASIM Foundation, and European Federation of Internal Medicine, February 5. Accessed at URL: http://annals.org/aim/fullarticle/474090/medical-professionalism-new- millennium-physician-charter.

5.State of Maine. 2018. Rights and Legal Issues – Involuntary Commitment. Accessed at URL: http://www.maine.gov/dhhs/samhs/mentalhealth/rights-legal/involuntary/faq/home.html.

6.Thom, D. H.Sabrina T. Wong, David Guzman, A. Wu, J. Penko, C. Miaskowski, and M. Kushel. Physician Trust in the Patient: Development and Validation of a New Measure. Ann Farm Med 9(2): 148–54. Accessed at URL: http://www.annfammed.org/content/9/2/148.

Ethics Summary Table How to Commit to Honesty and Trust

Recognize your limitations Aim for zero dashboard Prepare for possible cognitive and physical restrictions Engage in a trusting relationship with your patient Make a decision and admit issues and failures Respect patient’s autonomy

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Build trust Disclose interests Disclose errors Watch your legal limitations Be transparent Avoid arrogance

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Chapter 8

Disclosing Medical Errors

“Errare humanum est, perseverare autem diabolicum” Lucius Annaeus Seneca

Seneca’s words in English read “to err is human; to continue in error, diabolical.” All physicians, being wise, make mistakes; good physicians minimize the probability of a recurrence. Morbidity and mortality conferences enable all to better future results by learning what might have been done better when an adverse outcome has occurred. Protocols, by standardizing care, effectively reduce the risk of persistent error by having the institution learn from past mistakes either at the system making changes in contracts or at unknown institutions by the simple adoption of protocols in hospitals that have not yet experienced significant errors.

Metrics such as infection rates can be interpreted as a means to adjudge the existence of persistent error. The Center for Medical Services (CMS) mandates data collection, analyses of which partly determine whether physicians are permitted to practice in hospitals and clinics. Although some metrics are specialty specific, others (e.g., criminal medical records, malpractice claims, disruptive behavior) apply to almost all physicians. Hospitals and clinics also have metrics that relate to their performance (e.g., patients are seen or patients that have left without being seen, patient’s complaints, appropriate protocol usage for preventable diseases). Reimbursement is now linked to the quality of care metrics, meaning that failure to reach any of a variety of quantitative goals decreases income.

The Impact of Medical Errors There are estimated to be 98,000 deaths per year due to medical error. This means medical errors are the fifth leading cause of death in the United States. The most common avoidable errors are:

Two million hospital-acquired infections/year – 90,000 deaths: (a) Methicillin-resistant Staphylococcus aureus infection (MRSA); (b) Vancomycin-resistant E. coli; (c) Metronidazole- resistant Clostridium difficile Patient falls: 70% of “hospital accidents” – 30% Geriatric patients die within a year of fall. One million pressure sores (decubitus ulcers) and 60,000 related deaths. Medication errors: 400,000 drugs errors among Medicare patients/year.

Cost of treating injuries due to medication error: $3.5 billion/year. Lethal medication errors have resulted in:

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Revocation of nursing and physician licenses Charges of “criminal negligent homicide” Media reporting more incidents of adverse outcomes involving nursing care or allegations of nursing negligence or misconduct Increased responsibility, role expansion and scope of practice Expansion of federal and state health care laws Mandatory patient advocacy – especially support of informed decision making

Miscommunication Number 1! Likely, the most common and preventable errors stem from miscommunication. Computerized drug administration can prevent dosage mistakes. Electronic medical records can preclude reliance on a faulty memory of persons not immediately present. Nurse instructors/clinical educators can correct miscommunication between caregiver and patient, whether due to a lack of attention or communication skill on the part of the physician or a lapse in interest or memory on the part of the patient; written instructions, preferably signed by the patient after such interventions, are essential.

Faulty communication is among the most common underlying causes of medical error and can lead directly to the breakdown of a therapeutic patient–physician relationship. Once this failure occurs, patients become angry. Angry patients who feel they have been treated by defensive, evasive, hostile, arrogant, or inattentive physicians following a medical mishap are more likely to file a lawsuit. This is not necessarily because of the outcome of care but the lack of adequate communication by the physician following the incident.

Communication skills are most important after an adverse outcome. True sympathetic concern by the physician expresses itself in the form of an acknowledgment of the patient’s situation and distress.

Demonstrated compassion and understanding, not necessarily admission of fault or negligence, are the vital elements of such an enterprise. Such demonstration requires acceptance of the reality and acute analysis of the adverse outcome by the caregiver. Michael Woods’1 Healing Words: The Power of Apology in Medicine summarizes matters via five R’s: recognition, regret, responsibility, remedy, and remain engaged. Perhaps the most vital components of disclosure by physicians are (1) a clear explanation of the nature of the outcome and (2) a clear explanation of when results differ from what had been anticipated.

The Role of Apology It may not always be apparent when an apology is appropriate, so recognizing fear, frustration, or anger may be the first sign that an apology should be considered. Keep in mind that an excuse should not be reserved solely for medical mishaps but is also appropriate for situations of less severity such as long waits before appointments, rude behavior by staff, or delays in returning telephone calls. Physicians who practice the Golden Rule and truly respect the dignity of their patients are sensitive to patient needs and can more easily recognize the need for an apology.

Expressing regret for the patient’s situation, even when the case was not created by a medical error, shows a sense of compassion and understanding of the pain, anxiety, or fear the patient is experiencing. The responsibility then follows recognition. The physician takes responsibility for the patient care, disclosing the known facts and explaining that any unknowns will be investigated to prevent future occurrences. The last component of an apology requires an offer

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of restitution or remedy. The patient should be told what is being done to correct the problem, what the long-term effects will be, and who will pay for any additional costs.

Many malpractice insurers still take the position that admitting fault or apologizing to the patient will increase the likelihood of litigation and jeopardize their ability to defend the physician efficiently. There is no evidence to support the validity of that belief and, in fact, there is ample evidence to the contrary. In studies that have examined the reasons given for filing a lawsuit, patients and their families cited suspicion of a cover-up, lack of error acknowledgment, and failure to apologize as primary motivating factors. Many patients report feeling angry and frustrated because they were never given an explanation or an apology from any of their health care providers following a medical mishap. They perceived the physician’s behavior as avoiding the issue or acting as if the complication or catastrophe was not a big deal. Studies overwhelmingly show that a policy of providing an authentic apology and full and transparent disclosure is the best risk management tool an insurer can utilize.

In my experience, involving patients and their family when unanticipated outcomes occur has been very productive. The physician should remember that the health care team includes the patient and their family; teamwork, another word for collaboration, should be present at all times, including after the discovery by the physician of an unanticipated outcome.

Policy for Disclosure of Medical Errors In 2001, the Joint Commission for Accreditation of Healthcare Organization (JCAHO) required hospitals and health care organizations to disclose unanticipated outcomes of care or treatment to the patient and, when appropriate, to the family. We summarized some dos and don’ts in Table 8.1.

Table 8.1 Examples of Problems and Solutions in Approaching Patient

The standard states (RI.1.2.1)2 : Patients and, when appropriate, their families are informed about outcomes of care, including unanticipated results.

This accompanying intent provision (RI.1.2.2)3 indicates that the responsible licensed independent practitioner or his or her designee explain the outcome of any treatments or procedures to the patient, and when appropriate the family, whenever those findings differ significantly from the anticipated results.

These provisions had some controversy. The first step must be a collaborative effort between the healthcare team to develop a policy for complying with the requirement. Having a structured plan of action with pre-designated duties can help assure complete and timely disclosure of the event. The patient should be informed of the specific process and kept updated.

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The following is a suggested outline of what disclosure should contain:

An apology Simple explanation of how the event occurred Assessment of the harm Actions taken to treat the injury or address the problem Future preventative measures instituted Responsibilities for ongoing care Supply a contact person for follow-up communications Offer of counseling and support Accommodation for associated costs

Section 8.6 of the American Medical Association’s (AMA)4 code of ethics stresses the need to disclose errors to patients:

It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients … Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these circumstances, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred … (Gailey, L. (2015). “I’m Sorry” as Evidence? Why the Federal Rules of Evidence Should Include a New Specialized Relevance Rule to Protect Physicians. Defense Counsel Journal, 82(2), 172.). Concern about legal liability, which might result from truthful disclosure, should not affect the physician’s honesty with a patient.

By placing the patient’s best interest above their own, physicians can offer a sincere apology and, when necessary, begin the healing process and ask the patients forgiveness.

Notes 1. Woods, M. 2007. Healing Words: The Power of Apology in Medicine. Oak Park, IL: Doctors in Touch. 2. JCAHO. 2001. Pain standards for 2001. Accessed at URL:

https://www.jointcommission.org/assets/1/6/2001_Pain_Standards.pdf. 3. CRICO. Disclosure and apology: CRICO’s perspective. Accessed at URL:

http://www.mitsstools.org/uploads/3/7/7/6/3776466/disclosureaplogy_cricosperspective.pdf. 4. AMA. 2011. Code of medical ethics’ opinions on patient safety. Virtual Mentor, 13(9): 626–628. Accessed at URL:

https://journalofethics.ama-assn.org/article/ama-code-medical-ethics-opinions-patient-safety/2011-09.

Suggested Reading 1.Anderson R. E. 2004. Defending the practice of medicine. Arch Intern Med. 164(11): 1173–1178. 2.Claim Trend Analysis. 2004. ed. Rockville, MD: Physician Insurers Association of America. 3.Donaldson, M. S., Corrigan, J. M. and Kohn, L. T. 2000. To Err Is Human: Building a Safer Health System, ed.

Washington, DC: Institute of Medicine. 4.Gailey, L. 2015. “I’m sorry” as evidence? Why the federal rules of evidence should include a new specialized relevance

rule to protect physicians. Defense Counsel Journal 82(2): 172–9. 5.Harming Patient Access to Care: The Impact of Excessive Litigation. 2002. In: Subcommittee on Health Committee on

Energy and Commerce. Washington, DC, US Government Printing Office, 107–27. 6.Lucius Annaeus Seneca, De Clementia 1.9.1.1. (n. d.). Accessed at URL: http://latin.packhum.org/loc/1017/14/6#6. 7.Patient Rights Causes, Symptoms, Treatment - Emedicinehealth. (n.d.). Accessed at URL:

https://www.emedicinehealth.com/patient_rights/page2_em.htm. 8.Profitability by Line by State in 1976 and 2002. 2003. ed. Kansas City, MO: National Association of Insurance

Commissioners. 9.Ri-055 Disclosure Of Unanticipated Outcomes. Accessed at URL:

http://www.sjomagnet.org/documents/Organizational_Overview/OO14.3. 10.US Department of Health and Human Services. 2002. Confronting the New Health Care Crisis: Improving Health

Care Quality and Lowering Costs by Fixing Our Medical Liability System, ed. Washington, DC: Office of the Assistant

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Secretary for Planning and Evaluation.

Ethics Summary Table How to Disclose Errors

Error is part of human life. Continually making errors is not acceptable. Metrics are there to monitor the physician. In case of confusion protocols should be followed. Miscommunication needs to be avoided. Use electronic medical system tools for avoiding communication errors. Do not be afraid to admit errors. An apology is still good ethical behavior. Always involve patient and family in decisions and when disclosing errors.

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Chapter 9

Consent and Conflict of Interest

There is a fear in our society toward the medical profession, and there is an erosion of the public’s confidence in the profession.

When a physician acts in an unethical way it harms not only the individual patient but also the doctor–patient relationship and the relationship society has with doctors. Unethical behavior in the context of drug company-sponsored clinical trials multiplies the harm to society, affecting its relationship with the research enterprise and with the health care industry.

Consent Consent was seen as a formality, a preamble to treatment. Nowadays informed consent is an essential part of the ethical practice of medicine. It represents the opportunity to solidify the doctor–patient relationship. Valid informed consent describes the shift in primary care medicine to guide rather than dictate an individual’s health care decisions. This has been the road to the shared decision making. Furthermore, informed consent is increasingly relevant in today’s evolving legislative expectations and health care initiatives.

The physician has direct control over the process of informed consent than any other areas of medicine and can explain in better detail the pros and cons of the treatment or surgery. It is time consuming but it is time well spent. Thus, incorporating improvements to the process of informed consent is time well invested.

What is an Informed Consent Informed consent is a needed process in which the patient learns and understands the purpose, benefits, and potential risks of medical or surgical intervention.

Informed consent needs to include more details and alternative treatments and the possibilities of stopping medication in case they participate in a trial. The benefits of patient involvement in clinical trials and their alternatives to participation should be spelled out.

Informed consent is about patient’s understanding and willingness to participate in any study and not about signing a form. Prospective participants in any research study must understand the purpose, the procedures, the potential risks and benefits.

By Joint Commission’s interpretation, communication between a clinician and a patient that results in the patient’s authorization or agreement to undergo a specific medical intervention (see sidebar box for The Joint Commission’s glossary definition). In addition to the process of communicating with their patients, clinicians are concerned with obtaining the evidence of consent that serves to document their legal and ethical responsibility. Unfortunately, the emphasis on getting a patient’s signature as documentation of informed consent results in different effectiveness of the communication between a clinician and a patient. Communication

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issues are the most frequent cause of serious adverse events reported to The Joint Commission’s sentinel event database.1

Patient autonomy strives towards equality in this partnership, but a significant change in law and medicine will change the relationship. Therefore, first was the requirement for a simple consent for the treatment, specifically invasive procedure.

From an article of 2012, Daniel Hall and his coauthors2 reinforced the concept by outlining the following:

1. The process of informed consent in which physicians disclosed details about a treatment did not emerge until the 1950s, when courts first required physicians to disclose information customarily disclosed by experienced clinicians (e.g., the reasonable physician standard).

2. It was not until 1975 that American courts articulated the reasonable person standard, which required that physicians disclose the information that a “reasonable person” would want to know in a similar situation.

They concluded that: Informed consent is further predicated on the patient’s or surrogate’s capacity to make

decisions — not only should the decision maker understand the relevant information, he or she should also be able to appreciate the information’s importance and use it to weigh treatment options in light of their values.2

The Moral Purpose of the Consent Hall and his coauthors also commented on the moral purpose of the consent:

The moral purpose of informed consent is somewhat more abstract and ideological, seeking to respect patient autonomy by ensuring that treatment is directed toward the ends desired and is chosen by the patient. In this context, informed consent is intended to shift the ethical paradigm for decision making away from physician-centered models to more patient-centered approaches. The ethics literature regarding informed consent also emphasizes that it is not an event, but a process that precedes the “signing” of the document and continues for as long as the choice remains relevant. Thus, the consent to undergo dialysis or continue with chemotherapy is continually re- evaluated (and may change). The consent form should not be confused with the consent process; the type merely documents that the process has occurred. Importantly, other parts of the patient record (e.g., clinic and operative notes) should corroborate details of the process.

The Role of the Physician

Physicians themselves should be taking the consent from the patients since it is their time to bond fully with their patients. A delegation of this critical task could be dangerous.

In discussing the matter with the patient, the physician should cover:

The patient’s diagnosis, if it is known The nature and purpose of the proposed treatment or procedure The benefits and the risks of that proposed treatment or procedure The alternatives to the proposed treatment or procedure Alternatives should be discussed regardless of their cost and regardless of whether they will likely be covered by the patient’s health insurance The risks and benefits of alternative treatments or procedures The risks and benefits of not receiving or undergoing any treatment or procedure3

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Physician Conflict of Interest Before the event of managed care, conflict of interest was not even taken into consideration. In fact, managed care physicians running a business were not required to maximize their profit to make a good living. Reimbursement was not the issue even for a businessman who could make a good living practicing medicine. Physicians starting out were often told to take care of the patient, and the business of the practice will take care of itself but today this is not the case. A stakeholder is not just the individual patient but both the health care industry and the health care institution. Pool of people in a different direction, but unless such interest affects the patient care then no conflict exists. The conflict between the physician’s personal interests and the interests of the patient and the conflict that divides physician loyalty between two or more patients, or between the patient and the third party (e.g. physician takes care of friends or family member). The critical requirement of the physician is the nonmaleficence, do not harm, while beneficence means to be useful and obey the company policy act and the organization’s purpose. The rule for the conduct of medical research and for the practice of medicine is truth-telling and full disclosure in analysis and in the clinical scenario; it admits of no exception and is binding. When someone purchases a car, no one expects full disclosure on the price. The buyer does not disclose how much they are willing to pay nor does the dealer disclose the least they are willing to accept.

Declaration of Helsinki The Declaration of Helsinki after the World War II outlines the principle of independence and autonomy of patients by disallowed experiments and clinical trials on innocent or not informed subjects.

Much of the attention in the press came from the clinical care investigation published in 1947 regarding the first medical milestone research and establishment of the perceptive ethical human analysis. The Medical Association released the Declaration of Helsinki in 1964. In 1974 a revision of the coalition recommended a review of protocol by an independent committee. The United States published additional information and guidelines on the policy. The policy called for review of oversights by an independent committee to ensure they were right and that the welfare of those involved and methods for obtaining consent described the purpose of the procedure. That is why institutional review boards were created.

Enrolling Patients in Studies According to the National Institute of Health4 (NIH), individuals should be treated with respect from the time they are approached for possible participation—even if they refuse enrollment in a study—throughout their involvement and after their participation ends. This includes:

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Respecting their privacy and keeping their private information confidential. Respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without penalty. Informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating. Monitoring their welfare and, if they experience adverse reactions, untoward events, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study. Informing them about what was learned from the research. Most researchers do an excellent job of monitoring the volunteers’ welfare and making sure they are okay. They are not always so good about distributing the study results. If they don’t tell you, ask. It is impossible to give an exhaustive list of situations that might present a conflict. However, among the most common situations that may constitute a conflict are: holding an interest in or accepting free or discounted goods from any company or organization that does, or is seeking to do, business with the institution by any employee who is in a position to directly or indirectly influence either the institution’s decision to do business, or the terms upon which business would be done with such company or organization. Holding an interest in a group that competes with the institution. Being employed by (including working as a consultant) or serving on the board of any organization that does, or is seeking to do, business with the University or which competes with the institution. Gaining personally, e.g., through commissions, loans, expense or travel reimbursements, or other compensation, from any company or organization doing, or seeking to do, business with the institution.5

Disclosure: Research and Financial Relationship with Business A 1992 study published in The New England Journal of Medicine 6 found that doctors with investments in radiation sites prescribed such treatments more often than doctors without the direct financial interest. Physicians have been found to be susceptible to economic temptation. These relationships vary in the amount and method of compensation that a physician receives and in the amount of control the physician can exercise over the enterprise. The relationships promote patient welfare as well as providing the potential for a conflict of interest. Disclosure of funding sources, institutional affiliations, and potential conflicts of interest is necessary to overcome the perception of selfishness. Federal laws govern some of these relations and are essential for the physician to understand, e.g., stark, safe-harbor regulation and the nature of administrative law courts, and the Inspector General.