By Jodi Fletcher

How is value calculated? Webster Dictionary defines value as “the monetary worth of something” or “a fair return or equivalent in goods, services, or money for something exchanged” Should everything have a monetary worth? When it comes to how much a living organ is worth, there are factors that need to be considered. Is the organ worth more to the recipient, or to the donor? This is an ethical question that is hard to answer, but is a question in debate. 

There are multiple ethical facets to organ donation:

1. First, do no harm:
   1. The donor has no medical need for surgery.
   2. There is a risk/benefit balance that needs to be considered. The organ recipient reaps disproportionate benefits compared to the donor.
2. Informed consent: (for more information on informed consent go here)
   1. The donor must be competent and capable of understanding the risks involved.
   2. Must do so without any form of coercion.
3. Regarding the question of financial compensation, vulnerable populations must be considered where a donor may lack the capacity to make an autonomous, voluntary decision to agree to donate an organ.

There is a shortage of organs for patients in need of transplants. According to U.S. Department of Health & Human Services there is a continuing decline in available donors. There is a question on how to obtain more organ donations. Proponents for selling organs are suggesting suspending or revoking the prohibitions of the National Organ Transplant Act of 1984 (NOTA). National Organ Transplant Act prohibits the sale of organs based on the idea of valuable consideration. According to the NOTA “The term “valuable consideration” does not include the reasonable payments associated with the removal, transplantation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of human organ in connection with the donation of the organ”. Current arguments for and against the selling of organs consider and evaluate several ethical questions.

Current arguments in favor of financial compensation for organs:

1. Because demand for organs outpaces supply, it is believed that donation rates would increase if financial incentives were permitted.
2. Organ donors are the only participants that receive no tangible benefits.
3. Polls indicate societal support of compensation.
4. Legal compensation of semen, hair, and plasma suggests the right of a person to use body parts as they wish.

Current arguments against compensation for organs:

1. Potential abuse of vulnerable populations, such as those in a lower socioeconomic bracket.
2. Reduction of altruistic donors who feel that compensation weakens their donations.
3. Reduced donor disclosure due to motives based on compensation rather than altruism.
4. Financial neutrality is a more ethical alternative.

For living organ donations such as kidney and liver transplants, the costs can add up for the donor. Travel, housing, and lost wages are all expenses that a living donor can incur. According to Warren, et. al.,  donors can incur an average of $6,000 in additional expenses. The goal of financial neutrality or at least the removal of “disincentives” is considered a more ethical approach to obtaining more donors.  

Proponents of financial neutrality suggest the coverage of:

• Direct medical expenses: all pre and post donation costs related to the procedure
• Direct nonmedical expenses: travel, housing, food, etc.
• Indirect expenses: recovery time, lost wages

The recipient’s insurance may cover these expenses; however if it does not, there are organizations available to help. The National Living Donor Assistance Center (NLDAC) works to lessen the financial burden on donors through federal government grant funding.

            Although some countries allow the selling of organs, the theory of supply and demand may not be the best or most ethical motive. There are many other factors to consider.

Let us know your thoughts about the ethics of organ donation in the comments section. We’d love to hear from you!

Thanks for tuning in to the Hart Clinical Consultants Ethics Series!

By Jodi Fletcher

Summer is a great time to ramp up those New Year’s health goals. The good weather and longer days don’t leave any room for excuses not to get healthy. The month of June has not only Father’s Day in it, but is dedicated as Men’s Health Month. That means time for men of all ages to take a closer look at their health. According to Menshealthmonth.org, the purpose of this month is “to heighten the awareness of preventable health problems and encourage early detection and treatment of disease among men and boys.” Federal, state, and local governments have declared the month of June as Men’s Health Month: to see your state’s proclamation go here. Awareness programs, activities, social media attention, and Men’s Health Week are just a few of the methods designed to encourage men to seek out information about their health. Family involvement is also an important factor in ensuring the men in our lives get the help they need towards longer, healthier lives.        

            Men’s health facts:

• On average, men live 5 years less than women
• 1 in 2 will develop cancer
• Men have a higher death rate than women for most leading causes
• Approximately 30,000 men in the U.S die yearly from prostate cancer
• Men see the doctor half as much as women for preventative care
• More men are uninsured than women

Common men’s health issues are managing chronic diseases such as diabetes, obesity, hypertension, heart disease, and high cholesterol. Other issues that affect health and quality of life are low testosterone and depression. Low testosterone affects sexual health, mood, memory, and energy. Low testosterone increases the risk of other chronic conditions as well. Prostate health problems are common in men, especially over the age of 50, although younger men can experience problems too. 

Prostate health issues:

• BHP: benign prostatic hyperplasia is an enlarged prostate
  • Not cancerous
  • Most common in men over 50
  • Half of men age 50-60 and 90% by age 80
  • Causes discomfort and frequent, difficult urination
• Prostate cancer
  • Most common
  • 2^nd leading cancer resulting in death
  • No known prevention
• Prostatitis
  • Inflammation possibly caused by infection
  • Most common in men under age 50

The American Cancer Society recommends that men with average risk factors for prostate cancer get regular screening at age 50. Risk factors include age, race/ethnicity, geography, family history and genetic mutations. Early detection is crucial for treatment. There are two main screening tests used for early detection. One is a blood test that determines the prostate-specific antigen (PSA) levels. The other test is a digital rectal exam (DRE) that checks the prostate.

Steps to improve health and stay healthy:

• Eat healthy, include fruits and vegetables, and limit salt, sugar, and alcohol.
• Participate in at least 2.5 hours of physical activity every week.
• Quit smoking, for more information go here.
• Reduce stress, try meditation or yoga.
• Get regular checkups and preventative tests and screenings.
• Know the signs and get help:
  • Heart attack: chest pain, weakness, pain in the arm/shoulder or neck/back, shortness of breath
  • Depression: sadness, grumpiness, hopelessness, fatigue, thoughts of suicide

Friday June, 15^th is “Wear Blue Day” as a reminder of the importance of men’s health, but any day can be designated for group awareness building activities. Wear something blue to show your support, plan events, or create a fundraiser.   

Although the month of June is dedicated to men’s health, its message is important for the whole year. Join us in learning more about men’s health this month by going here  for more information.

Thanks for tuning in to Hart’s Healthy Tips!

Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure,  clinical protocol/protocol amendments, informed consent tracking,  and the use of advertisements.  Today we will be reviewing financial documents and insurance required prior to beginning a clinical trial.

The Good Clinical Practice (GCP)  guideline, ICH E6 R2, doesn’t go into great detail regarding how financial agreement should be arranged, but it does state that it should be addressed.  The guideline states that financial aspects of a trial should be documented in an agreement between the sponsor and the investigator or institution (page 19), and defines a contract as a “written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters” (page 3).

Many research institutions have checklists for what should be included in a contract between a study sponsor and the institution.  Things that may be required to address in your agreements yet may be overlooked include:

• Agreement that procedures will be used to protect research participants
• Dissemination of findings—roles that investigators and sponsors will play in publications, presentations, or other disclosure of results to the medical community, regulatory bodies, and patients
• Responsibility for medical care for research-related injuries
• Agreements for sponsor reporting of safety issues to the institution
• Handling of intellectual property
• Indemnification or insurance

If required by the applicable regulatory requirements, the sponsor should provide insurance or should indemnify the investigator or institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence (page25). In years past, it was virtually unheard of for sponsors in the United States to be required to purchase this type of insurance for U.S. -located studies. However, in recent years, the trend is growing for large institutions to require such a policy.

Generally, it is good business practice to have written agreements for each area that could be of value to the parties, such as intellectual property, for each area of potential liability, such as payments for research-related injuries, and for potential areas of disagreement, like dissemination of information.  It is no different for a clinical trial and the ICH E6 R2 GCP guidelines speak to the importance of having these documents in place without dictating exactly how they should be implemented.

Thank you for reading HCC’s glossary series!