Exploring Medical Research

Gloved hand focusing a microscope on a slide

“Research is formalized curiosity. It is poking and prying with a purpose.” – Zora Neale Hurston

Whole body donation plays a huge role in medical research and education. Cadavers offer a type of hands-on experience that cannot be recreated through technology and are used by medical students, physicians, researchers, and scientists to study things such as anatomy, identify disease sites, or determine causes of death. Typically, medical research can be broken up into three main categories.

  1. Basic Research
  2. Clinical Research
  3. Epidemiological Research

In medical research, there are two classified types – primary and secondary research. Secondary research is a summary of available studies in the form of reviews and analysis. Primary research is where the actual studies happen. Basic, Clinical, and Epidemiological research are classified as three types of primary research.

Chart showing types of primary and secondary research

The flow chart above provides a basic overview of what exactly happens in each category of medical research. Now that we have a quick overview, we can break down each category further.

Basic Research

Basic research is technically fundamental research or the study of life processes that are universal in their application to scientific knowledge. David Frank, MD, Associate of Medicine, Medical Oncology at the Dana Farber Cancer Institute quoted basic research as:

“If you think of it in terms of construction, you can’t put up a beautiful, elegant house without first putting in a foundation. In science, if you don’t first understand the basic research, then you can’t move on to advanced applications.”

Basic medical research includes animal experiments, cell studies, biochemical, genetic, physiological investigations, and studies on the properties of drugs and materials in fields such as biology and chemistry. These studies are the study of the core building blocks of life including DNA, cells, proteins, and molecules to help answer the questions about their structures and how they work.

Typically, in these experiments there is at least one independent variable that is varied, and those effects are what are investigated. The variable could be the population, number of groups, case numbers, treatments, or dosages. Also in these experiments, the confounding factors should be controlled or reduced, specific hypotheses are investigated, and causal statements are made.

Basic research will also include the development and improvement of analytics procedures. These procedures can include but are not limited to:
Analytical determination of

  • Enzymes, markers, or genes

Imaging procedures

  • Computed tomography
  • Magnetic resonance imaging

Gene Sequencing

Development of Biometric procedures

  • Statistical test procedures
  • Modeling and statistical evaluation strategies

Clinical Research

Clinical research is a step above basic and addresses important questions of normal function and disease by using human subjects. This type of research is geared more toward exploring whether new treatments, medications and diagnostics techniques are not only safe but effective as well.

Clinical trials are extremely rigorous and controlled so that they can accurately monitor progress and evaluate the treatment’s efficacy and benefits. Clinical research can be broken down into several distinct categories of study. Some of those include but are not limited to:

Treatment Research that involves the intervention of medicine, psychotherapy, new devices and innovative approaches to surgery or therapy.

Prevention Research which aims to better the prevention of disorders from developing or returning using medicine, vitamins, vaccines, minerals, or lifestyle changes.

Researchers looking at information on computer monitors

Diagnostic Research is the practice of looking for better ways to identify a particular disorder or condition.

Screening Research aims to find the best ways to detect certain disorders or health conditions.

Quality of Life Research finds new ways to improve comfort and quality of life for patients with chronic illnesses.

Genetic Studies are implemented to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related.

Research includes discovering why a person’s genes make them more or less likely to develop certain disorders.

While clinical research is commonly associated with new medications or devices, some studies include healthy volunteers that are needed to compare to results of patients with illnesses. These types of studies include:

  • Long-term studies that involve psychological tests or brain scans
  • Genetic studies that involve blood tests
  • Studies of family history

Epidemiological Research

This specific branch of medical research investigated all the factors that determine the presence or absence of disease and disorders to help understand how many people have a disease or disorder, if those numbers are fluctuating and how it affects our society and economy.

With epidemiology, the patient is the community and individuals that are viewed collectively. Epidemiology is the study (scientific, systematic and data drive) of the distribution (pattern and frequency) and determinants (causes and risk factors) of health related states and events in specific populations (neighborhoods, schools, states, cities, global).

When it comes to epidemiological studies there are some key terms you need to know:

1. Incidence: number of new cases in the population over a set period

2. Prevalence: number of exciting cases

3. Cost of illness: expenditures of medical care

4. Burden of disease: total significance of disease for society

  • Measured in years of life lost to ill health
  • Difference in total life expectancy and disability-adjusted life expectancy (DALY)

5. DALY – summary measure of health of a population. One DALY is one lost year of health and is used to estimate the gap between the current health of the world and an ideal situation.

There are several health problems or events that Epidemiological researchers are studying. These include environmental exposures like lead, heavy metals, air pollutants or asthma triggers. Infectious diseases such as foodborne illness, influenza, pneumonia. Injuries including increased homicides in a specific community or a national surge of DV. Non-infectious diseases that can include localized or widespread rise of a particular type of cancer or an increase in a major birth defect.

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Research For Life - Understanding Whole Body Donor Consent

Hello, my name is Garland Shreves, CEO of Research For Life. I want to take a moment to discuss some very basic information with you regarding consent forms, in general, that you may encounter when considering to donate to a whole body donor organization.

First and foremost, you need to understand and read the consent form, also known as the authorization form or document of gift, so you know what you are consenting to.  Ask questions of the organization if you don’t understand something. 

 All states require, under the Uniform Anatomical Gift Act, that consent be granted by an authorized agent of the donor or self-authorization before death.

Each state defines who in the consenting class has the most authority to direct donation. Such as the medical power of attorney, spouse, children, grandchildren, siblings, etc. and differs slightly in each state. 

Consent may be given by means of a verbal recorded consent or by a written document of gift.

Research For Life uses a written consent form which can be found on our website.

Understand that the donor or authorizing agent is giving the body to an organization. Once given it belongs to the organization to use in accordance with the consent form.

In other words, the donor organization is free to use the donor provided it does so within the terms

of the consent, it may not use the donor in a manner not consented too.  

The consent may state how the body may be used.  Educational and/or research purposes or some other purpose may be stated or in the discretion of the donor organization.

Research For Life provides cadavers and/or anatomical specimens for education and research purposes and does not do ballistic testing.

The consent may state that the body will be used in whole or in parts. It may also state that the anatomical parts may be used domestically and or internationally.

And most consents will cover some basic things like consent to test the donor for diseases and order medical records to help best determine the medical suitability for the donation.

The consent may also touch on issues like for profit or nonprofit status and if the donor or anatomical specimens will be used by one or more or both types of entities.  Remember that regardless of an organizations tax status they all charge fees to end users who order anatomical specimens and offer those specimens to both for profit and nonprofit entities.

From the very start of the donation process costs to the donor organization begin. 24-hour answering service, transport team to respond 24/7, qualified trained staff paid a livable wage with benefits and retirement, electric, gas, phone, insurances, building payments, maintenance, medical director, and regulatory requirements, and cremation fees. And these are just some of the expenses that an organization may have to cover.

Another item you may see on most authorization forms is a release of liability, a hold harmless agreement, excluding misconduct of course.  

Research For Life states clearly it will not and donor or agent agrees that Research For Life will not be held responsible for acts of third parties in connection with the donation.

Another item that reduces a donor organizations liability is the Anatomical Gift Act prohibits criminal, civil or administrative actions provided there is no intentional misconduct on the part of the donor organization. In other words, if the donor organization acted in good faith it is immune and provided some protection from lawsuits.

Another important part on a consent form is the person signing the authorization attests (affirms) that they have the authority to direct the donation. The donor organization accepts the authorizing agent’s authority in good faith barring any information known to it at the time of donation that would contradict the authority of the person authorizing donation.    

Remember, should you decide to register, tell your family and friends about your decision.

Also, the donation authorization form is not valid until notarized or signed by two witnesses; one witness must be non-family or disinterested party. 

Consent forms contain other important information that you need to read and understand.

All documents of gift or authorizations can be cancelled prior to death.

I want to thank you for taking the time to watch this video and I hope it helped provide you with some basic information regarding whole body donation consent forms.  Thank you.