The distrust of medical research by communities of color is well earned. In the past, terrible things have been done to minorities in the name of science, by white doctors, and white scientists.  Perhaps the most famous of these modern-day injustices is known as the “Tuskegee Project”. In this tragedy, hundreds of black men were abused by the United States Public Health Service and the Centers for Disease Control and Prevention. The goal of the study was to “observe the natural history of syphilis”. It began in 1932, when treatment did not exist. However, even after 1947, when penicillin was proven to be an effective treatment, these men received only fake therapy, and remained without treatment until 1972, when the experiment was leaked to the press.

Thankfully, our country has learned from these injustices. We have implemented many safeguards to make certain that every person involved with research is treated with dignity, respect, and above all, full knowledge of the risks and benefits of participating in FDA sponsored medical research.

These safeguards include:

Internal Review Board (IRB)

Every research trial must have the approval of an IRB to begin and continued oversight by the IRB is required to continue. The IRB typically consists of community members that represent different races, religions, sexes, and ethnicities. These members cannot be hired or fired by the research team. They are completely independent and can stop a research trial at any time. The IRB’s focus is to protect patients and families from dishonest practices and to make certain that research participants are fully informed of the risks and benefits of all aspects of a research trial. Every participant is given the contact information for the IRB so that he/she can report any concerns. It is the obligation of the IRB to protect patients and families.

Consent Form

Every research trial has a consent form explaining the following in plain language:

• Reasons for the research
• Length of trial, number of visits, and expected procedures
• Potential risks
• Rights of the participants
• IRB contact information
• Statements that the medication has not yet been shown to be effective or safe
• Disclosures regarding placebo
• The right to quit research without penalty or cost
• Research medications will not be used in place of proven medications unless this has been fully discussed
• All aspects of research occur without charge to the patient, family or insurance company

Inspections and Audits

All facilities are inspected on behalf of the pharmaceutical company or agency sponsoring the research to make certain they are safe and appropriate. Regular visits are conducted by these same bodies to make certain research is conducted ethically. The FDA reserves the right to inspect and audit at any time of their choosing.

Assignment of Responsibility

One person for every trial, at every research site, is listed as the “Principal Investigator”. He or She is the captain of the ship and accepts responsibility for all actions at the facility.  By putting this responsibility on a single person, it eliminates the possibility of spreading blame and therefore increases oversight by a person with the ability to stop poor or unsafe practices.

Good Clinical Practices

On a regular basis, all personal involved with medical research must take, and pass an FDA approved course on ethical practices in research.

With special thanks to Columbus City Council Member, Jerry “Pop” Barnes, we have compiled a number of important questions that he believes are frequently asked in communities of color. Pop has served us all for decades as a medical professional in the U.S. Armed Forces, Council Member, and tireless advocate for the underserved, and the prosperity of Columbus.

If you have a question that you feel should be addressed in this area of the website, please submit it via this link.

Question 1:

All research done in the U.S. must conform to the principles set forth in The Belmont Report or it cannot occur. These principles are as follows:

Respect for Persons:

• Individuals should be treated as autonomous Agents (self-governing, intelligent, make their own choices and opinions)
• Those who have diminished autonomy are entitled to extra protections. (Learning disabilities, children, aging adults with diminished faculties)

Beneficence:

• Persons are treated in an ethical manner not only by respecting their decisions and protecting them from Harm, but also making an effort to secure their well-being.

As a result:

• Investigators and members of their institutions are obligated to give forethought to the maximization of benefits and the reduction of risk that might occur
• Members of the larger society of scientific research are obligated to recognize the longer-term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures

Justice:

Who ought to receive the benefit of research and bear its burdens? Though we want all involved to receive the benefits of a study, there is a possibility that the benefits will not be felt until the next generation, your children, or grandchildren. There is a possibility that a person will receive placebo.

What is the benefit of research if I get Placebo?

• With placebo driven trials there is a chance that placebo will be given. The placebo looks like the researched drug but has no medicinal value.
• Studies are blinded, meaning the doctor and the study coordinator do not know who takes the placebo, and who takes the drug.
• Placebos are used to see if a treatment is safe and more effective than no treatment at all.

Requirement of informed consent:

Healing begins with knowledge. Informed consent sets today’s research apart from the 1940s. Subjects in the 1940s had little to no understanding of what was happening to them nor were they told of a cure. Today, subjects are well educated and if there is any doubt, they will be represented by someone with their best interest in mind.

Information:

• A Fair explanation of the procedure to be followed, including and identification of those which are experimental.

Comprehension:

• A disclosure of appropriate alternative procedures that would be advantageous for the subject.
• An offer to answer any inquiries concerning the procedures.

Voluntariness:

• An instruction that the subject is free to consent and to discontinue participation in the project or activity at any time.

Assessment of Risks and Benefits:

Systematic Assessment of Risks and benefits

• Brutal or inhumane treatment of human subjects is never morally justified
• Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all.
• When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk.
• When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. Several variables go into such judgements, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits
• Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

Selection of Subjects:

Individual Justice:

• Potentially beneficial research should not be offered to some patients who are in their favor or select only “undesirable” persons for risky research.

Social Justice:

• Requires that distinction be drawn between classes of subjects that aught, and aught not, to participate different kinds of research based on ability of member of that class to bare burdens and on the appropriateness of placing further burdens on already burdened persons.

Question 2:

How do you get involved in a trial?

Answer 2:

Getting involved is simple. Just fill out our Trial Registry Form and a coordinator from Columbus Memory Center will contact you. Research Studies are completely free, no insurance is necessary, and you will receive compensation for your time. Studies will reimburse you for travel and hotel room if you live outside of a reasonable distance. Any testing, such as genetic testing, MRIs and PET scans are all covered by the study.

Question 3:

What is the length of the trial?

Answer 3:

There are a number of factors that determine the length of a trial. They can be as short as a few months or as long as several years. When you consider a trial, you will be told about the length of your potential involvement and the frequency of needed visits in advance. When you enter a trial, you always have the right to quit. There is no penalty of any sort for leaving a trial.

Question 4:

We know nothing about this medicine. Does it really cure Alzheimer’s?

Answer 4:

Curing Alzheimer’s disease is our ultimate goal. However, current trials have a more realistic goal of slowing the progression of disease. In other words, keeping a person healthier than he/she would be without the medication. While research medications are experimental, they would have been tested in laboratories, on animals, and in healthy volunteers prior to reaching this stage of testing. This offers us reasonable insight into the experimental drug’s potential side effects, risks, and benefits.

Question 5:

How does this medicine work and will I have to be in a hospital?

Answer 5:

The good news is that we now have many different trials, and therefore many different ways to potentially slow Alzheimer’s disease. There are two particularly troublesome proteins that damage our brains in this disease. They are called Beta Amyloid and Tau. Many of the research medications are designed to slow down production or remove these proteins. Other trial medications add enzymes to our brains to improve memory, or remove certain bacteria from our bodies, that cause harm to the brain. This is just a partial list of the ways in which we are attempting to preserve brain function. Research is done at the Columbus Memory Center on an outpatient basis. So, hospitalization is never part of our therapies. Treatment is administered in one of three ways: Oral tablets, Injections, IV infusions. This is based on the type of medication in the trial. The average patient spends about an hour and a half, once or twice a month at our facility. Most participants will undergo intermittent thinking testing that can take a bit longer. Safety tests such as blood work, heart tracings, brain MRIs or PET scans are sometimes needed.

Question 6:

If some of the people are going to get the real medicine and some are not, if I am not going to get the real medicine why am I wasting my time?

Answer 6:

This is a critical question. The most important reason why you should participate is that if your race is not involved in the research, then the results will not represent your family, friends and community.

It is also important to think of medical research as “a little something extra”. In other words, after you have been placed on the best proven medications, research might offer extra benefit. Even if you do not receive medication, you will experience a time when an entire health care team is focused on your health.

No medication is considered to be effective, and allowed to be prescribed, unless it is better than taking nothing at all (Placebo). Therefore, some people will come into research and not get an active medication. That said, it is quite common for a research trial to have two phases. In the first phase some patients get medication, while others get placebo. In the second phase, everyone gets the research medication.

Every single medication that comes on the market today will have gone through the same type of trials, and without volunteers, none of these medications would be available. There is a cure out there. We need participation from every race to find it.