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June 2020 Newsletter
Inside This Issue
- Research and Race: A Human Subjects Research Primer
- Pat Buennemeyer Scholarship Deadline
- Quick Updates
- Body of Knowledge Review Sessions Schedule Update
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Unless you have been living under a rock or hiding in your underground bunker for the last month, you have taken note of the racially-charged atmosphere in the United States (US) and abroad. There have been numerous events to set the stage for what we see today. Although it may make us very uncomfortable, we know that exposing the bad helps usher in some good.
This issue reminds us of a couple of key evils from our research administration past, but it also highlights the many good things that came as a result. Let’s just call it a brief primer on why we do human subjects research the way we do it today. If I have your consent to discuss
Research
and
Race
, then read on.
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An International Evil:
Nazi Medical Experiments (1942-1945)
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During World War II, Nazi concentration camps were also sites for research experiments that were conducted on the prisoners who were mostly persons of Jewish, Polish, Russian and Gypsy descent.
(1)
These wicked research protocols included the following types of experiments:
- High-altitude experiments
- Freezing experiments for hypothermia
- Testing methods to make seawater drinkable
- Testing drugs and treatment methods being developed for contagious diseases, exposure to chemical weapons and bone-grafting
- Race experiments for establishing minority inferiority, sterilization and contagious disease handling
We will not go into the details of what these experiments did to its human subjects, but you can visualize it from the topics above. These experiments were extremely harmful, if not fatal to its subjects, and each experiment was conducted without their consent. Although some medical professionals and researchers were prosecuted for these atrocities, most perpetrators were not held responsible for their crimes and continued their careers.
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International Good #1: Nuremberg Code
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When the physicians and scientists were put on trial for war crimes after World War II, the war crimes tribunal held at Nuremberg, Germany, drafted 10 standards for judging their use of human subjects in research experiments. Those standards are known as the
Nuremberg Code.
(2)
The standards
included voluntary informed consent, avoidance of unnecessary harm and ensuring the benefits of research outweighed the risk. The standards, however, proved to be inconsistent, conflicting and hard to apply, but they were the prototype for broader and more effective ethical principles to be developed down the road.
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International Good #2: Declaration of Helsinki
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In 1964, the World Medical Association defined ethical principles for medical research involving human subjects in the
Declaration of Helsinki
(3)
. This
declaration, which now consists of 37 statements, went further than the Nuremberg code to ensure that the rights and interests of individual research subjects governed every decision made in the course of research.
Although progress was being made internationally on this front, the US seemingly lagged behind in adopting these standards.
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A National Evil:
Tuskegee Syphilis Study (1932-1972)
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Before World War II and its global effects engulfed the United States, another research study was fully underway, even in the midst of the Great Depression. The
“Tuskegee Study of Untreated Syphilis in the Negro Male”
(4)
was funded by the United States Public Health Service in 1932. The study was designed to follow black men in Macon County, Alabama, who were not treated for syphilis, which was a major health problem at that time. The study goal was to justify the need for treatment programs for black Americans. The human subjects enrolled in the study were 600 rural black men, most with syphilis and others without the disease. To encourage their participation in the study, the men were told they would be treated for “bad blood” and promised free medical exams, free meals and burial insurance.
However, the researchers did not reveal the true nature of the study to the men. The men received periodic examinations, but they did not actually receive treatment for their illness. The study was initially projected to last six months, but actually went on for 40 years. Several years into the study, the researchers published a paper that raised some red flags. Critics of the research could not determine if the men were being treated for syphilis. In fact, local physicians were asked to participate in the study, but not treat the men. It was at this point that the researchers decided to follow the men until their deaths. Even when the military draft for World War II ordered all men to be treated, the researchers hindered this treatment.
In 1945, penicillin became the accepted treatment for syphilis, and in 1947, the Public Health Service established rapid treatment centers around the nation, but the men in the study were not offered penicillin. Also, the men were not told that they could quit the study and seek treatment on their own. In 1968, more concern was raised about the ethics of the study, but in 1969, the Centers for Disease Control and Prevention concluded that the study was still needed and gained the support of the American Medical Association & National Medical Association to continue the study. It was not until news organizations condemned the study in 1972 that an investigation ensued and the study ended as it was deemed “unethically justified”. By then, dozens of men had died and an undetermined number of wives, children and others were infected by the participants. It was too late to reverse the physical, emotional and psychological damage of the study, and the long-term effects on the African American population and research are still felt today as many African Americans forgo participation in many beneficial studies due to the distrust and betrayal sowed by this study.
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National Good #1: National Research Act
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In 1974, Congress stepped up to strengthen the international human subjects research guidelines put in place by the Nuremberg Code and the Declaration of Helsinki. Their goal was to ensure that the Tuskegee study never happened again. They used their main weapon to fight evil in society and government: legislation. The
National Research Act
(5)
established the
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
. The commission was charged with identifying basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines to assure that research is conducted according to these principles. The end result was a comprehensive framework for ethical decision-making in human subjects research called the
Belmont Report
.
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National Good #2: Belmont Report
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Three principles make up the framework laid out in the
Belmont Report
(6)
.
- Respect for Persons involves a recognition of the personal dignity and autonomy of individuals, meaning individuals can choose for themselves whether or not to participate in a study when given all of the appropriate information (informed consent). This principle is to ensure that no individual joins a study via force, coercion or undue influence. This principle also protects the privacy and confidentiality of study participants. Special protections are incorporated for individuals with diminished autonomy due to maturity, illness, mental disability or restricted liberty (institutionalized).
- Beneficence entails an obligation to protect persons from harm by maximizing benefits and minimizing possible risks of harm.
- Justice requires that the benefits and burdens of research be distributed fairly. The selection of human subjects should be equitable, and studies should not rely on or recruit only the subjects who are easily available, in a compromised position or easy to manipulate, which tend to be more vulnerable populations (i.e. poor, disadvantaged, prisoners, and racial/ethnic minorities). Rather, the recruitment should relate directly to the problem being studied and not disproportionately involve groups who are least likely to benefit from the research subsequently or select only “undesirable” individuals for high risk research.
Informed Consent
Let’s do a deeper dive into the application of the
respect for persons
principle. The elements of informed consent are information, comprehension and voluntariness.
- Subjects must be given sufficient information to make an informed decision, including the purpose of the research, procedures and alternatives, risks, anticipated benefits, persons responsible for the research, and the ability to ask questions or withdraw from the research at any time.
- The information about the research should be conveyed in a manner that each subject can understand, and investigators are responsible for determining that the subject has comprehended the information.
- A subject’s consent to participate in research is valid only if it is given voluntarily (voluntariness).
Again, well informed individuals can make the best choice for themselves in all circumstances, especially in research. Sadly, none of the subjects in the studies described above gave informed consent.
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National Good #3: Institutional Review Board
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The National Research Act also established the Institutional Review Board (IRB), whose primary purpose is to review research proposals and studies to determine whether the rights and welfare of human subjects are protected and comply with regulations. IRBs conduct initial review of study protocols and approve, disapprove or require changes to such protocols. During the course of the study, the IRB performs regular reviews of the study progress and monitors the study for adverse events. The IRB has the authority to enforce the rules and suspend or terminate a study that is found to be non-compliant or unexpectedly harmful to subjects.
The work of the Commission under the National Research Act moved the Department of Health and Human Services to revise and expand its regulations for the protection of human subjects, which are codified in
45 CFR 46
(7)
. These regulations apply to research conducted or supported by all federal agencies, and subpart A of the regulation is informally known as the
“Common Rule”
. Within the regulations are additional protections for pregnant women, human fetuses, neonates, prisoners and children.
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So, for two great evils in research, we find many good things to help us walk a straight moral and ethical path for present and future research. Does this end the ability of rogue researchers determined to conduct unethical research? No, but it does put enough checks and balances in place to ensure that a study is effectively reviewed and monitored and will not continue for 40 years before harmful practices are stopped. We should applaud the work of our colleagues in the IRBs who are gatekeepers for human subjects research. Researchers may not love them, but I am sure IRBs do not follow the regulations just because it is the law, but rather because it is the right thing to do.
A reminder to all Research Administrators is found in RACC’s
Code of Ethics:
“Act in good faith promoting ethical integrity in all of my actions.”
References
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If you have additional perspectives on this topic or related ones, click the TALK BACK button to share.
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Reminder:
Pat Buennemeyer Scholarship Deadline 6/30
The Pat Buennemeyer Scholarship provides financial assistance to persons who wish to participate in a Body of Knowledge Review Session in pursuit of becoming certified.
The Award
:
Two awards will be made, each up to $1,000, which includes a waiver of the cost of the Body of Knowledge Review Session registration fee ($225). The remaining balance of the award (up to $775) will reimburse the awardee for the cost of travel to the city where the Body of Knowledge Review Session will be conducted.
Eligibility
:
At the time of application, the individual must meet the minimum requirements to take the examination.
Application Materials
: Applicants must submit: 1) a personal statement of 1-2 pages describing why the individual desires to become certified; 2) a letter of support from the individual’s current supervisor; and 3) a current curriculum vitae to
:
[email protected].
Applications are due June 30, 2020
.
Review Process
: Application packages will be reviewed by the RACC Nominations Committee on the basis of the credentials of the applicant and overall quality of the package. Awardees will be recommended by the committee and confirmed by the Executive Committee. Successful applicants will be notified by RACC by July 14, 2020.
Other Considerations
:
The awardee will have up to one year from the date of the award to attend a Body of Knowledge Review Session. The awardee will notify the RACC Executive Director regarding the date and location of the review session to be attended. The awardee will have up to 30 days after attending the review session to submit an expense report to RACC to seek reimbursement for travel costs.
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Ways to Earn Contact Hours
- RACC is calling on RAs who enjoy writing to join our Newsletter team. Why not contribute to the profession and earn contact hours, too? For a win-win opportunity, email us.
- See our Facebook page periodically for FREE webinars and other contact hour opportunities!
Body of Knowledge Review Sessions
Stay tuned as RACC will unveil a virtual Body of Knowledge Review Session in the coming months.
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Latest Employment Opportunity
- Executive Director, San José State University Research Foundation
opportunities on the RACC website.
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Learn More About Upcoming RACC Events
See our
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, and meetings/conferences where you can meet RACC.
OHRP Event Update
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Attend a Body of Knowledge Review Session Near You
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July 10, 2020
Auburn University
Auburn, AL
October 16, 2020
The Sheraton Boston Hotel
Boston, MA
October 23, 2020
Georgetown University
Washington, DC
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August 9, 2020
NCURA 62nd Annual Meeting
October 17, 2020
SRA International Annual Meeting
The Sheraton Boston Hotel
Note
: There are no CFRA Review Sessions scheduled at this time.
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Host a Body of Knowledge Review Session at Your Institution
Contact: Susanne MacDonald, Review Session Coordinator
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WHAT IS THE RESEARCH ADMINISTRATORS CERTIFICATION COUNCIL?
The Council is a private, independent, nonprofit organization that develops and administers a voluntary program for the certification of individuals who meet the requirements established by the Council.
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For Certification Candidates
Handbooks and Exam Schedules
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- November 1-30, 2020 (Application deadline October 7)
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- August 1-31, 2020 (Application deadline July 15)
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- September 1-30, 2020 (Application deadline August 19)
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The remaining 2020 examination periods have been extended to one month.
See our website for the upcoming 2021 examination schedule.
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For Recertification
At the end of each five-year period, recertification will be required in order to continue to use the CRA
®
, CPRA
®
, and CFRA designation.
Notice
: If your
certificate expires on
6/30/2020
and you did not submit your recertification application by May 31, you have been granted a one-time 6-month extension until December 31, 2020.
- Extensions will be processed by July 14 and viewable in the online directory.
- Your new recertification application deadline is November 30, 2020.
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