Monthly Archives : September 2017

Vulnerable Populations: who are they?

Vulnerable Populations: who are they?

This is the fourth in a series of articles about medical ethics.  Our previous posts in this series included the basics of medical ethics, the difference between utilitarianism and deontology, and the Belmont Report.

Today we will review vulnerable populations.  The idea of vulnerable populations falls under the ethical construct of respect for persons.  Remember that this principle is about autonomy, where an autonomous individual is capable of making decisions about their personal goals and beliefs. In research, this means that participants of research voluntarily agree to participate and have enough information provided to them for them to make that decision reasonably. Individuals who lack this capacity, either fully or partially, are considered vulnerable because they may not have the maturity or capacity to make an informed decision.


Vulnerable groups include children, the poor, elderly people, homeless, the mentally ill, and racial or ethnic minorities. It can also include the uninsured or uneducated. In the case of prisoners, soldiers, or other institutionalized individuals, they may be under the influence of subtle coercion or undue influence.  Vulnerabilities may be classified as physical, psychological, or social according to the American Journal of Managed Care.

The FDA regulates clinical research in certain vulnerable groups specifically.  Children, prisoners, pregnant women, mentally or physically handicapped or disabled persons, and economically or educationally disadvantaged persons are specifically addressed in the US Code of Federal Regulations Title 21, Part 56.111, Criteria for IRB approval of research, and under Health and Human Services regulations, Title 45, Part 46.201, Subpart B—Protections for pregnant women, human fetuses, and neonates involved in research, Subpart C—Protections pertaining to biomedical and behavioral research involving prisoners, and Subpart D—Protections for children involved in research.

With approximately 1% of US residents incarcerated as of 2013, the issue of research ethics in this population is an important one. A 2002 report indicated that despite the requirements of  45 CFR 46, Subpart C that curtails most research on prisoners, the majority of this type of research occurs outside the purview of federal regulations and without review or approval by an IRB. Little research is conducted in prisons as medical clinical trials or biomedical studies, however, most studies were social, behavioral, program evaluations, or record review in nature.

Using prisoners as an example, we’d like to remind you that the number of vulnerable individuals is growing in the US. The issues surrounding medical care, and specifically research in these populations continue to challenge bioethicists and clinical researchers. So, continue to ask questions during protocol and informed consent development, while consenting potential participants, and while reviewing medical records to be aware of patients who may fit a vulnerable description.

Thank you for tuning into HCC’s ethics series.

Essential documents Deep Dive: Agreements

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!

Hart Health Hints for September 2017: Atrial Fibrillation

This installment of Hart Health Hints celebrates a year of this blog series that aims to inform our viewers about some important health tips. We especially love finding out about events in our communities that help bring awareness to health problems that our friends, our families, or ourselves may have. 

In our industry, we are experts in technical details of the disease processes and cutting-edge treatment solutions, but sometimes we are not as involved in community health, and know much less about the opportunities available to educate ourselves and our loved ones about various conditions.

This month we are highlighting National Atrial Fibrillation Awareness Month, sponsored by the American Foundation for Women’s Health.

Many people in our communities may ask, “What is A-FIB?”  Atrial fibrillation, or A-fib, is a condition where the heart beats irregularly. This condition is very common, but often little is known about it.  If left untreated, it can lead to dementia, heart failure, stroke, and death. is an advocacy organization dedicated to raising awareness around A-fib, and describes the condition in detail, provides links for A-fib resources and treatment information, and fosters communication among the A-fib community.

So, even if you don’t know anyone with atrial fibrillation, we encourage you to take a few moments this September to learn more about the resources available in your community for people wanting to learn about this interesting, and often ignored condition.  Try looking here and here for more information.

                                                                                                                       Pic courtesy of

Have a great September, and keep learning!

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