Mid-Atlantic Consortium Newsletter Summer 2013

Protecting Human Subjects: Institutional Review Boards at Work

Illustration of a inverted pyramid of people holding each other upScientifically sound, well-conducted clinical trials are the gold standard of advances in medical treatment, and those who volunteer to participate in them are real heroes in modern health care. It’s important that families considering participation in research studies at one of the Mid-Atlantic Consortium research centers can do so with confidence that their safety and privacy are protected, their rights and interests are a priority, and they are well informed about the risks and benefits of their participation.

At the Johns Hopkins Hospital and School of Medicine, six institutional review boards (IRBs) review and approve research projects involving human subjects, including projects at the Kennedy Krieger Institute (KKI).

Neurologist David Cornblath, M.D., chairs one of the Hopkins IRB committees, which meet weekly to review three to six new proposals and five to 20 studies in need of assessment, renewal or updating. His committee, which oversees most of the human subjects research at KKI, includes two KKI faculty members and a community member.

“It’s a balance,” Cornblath says of the committee’s work. “We look at study risks including any procedures, the potential benefits, and make a determination as to whether the study should be conducted and under what conditions. We also consider if participants are being adequately consented,” meaning they are appropriately informed about risks and benefits of volunteering.

People who can’t consent for themselves, like young children and those with intellectual and developmental disabilities, have additional protections, Cornblath notes: “One of the things we have done is create additional forms, called ‘information sheets,’ that boil down the essence of research studies to 10 or fewer sentences summarizing the longer consent forms.”

Depending on the nature of the study, researchers may be required to obtain assent –  expression of willingness to participate in research – for those who are unable to consent for themselves. In these cases, responsibility for providing consent is assigned to someone legally authorized to act on a participant’s behalf.

At Hopkins, the IRBs operate under the direction of the vice dean for clinical investigation.

The IRBs are charged with determining that:

  • the rights and welfare of the research subjects are protected adequately
  • the risks to participants are outweighed by the potential benefits of the research
  • the selection of participants is equitable
  • informed consent will be obtained and, when appropriate, documented

Each study submitted to the IRBs for review must explain how participants will be identified and recruited. Once the pool of potential participants is identified, the IRBs consider how the investigator proposes to approach those individuals to ensure no one is coerced or recruited inappropriately.

In addition, investigators must respect and protect participants’ privacy. To assure these principles are met, IRBs review and approve study recruitment plans and advertisements. In some cases, other experts are called upon to weigh in on the potential importance of a project and the quality of the research plan. At Hopkins, each IRB has a bioethicist as a voting member to ensure that studies conform to the highest standards of ethical research.

Once studies are approved, study sites like KKI are responsible for conducting them properly. But even after approval, there is continuing oversight by the IRBs, which monitor studies on at least a yearly basis to ensure they are progressing and that any developments bearing on the safety and potential impact of the research are evaluated and understood.

IRBs follow a similar protocol at Children’s National Medical Center, the Children’s Hospital of Philadelphia, and many other academic medical centers. Research participants’ safety and rights are truly considered a priority.

 

For more information about Johns Hopkins’ IRBs, see http://www.hopkinsmedicine.org/institutional_review_board/about/

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