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Nov2013

by Jennifer Vergara-Jimenez, MD, MS Bioethics, Assistant Director of Research Compliance, Jaeb Center for Health Research and Adjunct Faculty, South University Health Programs

PRIM&R is pleased to continue our posts from members of the PRIM&R Blog Squad at the 2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who blog here, on Ampersand, to give you an inside peek of what's happening at the conference on November 7-9 in Boston, MA.

The responsibilities of institutional review boards (IRBs) are based on ethical principles that ensure the protection and welfare of research subjects' rights. Yesterday, Karen Hale, RPh, MPH, CIP, and Susan Kornetsky, MPH, CIP, successfully conducted the pre-conference program IRB 201: An In-Depth Analysis of the Criteria for Review. They explained each of the approval criteria that IRBs should follow to adequately protect research participants.

They faculty highlighted the principle that IRBs must be independent and capable of making decisions without coercion. This crucial requirement should be adequately reflected in the procedures for the appointment of IRB members, in the requirements for joining the IRB, in the management of any potential conflicts of interest, and in disclosures regarding IRB financing sources. To ensure that its work is executed free of biases and influences that could affect their independence, an IRB includes relevant scientific experts and persons representing the interests and concerns of the community. IRBs also always take into consideration the ethical principles of beneficence, justice, and respect for persons.

To accomplish its mission, the IRB is responsible for reviewing, approving, and monitoring proposed research protocols to ensure compliance with federal regulations and operationalize some of the ethical guidelines concerning the protection of human subjects participating in research such as The Belmont Report, the Declaration of Helsinki, the guidelines from the Council of International Organizations of Medical Sciences, and others. 

The IRB’s responsibilities and obligations start with the initial evaluation of the protocols that involve human subjects research. To approve a protocol, the IRB should find that it meets the following criteria:

  1. Risks to subjects are minimized.
  2. Risks to research subjects are reasonable in relation to anticipated benefits.
  3. The selection of research subjects is equitable.
  4. Informed consent is sought from each and every proposed subject or their legally authorized representatives.
  5. The informed consent process is properly documented.
  6. When appropriate, the data obtained from the research is monitored to protect the safety of the subjects.
  7. When appropriate, adequate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data.
  8. There are additional safeguards when a vulnerable population is involved in the protocol.

It has been an excellent start to the conference, and I have learned in more detail about each of the criteria that should be considered when the IRBs evaluate a research study involving human subjects.

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