Medical Ethics

Session 2

Session 2

What is clinical research and when does it involve a human subject?

Formal independent review of proposed clinical research is required when the regulatory (Common Rule) definitions of both research and human subject are met. Journal editors and peer reviewers scrutinize submitted manuscripts to determine whether authors have complied with ethical and regulatory requirements applicable to clinical research involving human volunteers.

Under certain circumstances, clinical research may not involve human subjects, or may be eligible for a determination that formal IRB review is not required.

Individuals with whom an investigator does not directly interact may still become human subjects if identifiable private information about them is obtained by the investigator. This may be the case, for example, in genetic research.

Objectives
  1. To understand the regulatory definitions (in the Common Rule) of research and the human subject.
  2. To review the circumstances when clinical research may be eligible for a determination that IRB review is not required, or when the research may be eligible for a process of expedited review.
  3. To understand the notion of "secondary" human subjects in the context of genetic research involving families.
  4. To explore the differences and similarities between quality improvement activities and clinical research.
  5. To explore the differences and similarities between public health surveillance activities and clinical research.
  6. To examine the differences between "innovative" clinical practice and clinical research.

 

Required reading for this session

Cases for discussion

Case 1

Dr. Jones, a cardiologist, and several colleagues perform cardiac catheterization procedures in their hospital-based clinical practice. This involves puncture of a femoral atery for catheter access. After completion of the procedure, hemostasis is achieved at the puncture site after removal of the catheter. A device manufacturer has approached the group in connection with the purchase of a mechanical device that may be used to achieve hemostasis.

The device is F.D.A.- approved for this purpose. The cardiologists presently employ the application of digital pressure over the puncture site -- some cardiologists perform this personally, while others use a laboratory tehnologist for this purpose. They do not have practice statistics on the frequency of complications such as peri-arterial hematomas.

After debating this issue, they decide both to standardize the method by which hemostasis is secured in their catheterization laboratory, and to evaluate the potential utility of the mechanical device, by adopting the following strategy: For a period of four months, they will randomize patients among the following maneuvers: digital compression over the puncture site for 10 minutes by the cardiologist; digital compression over the puncture site for 15 minutes by a laboratory technologist; and use of the device as recommended by the manufacturer. Assessments will be made after the application of pressure, and again after 3 hours. They will also call the patient the next day to ascertain whether any complications have occurred, such as a delayed hematoma. The assessments and complications will be tabulated and reviewed, and a decision whether or not to purchase the device made.

Questions

Is this a research activity subject to IRB review and approval, or solely a Quality Assurance or Quality Control issue?

If research, is this eligible for expedited review?

If IRB approval is needed, what aspects of this proposed activity should be scrutinized by the IRB?

Case 2

Dr. Jones, a clinical microbiologist and epidemiologist, has been requested to assist in the evaluation of an outbreak of meningitis at a local, community-based nursing home for the elderly. The result of a CSF culture in the first patient involved shows the presence of a particular species of Streptococcus, not recognized as a typical etiologic agent in meningitis. Dr. Jones recalls that a close friend in the Department of Molecular Genetics at the University is developing a genetic probe for the organism, and may appreciate CSF samples for his research. He calls his friend, who says "Yes, please! I just need about half-a -cc." He decides to set aside small portions of the blood and CSF samples, obtained for diagnostic purposes, for his friend's research.

Questions

Does the collection of a portion of the samples for research constitute an activity that necessitates IRB review and approval?

Does it make a difference if his friend asks Dr. Jones to be sure that he is given the samples without any identifiers attached?

If IRB approval and Informed Consent are judged necessary, can consent be obtained for the research use of the saved portions sometime later after the patient has recovered from the illness ? Dr. Jones does not want to bother the patient with this extraneous issue while she is ill.

Additional resources