Institutional Review Board: Management and Function,   ISBN:9780763730499

Customer Rating: 

INSTITUTIONAL REVIEW BOARD by E. Bankert and R. Amdur is 530 pages long, where the subject matter is divided up into about 100 tiny chapters. Most of these chapters consist of some 2 to 5 pages. Generally, this book serves as an excellent issue-spotting guide. But a problem is that the book refuses to disclose much in the way of concrete information. Please consider the following reviews of some of the chapters. "CSP" means Clinical Study Protocol.

Chapter 5-1. This chapter tells us that the first step of an IRB review is receipt of the CSP. The IRB assesses if the study design (randomization, nature of placebo or control, inclusion & exclusion criteria) is adequate to answer the qeustions. The IRB also assesses how the CSP is different from standard of care, whether the Schema is consistent with the text in the CSP, and if sample size is sufficient.

But this last point, regarding sample size, makes little sense, in view of the fact that this book fails to state that the IRB includes a statistician (only a statistician can properly evaluate sample size). The relevant chapters on IRB composition (Chapters 3-7, 5-14) fail to mention anything about IRB members knowing about statistics. My understanding is that IRBs are concerned with ethics, Consent Forms, and "big picture" types of things.

Chapter 5-1 tells us that the IRB must review recruiting methods, and that these methods must not be coercive, and the recruiters must be qualified. Chapter 5-1 tells us that an IRB can only approve a CSP if: (1) The risks are slight; (2) Procedures must present experiences comensurate with those in actual care (I found the writing at this point to be unclear and in need of more commentary); (3) Procedures are likely to result in knowledge useful for treating the disease; and (4) Consent forms are adequate. Another problem is that the authors fail to cite any authority, law, or guideline, for these requirements.

Chapter 5-2 (2 pages long) continues with the same subject matter, but the writing in Chapter 5-2 is so nebulous and indistinct that I was not able to understand a word of it. Chapter 5-2 tells us that IRB members need to use "common sense." But I am not sure how useful it is, to the curious reader, to find out that IRB members need to use "common sense."

Chapter 3-6. This 3-page chapter tells us that the IRB must review a CSP at least once a year, that each IRB meeting should last 4-5 hours, at most, that it is burdensome to arrange IRB meetings because you have to reserve a room for the meeting, and that IRBs typically meet once a month. But this chapter is misplaced, because the material really belongs in Chapter 5-1, which covers the same topics.

Chapter 7-4. This 2-page chapter is grandly entitled, "Data and Safety Monitoring (DSM Board)." Ordinarily, the topic of a DSM Board would warrent an entire book. Apparently, Chapter 7-4 is so short, because it covers only the overlap between an IRB and DSM Board. Chapter 7-4 contains an error. It states that the DSM Board can terminate a study. This is wrong. A DSM Board can only recommend termination of a study. Chapter 7-4 contains the useful information on how an IRB can establish the responsibilities of a DSM Board, for example, what reports are required from the DSM Board, features of the study taht warrent establishing a DSM Board (please note that not all clinical studies have a DSM Board), and the frequency that a DSM Board should meet. Chapter 7-4 is duplicative of Chapter 5-9.

Chapter 8-3. This 5-page chapter is grandly entitled, International Conference of Harmonization (ICH). Ordinarily the topic of ICH would warrent an entire book. Apparently, from this chapter, the only aspect of ICH that is relevant to an IRB is ICH E6. (ICH E6 is one of the 20 or so of the ICH Guidelines, covering various aspects of clinical trials.) This chapter compares ICH requirements and FDA requirements. We learn interesting information regarding these comparisons, as they apply to: (1) Lists of documents that must be reviewed by an IRB; (2) Definition of "vulnerable subjects," (3) Consent Forms; and (4) Written approval by IRB of deviations from the CSP.

Chapter 10-11. This chapter (9 pages) is excellent. Chapter 10-11, which concerns study design, contains a slam-dunk description of placebo-controlled trials and active-control trials, and when these two study designes are ethical or not ethical. For example, where the Standard Of Care is known to be of some benefit, but where patients often refuse this Standard of Care because of its severe toxicity, then using a placebo (instead of active control, the Standard Of Care) can be ethically justified. On the other hand, where irreversible harm is known to result from NOT using the Standard Of Care, then using a placebo cannot be ethically justified. Hurray for Chapter 10-11.

Consent Forms (Chapter 6-1 to 6-12, pages 200-256) are possibly the heart of the book, since Consent Forms are relevant to ethics, and IRBs make decisions on ethics. We learn that Consent Forms can be a tool for educating subjects about the study. We learn that a goal of IRBs is to edit Consent Forms, to correct grammar, to ensure that they'll be readable to a study subject, and sometimes to re-write Consent Forms (meant for studies on adult subjects) in a way readable by 6th graders. We learn that if a study involves children, the IRB should tell investigators that parents must fill out an ASSENT document and a PERMISSION document.

We learn that FDA prohibits Consent Forms from using language that takes away any legal rights (exculpatory language) from subjects. We learn of language found in Consent Forms that seem exculpatory, but is really not, e.g., a statement that the sponsor does not plan to pay for injuries to subjects, or that investigators will take out blood cells and put them to commercial use (page 205). Examples of exculpatory language is, e.g., I agree not to sue the investigators. We learn that a witness must sign the Consent Form where a "short form" consent document is used, and that witnesses are optional and useful where regular Consent Forms are used (p. 209). Where the study involves intentional deception of subjects (this is common in studies relating to psychology), the ethics of the study can be assessed using guidelines from the American Psychological Association. We learn that Consent Forms can be waived where the study involves only looking through medical records, at a time when the actual medical treatment/follow-up has been completed (p. 216-221).

Chapter 6-7 discloses the legal basis for Consent Forms, and how to arrange for surrogate consent, e.g., by using a court-appointed guardian or by getting Durable Power of Attorney for Health Care, or by using state laws (if any exist) allowing relatives to be used as surrogates. This chapter provides a decision tree for deciding on using family members as surrogates. Chapter 8-8 covers the same topic as Chapter 6-7, that is, surrogate consent, and it refers to three opinions from courts regarding clinical trials (these three courtroom opinions represents a tiny fraction of all the courtroom opinions on clinical trials).


CONCLUSION. The book is not really the model of organization. Because so many chapters are by different authors, the same topics (such as the Belmont Report) are disclosed (always in a cursory mannter) in several different chapters. A problem with many chapters is that the subject material is set forth by way of lists, where there is no development of the subject matter in these lists. In my opinion, this book could have been made better by including the following material. Information from the approximately 400 published lawsuits that concern Consent Forms and clinical trials, would have been valuable and on-point. It is common knowledge that the practices and guidelines for almost every profession derive, at least in part, from the outcome of courtroom trials. Published opinions from these lawsuits can be found on Google, by inputting the search terms "consent form" and "clinical trial." Also, I would have appreciated a few pages that reproduce dialogues from some actual IRB meetings (I was able to find a site on the internet reproducing the minutes several from a variety of actual IRB meetings).

The book is more like an issue-spotting guide, where the reader is challenged with the task of finding concrete information. At any rate, this book is better than no book at all. But for readers interested in a better written account of clinical trials, I recommend anything by Lawrence M. Friedman, by David L. DeMets, or by Elizabeth Eisenhauer. For people specifically interested in IRBs, I suggest reading articles in a journal called: IRB ETHICS AND HUMAN RESEARCH.

Customer Rating: 

This book is not perfect, but it is the most comprehensive resource in the somewhat obscure field of IRB administration. It's usefulness definitely outweighs its flaws. I recently passed the CIP exam, having read much of the other literature, but using Amdur & Bankert almost exclusively for review. Be sure it is the 2nd edition, the latest one at the moment. I found it so backbreaking to carry around for reading on the bus, etc., that I cut it up with a utility knife into its 10 sections. The way it is bound works well for this, and it was much easier to read "cover to cover" in portable chunks in time for exam day.

Customer Rating: 

Weighing in at over 500 pages, Bankert and Amdur's second edition of Institutional Review Board is filled with just about every topic imaginable in the ethics and law of human subjects protection, and the day-to-day operation of an Institutional Review Board. The content is divided into 11 parts, and numerous small chapters. This is a key strength of the book. Because the chapters are so well organized in the table of contents, and because the chapters are so short, usually three to six pages, it is very easy to obtain a quick answer to any question. The authors of each chapter take a balanced approach to their material, citing ethical principles, relevant law, and current opinion. The book is directed primarily at a US audience. I have one small complaint, the itsy-bitsy superscript citations to sections of the federal regulations. These would be better set in the regular line of text as full citations; for example (45CFR46.116).