Not blogging, trying to get studies approved

Everyone agrees--IRB members, investigators, administrators: It is not satisfying to delay research. So why do we?

Investigators
Either lack of qualified research staff (high turnover or no money to hire/retain) or interest to learn what IRBs want and ask for. They can make significant life-saving scientific discoveries, but they do not know how to submit an IRB application, respond to questions from the IRB, or simply have a general irritation towards the IRB which is reflected in their effort. Sloppiness leads to delay.

IRB members
Like investigators, overworked and limited resources. High turnover, little training for members. Terrible questions. Poor reviews such that upon first or second review, significant issues aren't raised and after three years of approval, major questions are asked. The current IRB gets blamed for mistakes and sloppiness of the past IRB, which may now have different and/or better trained members.

Chief Executive
Despite the spin, money talks. Inadequate resources are allocated to administrative IRB infrastructure, including investigator support and training, IRB staffing, IRB member training, and technology. Listen to your advisers, investigators, IRB members! But instead they are ignored and the system suffers from lack of action and mismanagement. No recognition that an efficient IRB will result in improved recruitment of top faculty and increased research money into the institution.

Back to work!

I'm sorry, Dr. X

Dear Dr. X,

I am sorry it has taken over 5 weeks for you to receive your letter from the IRB. What's more, your response, whenever you actually respond to it--because investigators such as yourself take a long time to respond but like to blame the entire time it takes for your study to be reviewed on the IRB--will have to go back to the full IRB. Lucky you.

We needed a consultant for your study because it was so obscure and strange in design. You won't like to hear this either but federal regulations require us to seek out expertise when none are available on the Board for your line of research.

But I hope you take my advice and simply answer the questions, give in and agree with the IRB on the minor issues raised, and did I say answer the questions? Most investigators (often study coordinators) DO NOT answer the questions. The result? More delays.

These sorts of delays are easily but erroneously blamed on the IRB. Still, the IRB is such an easy target and the temptation so great that it is understandable. However, it's a shared blame and one which can be fixed given a re-prioritization of the powers-that-be to resourcing, education, and collaboration. In time, I believe this will occur.... It must, actually, for the sake of advancement of science in the long run.

This is a letter I could never write in real life. And so I write this make believe letter here on this make-believe blog.

Busy is as busy does

I have not been able to write recently for the simple reason that the IRB has been as busy as ever. We lost a number of high level staff in the last six months and while always a struggle, it represents an opportunity to bring new energy and personnel with expertise in both applied research and human subjects protection.

The learning curve for anyone coming into a new organization in this field is quite steep regardless of one's prior experience. The work we do can be nuanced and difficult. There are multiple agencies which oversee an IRB at an academic research institution and sorting, interpreting, and coordinating all of the laws, regulations, and guiding documents is a formidable task.

I share this because it is not just enough to have the right number of staff to enable an IRB to function. Trained staff is important. So for those who loathe the time it takes for studies to be reviewed and approved by your IRB, among the many questions which could be asked, "How many trained staff are there?" should be one of them.

IRB Tip: Genetic Anaylses

If genetic analyses will be performed, I suggest you address the following in the cover letter and clarify these issues in the revised IRB application:

1. Describe the analyses that will be conducted on the saliva samples, and the genetic markers that will be analyzed.

2. Clarify the purpose of the genetic testing in this study and revise the Protocol Summary.

3. Clarify in the application and consent form whether subjects will receive their results from the genetic testing.

a. If so, clarify whether the genetic tests to be conducted have been scientifically validated and whether the lab where the testing will take place is CLIA certified.

i. If not, provide an ethical justification for providing subjects with their results from the genetic testing.

b. If not, revise the consent form to indicate that subjects will not be provided with their results from the genetic testing.

4. Revise the application to include background information regarding the genetic testing to be conducted in this study.

5. Clarify in the application and consent form whether there are potential benefits to society as a result of the genetic testing to be conducted in this study.

Super busy

Understaffed and overworked...welcome to any IRB in the country.

IRB Tip: Deferral avoidance for recruitment

Deferred is a categorization which an IRB gives a study after it has been reviewed by the Board and found to have significantly unclear or missing study procedures and/or goals. Most deferrals, believe it or not, are avoidable. Unfortunately, few on the research-side know how to accomplish this.

From time to time I think (mistakenly) that I could make a lot of money by helping biopharma or some for-profit consulting group manipulate the IRB review system such that as an IRB consultant I could prevent all studies I touched avoid deferral. Such an attitude is really quite silly. Like individuals, IRBs develop tendencies--personalities if you will--which cannot be predicted with 100% accuracy.

But I do believe I think I know my IRB pretty well and with that, another IRB tip.

When describing how you will recruit subjects for your study, it should almost never be just one sentence.

You would be surprised how many studies come across my desk with just this weakness.

You need not describe every second of the recruitment process, but you should describe it such that a reader who is unfamiliar with your project could envision when and how you identify, approach, screen, and enlist a prospective subject up to her signing the consent form.

There are some areas of an IRB application that you could be lazy and get away with it. However, recruitment procedures are not one of them. It's okay to use bullets, paragraphs, or even comic strip depictions--but clearly describe recruitment.

Suppose you are recruiting subjects directly in the context of clinical (non-research) procedures This is pretty common in medical research: You'd like to enroll your own patients in your study. Coercion, however, is a real concern. In other words, are your patients feeling pressure (real or imagined) to participate in a study for which you are both treating health care provider and researcher?

I recommend the following when recruiting subjects who are also patients: (1) Provide a study flyer, (2) recommend your patient review the flyer at home and talk to family members and/or friends about participating, (3) call the study team at the number on the flyer if interested in the study.

In this way, a prospective subject's real or perceived pressure to join your study is minimized. Of course, some patients will want to participate in your study straight away. And that is okay. Simply describe in the IRB application that if a patient asks to join the study during her clinical appointment, this will be clearly documented in her medical record.

Last but not least, include the following language (or something similar) on the first page of your consent form:

Disclosure Statement
Your health care provider may be an investigator of this research protocol, and as an investigator, is interested in both your clinical welfare and in the conduct of this study. Before entering this study or at any time during the research, you may ask for a second opinion about your care from another doctor who is in no way associated with this project. You are not under any obligation to participate in any research project offered by your physician.

Choose the name-brand placebo over the generic placebo

The New York Times is reporting that placebos which cost $2.50 are more effective than the $0.10 version. Yes, this is ridiculous but important at the same time.

Especially in psychiatric studies, the placebo effect shows her head time and time again.

What does this mean for research studies? We should never discredit, or over credit, the role of a placebo. Is it appropriate? It is harmful when proven treatments exist?

I will write more about this topic later and please do not mistake the length of this post as indicative of the complexity of the issue. I could never write enough about placebos in research.