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.

Super busy

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

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.

Data Suppression

I'm curious to know what researchers think about data suppression and whether they consider it a human subjects issue, academic ethics issue, or something else.

Howard Brody writes about recent new evidence of pharmaceutical companies practicing data suppression for financial gain. But if pharma can do it, surely an individual investigator could.

Without a doubt, data suppression is difficult to detect from the outside. Big pharma collects data from all of their research sites and analyze, clean, and process data without transparency. To manipulate data is frankly too easy and financially tempting.

As you might imagine, I see this as both a human subjects protections issue and an academic/business ethics issue. Let us not fool ourselves, the University is a business center as much as an educational one.

But before we begin to catch data suppression, we as a research community must agree it is a priority for science and the health care industry, and then we can address who should be responsible for investigation and enforcement.

Change is in the air

We have lost another senior staff person this week.

Such is the nature of IRBs around the country, actually.

Turnover comes is waves and it appears unavoidable. One person leaves and others follow. The effect is significant change--some good and some bad. With the changes in staff, institutional knowledge is unquestionably lost. But also with change comes new perspectives and new energy.

My hope is that the new energy can somehow make up for the significant loss when a co-worker and friend sets sail to another opportunity.

10,000 emails

That's how many I have in my email inbox after one year in this office. Keep in mind, I delete items from my inbox regularly.

So now it's come to haunt me and I'm sorting and cleaning my inbox.

This is what I do in my "spare" time. Sad, I know. But over the last 3 days, I'm down to a mere 8,800. It's a party.

What good are we? (and by "we", I mean IRBs)

Perhaps the most sweeping, bitter criticism comes from those who say IRBs are worthless and/or pointless. We are just a bunch of bureaucrats with nothing better to do except legitimize our existence by unrolling more red tape. A form of this criticism comes from the author of Scientific Misconduct Blog. (I am taking a bit of a liberty putting harsher words in his mouth but I wanted to reference his page in this post with a little emotion and this seems just as good as a way as any.) Although it was a short email, I think I understand his point. IRBs just don't cut it like they, perhaps, at one time did.

There are times I question whether the process itself is meaningful. In the end, I come to the definitive--and I mean definitive--conclusion that IRBs are important and necessary even if their responsibilities weren't codified in law.

However, I do believe IRBs are losing their way a bit. And I hope to be part of a movement that puts them on track and adapts to the modern times of research, compliance, and human subjects protections.

Specifically, this renaissance of human subjects protections begins with the acceptance that researchers are motivated by good and are well intentioned. Once that is agreed upon, the IRB's next goal is to promote and take active roles in ensuring the proposed and approved protocols are conducted ethically. This takes major form in Post Approval Monitoring. Most IRB's lack a strong PAM program. PAM is a terrific opportunity to ensure the research is being carried out as intended, study procedures are being followed, subjects are in fact being consented, and so on. I feel so strongly about this responsibility that I believe half of the resources of an IRB should be dedicated to this endeavor. It is that important.

I have little doubt this will be a common discussion item on this blog. But let's start here.

And so it begins

The first entry.