Whales Designed by Committees

18 months. In 18 months, my youngest has figured out how to walk, climb everything in sight, file various foodstuffs in the video (yep, still have a video), recount a long fairly incomprehensible story punctuated with pointing and dance like Snoopy. If I was able to figure out a way to inseminate a whale, it would have had time to calf (and I suspect I’d have an alternate career). And 18 months is the amount of time it took between me lodging the initial ethics application for my project and getting the final amendments approved.

Now, that might seem like I must have got a little careless at some point along the way and forgotten the whole thing was on. It’s actually a story of what it’s like doing your PhD part time, the delays that are standard as the whole thing works its way through the system and a little bit of poor timing.

In the spirit of research collegiality then and the theory that a PhD is more about what you learn on the way than the final thesis, herein are the lessons gleaned from this experience. Ultimately I had success, so follow these steps (starting here with the National Ethics Application Form and the SSA forms for NSW, Qld, SA and Vic) and you too can spend a year and a half of your life sending love letters back and forth to your friendly ethics committee.

1. Make sure to submit your application just before Christmas

Everyone likes holiday reading, right? If you’re considerate by nature, you’ll lodge all your paperwork in time for the final sitting of the year for your chosen ethics committee. That way they’ll just get time to review the notes the first time, not quite resolve anything, and then have to rehash the whole thing over in the subsequent meeting after the break. They also get to spend the break occasionally thinking about the hundreds of pages they get to read on their return.

You also get to twiddle your thumbs waiting for your approvals. Win win. Time added: 3 months

2. Leave yourself little things to fix up

The ethics committee probably has a bunch of guidelines they widely publish, or standard bits they’d like you to include in any application. You know, particular wordings for any information sheets or consent forms. Standard disclaimers or formatting requests. A request not to use jargon words.

So you should absolutely make sure that you put every single one of those in, bar one. That way, when they do their feedback, they’ll have to get you to change about one line of every bit of paperwork, and you’ll get the chance to do just a little more work on the basic text stuff, plus all the proof reads to check there wasn’t something else you messed up. It’s rewarding for both you and the committee to have done heaps of work, and have to revisit all of that, because you messed up one sentence. Time added: 1 month.

3. Lodge your ethics application with a committee in flux

Anyone can get their project approved by a committee that’s been operating in their standard way for as long as time has been recorded. What you really want to do, is lodge your ethics application with a committee that has just been amalgamated between 2 campuses.

That way, your project is a part of bringing disparate groups of people who’ve never met before and letting them thrash out the ways they will work forever more. So you’re not just lodging a project for consideration. You’re part of spreading peace and harmony. Time added: who knows?

4. Take the opportunity to practice the art of zen

It’s always nice when your efforts to do the right thing pay off. For instance, say you are working with an external entity you’ll need to sign an agreement with the committee to guarantee they’ll review your application (an external entity agreement). Then you can include it in your paperwork, so they know that’s all sorted.

It also means you’ll get to enjoy gems like the following 2 feedback points:

“6. As an external entity, separate to the hospital network,  you need to submit a signed external entity agreement before your application can be considered in full.

7. As a hospital project, all research work conducted as part of this trial will be considered to be the property of the [hospital network], and any intellectual property generated in the conduct of this trial will therefore be owned by the hospital network.”

That’s right, they want the paperwork you already submitted to prove it’s OK to look at your paperwork despite the fact you don’t work there. They are also demanding that they own all your intellectual property because you work there (and you thought the one hand clapping thing was a doozy).

People pay good money for that sort of spiritual training. Time added: 1 month off your life expectancy.

5. Design research that requires you to follow-up data at 8 different sites

By now, the ethics runaround is lining up as more fun than the Uni bar on cheap drinks night, right? Well, hopefully you’ve also realised that after you’ve cleared ethics, you get to do a whole different application with the individual sites you’ll be interacting with to ensure that they have the necessary local requirements for your approved trial to get what it needs done on those sites. This is the research governance part of your approvals (the Site Specific Assessment if you’re using the online ethics portal).

The great thing about the SSA process, is that it’s like having 8 ethics committees all making up rules that suit themselves. Yep, 8 times the fun.

So you’ll get to try and liaise with the site where the local departmental director insists that to let your own research team go and do all the data collection, with no requests at all from them beyond access to the records, they must be listed as a co-investigator. Or there will be the place that insists that the research nurse collecting data has to be added to your study protocol as a co-investigator.

Better yet, there might be the site which insists you enter a contract as a consulting research group, nominate a local principal investigator, have the research nurse given an honorary position, find office space and a computer for that nurse on the actual site of the hospital, not remove any data, even de-identified data, to your central records for your research, set up a trust fund for them to deduct fees from and  allow them to charge you through 2 separate departments to get your data (yep, double charge). Oh, and they’ll charge you more than $3500 to look at your application.

Time added: 8 months. That’s right 8 months.

6. Do it all again

Finally, you’ll get there. You’ll jump through every hoop, adopt every revision, and come up with exactly what they want. Then you’ll need to make an amendment. Hey, you’re a pro now, it would be a pity not to show off your expertise. Time added: 2 months.

7. Admit the truth

Despite all the frustration that may occur with the process, we’re all mindful of how important an ethical review can be. Most researchers you will come into contact with are thoroughly decent and ethical people. Yet the history of research is full of stories of researchers behaving badly.

Really? How bad could it be? Well if we need an example, might as well go with one of the worst, the Tuskegee Syphilis experiment. There’s another summary here, but I’ll include the synopsis anyway, to drive the point home.

In 1932, the US Public Health Service, along with the Tuskegee Institute, commenced a study in almost 400 poor black men from Alabama. They were known by the researchers to have syphilis. They were looking to find out more about what the disease does to the body, how it was spread and how it killed. The men were told they were being treated for “bad blood”, and were given free medical exams, free meals and free burial insurance.

In 1947 penicillin became the standard cure for syphilis. It was withheld from the men in the study, who still didn’t know they had syphilis.

The horror of this trial was uncovered  in July 1972. 4 decades in total. 25 years after a cure was available. Women and children had been infected by the men. Many of the men had died. It was shut down immediately and after a bit of time the US Government did apologise. In 1997.

So there is a very important role for rigorous oversight of trials. The ethics committee is essentially the voice of the voiceless in the research space. They are there to think about all the risks that might be imposed by the research, however remote, to anyone participating.

In doing so, they redesigned my big whale of a study. I was really worried as to what they’d do to it too. The annoying thing is they made it better. They made me re-examine every element of the study and it ended up better than when I submitted it.

After all that effort, and all my annoyance they handed me back a different whale. And they didn’t even have the good grace to leave me with my moral superiority. Bastards.

PS If you have a story of your tangles with the ethics committee, I’d love to hear it. If you’d like a more direct insight into stuff I learned along the way, feel free to get in touch.