The Art of Approval: Getting a New Protocol Approved by Your Institution
All of your planning has paid off. You just got the green light from your PI to start work on a new experiment that you have been plotting for weeks, but it involves some new techniques that you’ll need to run past your institution’s scientific approval committee first. No problem, right?
Not necessarily. While many may view this as yet another obstacle thrown in our way by evil bureaucrats that want to slow the pace of scientific progress, I promise you that there is nothing so sinister going on. Getting this kind of approval is a very important step in the modern scientific circle of life, and should be taken very seriously. Do a good, thorough job the first time around and you will save yourself many headaches and fist-shaking at the gods of bureaucracy.
Below are the most important steps to pleasing those gods, without needing to resort to any weird rituals.
Know Your Audience
Do a little research on how your institution’s committee works. Are they reviewing proposals based on scientific merit, or do they only grant ethical approval? Is the committee made up of senior PIs who also serve many other committees? Or is it a team of individuals who devote 40 hours a week to reviewing new protocols? Is their expertise wide-ranging, or does the world expert in your specific field chair the committee?
Knowing this will help you choose your level of focus. If the committee is made up of a materials scientist, a biologist, and a layperson with little scientific knowledge, don’t send them a chemical engineering proposal laden with jargon. As with most proposals, your goal is to make it as easy as possible for the reviewers to read, understand, and look upon favorably. Limiting the amount of non-technical language is a good first step to achieving this.
Ask other members of your lab if they have copies of protocols that have been approved in the past. More recently approved proposals will be especially helpful since the committee is unlikely to have changed since then. Also, ask your helpful lab-mates if you can look over what comments they may have received in the past, so you can be sure to address the same types of issues in your proposal.
Be Concise
Another way to get on the committee’s good side is to keep things brief. Remember how much you loved being assigned a whopping 30-page paper to read for journal club that one time? That’s how much reviewers love wading through verbose and overly explicit proposals. Also be sure to check that they don’t have strict page limits, and take the hint if forms ask you to “briefly describe” any of your methods.
Follow Directions
Speaking of paperwork, make sure you have all of it! Go to their website or office and make sure you have collected all the necessary forms to fill out for your protocol. If you are confused about any of this, don’t hesitate to ask someone who works for the committee. Ironing out procedural issues unrelated to your science can help to speed the process along.
Work Out a Timeline
Timing is everything, after all. As you are collecting all your materials for submission, look out for deadlines and estimates of how long the review process takes. Be sure to communicate this information to your PI as well, so he doesn’t expect preliminary data in a month when you know you’ll only have just submitted your protocol to the committee a month from now.
Remember Your Manners if You are Pressed for Time
If you are in a real hurry to get approval, check to see if there is an expedited review process. Requests for expedited review should not be used lightly, however. If you ask for this and are slow to respond to feedback from the committee, you may be doing yourself and your lab a greater disservice. It is only polite to meet their prompt feedback with a prompt response of your own. Otherwise, you might be shunted into the pile of applications for regularly scheduled (read: slow) review, or be denied permission to request expedited review for your next proposal. As soon as you receive the e-mail with the committee’s feedback, make a note of the date that they have requested to receive a response, or better yet, respond immediately!
In your request for expedited review, you should also cite the reason for your great hurry in seeking approval. Reviewers will look more kindly on a proposal that presents scientific justification for the rush, such as an impending grant deadline, or timing with an ongoing study that is complementary. Citing your PI’s impatience as the motivation, however motivating that may be, is not recommended.
Strike a Balance
In your quest to be as concise as possible, you will likely find it easiest to describe your protocol in very simple, direct terms. This is good. However, if it is appropriate, you should try to allow yourself some freedom. Not freedom of expression (this is not the time for interpretive dance), but of further experimentation. If this new protocol is for a pilot study, try to envision any follow-up studies you may want to conduct in as much detail as possible. Your next proposal will go through more smoothly if you can make the case that it is similar to an already accepted protocol. The trick is to strike the right balance of relevant detail and deliberate vagueness, without raising any red flags or seeming like you are trying to pull the wool over anyone’s eyes. Allow for the possibility of a future study, but remain very specific about your more immediate plans.
Wait! Don’t Submit Yet!
Before you hit send on that e-mail, do one final proofread. Make sure all your contact information has been filled out properly, and that you have actually attached all the relevant documents. Ask a lab-mate to look it over for you once more, and check in with your PI before submission. Once your PI has given you the final blessing, submit away! May the road rise up to meet you, the wind be always at your back, and may your institutional review committee smile upon all your proposals.
Do you have experience in getting protocols approved? We’d love to hear from you in the comments below.