Notes from Fall 2009

Speaker: Nancy Adair Birk
Notes by Trevor Burnham

A version of the slides used for this presentation can be found at http://www.irb.umich.edu/IRBIntro.ppt. If you have any questions about IRB, you should contact Elaine Kanka (mekanka@umich.edu).

Some history of IRB: Congress passed National Research Act in 1974, which mandated IRBs. The Belmont Report in 1979 established 3 principles: Respect for persons as autonomous agents, beneficience (the need to maximize risk/benefit ratio) and distributive justice (ensuring fairness to potential research participants). These continue to be the guiding principles of IRBs.

Is it regulated by the IRB? Yes, if it's research (systematic investigation) on human subjects (living individuals), using data generated through intervention or interaction with the individual, or private information. Research using public information does not generally require IRB approval.

Identifiability is an issue. Use anonymous data collection whenever possible. In the SI world, privacy and confidentiality issues tend to be primary. Privacy is defined by the IRB as the right to determine what will be known about oneself. Confidentiality is the determination that information will not be disclosed without permission.

Research design: If there is any risk and no potential benefits to your study, then your design will be rejected by the IRB (cost/benefit ratio is infinite). So there is a requirement that you practice good science. If you need to use deception in your study, then the benefits must be exceptional.

Recruitment issues: Is the population vulnerable? Do advertisements focus too heavily on compensation? ("Bring the font size down a little bit.") Will your recruitment reach all potential participants? How are you going to manage the imbalance of power?

Sponsorship issues: Are there financial conflicts of interest?

There are 9 IRBs at UMich. The one pertinent to SI students, generally, is IRBHSBS (Health Sciences & Behavioral Sciences). Only 8% of applications go to the full board. Most applications are "minimal risk or less" and go through an expedited process. You should start new applications through eResearch online: http://eresearch.umich.edu/

Ted's Notes

Doctoral Development Seminar: IRB Behavioral Sciences discussion
19 Sept 2008

Speakers:

Marianne Ryan
Served on IRB review board
5th year doctoral student

Archer Batcheller
4th year doctoral student

When polled, most people in the room had been the PI on a research project and many had been PEERRS certified at U-M.

IRB now more transparent, putting many more information materials online.

Main complaint on campus is that IRB approval takes a lot of time. Secondary complaint is that people were reviewing applications who didn't know anything about the underlying field (leading to irrelevant questions and misleading directions).

All IRB members are volunteers, so that contributes to bottlenecks. And, summers are generally slower periods as well. So, plan ahead.

The web site has a lot more info than it did six months ago, including tracking turnaround times. IRB has put up templates of different types of consent forms.

Three main web sites: OVPR, Human Subjects Protection Program (with manuals and guidelines), Behavioral Sciences IRB. See <http://research.umich.edu/IRB>.

New things since the February update:
- approval periods that last two years instead of one (you don't request it, it's offered to you if you're not expecting federal funding). This also delays continuing review.
- prospectively approved some heavily used data sets on campus. These are listed on the web site.
- reporting of adverse events is a more streamlined process.
- pilot in November to integrate proposal management into e-research.

Net benefit, more flexibility for researchers.

Discussion of multi-site research. Info at OVPR site on how to handle this. Some discussion about international sites where IRB equivalents don't exist, so U-M, unlike some other schools, gets very engaged in ensuring our policies apply in the other country.

Discussion of having IRB offices at multiple sites each wanting to be the last to approve the IRB request. Our IRB can offer dry approval, which gives limited permission and an option of the IRB changing approval later. The IRB can also approve with contingencies---which is better than tabling it (e.g., the translation of a consent form could be approved contingently pending approval of the final translation).

Discussion of using data that was collected incidentally in the research but now something the researchers would like to publish (without going back to the subjects). Answer is to go back to the staff person who shepherded through your proposal and see if you can file an amendment.

Note that even if an IRB request is approved for involving subjects from University housing, you still need to go through a separate Housing approval process.

Who is on the IRB? There are 11-14 people, the majority are faculty or deans who conduct research themselves. There also has to be a community member. There's a specialist in prisoner research and a non-scientist (currently a librarian). Student participation is not high, so volunteer if interested. Marianne learned alot about the process and got insights into innovative methods.

Categories of excluded and exempted is now documented online. First question asked, Is it research? Does it contribute to generalized knowledge? Second, Is it human subjects research? If it is human subjects research, is it exempt? Based on categories of risk.

What about IRB proposal approval for research involving virtual worlds? There is a relevant article on this topic appearing in the International Journal of Internet Research Ethics. Major challenge is not knowing who is behind the avatars---their ages or locations (e.g., international).

Some random notes from David Lee

Ted took really great notes, but here are some of my take away points from the session:
A majority of the people attending has at some point been intimately engaged with an IRB application. There have been major revisions of the information available on the IRB site within the last six months or so. It’s strongly recommended that you take a look at the re-designed IRB website available here: eresearch.umich.edu.

Of particular note the IRB group aims to increase the transparency of the IRB process. One of their changes includes delegation of greater independence to individual reviewers. This change delegates greater responsibility and power to the reviewer, enabling faster turn around times for applications.
In response to complaints regarding consistency, the new IRB website also has a number of templates for consent forms. These consent forms can be used as foundation of your consent form document.

Also relevant to the IRB discussion are a number of resources available from last year’s DDS session. Morgan has complied a number of interesting facts and discussion regarding the IRB process.

From personal experience, I would solicit help from colleagues experienced with the process. These persons may be able to provide tips, previous IRBs, and other stuff that will make your experience a little better. I found it worthwhile to spend some time and see who at the IRB understands your work the best. Everyone is really smart, but some individuals might jive with your work more than others.

At the end of the session Archer emphasized the value of the notes from last year's DDS.