FAQ about the IRBRhetoric & Writing @ MSU

Bill Hart-Davidson. Ph.D.Associate Professor of Rhetoric & WritingCo-Director, WIDE Research CenterMember (and past Acting Chair), Social Science IRB at MSU

Helpful LinksIRB at MSU

http://humanresearch.msu.edu

MSU HRP manual

http://www.humanresearch.msu.edu/hrpmanual.html

45cfr46 (protection of human subjects)

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

The Belmont Report

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

A Note…I’ve focused, in this set of materials, on the questions I tend to

get most often from folks in the program. They come from colleagues and students. And they are, to the best of my recollection, truly “frequently asked questions.”

I’ve not put some of the basic kinds of questions in here, but that doesn’t mean we can’t address these too. Just ask. And I will do my best to add to this our list of FAQs and answers!

One final note, if you’ve run across this and are not in the Rhetoric & Writing program at MSU…just know that some of these things might apply to you and some might be different. Best to check with somebody at your institution and in your field.

IRB FAQ: The List Do I really need to get IRB approval for my project?

Can my project be exempt from review? What does that mean?

If I do research as part of a class project, do I need IRB approval?

Ok, I did a project for a class, and now I think I’d like to talk about it at a conference…what do I do now?

I know I need to seek IRB approval, what should I do to get ready to do the online form?

How long does it take to get approved?

I’ve heard that you can’t say your project poses “no risk” to participants…so what’s up with that?

Do I have to get written consent?

Do I Really Need IRB approval for my project?

You do if:

your project involves human subjects and seeks to produce generalizable results

For our field, this usually means that you should seek IRB approval when your are watching, talking to, or otherwise asking living people to do something as part of your research.

You can take generalizable to mean “publishable,” and publishable to include presenting at a conference.

P.S. For theses & dissertations, the graduate school requires you to seek IRB approval or to certify that your project is not human subjects research.

Can my project be “exempt?”Yes. And it may well be determined to be “not human

subjects research” at all…which means that it is not reviewable.

But…both of these determinations still require some correspondence (at least) with the IRB. The IRB staff can make a determination of “not human subjects research.”

“Exempt” is a category that means the protocol has been reviewed by the IRB and has been determined to pose such a minimal risk to participants that it needn’t be reviewed again.

If I Do a Research for a Class Project, Do I Need IRB Approval?

Not necessarily*. In most cases where students are asked to do research involving human subjects as part of a course, the IRB delegates the authority to ensure that participants are dealt with ethically to the instructor of the course.

You should still follow all the same guidelines you would if you were doing the study with IRB approval: seeking informed consent, taking steps to minimize risk to participants, etc.

If you are the instructor, you should guide your students through a process similar to IRB review to ensure that they are adequately addressing issues of risk with regard to research participants.

*if you know you want to publish it , then the answer is yes.

Ok, I did a project for a class, and now I think I’d like to talk about it at a conference…what do I do now?It’s possible, in this one type of instance, to get the IRB to

consider retroactive approval.

See the MSU IRB handbook section 6-9-A subsection 6.1.1-6.1.4

I know I need to get IRB approval, what should I do in advance of filling out the form?1. If you haven’t already, take the certification training

2. Draft a description of protocol that includes who your participants will be and how you will recruit them, how you will gather data, & how you will analyze that data; don’t overdo it…just describe it in a straightforward way for an academic, but non-disciplinary audience

3. Draft your Informed Consent Agreement (use models provided via the IRB website)

4. Draft your recruitment language

5. Make a list of a) potential risks to participants, b) things you are doing to minimize risks, and c) potential benefits to participants, if any

How long does it take to get approved?

For most studies in our field, no more than 10 working days. (assumes expedited review category).

The IRB is committed to getting you a response in 10 working days. The thing that makes this deadline slip, most often, is delay by researchers in responding to reviewer and staff requests. If you respond quickly, you will get approved quickly too.

For studies that involve more than minimal risk to participants, the timeline is longer because you have to have your protocol reviewed by the full board at their once-monthly meeting.

I’ve heard you can’t say your study involves “no risk” to participants…what’s up with that?

While most of the work we do in R&W involves no more than minimal risk, there is usually some risk involved to participants when we collect personal information that folks would prefer to be confidential or anonymous.

We also ask our participants to give us their time and effort, which we should do only when there is some promise of benefit (if not to the person directly, then to society as a whole in the interest of building knowledge).

You do better to acknowledge these rather than to minimize or deny them in the spirit of treating all participants as persons in the spirit of the Belmont report that our IRB guidelines are based on.

Do I have to get written consent always?

No, not always. And there may well be good reason not to.

But if you are seeking to waive the documentation of consent, there are few conditions you need to meet.

See IRB manual section 6-4-A.