Responses:


Good questions. I would be glad to hear of your sense of what we all 
are doing when you have read these! Our IRB just discussed this last 
month, and came up with a policy that all student work is under the 
purview of the dept, which is responsible for asking for IRB 
approval. For lab projects, the dept is the sufficient authorizing 
body for us, then, but for indep. study it would go to the IRB.
We were also concerned about the amount of additional paper work for 
the IRB, though we thought it would be a good experience for the 
students to learn what is involved


>1. At your University, what types of student projects are required to go
>through the normal IRB review process?

research on a faculty's project, independent study

>Independent studies? Lab
>projects?

no on the lab projects

>2. When deciding whether a project must go through review, do you take
>into account what will ultimately happen to the data? (i.e. require IRB
>review only if the results would be published or presented in some form
>outside the university).
no


>3. Have you devised any special type of review for class projects that
>involve minimal risk to subjects, such as having the professor submit
>one application that would cover all projects before the class starts?

we have decided that the dept. is responsible, and that they can 
request advice or review by the IRB. In this way we hope to be more 
of an advisory group as needed, and a regulatory one when appropriate.

>I'd be happy to share the feedback I get on this with anyone
>interested. Please reply directly to me: L-Rueckert@neiu.edu
thanks!

Here at Murray State, we require ANY project that will be presented,
published, or otherwise disseminated OUTSIDE of the classroom to come
before the IRB. Yes, it does make for a heavy burden, but this committee
has decided that this is the best way to train our future researchers
(including undergraduates) in the protections due the human research
participant. If the research will not leave the classroom setting, we do
not require that it be reviewed by the IRB but we do leave that option open
to the instructor. Many of our Psychology faculty do have their students
put through protocols because it is good training and forces them to think
through their research much more thoroughly.

We have no blanket approval for classrooms because we have yet to see a
professor have his/her students use a single technique or ask a single
question. Everything we see involves individual projects with many
different surveys or research questions being asked.

I must also point out that MSU does not have an "exempt" category. As a
protocol must be reviewed to determine whether or not it is exempt, we have
chosen to combine that category with our "expedited" group. It has made
for much less confusion on the part of our researchers and it makes follow
up and closure much easier. Previously, we had studies that had been
approved as "exempt" for which we had no information on the outcome or
whether the university still needed to be aware of the data collection. We
have had "exempt" research which has had an "adverse event" attached to it
and we strongly felt that we needed to have some kind of annual reporting
as to the progress of the research and to determine if further review was
necessary.

If I can answer any other questions, please don't hesitate to ask.

>The IRB at our school is attempting to come up with a policy on the
>submission of student projects using human subjects. We currently
>require students using human subjects for Masters theses and Honors
>theses to go through IRB review, but we have no firm policy regarding
>other types of projects done by students. We will probably require
>students collecting data from humans for independent study projects to
>submit, but we're not sure what to do about students who test human
>subjects as part of a class project, e.g. in a lab class. We're afraid
>that if all of these were required to go through review, even expedited
>review, we would be overwhelmed with applications to read, and the
>students might have trouble getting their projects done within one
>semester. These are my questions:
>
>1. At your University, what types of student projects are required to go
>through the normal IRB review process? Independent studies? Lab
>projects?

Thesis projects that use subjects outside one course require IRB approval. 
Courses that have students in the class use themselves and others as subjects 
are generally not generating new data, therefore, they are exempt from IRB 
approval. However, the instructor is still responsible for helping students 
maintain confidentiality, and informed consent among classmates. Lab projects 
within classes are also exempt.
>
>2. When deciding whether a project must go through review, do you take
>into account what will ultimately happen to the data? (i.e. require IRB
>review only if the results would be published or presented in some form
>outside the university). Yes. Any pilot data or data that could potentially 
be publishable or used in grants etc. must be gained after IRB review.
>
>3. Have you devised any special type of review for class projects that
>involve minimal risk to subjects, such as having the professor submit
>one application that would cover all projects before the class starts?
Yes. We are asked, but not required to do this.

1. At your University, what types of student projects are required to go
through the normal IRB review process? Independent studies? Lab
projects?

ALL research involving human subjects goes through our IRB

2. When deciding whether a project must go through review, do you take
into account what will ultimately happen to the data? (i.e. require IRB
review only if the results would be published or presented in some form
outside the university).


No. if its normal educational practice it needs only a quick read
through by the head of the review board. That takes care of 99% of all
surveys given by faculty and administrators.

All student projects are reviewed. ALL

3. Have you devised any special type of review for class projects that
involve minimal risk to subjects, such as having the professor submit
one application that would cover all projects before the class starts?

We do recurring exercises like the cognition lab,. Developmental lab,
learning and once approved they don't have to be reviewed unless
substantial changes occur


George Spilich
Psychology
Washington College

Hi Linda,

I am the Psychology member on the IRB at Bucknell. We require all 
student projects that by some definition are the collection of new 
data for true investigatory purposes to go through a formal IRB 
procedure (of course, some will be exempt and many will be 
expedited). This includes independent and honors research by masters 
and undergrad students. We decided that we cannot foresee what will 
happen to such data in the future and the human subjects protections 
should be the same no matter what the ultimate fate.

For lab projects, we streamlined the process by allowing the 
professor to submit a general protocol, and then trusting the 
professor to make sure projects adhere to the protocol. In my lab I 
review the protocol and whole process with the students and it makes 
an educational point. Our dept has an internal form for the 
record-keeping. We would not submit a general protocol if the 
procedures required full review (but we couldn't really justify lab 
projects being so risky as to require full review).

Of course, lab projects using the enrollees as subjects are 
classified as class demos and do not require review at all.

We are currently discussing how to handle the myriad of email surveys 
that come out of (typically) management and statistics classes. Our 
computer center screens mass emails to students, so there is a point 
at which our IRB can screen. But we are hoping instead to develop a 
set of guidelines for professors to reduce the number of problems 
with email surveys (primarily when questions are of a somewhat 
personal nature and email responses are not confidential).

As Elaine mentions, a few of us will present a session on IRBs this 
summer; a companion article will appear in Dec CURQ.
-- 
_____________________
Andrea Halpern
Psychology Department
Bucknell University
Lewisburg, PA 17837
570-577-1295, fax 570-577-7007

Hi there

Currently we don't require IRB review for lab projects, but we do for
any research projects.

I'd be interested in knowing what you hear from other schools, since
I'm not really sure if this is a good policy or not!!

Helen I'Anson
Assoc. Prof. Biology
Washington and Lee University

Linda,
A colleague in chemistry forwarded your questions (below) to me to 
respond. I chair our department of psychology and our university IRB. 
I've chaired the latter since it was started on our campus about 20 
years ago.

>
>>To curlers involved in research with human subjects:
>>
>>The IRB at our school is attempting to come up with a policy on the
>>submission of student projects using human subjects. We currently
>>require students using human subjects for Masters theses and Honors
>>theses to go through IRB review, but we have no firm policy regarding
>>other types of projects done by students. We will probably require
>>students collecting data from humans for independent study projects to
>>submit, but we're not sure what to do about students who test human
>>subjects as part of a class project, e.g. in a lab class. We're afraid
>>that if all of these were required to go through review, even expedited
>>review, we would be overwhelmed with applications to read, and the
>>students might have trouble getting their projects done within one
>>semester. These are my questions:
>>
>>1. At your University, what types of student projects are required to go
>>through the normal IRB review process? Independent studies? Lab
>>projects?

All grad theses and undergrad independent study projects 
where human subjects are involved.

>>
>>2. When deciding whether a project must go through review, do you take
>>into account what will ultimately happen to the data? (i.e. require IRB
>>review only if the results would be published or presented in some form
>>outside the university).

Yes. Some projects are for internal use only (e.g. internal 
surveys, alumni surveys, research on educational practices, etc.). In 
general, these types of things do not require an IRB review. In 
addition, several types of things meet the federal "exempt from 
review" standards. This determination is made by the IRB chair. To a 
large extent, faculty decide whether or not it is in their interest 
to request a review. Although University policy requires that all 
research involving human participants undergo IRB review, it is not 
followed by all faculty and I do not feel, as IRB chair, that I 
should police this policy. If there should be legal action of some 
kind, and a project not be reviewed, the faculty member would be left 
"out on a limb".

>>
>>3. Have you devised any special type of review for class projects that
>>involve minimal risk to subjects, such as having the professor submit
>>one application that would cover all projects before the class starts?

This one is tricky and I think we all struggle with this. To 
some extent, it depends on whether the purpose of the project is 
primarily instructional (to learn how to do research) or a bona fide 
research project with the intent of external presentation or 
publication of results. Since it would be overwhelming for our IRB to 
review everything, class projects (even where students conduct 
individual research projects as a course requirement) are generally 
not reviewed unless the instructor feels uneasy about a particular 
project and requests that it be reviewed. Instructors in such courses 
are generally familiar with research ethics, can spot "red flags", 
and are capable of making such determinations. Some instructors do a 
good job of monitoring this themselves while others may send a 
listing and short description of projects to the IRB chair for 
informational purposes.


>>
>>I'd be happy to share the feedback I get on this with anyone
>>interested. Please reply directly to me: L-Rueckert@neiu.edu


Hope this helps.
George
-- 
George D. Goedel
Professor & Chairperson
Department of Psychology
Northern Kentucky University
Highland Hts., KY 41099-2000
(859) 572-5574
fax (859) 572-6085
goedel@nku.edu

Linda,

I can't answer your questions in detail. I can point you to our webpage
for IRB review and note that the procedure requires students doing
projects for class to submit a form but if it involves minimum risk
gives them the go ahead to proceed 1 week after submission of the form
regardless of whether they've received a formal approval just with the
caveat that if at some point later the committee questions their study
they must stop immediately. I've only used it once this spring but it
seemed like a reasonable approach.

Here is the website:

http://www.depauw.edu/admin/acadaffairs/IRBguidelines.htm

Bridget

Linda, the University of Wisconsin-River Falls requires anyone who is doing research or demonstrations involving human subjects to go through the IRB approval process. Does everyone do so? Doubtless not, but most do. 

We require researchers to tell us what will happen to the data upon completion of the study, especially if it includes sensitive information, which can be linked to an individual. If publication or presentation is the aim, then IRB approval is required for even innocuous, borderline studies. 

Our IRB manual (located at http://www.uwrf.edu/grants/irb.htm) includes a course certification protocol form (available at http://www.uwrf.edu/grants/irbcou~1.htm). Faculty who will assign projects to their students frequently submit one of these protocols to gain approval for the entire semester.

Sorry I was so slow in responding, I've been away for a while.

Regards, Bill 


Bill Campbell
Director, Grants & Research
University of Wisconsin-River Falls
715/425-3195
wm.e.campbell@uwrf.edu