(no subject) WILLIAM W. REEVES 24 Mar 1995 15:47 EST

Sorry for the delay in getting responses back on "our" questionaire, but
I was hoping for further responses.  Hope this is of value.

Bill Reeves
West Virginia University

 IRB/IACUC Questionnaire
 Institutional Review Board for the Protection of Human

1.   Total active IRB protocols.

Colo. State:   323

Indiana U
Bloomington:   971

Kent State U:  742

U of Oklahoma: 700

Baylor College:     2,000

Washington U:  2229

UCLA:     Not available.  Currently, UCLA does not have a
tracking system for active IRB protocols.

Harvard:  188

Temple U: 360

WVU: 769

2.   Total IRB Protocols in preceding 12 months.

Kent State U:  692

Washington U:  New - 935, Continuation - 1,294

UCLA:     Approximate 2,500 IRB protocols - - about 60% were
processed by full board review.

Temple U: 190

WVU: 284

Review Level - Full Board

Colo. State:   163

Indiana U
Bloomington:   13

Kent State U:  22

U of Oklahoma: 246

Baylor College:     657

Washington U:  New - 746, Continuation - 1,036

Harvard:  65

Temple U: 150

U of Mass:     20

WVU: 141

Review Level - Expedited

Colo. State:   99

Indiana U
Bloomington:   419       Exempt - 204

Kent State U:  98

U of Oklahoma: 183

Washington U:  New - 189, Continuation - 258

Harvard:  6

Temple U: 40

U of Mass:     70

WVU: 87

3.   Have you noticed an increase in the number of active
protocols over the last two years?

Colo. State:   Yes, 6% from 1993 to 1994

Indiana U
Bloomington:   Yes.

Kent State U:  No.

U of Oklahoma: Yes.

Baylor College:     Yes.

Washington U:  We consistently increase at about 15% a year.  Our
statistics don't indicate that this has changed.  We do seem much
busier, but I think the complexity of review is becoming greater.

UCLA:     Not available.  However, we have noticed an increased
in the number of submittals.

Harvard:  Slight increase in number of active protocols.

Temple U: Yes.

U of Mass:     No.l

WVU:  Yes.

4.   On a monthly basis, how may IRB Full Board and expedited
protocols are submitted for review (excluding continuing review)?

Full Board

Colo. State:   Avg 13.1, range 7-22

Indiana U
Bloomington:   1 Avg, some months 3-4, some months none

Kent State U:  2

U of Oklahoma: 15-40 (average is 20)

Baylor College:     50

Washington U:  New - 62p/ mo

UCLA:     New/renewal applications reviewed by full board every
month:  60

Harvard:  8-4 average

Temple U: 12-15

U of Mass:     2

WVU: 30


Colo. State:   Avg. 7.9, range 2-9

Indiana U
Bloomington:   Expedited and Exempt - 31

Kent State U:  8

U of Oklahoma: 10-25 (average 15)

Baylor College:     5

Washington U:  new -17 p/mo

UCLA:     10

Harvard:  1-2 average

Temple U: 3-5

U of Mass:     12

WVU: 35

5.   On a monthly basis, how may IRB Protocols are considered for
annual confining review?

U of Oklahoma: We do not separate out.  Varies from 40-65 per
month total.

Washington U:  108 p/mo

Full Board

Colo. State:   Avg. 5.5, range 2-9 (all are full board review)

Indiana U
Bloomington:   less than 1 average

Baylor College:     100

Washington U:  86 p/mo

UCLA:     Continuation applications reviewed by full board every
month:  40

Harvard:  4-17

Temple U: 5

U of Mass:     1

WVU: 50


Colo. State:   Can't expedite a continuation

Indiana U
Bloomington:   10 + 13 termination reports

Kent State U:  20

Washington U:  Cont - 22 p/mo

UCLA:     35

Harvard   All are sent through full committee unless there is a
special situation.

Temple U: 30

U of Mass:     12

WVU: 40

Are these handled the same as initial submissions or have you
initiated a different process for annual continuing review?
Please explain as necessary.

Colo. State:   Committee reviews all continuations, expedite not

Indiana U
Bloomington:   Most are expedited, may be 2-3/year go back to
full board.

Kent State U:  Separate review procedure utilizing expedited
review with Board acceptance or non-accepting.

U of Oklahoma: No, we use a primary reviewer system for
continuing review.

Baylor College:     Different, listed on agenda, brought to
meeting, assigned at meeting, reviewed there.

Washington U:  Investigators submit a Continuing Review Report
that outlines status, accrual data, ethnic/racial info,
preliminary observations, verification of receipt of all adverse
even report. proposed changes, and verification that consent is
identical or an explanation if changes have been made.

IRB staff review information and compare the consent form to the
one previously approved; the IRB is provided with information
accordingly.  Significant revisions, amendments, or adverse
events are assigned to a reviewer for a more complete review; the
Continuing Review Report for all continuation submissions are
reviewed by all reviewers (mailed in meeting packets and briefly
discussed at the meeting.)

UCLA:     We are revising our annual continuing review process.
If you are interested in knowing what our new process is, please
let me know.

Harvard:  Continuing review goes through the full committee just
like new applications.

Temple U: There is a primary reviewer as for initial review since
the OPRR Report.

U of Mass:     It receives a review by either the original
reviewer or the IRB Chairperson to ascertain that the protocol
remains as originally submitted or that changes are satisfactory.

6.   Does your IRB review medical protocols, academic protocols,
or a mixture of both?

Colo. State:   Both, but primarily academic.

Indiana U
Bloomington:   Only academic protocols, except for optometry

Kent State U:  Academic

U of Oklahoma: Both.

Baylor College:     Both.

Washington U:  Medial and behavioral on the Washington University
Medical School Campus.  The academic campus has a separate IRB.

UCLA:     Our IRBs review medical protocols, social-psychological
behavior protocols and academic protocols.

Harvard:  Mostly academic protocols, medical procedures are often
included, but this is not a hospital IRB.

Temple U: Medical

U of Mass:     Predominantly academic, but some involve faculty
or students at health centers.

WVU:  Both.

7.   How may Boards do you have?

Colo. State:   One.

Indiana U
Bloomington:   Only 1 IRB for human subjects.

Kent State U:  One.

U of Oklahoma: One.

Baylor College:     One.

Washington U:  4 Reviewing Committees, 1 Administrative Committee
(sets policy and oversees IRB activities)

UCLA:     Three IRBs

Harvard:  One.

Temple U: One.

U of Mass:     One IRB, One IACUC

WVU: One.

8.   How many members on the Board(s)?

Colo. State:   10, with one alternate.

Indiana U
Bloomington:   13

Kent State U:  19

U of Oklahoma: 21

Baylor College:     35

Washington U:  14 - 16

UCLA:     42 members.  We are currently recruiting more members

Harvard:  12

Temple U: 18

U of Mass:     9

WVU: 14

9.   How often does your Board(s) meet?

Colo. State:   Monthly

Indiana U
Bloomington:   Full board meets once a month.  Expedited and
Exempt studies review once a month by chair of committee.

Kent State U:  Biweekly.

U of Oklahoma: Twice a monthly.

Baylor College:     Every two weeks.

Washington U:  A reviewing committee meets each week; the
Administrative Committee meets quarterly.

UCLA:     Weekly.

Harvard:  Once per month, except August (special meetings are
arranged if there is a problem in August).

Temple U: Once per month.

U of Mass:     Once per moth and as needed.

WVU: Montly.

10.  Do you utilize a separate Board for multi-center protocols?

Colo. State:   No.

Indiana U
Bloomington:   No.

Kent State U:  No.

U of Oklahoma: No.

Baylor College:     No.

Washington U:  No.

UCLA:     No.

Harvard:  N/A

Temple U: No.

U of Mass:     No.

WVU: No.

11.  Do you utilize a separate Board for protocols subject to
continuing review?

Colo. State:   No.

Indiana U
Bloomington:   No, see #5

Kent State U:  No.

U of Oklahoma: No.

Baylor College:     No.

Washington U:  No.

UCLA:     No.

Harvard:  No.

Temple U: No.

U of Mass:     No.

WVU: No.

12.  What is your definition of adverse event?

Colo. State:   "Serious complication, unexpected risk or
injuries", I've also seen it treated as simply a "compliant," as
about invasive question on a survey.

Indiana U
Bloomington:   We rarely have problems that are considered
adverse events.

Kent State U:  Injury.

U of Oklahoma: Any serious unanticipated adverse event
experienced by subjects whether or not effort is directly related
to protocol.

Baylor College:     Serious and unexpected events.

Washington U:  Unanticipated, life-threatening or fatal event.

UCLA:     Any adverse reactions encountered by subjects.

Harvard:  ANY problem that occurs (medical issues to participant

Temple U: Unexpected.

U of Mass:     Unexpected negative outcome that presents a
potential risk.

WVU: Serious and unexpected events.

13.  Do you use a form to report adverse events to the IRB?

Colo. State:   No, but the continuation form has a question about

Indiana U
Bloomington:   No, just require explanation in memo form.

Kent State U:  Yes.

U of Oklahoma: No.

Baylor College:     No.

Washington U:  Yes.  We have forms for everything!!

UCLA:     The form is being developed now.

Harvard:  No. Investigators are told that they must write or call
us any time there is an unexpected outcome with their research.
This is communicated with the approval letter, at least annually
in an update letter to the entire research community, and on the
continuing application.

Temple U: No.

U of Mass:     No.

WVU: No, in the works.

14.  How do you inform investigators when to report adverse
events?  Is this information in your approval process?

Colo. State:   Yes, a paragraph on the approval form.

Indiana U
Bloomington:   Yes, in approval letter.

Kent State U:  Separate form if need arises plus asked about on
annual review.

U of Oklahoma: Yes, also in IRB Guidelines and mentioned at all
IRB workshops and seminars on campus.

Baylor College:     Don't inform investigators "when".  Yes, the
information is approval letter, "develop if unexpected or unusual

Washington U:  Our approval is documented on the investigator's
submission form.  The statement on the form is "In cast of an
unanticipated adverse reaction ... an immediate report will be
sent to ...

UCLA:     The information is in our approval notice.  In
addition, we are developing a PI procedure manual that will
include a detailed procedure for PI to report adverse events.

Harvard:  See above.

Temple U: Yes, it is in the Certification of Approval.

U of Mass:     It is in Policy and Procedures Manual.

WVU: Approval letter.

15.  Does your application for annual continuing review include
reporting both expected and unexpected adverse events?

Colo. State:   1)Is the study ongoing as originally approved.
2)Have any unexpected risks or problems been encountered since
the pervious review.
3)Were any subject(s) withdrawn from this study, describe the

Indiana U
Bloomington:   Yes.

Kent State U:  Yes.

U of Oklahoma: Yes.

Baylor College:     Yes.

Washington U:  Only expected adverse events when the event is
life-threatening or results in death.

UCLA:     Yes.

Harvard:  Yes.

Temple U: Yes.

WVU: Yes, it will.

16.  Please summarize your procedures regarding compassionate

Colo. State:   Not applicable to our protocols.

Indiana U
Bloomington:   N/A

Kent State U:  N/A

U of Oklahoma: The current term is emergency use.  We require a
brief point history protocol and consent which is reviewed and
approved by the IRB chair and another IRB member, preferably a

Baylor College:     Call to chair (or vice chair) memo follows.

Washington U:  We take true "compassionate use" protocols to full
board (we have a form for treatment with an investigational
Rx...).  Because we have a meeting each week, patients to not
have to wait long for treatment.  The form that the investigator
is required to complete is only one page.  If the investigator
anticipates that s/he will see other patients with similar
compassionate needs, we require that s/he complete required
paperwork as for any research for any subsequent patients.  An
emergency (immanently life-threatening situation) is treated as
such.  If the investigator has time to call the IRB, s/he is to
do so.  An MD reviews the emergency request; if deemed
appropriate by the MD (usually the chairperson), approval is
granted and a report is provided to the upcoming IRB meeting.

UCLA:     Handled by the investigator's department.  Some
departments have an ad hoc committee to review and approve
compassionate use of patients.  Some just reviewed and approved
by the department chair.

Harvard:  N/A

Temple U: Letter must be sent to the Chairman who reviews the
case himself or with the assistance of other IRB members.

U of Mass:     None.

WVU: Use form, form submitted for full board review, follow-up
status requested

Are these always life-threatening circumstances?

U of Oklahoma: Yes.

Baylor College:     Yes.

Washington U:  An example of an emergency that is not life-
threatening is a recent case in which the patient would lose his
or her eyesight.  The administration if the inv. rx. was granted
as an emergency because we considered it to be "life-
threatening" to the open.

UCLA:     Yes.

Temple U: No, but mostly

U of Mass:     N/A

Does your Chair sign off on a compassionate use form before
compassionate use is granted?

U of Oklahoma: Yes, when at all possible.

Baylor College:     No, letter.

Washington U:  He does for emergencies, but compassionate use is
a treatment situation and as such goes to full board as any full
protocol submission.  The difference is that the submission
paperwork is only one page addressing the specific needs of the
patient in need of treatment.

UCLA:     No.

Harvard:  Yes.

U of Mass:     N/A

WVU: No.

 Institutional Animal Care and Use Committee

1.   Total active IACUC protocols.

Colo. State:   510

Washington U:  1,000

Kent State U:  37

Baylor College:     600

UCLA:     Not available.

Temple U: 236

U of Mass:     4

WVU: 237

2.   Total IACUC protocols in preceding 12 months.

Washington U:  370

Kent State U:  30

UCLA:     1200

Temple U: 174

WVU: 117

Review Level - Full Committee

Colo. State:   323

U of Calf, Irvine:  150

Kent State U:  30

Baylor College:     130

UCLA:     800

Temple U: All protocols

U of Mass:     10

Review Level - Expedited

Colo. State:   We don't expedite IACUC protocols.

U of Calf, Irvine:  12

Baylor College:     111

Temple U: 0

U of Mass:     4

3.   Have you noticed an increase in active protocols over the
last two years?

Colo. State:   No, 2% decrease 1993 to 1994.

U of Calf, Irvine:  No

Washington U:  See note #4.

Kent State U:  No.

Baylor College:     Yes.

UCLA:     No.

Temple U: Yes.

U of Mass:     No.

WVU: Yes, a slight increase.

4.   Are all laboratory inspections conducted by your Office of
Laboratory Animal Resources, IACUC members, or a combination of

U of Calf, Irvine:  1. IACUC and Vet

Kent State U:  Both.

Baylor College:     Combination.

UCLA:     Combination of both.

Temple U: IACUC members.

WVU: IACUC members.

Please explain as necessary.

Colo. State:   Semiannual lab inspections conducted by IACUC
members, one of which is the director of the vet car office;
institutions's bet also is included and vet care staff are
sometimes included.  Vet care is responsible for follow-up and
corrective actions.

U of Calf, Irvine:  Responsible parties to renew and visit labs
are the IACUC members.  Vet and vivarium managers as well as
AHT's are invited to come along on inspection.

Washington U:  Inspections have two IACUC members and a

5.   What is your process for annual continuing review?

Colo. State:   One page form completed before approval cycle
expires.  If no changes or problems reported, approved by
Administrator on behalf of IACUC.  If changes or problems, routed
to IACUC chair (and second member if problematic) for review.

U of Calf, Irvine:  Renewal form gets completed.  Unless there is
a change, IACUC only gets copy of PI, Title, Species.  If there
is a change, IACUC performs full review.

Washington U:  I developed an annual review from.  If PI does not
respond he is given a second notice.  If still no answer,
protocol is voided.

Kent State U:  Two annual review then resubmit full application.

Baylor College:     Reviewed by Vet.

UCLA:     The investigator is asked to complete a continuation
application that is sent to PI automatically 2 months prior to
the expiration date.  Continuations with changes require a
pre-committee review by the Chair and the veterinarian.
Continuations with out changes are presented to the full
committee for review and approval.

Temple U: Annual review forms sent to PIS 2 moths prior to
anniversary of approval date.  List of protocols for annual
review sent to IACUC members prior to IACUC meeting.  Protocols
for annual review are either approved at the meeting or PIs are
requested to submit additional information which is reviewed at
the next meeting.

U of Mass:     Reviewed at regular scheduled meeting.

WVU: Inspections and annual review done simultaneously, sent 1
month prior to anniversary, list sent as agenda item and approved
at meeting.

6.   Do you use a form to submit revisions to an existing active

Colo. State:   We have one for change in number of animals, but
it is rarely used.  Most changes come as memos or e-mail, with
major changes requiring a new full application.

U of Calf, Irvine:  Yes, we have a modification form.

Washington U:  Yes, an amendment form, we processed 147 of these
in 1994.

Kent State U:  Yes.

Baylor College:     Yes.

UCLA:     Yes.

Temple U: No, minor changes to protocols can usually be addressed
by letter to the IACUC and reviewed at a meeting.  Most revisions
would require that a new Animal Care and Use Protocol form be
filled out and reviewed at the IACUC meeting.

U of Mass:     Same form.

WVU: No, done by memorandum.


1.   Does the same staff support both IRB and the IACUC?  Or is
there a separate staff for each?

Colo. State:   Same staff does both, plus biosafety (144
protocols/year), radiation safety and drug review (42/year),
Misconduct in Science and Conflict of Interest.  1.0 FTE
professional, 1.0 FTE clerical.  I have approval to add 0.5 FTE
professional but hope to increase that to 1.0 FTE professional.

U of Calf, Irvine:  Separate staff for each.

Washington U:  Separate.

Indiana U
Bloomington:   Separate.

Kent State U:  Both.

U of Oklahoma: Separate staff/separate departments.

Baylor College:     Separate, but crossed-trained.

UCLA:     There is a separate coordinator for each committee.
One administrative assistant provides support for one IRB, the
IACUC and the Biosafety Committee.

U of Mass:     Separate.

WVU: Both

2..   How many FTE on the support staff to the IRB?

Kent State U:  1.5


Indiana U
Bloomington:   1

U of Oklahoma: 1.3

Baylor College:     .5

UCLA:     5.5

U of Mass:     .5


Baylor College:     1

WVU: 2


U of Calf, Irvine:  2

Indiana U
Bloomington:   .25

U of Oklahoma: 1.2

Baylor College:     .5

UCLA:     5

U of Mass:     .5

WVU: 1

3.   How many FTE on the support staff to the IACUC?

Kent State U:  1.5

U of Oklahoma: Separate Office.


Washington U:  1

Indiana U
Bloomington:   1

Baylor College:     .25

UCLA:     2

WVU: 2


Baylor College:     1


U of Calf, Irvine:  2

Washington U:  1

Indiana U
Bloomington:   .25

UCLA:     1

WVU: 1

4.   Are there any issues that we have not addressed which might
be of interest?

Colo. State:   a)To what extent is the office computerized? What
software?  What does it accomplish?  Do you like it?  What would
you change about it?  We are not computerized enough beyond word
processing, and I am searching for suitable software, especially
IACUC and IRB, to track protocols, assist in producing corrective
letters, produce approvals, built agendas, monitor status, alert
for renewals.
 b)How often are you audited?  By whom?  What have
been common audit deficiencies?  I haven't been in the position
long enough to know, but I've been told regional USDA comes
through as often as once a year, a FDA IND project will often
result in an FDA inspection (we've only ever had one inspection
from them, after our first IND, but now have two more INDs), and
OPRR was on campus last summer.  I understand OPRR's chief
concern had to do with the departmental reviews that had evolved
to be outside the IRB process.

U of Calf, Irvine:  1)How is monitoring (post-approval of
protocols) conducted by IACUCs.  2)Grant/Protocol review - how is
it done - is it done?

Washington U:  Yes, we previously processed approximately 1,000
protocols a year when they were "grant-based".  This figure
dropped approximately 50% when we switched to a "procedural
base".  One protocol can be submitted to several agencies.

U of Mass:     No.