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 Subjects 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 Expedited 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 Expedited 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 possible. 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 clinical. 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 complaints) 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 it. 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 complications". 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 reasons. 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 use? 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 vice-chair. 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 both? 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 veterinarian. 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 protocols? 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. General 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 Professional Indiana U Bloomington: 1 U of Oklahoma: 1.3 Baylor College: .5 UCLA: 5.5 U of Mass: .5 Technical Baylor College: 1 WVU: 2 Clerical 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. Professional Washington U: 1 Indiana U Bloomington: 1 Baylor College: .25 UCLA: 2 WVU: 2 Technical Baylor College: 1 Clerical 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.
