MAY 2008 COMIRB Newsletter

Reminders:

May 15, 2008 at 1 pm in Rm. 204, Nighthorse Campbell –   Jeff Cohen will discuss “What investigators should know about accreditation.” Investigators will be randomly interviewed as part of the site visit for accreditation so it is best to be prepared!!  

Beginning June 1, 2008: CONSENT FORMS must be written using the new standard language:

The consent template can be found on the COMIRB website under the:

- “How to’s of COMIRB ”:

-  How to submit for Full Board Review

- Consent Template

Please use this language if applicable to your study. If there are any questions please don’t hesitate to contact the COMIRB office at 303-724-1055.

Beginning July 1, 2008 – WIRB fees increase:

All investigators who currently utilize WIRB should have received a letter explaining the fee structure changes –

Initial Review fee will be $3000 and continuing review fee will be $1800

[All other fees will be billed directly from WIRB to the PI]

* Bring your lunch and your questions:*
If you have questions about the application process or questions about how to complete the forms as it relates to your study, come to one of the open forum sessions at COMIRB

The Director and various staff will be available for questions and answer sessions from 12.00 to 1.00 on the following Thursdays in the COMIRB conference room, 3rd floor Building 500 room N3214:         
            May 22
            June 19
            July 17

Based on your feedback - new versions of all forms are now available on the website      

*Regarding OHRP’s new pamphlet for Spanish speakers:*

Research studies that include Spanish speakers may want to order OHRP’s new pamphlet "Becoming a Research Volunteer: It’s Your Decision" is now available in Spanish, "Ser Voluntario en Estudios Clínicos: Es Su Decisión."

You may order up to 50 (fifty) free copies by calling OHRP's toll-free number, (866) 447-4777. You may also download at no charge an electronic copy at http://www.hhs.gov/ohrp/espanol/OHRP3PanelSpanish.pdf for your own reprinting and distribution.

*REQUIREMENTS FOR A DRUG / BIOLOGIC STUDY*

In the checklist at the end of an Initial Application is a section labeled:

If a DRUG / BIOLOGIC study, please include these additional documents:

1)      Investigator Drug Brochure / drug package insert

2)      Background Information for Food Supplements

3)      Copy of the FDA 1572 form, if there is an IND

Only if a study involves food or food supplements is the Background Information for Food Supplements required, and it is a rare occurrence.  However, the Investigator Drug Brochure and the FDA 1572 form are much more common in initial reviews.

If a study is using an IND – therefore the drug is not approved by the FDA – three copies each of the Investigator Drug Brochure and a FDA 1572 form and validation of the IND number either from the sponsor or FDA form must be submitted.

If a study is using a drug that is approved by the FDA – only 3 copies of the drug package insert must be submitted.

Changes to the Expedited/Exempt Team:

Sadly, Mary Geda will be leaving COMIRB on May 15.

Amy Taylor and Yvonne Kellar-Guenther have agreed to take on the responsibilities for reviewing Expedited and Exempt protocols.

 

Alison Lakin RN, LLB, LLM, Ph.D

303 724 1058

303 668 3357- cell

April 2008 COMIRB Newsletter:

Bring your lunch and your questions:
If you have questions about the application process or have questions about how to complete the forms as it relates to your study, come to one of the open forum sessions at COMIRB.

The Director and various staff will be available for questions and answer sessions from 12.00 to 1.00 on the following Thursdays in the COMIRB conference room, 3rd floor Building 500 room N3214:
            April 17
            May 8
            May 22
            June 19
            July 17

Based on your feedback - new versions of all forms are now available on the website

Regarding WIRB studies:
Please note that an investigator's CV is only required with the first submitted protocol in which they are listed as an investigator.  WIRB will have their CV on file for all subsequent protocols.  
The fees for studies reviewed by WIRB for UCD will be increasing July 1, 2008. More information will be sent to the investigators directly once the fees for next year are finalized.

Initial Protocol Full Board Review Submission Tip:

COMIRB requires:

18 copies of all documents including:
[to help reduce paper until electronic submission is available]

• 18 copies of the Protocol (this may be submitted as 3 single sided with 15 double sided protocols)
• 18 copies of the Protocol Application (including all attachments)
• 18 copies of other materials to be provided to the subjects (which are not included in the protocol) such as advertisements questionnaires, subject diaries, etc.
• 18 Consent/Assent forms
• 18 copies of the grant if used as the Full Protocol (note only 3 are required if the grant is federally funded, and not used as the Full Protocol.)
• 18 copies of HIPAA Authorization (if applicable)
• For a COI please note that: ( COMIRB does not require 18 copies submitted)
1. For question 1 if this is answered “no” please state who has not submitted the form and explain why this has not occurred.
2. For question 2 on the Protocol Application, if checked “yes” a COI management plan must be developed.
3. If question 3 on the Application is checked “Pending” the submission will receive minor modifications, until the management plan is complete.
4. If an affiliate (for example The Children’s Hospital or Denver Health) a Conflict of Interest plan must be submitted to the COI manager.

If applicable the following:

• 3 copies of the grant if federally funded
• 3 copies of the Investigational Brochure
• 3 copies of information for Food Supplements
• 3 copies of  FDA 1572 form
• 1 copy of a Device Manual
• 1 copy of the FDA Letter
• 1 copy of the Letter of Sponsor
• 1 copy of the Letter explaining why the investigational is exempt from IDE requirements

Remember, COMIRB staff is happy to answer questions regarding COMIRB submissions. Please call us.

COMIRB January 2008 Newsletter

Accreditation is coming!!

There have been a number of changes to COMIRB policies and procedures in a short period of time in preparation for accreditation. I know that this has led to some confusion but I am hopeful in the longer term it will be worth it.

Thank you for working with us to try to achieve an important goal.

It is, therefore, particularly important to go to the website for the latest forms and information. A number of forms are currently being updated based on your feedback and should be posted by the end of January.

Please continue to feedback any suggested changes.

As promised:

There is now a new consent template and assent template with revised standard language available on the COMIRB web-site. From February, we will gradually start to transition from the old template to the new.

Training sessions:

As soon as the application for accreditation has been submitted there will be a number of training sessions for researchers and their staff to ask questions about the new forms, policies and procedures. We will begin scheduling these sessions in March.

WIRB Op-in Time

There will be an opt-in period for WIRB beginning February 1 until March 1. If you have been using WIRB and now what to start using COMIRB or if you have been using COMIRB and would like to switch to WIRB, please contact Kim Buda at kim.buda@uchsc.edu or 303 724 1062.

Remember:

There is always COMIRB staff available to answer your questions:

Bernie Pistone                    Mary Geda                            Monica Devine

303 724 1065                        303 724 1551                        303 724 1061

HAPPY NEW YEAR

COMIRB July 2007 Newsletter

Exciting change is coming at COMIRB!!

Fall will see the introduction of new forms and processes.

Why the changes?

• To provide clearer guidance to investigators
• To eliminate the protocol summary
• To have one application form for the Adult GCRC, Pediatric CTRC and COMIRB
• This is the first step towards the implementation of electronic submissions
• Is a necessary step for accreditation of UCDHSC’s human research protection program

What to expect:

• New application form instead of protocol summary
• New continuing review form
• New electronic reporting of unanticipated problems/SAEs  (including a new definition of SAEs)

Where to go for more information:

• All the proposed documents will be available for preview on the web-site from late August
• Education sessions will be posted in September
• Office hours for assistance completing the forms will be offered

Reminder:

“I am a researcher and my office is moving. What do I need to do?”

Please notify your research subjects AND COMIRB.

The following steps will help with the transition:

1. Update your contact information via the protocol manager on the COMIRB website (http://comirbweb.uchsc.edu). 
1. Address and phone number changes can be made under “Edit Profile” using Protocol Manager.

2. Inform your current research subjects by creating and distributing an Information Sheet to study participants.
1. Please submit an Alterations/Update form to COMIRB that includes a copy of your Information Sheet and planned methods for distribution.
2. Document your efforts in your research records.

3. Inform your future research subjects by revising your Consent Form.
1. Please submit an Alterations/Update form to COMIRB that includes a copy of your revised consent form.

In addition to your contact information, do not forget to inform research subjects of any site changes that impact follow-up visits or testing locations.  The hospital or research sites, such as the General Clinical Research Center, may have a template/ brochure available for you to provide to your research subjects which will not need COMIRB approval.

REMEMBER TO ALSO MAKE ALL RELEVANT CHANGES TO THE 1572 FORM, if needed.

COMIRB MARCH 2007 Newsletter

Please remember:

You cannot follow a participant who subsequently becomes a prisoner without prior COMIRB approval.

When a previously enrolled research subject becomes a prisoner and the relevant research protocol was NOT reviewed and approved by the institutional review board (IRB) in accordance with the requirements of HHS regulations at 45 CFR part 46, subpart C, the principal investigator should promptly notify the IRB of this event. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must cease until the requirements of subpart C have been satisfied with respect to the relevant protocol.

 NOTE: OHRP has allowed one important exception. In special circumstances in which the principal investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated, the IRB Chairperson may determine that the subject may continue to participate in the research until the requirements of subpart C are satisfied.

Please refer to section 11 of the Guidelines for Clinical Investigators for more details

 Tips from the exempt/expedited team:

Medical Record Reviews- When is it exempt and when is it expedited?  

The regulations pertaining to exempt chart reviews can be found in 45 CFR 46.101(b)(4).  Exemption can be given for: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

You must fulfill both criteria to be eligible for an exempt review:

1. Existing Data

Existing data refers to records that are ‘on the shelf’ at the time of the IRB application.  This means that exempt research can only be approved if the medical records pre-date the application.  Once the project is approved, you cannot change the dates to include medical records that were obtained after your COMIRB approval. 

2. Subjects cannot be identified, directly or through identifiers linked to the subjects

Since medical records are not considered publicly available, you cannot keep any identifying information or maintain any links for tracking purposes.   If you are accessing identifiable medical records for your project will need to complete a HIPAA waiver form.  You can LOOK at the information, but you cannot RECORD any identifiers such as admission dates, treatment dates, medical record numbers, or age over 89. 

If you need to track your data extraction, you can keep a list of the medical records that you wish to extract (and cross them off the list as you proceed).   For example:

John Smith MR #909090

Mary Jones MR #787878

What you cannot do is keep a list that tracks individuals to research records- this would establish a link.  For example:

John Smith  MR #90909090,   Research ID- 001

Mary Jones  MR #78787878,  Research ID- 002

If you think you will need to collect prospective data, identifiers, or track data extraction through links, you may be better served through an expedited application.   COMIRB will request a copy of your data collection tool for studies involving medical record reviews.  If you have any questions regarding medical record reviews, feel free to contact Ita Leitner the Expedited/Exempt coordinator at 303-724-1068 or Mary Geda the Expedited/Exempt manager at 303-724-1551.

Updated WIRB Submission Form…

….also a reminder to those PI’s who are using WIRB, to please use the WIRB Initial Review Submission Form with the revision date of 10-2006, located in the lower left hand corner of the form.  Only this form will be accepted. 

There is also a shorter form, titled “Investigator Submission Form for Multi-Center Protocols” for those investigators participating in multi-center protocols that have already been reviewed by WIRB.  If the protocol you are submitting has already been reviewed by WIRB, you may use the shorter form.

Both forms can be accessed from the COMIRB website, http://comirbweb.uchsc.edu, under WIRB / Required WIRB documents and forms / WIRB website.      

AAHRPP update

COMIRB is currently reviewing all its policies and procedures, looking at systems and all the documents that we use to make sure that they meet the standard of the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The aim is for UCDHSC to submit its application for accreditation by March 2008, with a site visit to follow in June 2008. This is a great opportunity to re-evaluate, refine and upgrade efficiency within the system, so if you have suggestions as to how we can improve the process please contact us via the COMIRB.

Changes will include:

·        A detailed protocol application form instead of a protocol summary;

·        Revisions to the continuing review form;

·        Electronic submission of SAEs; and

·        Consent form format and standard language will be revised.

We will use this newsletter and the COMIRB website to keep you up to date.

FDA mandated changes

The FDA recently completed a routine audited of COMIRB. Their feedback has triggered several prompt changes:

1. Relating to data and safety monitoring boards (DSMB):

·        A data safety monitoring board is now defined as an independent board comprising of at least three individuals who are not related to the study and have appropriate expertise.

·        COMIRB requires a description of the members of the DSMB, the frequency of meetings, a description of the board’s level of oversight.

·        Submit copies of any DSMB reports to COMIRB as soon as you receive them.

·        At continuing review, please submit copies of any DSMB reports since the last continuing review. If you do not have a recent report, submit in a cover letter why the board has not yet met and / or when a report is anticipated.

2. Changes that can be reviewed by the Chair using expedited review:

Only minor changes can be reviewed by the expedited process. So for example, the following will be sent for full board review:

New safety information;

Changes in drug dosing;

Increases in enrollment numbers;

Changes to the science of the study;

Dropping an arm of a study

This particularly becomes an issue when submitting a continuing review with an amendment and / or update. Minor modifications at that review can lead to a study expiring so please plan carefully, be thorough when making changes to the protocol summary or consent and if possible submit the continuing review and then the amendment or update once the continuing review has been approved.

Having problems writing the consent form to an appropriate reading level?

The compliance office now has a resource to help you.

Consent Form Class:  In this course taught by Dr. Yvonne Kellar-Guenther on Tuesday, March 13, 2007, 9 a.m. – 12 noon, you will learn how to write consent forms and recruitment literature at “consumer-friendly” reading levels.  The course materials will include a template for the standard consent forms at the 4^th and 7^th grade reading levels.  The last hour of the class will be used to apply what you have learned on a document you want help with (bring your own laptop).  For more information or to register for the course, please send an e-mail request to Marie.Wade@uchsc.edu.

These workshop will be conducted periodically, so please contact Marie to find out when the next session will be held.