What is your FWA assurance number and how do I verify PCIRB's assurance?

PIRB is registered with DHHS and operates under UICOM-P Federal Wide Assurance #00005172.  Each institution that requests review by PCIRB must complete and submit the IRB Authorization Agreement.  Confirmation of PIRB's FWA and the institutions that rely upon this IRB, can be accessed by visiting the OHRP Website.

How often does the Board meet?

PCIRB has 3 committee panels.  IRB I meets the second Thursday of each month, IRB II meets directly after, and IRB III meets the following Tuesday of each month.  For a full schedule of times and dates, please refer to Meetings.

How do I get copies of your current forms?

All of our forms can be downloaded from the Forms page of our Website.

I am a new investigator and I have no idea what form to complete or if my project is really research?

Please refer to our guidelines for new investigators conducting research: Guideline for PI's

Where are you located and what is your mailing address?

Your study will be reviewed upon receipt at the IRB office.  Any significant questions will be presented to the investigator either by phone or by mail to resolve any issues prior to Board review at the next convened meeting.

Do you have any resources to help me write my research proposal?

Yes, a great resource can be found at:

http://www.who.int/rpc/research_ethics/format_rp/en/index.html

Your study will be assigned to one of the three Boards for review at the next convened meeting. The Board will review the study and study documents will be processed and distributed to each member.  You will be contacted by a member of the staff to set up a time on meeting day to present your protocol to the full board, if applicable. Following review by the Board, a letter will be sent to the investigator detailing the Board's decision.

In an effort to simplify the process as well as conserve your time, PIRB has developed a Change in Research Form. This form is available on the Forms page of our Website. This form has check boxes for various types of requests and gives information about any additional documents which must be submitted with the different types of requests.  Although the form alone is sufficient for submission, please verify with your sponsor if a cover letter is required for regulatory purposes.  If this is a non-sponsored trial, the cover letter for changes in research is optional.

Our fee schedule is available on the Fee Schedule page of our website.

When do I notify PIRB when a study has been completed?

One of the procedural requirements found in Title 21 CFR 56.108(a)(3) requires ensuring "prompt reporting to the IRB of changes in a research activity."  Therefore, upon completion of the study PIRB requires notification.  Please utilize PIRB's Closed to Enrollment Form or Final Report Form, as applicable.

What items can an IRB review by expedited review? (One of the most common findings issued by the FDA in recent warning letters include having members of the IRB approve  new protocols and full board amendments by expedited review.)

1.) Research that presents no more than minimal risk and is listed in a
     National Institutes of Health guidance document as an "adjunct"
     to the DHHS and FDA regulations (see list below);
 2.) "minor changes" to previously approved research during the period
      (one year or less) for which approval is granted; and
 3.) some materials used for subject recruitment.

(Categories of research that qualify for expedited review):

1. Clinical studies of drugs and medical devices whenever there is:
    a.research on drugs for which an investigational new drug application
       is not required; or
    b.research on medical devices for which (i) an investigational device
       exemption application is not required or (ii) the device is
       cleared/approved for marketing and is being used in accordance with
       its cleared/approved labeling.

2. Collection of blood samples by finger stick, heel stick, ear stick
    or venipuncture (with restrictions such as age, weight, frequency and
    amounts of blood drawn).

3. Prospective collection of biological specimens for research purposes by
    noninvasive means; for example, mucosal and skin cells, hair and nail
    clippings, external secretions, placental removal at delivery, mucosal
    and skin cells.

4. Collection of data through noninvasive procedures (not involving general
    anesthesia or sedation) routinely employed in clinical practice, excluding
    procedures involving x-rays and microwaves, but including procedures
    such as MRI, ECG, EEG, ultrasound, doppler blood flow, muscular
    strength testing, flexibility testing and more.

5. Research involving data, documents, records or specimens, that have
    been collected for any reason or will be collected solely for non-research
    purposes such as medical treatment or diagnosis.

6. Collection of data from voice, video, digital or image recordings made for
    research purposes.

7. Research on individual or group characteristics or behavior or research
    employing survey, interview, oral history, focus group, or other such
    methodologies. (This listing applies only to research that is not exempt
    from HHS Regulations.)

8. Continuing review of research previously approved by a convened IRB
    where:
    -enrollment is permanently closed;
    -all subjects have completed all research-related interventions; AND
         -only long-term follow-up of subjects continues; OR
         -no subjects have been enrolled and no additional risks identified;
         -or remaining research is limited to data analysis.

9. Continuing review of research not conducted under an IND application
    or IDE where Categories 2-8 do not apply but the IRB has determined
    and documented at a convened meeting that the research involves no
    greater than minimal risk and no additional risks have been identified.

   *Categories 1-7 pertain to both initial and continuing review.

Protocol violations are those events clearly occurring outside of the approved research activity, which also represent a failure to comply with the protocol.  The terms protocol deviation and protocol violation are similar, although protocol violation refers to more serious non-compliance, which more often leads to exclusion of subjects from eligibility analysis or their discontinuation from the study.

The investigator must report protocol violations to PIRB, the sponsor, and all participating institutions.  The report must be issued immediately if the health or welfare of the subject was jeopardized. 

Protocol deviations are study events that are not covered under the approved research protocol, which represent a failure to comply with the protocol.  (e.g. A subject does not have a kidney biopsy, which is required six months after beginning transplant medication because she is in the ICU).  The investigator should report a protocol deviation to PIRB immediately, if it represents a significant alteration in the approved written protocol and/or affects the safety and welfare of the subject. 

Please utilize the Unanticipated Problems Involving Risks to Others Form to reports these events to the IRB.

Where can I find the IRB Policies?