Strong Children's Research Center

Pediatric Clinical Research Office

Frequently Asked Questions

Q: Where is the Pediatric Clinical Research Office (PCRO) located?

A: The PCRO is located on the 4th floor in the Department of Pediatrics, Room
4-7129. Telephone Number: (585) 275-5204. Fax: (585) 273-1038

Q: Where can I obtain the required forms to request PCRO Sign-Off and/or request a Scientific Review?

A: Required forms are either available in the PCRO Office, 4-7219, or on our website.

Q: If I submit a study for Scientific Review, how long does it take?

A: If your study is a minimal risk study (for instance utilizing a survey, etc.) the PCRO can complete an Administrative Review with 24-48 Hours. If your study requires a review by a Member of the PCRO Scientific Review Committee, the PCRO will strive to have the study reviewed within 10 business days.

Q: What are the components of a Scientific Review?

A: A Scientific Review includes the following criteria:

Sufficient background and justification
Reasonable hypothesis
Study design
Statistical plan
Likelihood of answering the hypothesis
Environment of care assessment
Resources
Feasibility of successful study completion
Investigator qualifications
Major safety concerns
Major data monitoring concerns
Major conflict-of interest concerns

A favorable review by the PCRO Scientific Reviewer confirms that the study has sufficient scientific merit to proceed and that the investigator team is qualified to perform the research.

Q: What are acceptable methods of peer Scientific Review?

A: Acceptable methods scientific review are:

Certified Pediatric Division Review Committee
Review by an internal University group (e.g., Clinical research Center (CRC), Cancer Center (URCC/CTO), Perinatal Review Committee)
FDA review of Investigator-Sponsored IND or IDE application
External peer review by a scientific body (e.g., NIH)
Review by a NIH funded collaborative study group (e.g., COG, ACTG)
Review by PCRO Scientific Review Committee or PCRO Administrative Review
Thesis/dissertation Committee Review

Q: What is acceptable evidence of peer scientific review?

A: Acceptable evidence of scientific review is:

Letter of approval from an internal University Review group (e.g., CRC, URCC/CTO, Perinatal Committee)
Letter of approval from a divisional review group
Letter of approval by PCRO Scientific Review/Administrative Review
Notification of funding by intramural grant program
Letter of approval from Thesis/Dissertation Committee
Notification of approval for funding by a federal sponsor (e.g, NIH Just-In-time notification)
Notification of study approval by NIH-funded collaborative study group (e.g., COG, ACTG)

Q: Can the PCRO conduct Scientific Reviews?

A: The PCRO Scientific Review Committee is available to perform Scientific Reviews when the Principal Investigator has no other recognized resources for review. To request a review, the materials listed below are required. Documents should preferably be delivered in electronic format or deliver two (2) sets of printed copies to the PCRO Office, 4-7219. For more information contact Nicholas Ferraio.

Request for Scientific Review Cover Sheet: Contains an abstract of the research, the most appropriate reviewer background, and any other comments helpful for the reviewer.
Proposal Documents: Contains the scientific proposal and the PI curriculum vitae.
Documentation of other internal or external outside reviews: May be provided if the PI feels the information would be helpful for the PCRO Scientific Review.

Q: Do I need Departmental approval for my study prior to submission to the IRB?

A: Yes. Approval of IRB applications by the Office of the Chair of Pediatrics or designee is required for all IRB Applications. For assistance in this process, please contact the PCRO Office.

Q: What is the difference between Research, Clinical Research, Departmental Research and Sponsored Research or Project?

A: Research is defined activities of inquiry to answer general scientific questions and to add to a body of knowledge.

Clinical Research is defined as (a) patient-oriented research conducted with human subjects; (b) epidemiological and behavioral studies; (c) Outcomes research and health services research.

Departmental Research is intramural projects not funded or supported by a source external to the University. Resource and financial accountability must be established and approved by the unit chief and the Department before commencing any Departmental activities in Pediatrics.

Sponsored Research can be a individual, company, institution or other organization that takes responsibility for the initiation, management and financing of a research project or study.

Q: When should a Consent Form, Assent Form or Parental Permission Form be used:

A: The general guidelines accepted by the University of Rochester IRB are:

Ages 0-6	Parental permission only because children have not reached the age of consent
Ages 7-12	Parental permission plus age appropriate verbal assent
Ages 13-17	Parental permission plus age appropriate written assent
Ages 18 and older	Consent form

Q: How will I know if my study has been scheduled for a Clinical Study Quality Assurance and Research Clinical Billing Review?

A: Approximately four (4) weeks prior to the scheduled review, the PI will receive in the intramural mail a “Letter of Notification of Review.” This notification will state the scheduled date and time of the review as well as to ask for pertinent information (copy of Study Protocol, Informed Consent, approved budget). In addition the PI will receive a Pre-Audit Information Form to complete and return to the PCRO prior to the review date. If you have questions about the review, contact the PCRO Office at 273-5204.

Q: Once the Research Clinical Quality Assurance and Research Clinical Billing Review are completed how soon will I know the results?

A: Once the review is completed, you will be notified of the results within 72 hours. During the course of the review, the reviewer will keep the PI and/or Study Coordinator aware of any issues identified. The PI will receive a “Draft Review Summary” for review and response. Once the “Draft Summary” is mutually approved by the PI and the reviewer, a “Final Review Summary” will be issued.

Q: What is the Clinical Trial Registry?

A: The International Committee of Medical Journal Editors (ICMJE) has established a requirement that all clinical trials be entered in a public registry before the onset of patient enrollment, as a condition of consideration for publication. The University of Rochester Medical Center has selected the protocol registration system established by ClinicalTrials.gov as the study registration site for clinical studies performed by URMC investigators. ClinicalTrials.gov provides a vehicle which allows organizations and individuals to provide the data requested by ICMJE, which has adopted the World Health Organization (WHO) minimal registration data set.

The ICMJE has defined a clinical trial as “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.” The ICMJE definition of “medical intervention is any intervention used to modify a health outcome. This definition includes drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like. The ICMJE further explains that a trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration (e.g.: observational studies need not be registered).

The PCRO registers users in the PRS system and provides technical assistance for study registration. To obtain a User ID email PCROadmin@urmc.rochester.edu.

Q: Do I need to register my study with Clinicaltrials.gov?

A: That depends on whether you wish to publish your study results. Per the ICMJE Guidelines, investigators are required to register their study if they wish to publish and, the study prospectively assigns human subjects to intervention or comparison groups in order to study the cause-and-effect relationship between a medical intervention and health outcome. If there is any doubt about whether a study should be registered, it is safer to do so.

Q: How do I register my study with Clinical Trials.gov?

A: The PCRO is available to assist you with this process. You can, however, register yourself:

1. Log on to http://register.clinicaltrials.gov
2. Complete the three fields on the Login screen:

Organization login name: URochester
User login name: your first initial lastname (ex. RJones)
Password: change_me

3. Click [Login] and the Main Menu of the PRS appears
4. To log out of the PRS, select [Logout] from the Main Menu screen.
5. Create your Clinicaltrials.gov Record:

Click [create] from the Main Menu screen.
Enter your unique Protocol ID (RSRB or WIRB#) and Brief Title for your record on the Create New Protocol Record screen.
Click [Continue] to save data and proceed to next screen. Repeat data entry for successive screens.
After clicking [Continue] on the final data entry screen (Links), click [OK] on the Study Completed screen.

6. To create a record and save for completion at a later session, click [Quit] to
stop data entry.

Click [Save Protocol Record] to keep your data for later sessions.
Click [Delete Protocol Record] to erase the record.

Q: What is minimal and greater than minimal risk research?

A: “Minimal risk, as defined in the United States federal research regulations, means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” “Greater than minimal risk” represents a minor increase over minimal risk.

Current Federal guidelines are:

45 CFR 46.404 – Research not involving greater than minimal risk to children for this category of research, the IRB must make the following determinations:

The research presents no greater than minimal risk to the children, and
Adequate provisions are made for soliciting the Assent of the children and permission of parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

45 CFR 46.405 – Research involving greater than minimal risk but presenting benefit to the individual child subjects involved in the research. To approve this category, the IRB must make the following determinations:

The risk is justified by the anticipated benefits to the subjects,
The relation of the anticipated benefit to the risk presented by the study to the subjects as that provided by available alternative approaches, and
Adequate provisions are made for soliciting the assent of the children and parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

45CFR 46.406 – Research involving greater than minimal risk and no prospect the individual child subjects involved in the research, but likely to yield generalize knowledge about the subject’s disorder or condition. In order to approve research, the IRB must make the following determinations.

The risk of the research represents a minor increase over minimal risk,
The intervention or procedure presents experiences to the child subjects commensurate with those inherent in their actual, or expected medical, social, or educational situations,
The intervention or procedure is likely to yield generalizable knowledge about the disorder or condition which is of vital importance for the understanding of the disorder or condition, and
Adequate provisions are made for soliciting the assent of the children and the parents or guardians, as set forth in HHS regulations at45 CFR 46.408.

A fourth category of research requires a special level of HHS review:

45 CFR 46.407 B Research that the IRB believes does not meet the condition 46.405, or 46.406, but finds that the research presents a reasonable opportunity for understanding, prevention, or alleviation of a serious problem affecting the children.