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Instructions for Informed Consent Assent

Subjects who are age 18 and older are considered adult subjects unless they are mentally disabled or incapable of giving legal consent.  Here are the basic things you need to remember when writing a consent form:  Details…

IRB Application Instructions

ALL information must be filled in. Incomplete forms will not be accepted by the IRB Office for review.  Your  IRB application should include IRB Application Form (Version 11/2008), Record Review Form, if applicable, and the Research Plan, Details…

When do I have to turn in my review materials?

As soon as you have completed preparing your materials. You will need to turn in three complete sets of information to the Office of Research Administration to start the review process. There are IRB deadlines for submissions.  However, if you wait until the IRB deadline to actually turn in your materials, it is very unlikely that your study will be through the content and consent review in time to that specific meeting.

Do I have to come to the IRB meeting?

It is the policy of the Rady Children’s IRB that the Principal Investigator does not have to be present at the IRB meeting unless there are substantive or controversial issues involved, the IRB membership requests that the PI attend, or the Principal Investigator chooses to attend the meeting.

Is there an IRB fee to have my study reviewed?

Yes, there is a $1,500 fee for IRB review. This is a one-time fee that covers your study for three years. If your study continues into a fourth year, a $400 fee will be charged when you apply for your fourth-year continuation approval.

What happens after the study is turned in?

After you have your IRB application ready, you would submit the original, plus nine sets to the Office for Human Subjects Protection. Send an email to research@rchsd.org if you have any questions and/or if you think your study may qualify for expedited review.  Details…

Where do I get information about the IRB policy and updates?

The IRB policy manual is current not available online. The Office of Human Subjects Protection sends a notification via IRB Newsletter whenever there is any changes to the IRB policy and procedures. The Newsletter is also posted online.

Renew or Close your Study

How do I renew my study approval?
The Office of Human Subjects Protection sends out a letter of notification when a study approval period is nearing its end. This letter will include a Study Status report form for you to complete and return, along with a Study Summary report.

Please note that the letter of notification sent out by the Office of Human Subjects Protection is a  courtesy reminder, and should not substitute for the researcher’s own internal tracking of expiration dates. It is ultimately the investigator’s responsibility to ensure that the continuing review request for the study is submitted to IRB on, or before the study’s expiration date.

Important information about the study renewal

It is very important for investigators to plan ahead to meet required continuing review dates. The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. Therefore, continuing review and re-approval of research must occur on or before the date when IRB approval expires.

To prevent lapse in continuing review, a continuing review request must be submitted to IRB 30 days prior to the study’s expiration date. IRB will not accept any continuing review request that is submitted to IRB less than 15 days prior to the study expiration date. Exceptions will only be granted for extenuating circumstances.

Your initial study approval letter includes the approval period the IRB has assigned to your study. This approval may not exceed 12 months, per Federal Regulation. The IRB may choose to approve a study for less than 12 months, based on the level of risk.  Details…

When There are Problems

The Office of Human Subjects Protection and the IRB want to help you solve small problems before they become big problems. Contact the office to discuss any issues or problems that arise early on. Some of the more common types of problems that can occur are included here. Details…

What Needs to be Reported?

The Principal Investigator is required by Federal Regulation and hospital IRB policy to report the following to the IRB:

  • Serious adverse events
  • Changes to ongoing research protocols which include:
    – procedure changes
    – consent form changes
    – drug dosing changes
    – adding or dropping a test
    – adding or dropping study personnel
    – new findings impacting the research
  • Protocol Violations
  • Emergency use of an Investigational Drug