Required Pre-Implementation Review of Research Policies RIA-01 Page 1 of 6

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1 Required Pre-Implementation Review of Research Policies RIA-01 Page 1 of 6 SEATTLE CHILDREN S HOSPITAL RESEARCH INSTITUTE OPERATING POLICIES / PROCEDURES DEPARTMENT: Research Institute Administration POLICY NUMBER: RIA-01 REPLACES: EFFECTIVE DATE: July 17, 2008 REVISION DATE: POSTED FROM: May 16, 2008 to June 16, 2008 TITLE: Required Pre-Implementation Review of Research Policies RIA-01 SUMMARY: Seattle Children s Research Institute generates, reviews, revises, and implements institute-wide policies and procedures to guide and support staff in the day-to-day operations of conducting research. Policies and procedures are intended to ensure institute compliance with federal and state requirements, document procedures and harmonize them with Children s Hospital operations, and to ensure uniformity throughout the Institute. In order to ensure all stakeholders are represented in said policy creation, a process for review and comment of all new institute policies, prior to adoption, has been created. This Required Pre-Implementation Review of Research Policies policy details the requirements for all policies developed within the Research Institute. POLICY/PROCEDURE: All policies developed for the Seattle Children s Hospital Research Institute and implemented subsequent to the implementation of this policy (RIA-01), except as otherwise allowed for herein, shall conform to the policy procedures outlined below New and Revised Policy Generation The Research Institute has established a centralized system of policy development in order to improve efficiency and: Avoid duplicative policies; Avoid contradictory policies; Assure that policies that are applicable in more than one center or department undergo shared policy development; Assure appropriate policy review by executive leadership; Maintain a consistent approach to routinely scheduled policy review, revision, and approval; and Assure that institute policies are created when necessitated by federal or state regulations or other regulatory bodies.

2 Required Pre-Implementation Review of Research Policies RIA-01 Page 2 of When deciding upon the need for new or revised policies, careful consideration is given to relevant sources of information, reference of guidance, and: Appropriateness of the policies and procedures in actual use; Relevant ethical and legal concerns; Current business, scientific, and evidence-based research knowledge; Findings from performance improvement activities or other system or process reviews; Information received from experts within Children s as well as other children s hospitals pediatric research settings and other research institutions; and National standards or guidelines Staff Accountability Staff and faculty are expected to be knowledgeable about, and to adhere to, all Research Institute policies and procedures that are applicable to their scope of employment Some staff and/or faculty may be required periodically to certify their knowledge or compliance with these policies that are applicable to their scope of employment Writing the Policy Research Support Services departments, research cores, research centers, research administration and/or research committees are responsible for the development and revision of policies that: Maximize the protection of research participants; Facilitate conduct of the highest quality research; Meet external regulatory and accreditation body standards; Minimize the liability and risk exposure of the institute and its staff; Define the operational aspects of research; Regulate the institute s business operations; Establish standards for the ethical behavior of staff; and Manage priorities of the Institute and the Institution Before a new policy is created, the individual creating the policy (the Policy Originator ) should discuss the policy with the appropriate administrator(s) of the areas impacted by the policy The Policy Originator will use the standard template for proposed policies (known as the Review Proposed ) Posting the Policy for Comment The Policy Originator will send the new or revised policy in the Review Proposed template format to the single point of contact (known as Single Point of Contact see definition of contacts below) within Research Institute Administration. This person shall: Confirm that the standard Review Proposed policy template has been utilized and that the template is complete; Initiate a comment tool designed specifically for the said policy;

3 Required Pre-Implementation Review of Research Policies RIA-01 Page 3 of Post the Review Proposed on Children s intranet (CHILD); and Notify the owner of Research News for the announcement out to the research community Reviewing All faculty and staff (known as End Users ) shall have 30 calendar days from the time the policy is open for comment in which to review the proposed policy and visit the comment tool to provide comments. All comments shall be: Collected via the comment tool and Identified by name for the policy originator but will not be published in the Review Response document Collection The Single Point of Contact within Research Institute Administration shall: Contact the owner of Research News for an announcement to be sent as a reminder to the End Users that the comment period is approaching. This reminder will be five days before the deadline Gather the comments from the comment tool; Close the comment tool at the end of the 30 days; and Send the comments along with identifiers to the Policy Originator for review Revision and Response The Policy Originator shall use the comments to: Make appropriate revisions to the policy (known as the Draft Policy ) based on the comments collected; Utilize the Draft Policy template; Respond to comments (known as the Review Response ); and Submit the Draft Policy and Review Response to the appropriate executive(s), see 01-10; Prepare the final policy document (known as the Final Policy ) for posting on the external research web site Revision and response will be completed in 30 calendar days Re-evaluation of Policies Should the Policy Originator determine that during the comment phase significant revisions to the policy are required the Policy Originator must revise the policy and re-issue the revised policy for comment using the steps outlined above Approvals Should the policy have minimal changes the Policy Originator is required to obtain approval for the Draft Policy and the Review Response by the appropriate executive(s).

4 Required Pre-Implementation Review of Research Policies RIA-01 Page 4 of Approvals will be accepted in electronic format such as an approval without a hard copy signature in order to reduce document file sizes Posting The final posting shall consist of two parts: The Review Response with comments and responses shall be posted on the intranet (CHILD) for end user review; The Final Policy (without comments etc.) shall be posted on the external research web site for use; and Final posting shall occur within 30 calendar days of the comment period closing Process Map A process map may be found below detailing the process Dissemination All administrators, center directors, department directors, managers, and supervisors are responsible for: Informing their staff of new or revised policies and procedures; Providing reasonable access to policies; and Enforcing policies Exemptions The pre-implementation review requirements described herein may be waived under limited circumstances Instances where waivers may be granted include, but are not limited to: Policies developed in response to a requirement of a federal, state or other regulatory body which mandates immediate implementation; Policies developed in response to a safety or ethical issue such that delay of implementation could pose a risk to faculty, staff or research subjects; Policy revisions that make non-substantive changes to policies already in force Waivers to the review requirements contained herein may be granted only by the President or Vice-President of the Research Institute Definition of Contacts Single Point of Contact: Assistant to the Vice President and Chief of Research Operations Research News & MarComm: Research Marketing Manager. Submitting Office: Research Institute Administration

5 Required Pre-Implementation Review of Research Policies RIA-01 Page 5 of 6 Approved by: \s\ James B. Hendricks, PhD, President, July 16, 2008 \s\ Erik Lausund, Vice President, July 16, 2008

6 Required Pre-Implementation Review of Research Policies RIA-01 Page 6 of 6 Required Pre-Implementation Review of Research Policies Faculty & Staff MarComm Policy Orginator Executive Leadership Single Point of Contact Review Proposed Confirm Format, Post to CHILD & Initiate Tool Research News Announcement Sent Review & Comment YES Significant Revisions Needed Gather Comments & Close Tool NO NO Edit policy & respond to comments Draft Policy Approval Review Response YES Review Response Posted to CHILD Review Final Policy Posted to the external web site Utilize 30 Calendar Days 30 Calendar Days