/ Quality Management
INVESTIGATIONAL REVIEW BOARD POLICY
Scope:
To establish the MultiCare Health System (MHS) policy and procedure for the Institutional Review Board
Policy Statement:
The Institutional Review Board (IRB) shall review all new and continuing research projects that fall within MultiCare Health System’s jurisdiction to provide for the protection of the rights and welfare of human participants involved in such research. No research involving human participants may begin until MultiCare Health System’s IRB has granted its approval or accepted a waiver of IRB review under a duly executed institutional agreement.

The IRB operates in compliance with the U.S. Code of Federal Regulations, Department of Health and Human Services (DHHS) Title 45 Part 46, entitled “Protection of Human Subjects,” as well as the Food and Drug Administration (FDA) regulations on human subjects research.

Special Instructions:
  1. This policy applies to all research conducted at MultiCare Health System which uses human subjects or their medical records and/or tissue as research participants.
  2. The IRB chair or Research Services Manager or its designee, as appropriate, shall review the research project and determine if the research meets the mission, vision and values of MHS and whether the resources necessary to conduct the research are available. If it is determined that the project does not meet the mission, vision and values of MHS or the applicable affiliate, or resources necessary to conduct the study are not available, the investigator shall be so notified.

Procedure:

I.MHS requires that all research involving human subjects, their medical records or tissue be reviewed and approved or declared exempt by the IRB before project may be initiated.

A.The primary concerns of the IRB in all deliberations are to determine that:

1.Risks to subjects are minimized

2.Risks to subjects are reasonable in relation to the anticipated benefits;

3.Selection of subjects is equitable; and

4.Informed consent is sought from each prospective subject and appropriately documented

II.The IRB shall require progress reports in way of continuing review applications and oversee the conduct o the study at intervals appropriate to degree of risk but no less than once per year.

III.The IRB shall suspend or terminate its approval of research activities that are not being conducted in accordance with MHS IRB’s requirements or federal requirements. Research will also be terminated if it is found to have been associated with unexpected serious harm to subjects.

A.When research is suspended or terminated the action will be reported to the Professional Activities Committee, the investigator and applicable federal agencies (Federal Drug Association, Office of Human Rights Protections).

1.Reports to FDA and OHRP will be made in a letter from the IRB co-chair and sent certified mail.

2.Suspensions and terminations will be reported promptly to appropriate agency.

IV.All IRB actions and decisions are reported to the Professional Activities Committee which is a subcommittee of the MultiCare Health System Governing Board.

V.Compliance with this policy or the procedures set forth herein will in no way render inapplicable pertinent laws of the State of Washington, MultiCare Health System policy and procedures or the regulations of the Board of Executives.

VI.The MHS IRB will review human subjects research within its jurisdiction to ensure the protection of participants. Human research participants are defined as:

A.A living individual, about whom an investigator conducting research obtains data through interventions or interactions with the individual, or collects identifiable private information,

B.Human participant of research may be either healthy or a patient

C.Interventions with human participants include physical procedures by which data are gathered, and manipulations of the subjects include communications or interpersonal contacts conducted for research purposes.

D.Private information included information about behavior that occurs in a contact in which the subject ca reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public, e.g. medical records.

VII.Additional safeguards shall be incorporated in studies involving vulnerable participants to protect their rights and welfare; and to minimize coercion and undue influence. These participants include:

A.Children

1.Project will be reviewed in accordance with additional protections for children

2.A category of risk will be assigned to all research involving children.

3.The MHS IRB will only review pediatric research within the board’s expertise. All other protocols will be referred to Seattle Children’s or Western Investigational Review Board (WIRB)

B.Pregnant women

1.Research will only be reviewed if risk to both mother and fetus is minimal as assessed by the board
2.Project will be reviewed in accordance with additional protections for pregnant women and fetuses.

C.Mentally disabled/cognitively impaired persons

D.Economically disadvantaged persons

E.Educationally disadvantaged persons

F.MultiCare Health System employees

1.When MHS employees are used in research special consideration will be made to assure their identity is protected, they are not victims of coercion and that participation does not negatively affect employment.

VIII.Protocol Fees:

A.A $1500.00 will be charged for the initial review of studies. $500.00 will be charged for the annual review. $250.00 will be charged for the review of full board interim status reports requiring a change to the protocol or to the consent form.

1.These fees do not apply to studies were an institutional grant is awarded to MultiCare Health System

2.These fees are waived for MultiCare Health System employees when they are investigators.

B.These monies will be used to support the services of the IRB and to help provide continuing education for IRB members.

C.The IRB coordinator is responsible for generating this invoice, sending the invoice to the appropriate investigator with the applicable funds and forwarding these funds to the Accounts Receivable department when received.

D.The IRB coordinator will notify the IRB if a study investigator or sponsor fails to pay the required fees upon request.

E.The IRB has the authority to place sanctions on studies who fail to pay the required fees

IX.Initial Review:The IRB shall review all new research projects involving human participants to ensure adherence to the ethical principles of respect for persons, beneficence and justice. Projects must meet compliance with applicable federal regulations, stat law, and institutional policies for the protection of human subjects.

A.In consideration of approval of a new research project involving human subjects the IRB will review application materials to determine if the following criteria:

1.Risk to subjects are minimized

a.By using procedures consistent with sound research design and which do not unnecessarily expose subjects to risk; and

b.When applicable, by use of procedures already being preformed on the subject for diagnostic or treatment purposes
2.Risks to subjects are reasonable in relation to anticipated benefits. To assure this the IRB must:
a.Identify the risks associated with the research, as distinguished from the risks of therapies the subjects would receive if not participating in the research;
b.Determine that the risks will be minimized to the extent possible;
c.Identify the probable benefits to be derived from the research
d.Determine that the risks are reasonable in relation to the benefits
e.Ensure that the potential subjects will be provided with an accurate and fair description of the risks and/or discomforts and the anticipated benefits

3.Selection of research participants is equitable. When determining whether the burdens of research are being distributed equitably, the IRB shall consider:

a.Whether the burdens of participating in the research fall on those most likely to benefit from the research;

b.If the solicitation of the participants places a disproportionate share of the research burden on any single group;

c.If the nature of the research justifies or requires using the proposed research participant population;
d.Whether it would be possible to conduct the research using a less vulnerable subjects;
e.Whether the selection process excluded potential participants who are likely to benefit; and
f.If the participants are susceptible to undue influence or coercion there are mechanisms in place to reduce the influence
4.Informed consent will be sought from each prospective participant or legally authorized representative as required; and it shall be appropriately documented as well as:

a.Written in accordance with 45 CFR 46: United States Department of Health and Human Services 21 CFR 50.25: Food and Drug Administration

b.Include all elements in the MHS IRB consent form checklist (See Related Forms)
c.Inform subjects of how their protected health information will be protected in accordance with HIPAA
d.When consent in given for minors the relationship between the child and signature will be verified by investigator and documented

5.The IRB may approve a full or partial waiver of informed consent in accordance with 45 CFR 46 Section 116 (d) and 21 CFR 56.109(c)(1). The minutes will address the justification for waiver. Reasoning for waiver includes:

a.The research involves no more than minimal risk to subjects;

b.The waiver or alteration will not adversely affect the rights and welfare of the subjects;
c.The research could not practicably be carried out without the waiver or alteration;
d.Whenever appropriate, the subjects will be provided with additional pertinent information after participation
e.The only record linking the subject and the research would be the signed consent form and the risk of a breach of confidentiality would result in harm to the subject. In this case the subject will be asked if they want their consent documented and their wishes will be followed by the investigator; or
f.The research presents no more than minimal risk as defined by the IRB and involves no procedures for which written consent is normally required outside of the research context
g.The investigator hascompleted human subjects training

X.IRB Meeting

A.The MHS IRB uses a primary and secondary reviewer system to review all issues before the convened board except Annual reviews which are reviewed by the IRB co-chair. Reviewers will consider:

1.Reasonableness of eligibility requirements
2.Adequacy of monitoring
3.All ethical issues
4.Risk vs. benefit ratio
5.Adequacy of consent form

B.All members have access to all review materials via a document management website including:

1.Protocol
2.Consent form
3.Investigators Brochure (if applicable)
4.Applicable literature
5.Adverse Events Summary
6.MHS form for submission:
a.Continuing review application
b.New Submission Application
c.Interim Status Report
d.Change in Status
e.New PI Application
  1. 1572 form (if applicable)
  2. Complete set of case review forms
  3. Funding source information
  4. Questionnaires, surveys and recruitment materials
f.The reviewers will receive a “Reviewer Assessment Form” (See Related Forms) to complete for his/her review. This form will be filled out and returned to the IRB staff after the meeting to outline recommended changes if requested.
7.Any board member may request additional information from the investigator before or after the meeting to support the reviewer’s recommendation to the board.
a.Members can contact the investigator directly or may ask the IRB staff to request additional information
b.The primary or secondary reviewer may extend an invitation to the investigator so that (s)he may explain the research to the board
  1. If the investigator attends the meeting (s)he may only be present to present and answer questions on her/his protocol and must leave the room before the board deliberates or votes. At no time with the investigator be present during a vote on her/his protocol.
8.The reviewers will recommend the frequency of the review not to exceed once a year taking into consideration:
a.Risk of research, including physical, psychological, emotional or social
  1. inclusion of vulnerable subjects
  2. Experience of researcher
  3. Monitoring mechanisms
9.The reviewers together with the convened board will vote whether a study should be:
a.Approved without revisions
b.Approved with response required (pending minor changes)
c.Denied
  1. When a protocol is denied the investigator will receive written notice of the decision with an explanation as to why the board denied the application. The investigator’s recourse is to address the issues and resubmit the study for review.
  2. Tabled pending additional information
a.)When an action is tabled once requested information is submitted it will be reviewed by the full convened board
d.The actions of the board will be recorded in the meeting minutes with a description of the issues discussed and the investigator will receive written notification of determinations.

XI.Continuing Protocol Review

A.The IRB shall conduct ongoing monitoring and review of all approved studies at least annually and at more frequent intervals if the element of risk so warrants.

B.Regular monitoring of previously approved protocols will be in the form of continuing reviews.

C.As condition of approval, investigators of active research protocols shall complete a continuing review application (See Related Forms) on or before the annual review date. With this application the following information will be included:

1.Status of research

2.Information about the number of subjects participants enrolled to date and continuing protocol treatment;

3.Summary of adverse events including anticipated and unanticipated events and how they were resolved. Investigator will be asked to judge if the events warrant changes to the consent form;
4.Problems, complaints, protocol deviations, or withdrawal of participants since the last IRB review
5.A brief progress report and a summary of any relevant recent literature. If there are manuscripts or publications that resulted from the study, investigators shall provide copies of the publications to the board
6.Summary of any amendments since last review
7.A description of any proposed changes to protocol or/and consent
8.Current copy of protocol and MHS approved and stamped assent/consent form

D.The IRB staff will send out continuing review requests to investigators three months before review is due. It is the investigator’s responsibility to provide the board with review materials before annual review date.

E.All members have access to the IRB master file through the IRB staff members. The master file is stored according to MHS records policy and is kept for three years after a study is completed per FDA and OHRP guidelines.

XII.Revisions to Active Protocols

A.Investigators are required to submit revisions to protocols, consent forms, status updates, and local and non-local adverse events to the IRB using the appropriate forms (See Related Forms)

B.Submissions will be reviewed by the IRB co-chair and a determination will be made as to what avenue for review will be taken:

1.Expedited review based on 45 CFR 46.110 and 21 CFR 56.110.
a.The board will be provided with a log of expedited actions that will be voted upon at the next convened meeting of the IRB
2.Full convened meeting of the IRB

XIII.Local Adverse Event/Unanticipated Problems Reporting

A.Serious and unexpected adverse events should be promptly reported to the MHS IRB

B.These events should also be reported to the study sponsor and the FDA using a FDA MedWatch form. A copy of such reports should be submitted to the MHS IRB

C.The report should include the study therapy, investigators assessment of the relation to protocol therapy, description of the event and outcome

D.Unanticipated problems should be promptly reported to the MHS IRB

XIV.Quorum

A.The MHS IRB meeting will only began once quorum is present.

1.Quorum is accomplished when:
a.A majority of the IRB is present (half of membership plus one)
b.At least one non-scientific member is present

XV.IRB Membership

A.The MHS IRB will conduct business with the participation of the following persons: regular voting members, alternate members, non-voting members and ad hoc reviewers

1.Appointment

a.Members are appointed by the MHS IRB co-chair

b.Co-chair terms are three (3) years with the option for reappointment for a second term. After two terms a new IRB co-chair will be appointed.

2.Regular members

a.The IRB shall have at least five regular voting members, including the chairperson
b.At least one IRB member will be a scientist and one a non-scientist
c.At least one member will be unaffiliated with MultiCare Health System nor a par of the immediate family of a person affiliated with MultiCare Health System
d.Non-affiliated members may be a scientist or non-scientist
e.MHS shall ensure that the IRB membership possesses the expertise necessary to ascertain the acceptability of the research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice
f.MHS shall ensure that the MHS IRB has the expertise, professional competence and diversity to review research involving human participants
3.Alternate members
a.The IRB may, at its discretion, recruit alternate members for any of its regular voting members to maintain diversify and expertise
b.Alternate members have the same rights and privileges of regular members but their vote can only be counted when their respective (paired) regular member is absent, they will also not be included in quorum in this case
4.Non-voting members
a.Non-voting members will have the same rights and responsibilities as regular members but will not vote or be counted in quorum
5.Ad hoc Reviewers
a.The co-chair may invite any individual who is not a member of the IRB but has an expertise needed by the board to act as an ad hoc reviewer.
b.This reviewer will sign a confidentiality agreement prior to receiving any reviewer materials
c.This reviewer may participate in deliberations and make recommendations but may not vote
d.The ad hoc reviewer will remain confidential

XVI.Recruitment

A.Members will be recruited to join the IRB in consultation with the IRB co-chair and coordinator and will provide the coordinator with a new member application (See Related Forms) if interested in joining the board