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Table of Contents:

I.     Institutional Authority 
II.    Purpose 
III.   Governing Principles 
IV.   Authority of the IRB 
V.    IRB’s Relationships to the Research Community
VI.   Membership
VII.  Management of the IRB
VIII. Conflict of Interest 
IX.   Functions of the IRB
X.    Operations of the IRB
XI.   IRB Record Requirements 
XII.  Information the Investigator Provides to the IRB 
XIII. Exemption From Prospective IRB Review 
XIV. Emergency Research Consent Exemption for Drug, Device or Biological 
XV.  Genetic Research and DNA Banking

Go to: Appendices

Institutional Authority

In order to support research activities at PeaceHealth by qualified investigators and to provide for the protection of subjects of those research activities, a centralized PeaceHealth Institutional Review Board has been established jointly by the PeaceHealth regional entities at the direction of the PeaceHealth Executive Team on December 20, 2001. The activities of the Board will be in accordance with existing guidelines of the Code of Federal Regulations (45 CFR 46). The regions’ Medical Staff and Hospitals Administration will be informed of the activities of the Institutional Review Board by receiving minutes of all meetings.

II. Purpose

The purpose of the IRB is to conduct prospective review of proposed research and monitor continuing research in order to safeguard the rights and welfare of the participants. 

III. Governing Principles

PeaceHealth IRB is guided by the ethical principles regarding all research involving humans as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report” – Appendix A).

All institutional and non-institutional study sites for this institution will be obligated by this institution to conform to ethical principles which are at least equivalent to those of PeaceHealth and site specific Policies/Procedures and Medical Staff Bylaws and as cited in the previous paragraph or as may be determined by the Department of Health and Human Services (DHHS) Secretary.

Before any human subject is involved in research in relationship to PeaceHealth institutions, the Institutional Review Board (IRB) will give proper consideration to:
· The risks to the subjects
· The anticipated benefits to the subjects and others
· The importance of the knowledge that may reasonably be expected to result
· The informed consent process to be employed
· Research projects shall not impede or hinder normal patient care
· The research shall not result in any additional hospitalization of a participant without their knowledge or approval 

IV. Authority of the IRB 

A. All research involving human subjects which is designed, in whole or in part, to develop or contribute to generalizable knowledge through publication or presentation in any medium must receive IRB approval prior to initiation whether medical staff, students, or staff conducts it. The type of review required depends upon the nature of the research, the subjects, and the risk imposed on the subjects. The three categories of research involving the use of human subjects are exempt, expedited and full board review.

B. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove all research activities funded and not funded involving human subjects conducted at PeaceHealth as well as research conducted elsewhere by PeaceHealth staff. This review will be in compliance with 45 CFR 46 unless the project is determined to be exempt by the IRB Chair. The decisions of the IRB are to be based upon consideration regarding the protection of human subject.

C. The IRB has the authority to conduct initial and continuing review of research, as well as require progress reports from the investigator. The IRB will report the findings and actions to the investigator and retain a copy on behalf of the institution. This includes the review of proposed changes (revisions and amendments) to previously approved human subjects research.

D. The IRB has the authority to restrict, suspend, or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects.

E. The IRB has the authority to review the Principal Investigators’ protocol research records on demand.

V. IRB’s Relationships to the Research Community

A. The Administration

The PeaceHealth IRB is appointed by the PeaceHealth Chief Executive Officer in consultation with the PeaceHealth Executive Team. IRB members represent the regional medical staffs, communities, and PeaceHealth regional administration.

Administratively the IRB reports to the PHOR Vice President of Quality Improvement who reports to the PeaceHealth Executive Team.

B. Other Committees and Department Chairpersons within the institution

1. The PeaceHealth IRB functions independently of (but coordinates its activities with) regional medical staff committees, administrations, and other groups as identified.

C. The research investigators

1. To be a Principal Investigator a person must be a member of the medical staff, an allied health professional, or a member of the employed professional staff. This person will be responsible for the protocol. Individuals who hold non-salaried or other non-affiliated appointments at a PeaceHealth facility may qualify as a Principal Investigator by obtaining a letter from the regional director of the service where the research will take place. The letter is to be submitted with the initial protocol request.

2. Students are not eligible Principal Investigators. Faculty and a Medical Staff sponsor are required for student projects. 

3. All investigators must be authorized (on a project by project basis) to conduct research at PeaceHealth.

D. Other institutions

1. 

E. Regulatory agencies

1. Breaches in scientific integrity, actions related to adverse events, or terminations of research determined to be serious by the IRB may be reported as they occur.

2. Advice and counsel are sought from Office Human Research Protections (OHRP) whenever issues of regulations require clarification.

VI. Membership

A. The IRB must have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.

B. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. PeaceHealth IRB membership representatives are:

1. At least one member of the local community whose primary concern is in a nonscientific area, to be appointed for a two-year period, with renewal option, by the PeaceHealth Administration.

2. At least one member of the community, not otherwise affiliated with PeaceHealth, to be appointed for a two-year period, with renewal option, by the PeaceHealth Administration

3. Medical Staff member to be appointed Chair for a two-year period, with renewal option, by the PeaceHealth Administration

4. At least one Medical Staff member to be appointed for a two-year period, with renewal option, by the PeaceHealth Administration

5. Vice Chief of Staff, Sacred Heart Medical Center

6. Chief of Medicine Division, SHMC

7. Chief of Surgery Division, SHMC

8. At least one Administrator or delegated representative of the Administrative Staff of PeaceHealth

9. At least one member of the nonmedical professional staff, PeaceHealth, to be appointed by the PeaceHealth Administration

10. At least one member from each region involved in research.

C. If the IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

D. Effort shall be made to ensure that the IRB does not consist entirely of men or entirely of women. The institution shall consider qualified persons of both sexes, so long as no selection in made to the IRB on the basis of gender. 

E. The IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

VII. Management of the IRB

A. Chairperson 

1. Selection and appointment – A member of the Medical Staff to be appointed chairperson for a two-year period with renewal option, by the PeaceHealth Administration.

2. Duties – See job description (Appendix B).

3. Removal – The Chairperson may be relieved of his/her responsibilities for failure to perform the duties of the Chair in an appropriate manner at the discretion of the PeaceHealth Administration.

B. The IRB members

1. Selection and appointment – Members are selected among other things for their ability to evaluate the risks/benefits to study participants, and to determine the ethical and scientific merit of proposed research. IRB members regular and alternate (if so designated) are appointed by the PeaceHealth Administration. Nominations for membership may be sent to the PeaceHealth Administration, the IRB Office, or to the IRB Chairperson.

2. Length of term – Two years with option for renewal by the PeaceHealth Administration or by position assignment (i.e. Administrative position; maybe held as part of that individuals ongoing job responsibilities). Members will be notified by mail.

3. Duties – See job description (Appendix B).

4. Attendance requirements – Members are encouraged to attend all meetings, but at a minimum 50 percent.

5. Removal – IRB members may be removed at the discretion of the PeaceHealth Administration.

C. Training of the IRB Chair and members

1. Orientation – Members will be oriented to the IRB through any of the following:
a. Discussion with IRB Chair or IRB staff
b. Review of IRB orientation materials
c. Review of the NIH video “Protecting Human Subjects”
d. Proctoring an IRB meeting
e. Attend programs on IRB principles and operations

2. Continuing Education - IRB members are encouraged to obtain education on IRB related issues. 
a. This education should include information on research ethics and human subject research. The PeaceHealth IRB recommends that each IRB member at a minimum complete the National Institute of Health (NIH) Human Participant Protection Education module(http://cme.nci.nih.gov/) upon appointment to the IRB.
b. Annually members are encouraged to obtain education related to IRB operation.

3. Reference Materials – Reference materials located in the IRB office.

D. Compensation of IRB members

1. The Chairperson is compensated for his/her duties.

2. IRB members serve in a voluntary capacity. They may receive reimbursement for out of pocket expenses for education and travel.

E. Liability coverage for IRB members

1. Liability coverage for IRB members is through PeaceHealth’s Directors and Officers Insurance.

F. Use of Consultants

1. There may be times when the IRB requires a consultant to provide additional expertise or cultural diversity. The IRB or Chair will determine when such assistance is needed. The consultant will not increase the requirement for quorum or other factors that are associated with adding additional members to the IRB.

G. Administrative Support Staff

1. See Job description (Appendix B).

H. Resources

1. PeaceHealth is committed to providing appropriate resources for the support of IRB operation.

VIII. Conflict of Interest

Conflict of Interest is defined as a member being a principal or co-investigator for the project, a member of the project’s support staff, or has a major financial interest in the conduct of the project.

A. IRB members present at a given meeting cannot take part in the IRB’s initial or continuing review of any project in which the member has a conflicting interest. 

B. When an IRB member thinks that he or she has a conflict of interest with the IRB evaluation of a project this will be documented in the IRB minutes.

C. An IRB member with a conflict of interest will be excused from the room after he or she has presented any necessary information to the IRB.

IX. Functions of the IRB

A. Conducting Initial Review

45 CFR 46 suggests that the IRB review and approve protocols based on the following specified criteria:
1. Introduction, specific aims, and background
a. Objectives of study are specified
b. Aims are clearly specified
c. Preliminary data is adequate to justify the research
d. There is appropriate justification for this research protocol

2. Scientific design 
a. Scientific design is adequate to answer the research question
b. Objectives are likely achievable within a given time period
c. Scientific design, (i.e., randomization; placebo controlled; phase I, II, or III) is described and adequately justified

3. Inclusion/Exclusion criteria for subjects
a. Inclusion and exclusion criteria are clearly specified and appropriate
b. Inclusion or exclusion of women, minorities, or children is justified
c. Choice of subjects is appropriate for the question being asked
d. The principle of distributive justice is adequately incorporated into the inclusion and exclusion criteria for the research protocol. The subject selection is equitable.

4. Recruitment of subjects
a. Methods for recruiting potential subjects are well defined.
b. Location and timing of the recruitment process are acceptable.
c. The individual performing the recruitment is appropriate for the process.
d. All recruitment materials are submitted and appropriate.
e. Acceptable methods for screening subjects before recruitment are identified. 

5. Research Procedure
a. The rationale and details of the research procedures are accurately described and acceptable
b. There is a clear differentiation between research procedures and standard of care and evaluation
c. The individuals performing the procedures appropriately are trained, and the location for performing the procedure is acceptable
d. There are adequate plans to inform subjects about specific research results if necessary

6. Drugs, Biologics, and Devices
a. The status of the drug is described and appropriate (investigational, new use of an FDA-approved drug, or as FDA-approved drug within approved indications)
b. The drug dosage and route of administration are appropriate
c. The drug or device safety and efficacy data are sufficient to warrant the proposed phase of testing
d. The significant risk or nonsignificant risk status of the device is described and appropriate

7. Data Analysis and statistical analysis
a. The rationale for the proposed number of subjects is reasonable
b. The plans for data and statistical analysis are defined and justified, including the use of stopping rules and endpoints
c. There are adequate provisions for monitoring data – the Data Safety Monitoring Board (DSMB)

8. Potential risks, discomforts, and benefits for subjects
a. The risks and benefits are adequately identified, evaluated, and described
b. The potential risks are minimized and likelihood of benefits maximized
c. The risk/benefit ratio is acceptable for proceeding with the research
d. All criteria within the category of vulnerable populations are adequately addressed

9. Compensation and Costs for Subjects
a. The amount or type of compensation or reimbursement is reasonable
b. There are adequate provisions to avoid out-of-pocket expenses by the research subject, or there is sufficient justification to allow subjects to pay
c. When children or adolescents are involved, it is clear who receives compensation, if any, and it’s appropriate

10. Privacy and Confidentiality
a. There are adequate provisions to protect the privacy and assure the confidentiality of the research subject
b. There are adequate plans to store and code the data
c. When the use of identifiers or links to identifiers are necessary the information is adequately protected


11. Other issues
a. Adequate references are provided
b. Determination of the frequency of review based on degree of risk
c. Institution-specific criteria is met
d. Compensation for physicians
12. Informed Consent
a. How confidentiality will be protected; who has access to the data
b. Statement that the study involves research
c. Purpose of research stated in lay language
d. Reason subject is asked to participate
e. Expected duration of study
f. Study design described in lay language (number of groups, randomization, use of placebo)
g. Study procedures or treatments
h. Description of drug or device (if applicable); state whether it is investigational
i. Compensation or reimbursement
j. Number of subjects in the trial
k. Potential risks or discomforts to the subject
l. Potential direct benefits or benefits to society
m. Alternatives available (indicate if none)
n. Statement that participation is voluntary and subject may withdraw
o. Additional non-reimbursed costs to the patient, hospitals, or to third payers will be addressed

If applicable:
p. Anticipated circumstances under which a subject’s participation may be terminated
q. Statement that significant new findings will be disclosed
r. Consequences of withdrawal
s. If greater than minimal risk, statement included regarding compensation in event of injury

13. Process for obtaining Informed Consent/Assent
a. The process is well defined
b. The individual obtaining consent is appropriate
c. The issues of subject’s comprehension and autonomy are considered

14. Assent for Children—Assent is required unless the child is not capable (age, psychological state, sedation) or the research holds out the prospect of direct benefit that is only available within the context of research
a. It’s been determined if assent is required
b. The children who are potential subjects are all capable of providing assent
c. The method of obtaining assent is appropriate

15. Waiver or Modification of Informed Consent
a. Criteria for waiver of parental consent are provided and acceptable
b. Criteria for waiver of written informed consent criteria are provided and acceptable
c. Procedures for modification or alteration of written consent are provided and acceptable 

16. Meeting minutes will reflect that the criteria as outlined in this policy were discussed as part of the review and approval process.

A.1. Conducting Continuing Review
45 CFR 46 requires that the IRB review and approve protocols for continuation based on the following specified criteria: 

1. All research will be reviewed by the IRB. The degree of risk will determine the frequency, but at least annually.

2. Investigators will be notified at initial review/approval:
a. Of the date of the next review
b. That they must report planned changes in protocol or informed consent
c. Report adverse events
d. Location of PeaceHealth IRB website which includes policy and procedures

3. The IRB Chair or delegate member of the IRB will present the continuation review. Amended documents submitted to the IRB as part of the continuation review will be reviewed and documented in the minutes as part of the approval process. At the presentation the IRB will have available a copy of the current informed consent. A copy of the current informed consent will be submitted and maintained with the Continuing Review of Research with Human Subjects form. 

4. The presenter will review the continuation report for risk, protocol benefits, informed consent, and appropriate safeguards. The following data will be used in the determination of the above:
a. Protocol name/summary statement
b. Amendments to protocol (Amended documents submitted to the IRB as part of the continuation review will be reviewed and documented in the minutes as part of the approval process.)
c. Number of subjects enrolled/anticipated in the next year/withdrawals
d. Adverse events/unanticipated problems
e. Any complaints
f. Most recent DSMB report of risks, literature survey, and 
g. Current informed consent

B. Reporting findings and actions to the Investigators and Institution

1. The Board will notify the Principal Investigator of the results of its deliberation including requests for additional information.

2. Minutes of each IRB meeting will be distributed as appropriate to each PeaceHealth site’s Medical Staff and Hospital Administrator.

C. The Board reserves the right to request progress information from the Principal Investigator at more frequent intervals as may seem appropriate. The Board will determine if the protocol requires review more than once a year. This determination will be documented in the meeting minutes and communicated to the investigator through written correspondence. Examples of protocols that may require more then annual review include protocols involving pregnant women, children, prisoners, mentally challenged subjects, or drug/devices that the Board believes warrants additional review.

D. During review the Board may determine that a study may require verification from sources other than the investigator. The Board may contact those sources.

E. Changes in the protocol may not be initiated without IRB approval except where necessary to eliminate apparent immediate hazards to human subjects. Each investigator shall be required to report any proposed changes and/or unanticipated complications to the IRB immediately.

F. Failure to comply with the procedures as outlined in the approved protocol, including the approved informed consent form, shall result in a report to the Food and Drug Administration by the Chairperson of the IRB.

G. Ensure prompt reporting, by the investigator to the IRB, and the appropriate federal department or agency (when applicable), any significant or material findings or action, including:

1. Injuries or any other unanticipated problems involving risks to subjects or others.
2. Any serious or continuing noncompliance with regulations or requirements of the IRB.
3. Any suspension or termination of IRB approval. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action.

H. Medical Devices – Significant or Non-significant Risk

1. Whenever a medical device is reviewed by the IRB, the Board will determine whether the device may create a significant or non-significant risk to the patient.

Definitions:
a. Significant Risk Device are those that present a potential for serious risk to the health, safety, or welfare of subjects and are subject to FDA control and approval.
b. Non-Significant Risk Device includes such devices as crutches, elastic knee braces, bedpans, medical chairs, and tongue depressors.

2. This risk will be determined by:
a. The device has an Investigative Device Exemption (IDE) number
b. Review of the PeaceHealth IRB policy and procedure Appendix C (FDA document, “Significant and non-Significant medical device studies”) will determine whether the device is listed as a significant or a non-significant risk device.
3. If a Non-Significant risk device is determined by the IRB to be Significant the investigator will be directed to apply for an IDE#. The investigator must present the IRB with a brief explanation as to why the device is not a significant risk device.

4. The Board may determine that the device is a significant risk if:
a. A surgical or invasive procedure is required to implant the device or the device’s components in the patient.

X. Operations of the IRB

A. Scheduling of Meetings

The IRB will meet at least nine times per year on the first Friday of each month at 7:00 a.m. or as determined by quorum of members.

B. Pre-meeting Distribution to Members

Copies of the protocol summary and informed consent along with a protocol review checklist shall be mailed to all members of the Board at least seven days prior to the date of the convened meeting. A copy of the complete protocol shall be on file in the Institutional Review Board office for Board review. The purpose of the protocol review checklist is to provide guidance to IRB members when reviewing protocols and is not intended to be retained in the IRB files.

C. Review Process—(Also see Appendix D)

1. Description of the review process
a. Copies of the protocol summary and informed consent along with a protocol review checklist shall be mailed to all members of the Board at least seven days prior to the date of the convened meeting. A copy of the full protocol will be kept on file in the IRB office for Board review upon request.

b. A member of the IRB shall present the proposed research project to a convened meeting of the Institutional Review Board. The presenter will receive the full protocol, investigators brochure, informed consent, and related materials. The Principal Investigator will be invited to attend the portion of the meeting that his protocol is being presented and respond to questions or requests for additional information from the Board members. The investigator will then be asked to leave for discussion and vote. It is optional that the investigator attend the meeting.

2. Role of Subcommittees of IRB
a. A consultation from a subcommittee of individuals knowledgeable of IRB issues, and/or individuals with specialized knowledge or training may be obtained to evaluate the proposed project when additional expertise is required.

3. Emergency Use Notification and Reporting Procedures
a. Emergency medical care or compassionate use of a pharmaceutical agent may be granted by the IRB Chair, for subjects who cannot then be included in the research protocol (OPRR Reports No. 91-01, Human Subject Protections, 05/15/91).
b. If the IRB Chair is not available the regional facility Administrator and Chief of Staff or their designees may approve use. The Investigator will then be required to notify the IRB Chair within a 5 day time frame required by 21 CFR 56.104 (c).
1) Emergency use is defined as the use of an investigational drug or biological product with a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. The emergency use provision in the FDA regulations [21 CFR 56.104(c)] is an exemption from prior review and approval by the IRB. The exemption, which may not be used unless all of the conditions described in 21 CFR 56.102(d) exist, allows for one emergency use of a test article without prospective IRB review. FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval. FDA acknowledges, however, that it would be inappropriate to deny emergency treatment to a second individual if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review the issue. 
2) Life threatening, for the purposes of 21 CFR 56.102(d), includes the scope of both life threatening and severely debilitating, as defined below. 
3) Life threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life threatening do not require the condition to be immediately life threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible. 
Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
4. Expedited Review
a. Expedited review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among the members of the IRB (OPRR 48 CFR 46.110; FDA 21 CFR 56.110). The reviewer(s) have all the rights and privileges of the full IRB. 
b. This expedited review process may be used to review minor changes in previously approved research, as well as for certain kinds of research involving no more than minimal risk as detailed in OPRR 45 CFR 46, pg. 17; FDA 46 CFR 8392, 1/26/81 (Appendix E).
c. A research project may not be disapproved by the expedited review process.
d. Members of the IRB committee shall be kept informed of proposals approved under this procedure at the next regularly scheduled meeting.

D. Criteria for IRB approval

1. Risks to subjects are minimized: 
a. By using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk.
b. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
c. Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may result from the research.

2. Selection of subjects is equitable
a. The IRB will take into account the purposes of the research and the setting in which the research will be conducted and will be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons.

3. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative
a. An investigator shall seek such consent only under circumstances that provide the subject or the representative with sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
b. Information contained in the informed consent shall be in language understandable to the subject or the representative.
c. The informed consent, whether oral or written, may not include any exculpatory language through which the subject or representative is made to waive or appear to waive any of the their legal rights, or releases or appears to release the investigator, the sponsor, PeaceHealth, or its agents from liability for negligence.

4. Informed consent will be appropriately documented
a. Informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or legally authorized representative at the time of consent.
1) Each page of the approved consent form will be stamped with the following statement, “Approved by PeaceHealth IRB on --/--/--.”
2) A copy shall be given to the person signing the form.

E. Voting Requirements

1. Quorum required to transact business
a. A majority of the membership must be present to conduct a meeting.

2. Diversity requirements of quorum
a. At least one member whose primary concern is in nonscientific areas must be present.

3. Percentage needed to approve or disapprove a study
a. It takes a majority of quorum to approve or disapprove a study (over 50%).

4. Voting rights of membership
a. All members of the IRB have full voting rights to approve or disapprove a study.

5. Proxy votes
a. Proxy votes either by non-IRB approved alternate, telephone, written, or fax will not be accepted.

6. Prohibition of conflict of interest voting
a. No IRB member may participate in the IRB’s initial or continuing review of any project if the member has a conflicting interest, except to provide information requested by the IRB.

F. Review/approval of IRB actions by others within the institution

1. Research reviewed and approved by PeaceHealth IRB may be subject to further appropriate review and approval or disapproval by officials of PeaceHealth. However, those officials may not approve research if it has not been approved by the IRB.

a. No financial assistance or obligation by PeaceHealth or Sacred Heart Medical Center is implied by Institutional Review Board approval. Nonreimbursed cost to the patient or the hospital may be a reason for denial.

G. Communication from the IRB

1. To the investigator for additional information
a. The Board will notify the Principal Investigator of the results of its deliberation including requests for additional information. If the Board determines that the investigator has not provided the required information, it will be the responsibility of the investigator to provide the necessary information before the Board considers the protocol further.

2. Investigator notification of IRB decisions
a. The IRB shall notify investigators in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification, a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. 

3. Administration notification of IRB decisions
a. Institutional officials impacted by the protocol will receive copies of the IRB minutes from the regions HPA (Human Protections Administrator).

4. Sponsor notification of IRB decisions
a. The IRB delegates the responsibility to the Principal Investigator of informing the sponsor of required changes to research documents.
b. The IRB reserves the right to contact the sponsor of research.

H. Appeal process of IRB decisions

1. Criteria for appeal
a. If the investigator wishes to appeal a decision of the IRB, (s)he must send a written statement with the reasons for appeal to the Chair. This statement will be distributed to all members of the IRB and the protocol will be scheduled for reconsideration at a future IRB meeting. The Principal Investigator will be invited to attend this meeting. After discussion of the protocol and the reason for appeal, the IRB will formally revote. The Principal Investigator will be asked to leave prior to the vote.

b. If approval is still withheld after appeal, a protocol will not be reconsidered by the Board until significant changes have been made. The appeal and all records of the actions and decisions of the IRB will be placed in the protocol file. (Override of IRB disapprovals by any external body/official is prohibited.)

XI. IRB Record Requirements

A. IRB membership roster

1. The IRB will maintain a current membership roster that will include
a. The name of the individual
b. Highest Degrees Earned
c. Primary Scientific or Nonscientific Specialty
d. Affiliation with Institution
e. Date Appointed to committee
f. Address, phone number, email

2. The IRB membership rosters will be maintained for a period of five years.

B. Written procedures and guidelines

1. The IRB will follow written procedures for the following functions and operations:
a. Conducting initial and continuing review of research and reporting its findings and actions to the investigator and the institution.
b. Determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review.
c. Ensuring prompt reporting to the IRB of changes in research activity.
d. Ensuring that changes in approved research, during the period for which IRB approval has already been given may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.
e. Ensuring prompt reporting to the IRB, and, where appropriate, institutional officials and/or federal agencies of any serious breaches of protocol or any serious adverse events.

C. Minutes of Meetings

The IRB shall prepare and maintain adequate documentation of IRB activities including minutes of IRB meetings, which shall be in sufficient detail to show:

1. Attendance at the meetings (any consultants/guests/others shown separately)

2. Actions taken by the IRB (approval, approval with modifications, deferral pending revisions, or disapproval) and the vote on these actions including the number of members voting for, against, or abstain

3. The basis for requiring changes, deferring, or disapproving research

4. A summary of discussion of risk, benefit ratios, informed consent and controverted issues and their resolution

5. The recommended frequency of continuing review and/or time interval for submission of progress reports

6. The rationale for Significant Risk/Nonsignificant Risk decisions for medical device studies

D. Retention of protocols reviewed and approved consent documents, and scientific evaluations, if any, that accompany the proposals

E. Copies of all correspondence between the IRB and the investigators

F. Adverse event reports of injuries to subjects or breaches of protocol

G. Documentation that the IRB reviews adverse reaction reports

H. Records of initial and continuing review and review of additions, revisions, and amendments to the protocol and/or consent form

I. The IRB shall prepare and maintain adequate documentation of IRB activities for at least three years after completion of the research. Records shall be accessible for inspection and copying by authorized representatives of the federal agencies at reasonable times and in a reasonable manner. As appropriate each protocol file will include D, E, F, G, H, & L.

J. Budget and accounting records. Maintained for three years.

K. Emergency use reports are to be maintained for three years. (Emergency use of a test article may be exempt from IRB review, provided that such emergency use is reported to the IRB within five working days. Any subsequent use of the test article at institution is subject to IRB review.) 

L. Progress reports submitted by investigators and statements of significant new findings provided to subjects

XII. Information the investigator provides to the IRB

A. Professional qualifications to do the research

1. A member of the medical staff, an allied health professional, or a member of the employed professional staff must be the Principal Investigator and will be responsible for the project.

2. Protocols submitted for initial review will be accompanied with Curricula Vitas from all the investigators, which outline education, training, previous research activities. 
a. A curricula vita is required for the research coordinator

B. An investigator submits the following, to be received two weeks prior to the convened IRB meeting (IRB usually meets the first Friday of every month):

1. The investigator will complete the Administrative Checklist and submit to regional HPA for approval prior to submission of the protocol to PeaceHealth IRB. (Appendix F)

2. A cover letter requesting the IRB to review protocol and includes who the investigators will be

3. A 1-2 page summary of the protocol in lay language

4. Study protocol that includes/addresses
a. Title of the study
b. Purpose of the study (including the expected benefits obtained by doing the study)
c. Sponsor of the study
d. Results of previous related research
e. Subject inclusion/exclusion criteria
f. Justification for use of any special/vulnerable subject populations (i.e. the decisionally impaired, children)
g. Study design (including as needed, a decision of the appropriateness of research methods)
h. Description of procedures to be performed
i. Provisions for managing adverse reactions
j. The circumstances surrounding consent procedure, including setting, subject autonomy concerns, language difficulties, vulnerable populations
k. The procedures for documentation of informed consent, includes any procedures for obtaining assent for minors
l. Compensation for subjects for their participation
m. Any compensation for injured research subjects
n. Provision for protection for subjects privacy
o. Extra cost to subject for their participation in the study
p. Extra cost to third party payers for subject’s participation

5. All promotional/educational material linked to the protocol

6. A completed copy of the Statement of Ethical Commitment and Financial Disclosure. (Appendix G)

7. $1200 initial review fee for initial protocol review, informed consent ($600 for annual continuing review). Fees may be waived by petition. (Appendix H)

8. Documentation showing that the Principal Investigator, Co-Investigators, and the Study Coordinators have received training in research methods and the protection of human subjects.

9. Investigator’s brochure (or Package Inserts for studies of approved drugs) and IND number

a. The IRB member presenting the protocol will receive the investigators brochure. The primary responsibility in reviewing the investigator brochure is the same as in reviewing the proposed protocol involving human subjects: to determine whether the proposed use exposes the subjects to unreasonable or unnecessary risk, to review the informed consent forms and process and to monitor the progress of the treatment.

10. The case report form (when one exists)

11. The proposed informed consent document that meets the PeaceHealth IRB requirements.
a. Purpose/Procedure
Statement of research, purpose, duration, description of procedure(s) and identification of any procedures, which are experimental.

b. Risks
Description of any reasonably foreseeable risks or discomforts in understandable language; including physiological, psychological and emotional risks

c. Benefits
Description of potential benefits to the subject or to others

d. Alternatives
Description of appropriate alternative procedures or courses of treatment

f. Confidentiality
Statement of extent. Note possibility that FDA (and others) may inspect records

g. Compensation/Medical Treatment For Injury
Statement as to whether any compensation for time, job loss, injury, etc., is available and from whom; this should include statement when compensation is not provided. Statement explaining that if injury occurs, whether any medical treatments are available, what they consist of and/or where further information may be obtained. 

PeaceHealth requires the following statement: “You do not waive any liability rights for personal injury by signing this form. All forms of medical diagnosis and treatment, whether routine or experimental, involve some risk of injury. In spite of all precautions, you might develop medical complications from participating in this study. If such complications arise, the researchers will assist you in obtaining appropriate medical treatment, but PeaceHealth does not provide financial assistance for medical or other costs.” 

h. Contacts
Explanation of whom to contact for questions regarding medical problems during the study. (Principal Investigator's name and phone number)

Contact the PeaceHealth Institutional Review Board, 541/686-6949, in the event you have questions about your rights as a research subject.

i. Voluntary Participation /Withdrawal /Guarantees /Termination
Statements that explain voluntary participation, that the patient will receive care regardless of whether they choose to participate in the study or not and that they will not be penalized if they enter the study and choose to withdraw.

Statement of no guarantee of benefits and that treatment or procedure is still considered investigational.

When applicable, a statement that the study may be terminated without patient consent based on certain circumstances.

j. Acknowledgements/Signature
Statement that subject has had explanation of above, understands rights as a research subject, has had opportunity to read the Informed Consent, and has received a copy of the informed consent. All questions have been answered and I agree to participate. Signatures and date of patient, witness, and investigator.

C. Requests for changes in study after initiation

1. Changes in the protocol may not be initiated without IRB approval except where necessary to eliminate apparent immediate hazards to human subjects. Each investigator shall be required to report any proposed changes and/or unanticipated complications to the IRB immediately.

2. In accordance with 21 CFR 56.110(b)(2), the IRB may use expedited review procedures to review minor changes in ongoing previously approved research during the period for which approval is authorized.

3. When a proposed change in a research study is not minor (e.g., procedures involving increased risk or discomfort are to be added), then the IRB must review and approve the proposed change at a convened meeting before the change can be implemented. The only exception is a change necessary to eliminate apparent immediate hazards to the research subjects [21 CFR 56.108(a)(4)].

D. Reports of unexpected adverse events
1. Expected adverse events - Adverse events that may be reasonably anticipated to arise as a result of study procedures should be described in the consent form. Expected adverse events need not be reported to the IRB on an individual basis. At the time of renewal, the researcher must report the incidence of these adverse events. 
If, in the course of conducting the study, the investigators find that the expected adverse events are occurring with a greater frequency than anticipated or at a higher level of severity than expected, they should report this to the IRB as soon as the finding is noted. The consent form language describing the risks should be appropriately revised and subjects already enrolled in the research should be appropriately advised. The Board may request that the researcher advise already enrolled subjects of these changes.
2. Unexpected or more serious than expected adverse events - Occasionally, adverse events occur during the course of a research activity that were unanticipated or are more serious than expected. In these cases, the investigator should contact the IRB in a timely manner. The report will be reviewed by the IRB for a determination about whether the study should be modified to reduce the risks or the consent form should be revised to include the unanticipated adverse effects. 
The death of any study subject should be reported immediately to the IRB. The only exception is when the study is conducted among subjects who are expected to have a high rate of mortality from their underlying condition, and the investigator has absolutely ruled out any connection between any study procedure and the subject's death.

E. Continuation Review/Progress Report

1. The Principal Investigator on all projects approved by the IRB is required to file a continuation status report for the project within one year from the date of approval or as designated by the Board. The IRB office will send the continual status review form to the Principal Investigator two months prior to renewal date.
a. A fee of $600 shall be submitted with the report.

2. Also see section IX. A.1

F. Final Report

A final report must be filed with the Board within a reasonable period of time after the completion or termination of a project. No research activity with human subjects may be conducted after the approval has been terminated.

G. Institutional forms and reports

H. Investigators and their staff are responsible for maintaining current, complete and accurate files containing all documents related to human subjects studies. 

1. These files must contain all approved versions of protocols, consent forms, investigator drug brochures, revisions, amendments, and other communications between the IRB and the investigator. 

2. The IRB Office maintains a similar file with all documents and communications related to a protocol.

3. In extraordinary circumstances, the IRB Office will provide duplicate copies of these materials to an investigator. 

4. Such a request must be accompanied by an explanation as to why the investigator’s file lacks the documents and what steps have been taken to ensure that this will not reoccur.

5. Any second request for duplicate documents from the IRB file may lead to suspension of a study pending a research compliance review of that study.

XIII. Exemption from prospective IRB review

A. Exempt: Studies that meet OHRP [45 CFR 46.101] criteria will be classified as exempt from IRB review. However, only the IRB can make the determination of whether or not research activities in one or more of the following categories is exempt from IRB review.

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
b. Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk or criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if:
a. The human subjects are elected or appointed public officials or candidates for public office; or
b. Federal statute requires without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5. Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
a. Public benefit or service; programs
b. Procedures for obtaining benefits or services under those programs
c. Possible changes in or alternatives to those programs or procedures; or
d. Possible changes in methods or levels of payment for benefits or services under those programs

6. Taste and food quality evaluation and consumer acceptance studies
a. If wholesome foods without additives are consumed or
b. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the US Department of Agriculture.

XIV. Emergency research consent exemption for drug, device or biological 

A. Approval 

IRB may find that the requirements for an emergency waiver are met. Sec. 50.24 (See XIV D)

B. Denial of Approval

The IRB may find that it cannot approve a 50.24 study. In those situations the IRB shall promptly notify the investigator and the sponsor.

C. Public Disclosure

The IRB must work with the investigators to make the communities aware of the purpose of the research and its possible risks and benefits before the research begins. At the conclusion of the research the IRB will work with the investigator to make the communities aware of the results of the research (including the characteristics of the subject population). The IRB will notify the sponsor of what has been publicly disclosed.

D. Conditions for Approval of Exemption

1. Subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory and collection of scientific evidence is necessary.

2. Obtaining informed consent is not feasible because:
a. Medical condition precludes consent
b. No time to get consent from legally authorized representative
c. Prospective identity of likely subjects not reasonable

3. Prospect of direct benefits to study subjects because:
a. Life-threatening situation that necessitates treatment
b. Data support potential for direct benefit to individual subjects
c. Risk/benefit of both standard and proposed treatments reasonable

4. The research could not practicably be carried out without the waiver

5. Plan defines therapeutic window, during which investigator will seek consent rather than starting without consent. Summary of efforts will be given to IRB at time of continuing review.

6. IRB reviews and approves consent procedures and documents, the investigator’s process for identifying the subject and locating the legally authorized representative and/or family members. 

7. Additional protections, including at least:
a. Consultation with community representatives
b. Public disclosure of plans, risks, and expected benefits
c. Public disclosure of study results
d. Assure an independent Data Monitoring Committee established
e. Objection of family member summarized for continuing review

8. The investigator will inform each subject or legally authorized representative and/or family member of the subject’s inclusion in the investigation, and the subject’s and representative’s rights.

9. A separate Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required, even for marketed products.

XV. Genetic Research and DNA Banking

A. PeaceHealth IRB requires a separate Informed Consent for genetic research and shall contain items outlined in Appendix I.

1. See Appendix I  

B. Genetic research performed in PeaceHealth facilities shall comply with the standards set forth in the Oregon Revised Statutes ORS 192.531 through ORS 192.549 and any other applicable state or federal statutes or regulations. http://www.dhs.state.or.us/publichealth/genetics/research.cfm 

C. Requirements for compliance with Oregon standards does not mean the state or its agencies may enforce such standards for hospitals not located in Oregon.

• Appendix A The Belmont Report 

• Appendix B Job Summaries 

• Appendix C Significant Risk & Nonsignificant Risk Medical Device Studies  

• Appendix D IRB Process 

• Appendix E Expedited Review Procedures 

• Appendix F PeaceHealth Checklist for Administrative Review of IRB Protocols 

• Appendix G Statement of Ethical Commitment and Financial Disclosure 

• Appendix H Protocol Processing Fees 

• Appendix I Genetic Research & DNA Banking

Institutional Review Board
1255 Hilyard St., Eugene, OR  97401
541.686.6949 phone - 541.685.1839 fax

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