Pacific Northwest National Laboratory | PNNL Home | Inquiry | Security & Privacy | Index |

The Institutional Review Board (IRB)

PNNL applies advanced high resolution liquid chromatographic separations and high sensitivity mass spectrometric technologies to small samples to study the human proteome
PNNL applies advanced high resolution liquid chromatographic separations and high sensitivity mass spectrometric technologies to small samples (1µg - 100µg) to study the human proteome — the entire complement of proteins and their respective abundances in a cell or tissue or biofluid under a specific set of conditions at a specific time. Ongoing investigations at PNNL include the comparative quantitative proteomic characterization of human samples from normal and diseased subjects including breast cancer and subjects infected with pathogens.

Independence, Authority and Jurisdiction

By delegation of the Laboratory Director and Institutional Official (IO) (.pdf 158kb), the PNNL Institutional Review Boards (IRB) have the authority to:

Research that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by other officials of the Institution. However, those officials may not approve the research if it has not been approved by the IRB [45 CFR 46.112].

At PNNL, human subject research is treated as a "corporate sensitivity" in the risk assessment process and any attempt to influence IRB members in the conduct of their business, or failure to comply with the requirements for conducting human subject research is considered serious misconduct. IRB members are obligated to report any inside or outside attempts to intimidate, coerce, or inappropriately influence the IRB decision-making process directly to the Institutional Official who has the authority to determine the appropriate action on a case-by-case basis. Possible actions could range from censure, disapproval of a protocol or in the case of a serious ethical breach, termination, in accordance with the section entitled "Disciplinary Action" (Restricted Access to contentrestricted access) in SBMS.

IRB Responsibilities

The IRB is responsible for ensuring that the protocols under its jurisdiction are reviewed and conducted in accordance with federal and state regulations and Battelle policies and procedures. IRB oversight includes substantive continuing review of approved protocols at intervals appropriate to the degree of risk, but not less than once a year and monitoring and compliance reviews as deemed necessary. In its review of protocols, the IRB must thoroughly assess the anticipated risks and benefits to subjects with particular focus on the effectiveness of the informed consent process. To approve research, the IRB must determine that all of the following requirements have been met [45 CFR 46.111]:

For a more detailed list of individual IRB responsibilities, see the Organizational Structure, Roles and Responsibilities section. For policies and procedures related to the IRB's review of protocols, refer to the IRB Review and Approval section.

IRB Structure and Composition

PNNL strives to maintain an IRB membership that provides a healthy balance between relevant scientific expertise, institutional awareness, and a broad and diverse community perspective in particular, as it relates to the protection and oversight of vulnerable subjects. The IRB is currently composed of 12 voting members; six active and/or retired PNNL employees and six community members who, in addition to their unique technical and professional expertise, represent a variety of local interests including early childhood education and prisoner advocacy. Four of our members are unaffiliated with PNNL, other than their membership on the IRB.

The IRB Administrative Team

The IRB has three executive officers; the Chair, Vice Chair, and Program Manager (PM). The three officers and the Chair-in-Training form the IRB Administrative Team which meets on a regular basis to discuss IRB business, review new protocols, perform expedited reviews and/or meet with investigators to discuss their protocols, unanticipated problems or noncompliance. Under the authority of the IO, the IRB Chair, Vice Chair, Program Manager and Chair-In-Training conduct expedited review as a group or subset of that group. Those delegated to conduct expedited review must have sufficient experience as an IRB member to be knowledgeable of regulatory requirements for approval to conduct expedited review. In general, members are considered sufficiently experienced after one year of service on the IRB.

The Vice Chair, who serves the IRB in terms of institutional commitments and regulations, legal counsel, and standards of professional conduct and practice [45 CFR 46.107(a)], acts in the Chair's absence. The IRB Program Manager serves as the Laboratory's point of contact for all external and internal human subject activities and as the PNNL IRB contact on all consent forms.

Picture of Research Scientist in LabThe Chair-in-Training position was established to ensure a smooth transition when the IRB Chair position is vacated. The Chair-in-Training must be a current PNNL employee to facilitate daily activities of the IRB. The Chair-in-Training must have sufficient experience as an IRB member to be knowledgeable of regulatory requirements for approval to perform expedited reviews, act in the Chair's absence, or assume the role of Chair.

The term IRB Administrative Team means collectively or singularly. For instance, "the IRB Administrative Team reviews," etc., means one or more members, or a "subset" of the Team are involved in the activity.

To facilitate daily operations such as the processing of non-issue, new and continuing exempt and expedited reviews, the IRB Program Manager (PM) at PNNL is a voting member of the IRB. A number of built-in protections exist to prevent some of the common pitfalls that might occur as a result of this practice. For instance, the IRB Administrative Team meets often to assess new studies and determine the appropriate level of review for those that meet the criteria for human subject research. Also, the entire IRB reviews all approved expedited protocols at a convened meeting. OHRP and AAHRPP approve of this practice with one important stipulation. To prevent any real or perceived conflict of interest, the PM should not be a scientist. The success of this practice is dependent upon the strength and make-up of the board and the PM's ability to remain impartial and mindful of his/her limits when performing scientific review of human subject protocols. The PM is also required to maintain IRB certification with a nationally recognized professional institution.

IRB Membership

The IRB meets the following federal requirements for membership [45 CFR 46.107]:

Current IRB Expertise

PNNL Laboratory Employees

Community Members

Selection, Appointment, and Performance Evaluation of the IRB Chair

The IRB Chair is selected by the IRB Administrative Team from likely candidates at PNNL and approved by the Institutional Official. The Chair must be a PNNL employee, residing and working at the laboratory to facilitate the business of the IRB. Unless the Chair-In-Training has previously served as a member of the IRB, the Chair-In-Training is expected to serve at least one year before assuming the role of Chair. The IRB Chair, Vice Chair and Chair-in-Training's performance is evaluated during the annual IRB Assessment and Performance Review.

Selection, Appointment, and Performance Evaluation of IRB Staff

IRB staff, which consists of the Program Manager and part-time secretary, is solicited through standard hiring mechanisms at PNNL. They are interviewed by the IRB Administrative Team and their potential appointment discussed with the IRB. IRB staff must be familiar with research conducted at PNNL and with basic administrative and electronic systems. If appropriate, the Program Manager might be solicited from outside of PNNL to obtain the necessary expertise required for that position. The Program Manager and the Secretary must maintain current human subject training and the Program Manager must be certified as an IRB professional. IRB staff performance is evaluated as part of the annual PNNL Staff Development Review (SDR) process and during the annual IRB Assessment and Performance Review.

Selection and Appointment of IRB Members

The IRB recruits its members from PNNL and the local community. Anyone can bring forth a name to the IRB Administrative Team. The term of service for IRB members is indefinite, but is reviewed every year during the annual IRB Assessment and Performance Review and the composition and membership of the IRB is adjusted at that time if needed to meet regulator and organizational requirements.

Step 1: The IRB Administrative Team assesses the need for a new member and solicits suggestions from the Board and, in some instances, scientific staff.
Step 2: The IRB Administrative Team narrows the selection and reviews the candidates with the IRB and other internal staff, if necessary, to confirm that no conflict of interest exists.
Step 3: The IRB Chair discusses IRB membership with the potential candidate and requests a resume for distribution to the IRB. If there are no objections, Step 4 is implemented.
Step 4: If willing to serve, the candidate is asked to:
  • Review PNNL human subject web and SBMS sites.
  • Complete human subjects training.
  • Sign an indemnity and nondisclosure agreement.
  • Discuss compensation/establish a subcontract.
Step 5: The new member is provided with the IRB Manual as well as other educational materials and, if desired, is assigned a mentor from the IRB.
Step 6: The new member is welcomed in a formal letter from the Laboratory Director/IO.
Step 7: Documentation of the change in membership is provided to DOE/SC and to DHHS through the Battelle Office of Research Administration (ORA). The PM is responsible for reporting changes in membership to the Battelle ORA.

Responsibilities of IRB Membership

IRB Members receive and are expected to comply with the requirements of membership found in the "IRB Member Roles and Responsibilities" (.pdf 24kb).

Meetings: IRB members are expected to review the meeting materials, arrive promptly and contribute to the discussion by freely expressing their opinion and, likewise, by respecting and encouraging the same from others. IRB members must be familiar and conversant in the tenets of the Belmont Report and the requirements of the "Common Rule" [45 CFR 46] and are expected to utilize the IRB Decision Quadrant and Informed Consent Checklist (.pdf 161kb) as a guide in their review of protocols to ensure that all of the requirements for approval have been fully satisfied.

Education: IRB members are responsible for maintaining current certification of human subject education, which is required every two years, and are expected to actively participate in on-going educational activities. IRB members may be called upon to provide or participate in educational presentations to the Board or attend local or national educational conferences. IRB members use the NIH Site for IRB Members to complete Human Subjects training.

IRB Review Using Primary Reviewers

The Primary Reviewer (PR) system is used for initial and continuing review and review of protocol modifications as described in the IRB Review and Approval section.

Resolving Disputes or Differences of Opinion

Whenever there is a difference of opinion among board members and/or consultants that cannot be resolved through discussion, additional expertise may be solicited and, if more than two members are involved, a vote may be taken (IRB members only) and the majority will rule. In all instances, the IRB Chair will have the final say. If the IRB Chair is not available, the IRB Vice Chair will have the final say.

Conflict of Interest - IRB Members and Consultants

A conflict of interest exists when IRB members, consultants and their immediate family members, who are defined as a spouse, life partner, children, parents or other dependent:

IRB Members

IRB members are required to notify the IRB Chair or PM that a conflict of interest exists prior to reviewing a protocol. They may accomplish this by contacting any member of the IRB Administrative Team prior to the convened meeting or by declaring the conflict at a convened meeting where conflict of interest is addressed as a standing agenda item. In either case, the IRB Chair will notify the IRB at the convened meeting before the protocol review. IRB members with a conflict of interest must leave the room, cannot participate in the discussion, vote, or be counted toward quorum for the review of the protocol with which they have a conflict of interest.

Consultants

When consultants are invited to participate in the review of a protocol, the person inviting the consultant (a member of the IRB Administrative Team) will explain PNNL conflict of interest requirements and establish with the consultant and the IRB Administrative Team, if necessary, whether or not a conflict of interest exists. Once it has been established that no conflict of interest exists, the consultant may provide information, pose questions to the investigator, and participate fully in the discussions. Consultants will be asked to leave the room before the final discussion and are not allowed to vote. If approved under expedited procedures, information and comments provided by consultants will be included in the expedited review package provided to IRB Members. If approved under full board review, information provided by the consultant and their contribution to the discussion will be provided to the IRB Members and recorded in the minutes.

Consultants with a conflict of interest will not be asked to participate in, or contribute information to, the IRB review.

Nondisclosure and Indemnification: IRB members not currently employed by Battelle are required to sign a Nondisclosure and Indemnity Agreement to establish the conditions under which they: 1) may or may not disclose or exchange confidential information and 2) will be indemnified and defended if sued for activities conducted for the IRB. The Agreement is designed to protect members from civil liability, to the extent permitted by law, for claims that result from the good faith performance of their duties where they are not involved in a known wrongdoing or conflict of interest.

Resignation

IRB officers and members are free to resign at any time but are expected to submit their resignation in writing at least one month prior to their anticipated end date to allow time to fill the vacancy that will exist as a result of their resignation. Resignation by the Chair must be submitted in writing to the IO and copied to the IRB.

IRB Administration

Resources/Financial Support

The IRB is provided with an independent budget that is sufficient to maintain the program in full compliance with federal, state, and institutional requirements including educational activities, such as travel to local and national meetings by members of the IRB and current efforts to obtain accreditation of the PNNL HRPP. The budget is established on a fiscal-year basis with the PMs input and concurrence and is managed by the PM. The need for additional IRBs is also assessed during the yearly budget process. The IRB PM is funded as a full time employee (FTE); the secretary is funded on an as-needed basis.

Compensation for IRB Members

Community members not otherwise compensated for participation on the IRB and Battelle retirees may choose to accept a stipend of $200.00 per meeting through a formal subcontract. Subcontracts are renewed every 2 years, at which time members may discuss their willingness to continue serving on the IRB. Financial support is also provided for PNNL staff members who have no other source of funding to perform their IRB duties.

Outside Resources

The Department of Energy, Environmental Health Department provides funding to support PNNL's review of the Former Worker National Medical Surveillance Program that is currently being conducted at Hanford and 15 other DOE sites. PNNL is the lead IRB for those studies.

Meetings

IRB meetings are scheduled for the 2nd Wednesday of every month from 8:30 -10:30 am and are held at least 4 times during the fiscal year. Educational activities are often conducted during the meetings. The IRB will convene off-schedule or emergency meetings to provide expeditious review of protocols, address concerns regarding the rights and welfare of subjects, or review unanticipated problems or noncompliance. Any member of the IRB may call for an emergency meeting. Investigators may request a meeting through any member of the IRB Administrative Team.

In rare circumstances, members may participate in a meeting and vote by phone if they have received the complete review package at least 5 days in advance of the call and are able to participate fully in the discussion. Participation by phone will be recorded in the minutes as "one vote by phone." Full Board emergency meetings may also be convened by phone when standard requirements, such as quorum, can be met. The IRB may, in an emergency, allow less time for the review of meeting materials.

Attendance at IRB meetings is limited to Board members, support staff, presenting investigators, invited consultants and guests. The meeting schedule is established and provided to members at the beginning of each fiscal year by email and hard copy. IRB members are notified by email and/or phone whenever meetings are cancelled, generally the week prior to the scheduled meeting.

Consultants

When the IRB determines that additional technical expertise or subject representation is required, consultants may be invited to participate in the review of a protocol. The IRB Administrative Team and members of the IRB will discuss potential candidates to serve as a consultant which may be obtained internally or externally depending on the expertise needed. Any member of the IRB Administrative Team may invite the potential consultant to participate. Initial invitations are usually verbal with a follow-up email to confirm the arrangements. Consultants internal to PNNL will be provided with a work package number to cover their time. Outside consultants will be paid the standard stipend of $200.00 per meeting.

The person inviting the consultant will explain PNNL conflict of interest requirements and establish with the consultant whether or not a conflict of interest exists. Once it has been established that the potential consultant has no conflict of interest associated with the study undergoing review, the consultant may provide information, pose questions to the investigator, and participate fully in the discussions. Consultants will be asked to leave the room before the final discussion and will not be allowed to vote. If approved under expedited procedures, information and comments provided by consultants will be included in the documentation provided to IRB members. If approved under full board review, information provided by the consultant and their contribution to the discussion will be recorded in the minutes.

Consultants with a conflict of interest will not be asked to provide information or participate in the IRB review.

Dissemination and Timing of Materials

IRB members receive final notification of the meeting, the agenda and materials package at least one week before the meeting, unless circumstances warrant otherwise, as in the case of an emergency meeting in response to a serious unanticipated problem or noncompliance. Any changes that occur to the agenda or pertinent documents after distribution of the package are provided at the meeting. All materials are treated as Business Sensitive and are returned to the IRB secretary at the end of each meeting. Basic materials provided to IRB members for meetings are listed in the IRB Review and Approval section.

Establishing and Maintaining Quorum

At least 2-3 weeks before a scheduled meeting, IRB members are contacted by email or phone to confirm their availability and establish that a quorum can be achieved. A quorum requires:

A majority of the members present at the meeting is required to approve or disapprove research. If quorum is lost during a meeting for any reason, no vote may be taken. Should quorum fail during a meeting (i.e., loss of a majority through recusal of members with conflicting interests, early departures, or absence of the nonscientist member), the IRB may not take further action or vote until the quorum is restored. Changes in the quorum that may occur during the meeting will be recorded in the minutes, but comments or opinions of individual members will not be attributed to them. Members will be identified by name only if they arrive after a vote is taken, recuse themselves, or leave the meeting for any reason during a vote. If the number of members is uneven, the required number to meet quorum is rounded up. For instance, if there are 11 members, 7 would be required to make quorum. The IRB Secretary is responsible for monitoring the members present at the meeting and for maintaining quorum. Any member with a conflict of interest will not be counted toward quorum for the vote on the protocol for which a conflict of interest exists.

Voting

All voting is conducted in closed session and voting privileges are limited to IRB members present at the meeting. Proxy votes are not accepted, and a separate vote is required for each protocol under review. Member votes are recorded via a show of hands or by signifying the number of members voting for, against, or abstaining from the motion. A majority vote of the quorum present, as described above, is required for any IRB determination. If the vote of the IRB is not unanimous, the minority opinion is recorded in the meeting minutes. See the IRB Review and Approval section for procedural details.

IRB members may abstain from voting for reasons other than a conflict of interest, provided they offer an adequate explanation that is acceptable to the Chair. The abstention and explanation provided by the Board member must be recorded in the meeting minutes. Consultants may not vote or be present for a vote.

Meeting Minutes

IRB minutes are taken in sufficient detail and include, at a minimum, the following information:

Convened meetings are tape recorded and the secretary, who also takes supplemental notes, transcribes the minutes immediately following the meeting and forwards them to the IRB Administrative Team for review. Once approved by the IRB Administrative Team, the minutes are distributed to the IRB members with a note requesting their review and comment as soon as possible. Because the IRB does not meet every month, IRB members are expected to notify the secretary or PM immediately with any changes or problems to facilitate the resolution of critical action items or major changes that might be required. The minutes are reviewed at the next convened meeting and, if found sufficient, approved by the full committee.

The minutes are considered final following approval of any corrections by the Chair. Minutes are stored chronologically in a separate file in the IRB office for three years and then sent to permanent storage in the secure vault.

Reporting Requirements

The IRB is responsible for reporting to the Institutional Official:

The IRB is responsible for reporting Unanticipated Problems, Terminations, Suspensions and Non-Compliance as follows:

IRB Records

The IRB maintains the following records, some of which are housed permanently* in the IRB Office; [45 CFR 46.115], all of which are maintained permanently in the PNNL vault/records holding area.

Protocol Records

Proposals: Proposals are logged into the IRB database using the PNNL or Environment Molecular Sciences Laboratory (EMSL) proposal number and are maintained in the Pending Proposals file until they are either reviewed by the IRB or closed out as unfunded. All documentation and correspondence relating to the proposal is included in the file. Proposed protocols are generally not reviewed by the IRB until funding is indicated or as otherwise required by the investigator or sponsor for scientific review. The Pending Proposals file is reviewed at fiscal year end to assess current status. Unfunded proposals are sent to the PNNL vault and stored indefinitely.

Approved Protocols: Approved protocols are assigned a unique, chronological number to indicate the fiscal year and order in which they are approved by the IRB, i.e., IRB No. 2006-01. Exempt protocols are managed under a separate numbering and filing system. With some exceptions, IRB records for approved protocols include the following:

IRB records for initial and continuing review by the expedited procedure include:

Human Subject Training Records

The IRB maintains a log and the actual certificates for IRB members, investigators and their project staff, and PNNL management who have completed the NIH Human Subject Training courses for IRB members and/or IRB Research Teams. The log indicates the last date training was taken and the required retrain date, which is scheduled for every 2 years. Specialized group training is documented by the sign up sheets and materials provided.

Copies of all training and informational materials, including records of local seminars and conferences attended by IRB members are maintained in the IRB office.

Databases

PNNL IRB: All proposed, active, completed and unfunded protocols are recorded in an Excel database which includes the IRB and other reference numbers, investigator, management and sponsor names, study title, type of review, funding, and continuing review date. The IRB database is managed on a fiscal year basis.

Department of Energy (DOE): All active full board and expedited 1830 DOE and Work for Others protocols are reported to the DOE Human Subjects Database on a fiscal year basis.

Records Retention and Access

All records, and documentation of those records, related to human subject research are retained indefinitely and are accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner [45 CFR 46.115(b)]. PNNL IRB records are never destroyed.

Currently active IRB proposal and project records are stored in the IRB Program Manager's (PM) office in a locked inner office in a secured hallway. They are maintained for a minimum of three years after completion of the study and are then archived indefinitely in the PNNL Records Holding Area in accordance with the PNNL Records Inventory and Disposition Schedule (RIDS). Archived records are clearly identified with any special handling requirements, in particular as it relates to the DOE moratorium on destruction of records which requires that the records not be destroyed for 75 years. Records with restricted access require approval by the investigator or the IRB Chair.

Annual IRB Assessment and Performance Review

The IRB budget, composition and performance of the IRB are assessed at fiscal year end. The IRB Program Manager works with management and finance representatives of the Legal department, in which the IRB resides, to assess the IRB's financial requirements for the next fiscal year. At the same time, the IRB Administrative Team reviews the current composition of the IRB to ensure it meets federal requirements and institutional needs. IRB members are asked to assess their performance against the "IRB Member Roles and Responsibilities" sheet and to notify the IRB Chair if they have particular concerns regarding the performance of the Administrative Team members or of any other IRB member. Separate sheets are provided to each member to assess the Chair’s performance and the results are provided directly to the Institutional Official.

List of IRB Members

The list of IRB members includes their name, scientific or non-scientific status, earned degrees, representative capacity, experience, such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contribution to IRB deliberations; and indicates their affiliation status with Battelle such as any employment or other relationship between each member and the institution such as full-time or part-time employee or member of the family of a PNNL employee. Changes in membership are reported to DOE/SC and to BMI for inclusion in the DHHS Federal Wide Assurance [45 CFR 46.103 (3)]. The IRB PM may be contacted for the complete list.

IRB Contact Information

IRB Chair James E. Morris, Ph.D.
IRB Vice Chair Alan C. Rither, JD
IRB Program Manager Kathy B. Ertell, MS
IRB Secretary Janet I. Jacobus
Telephone (509) 375-3610
Onsite Address Mail Stop K1-67, ROB/1414
Office Address Institutional Review Board
902 Battelle Boulevard
PO Box 999, MS K1-67
Richland, WA 99354
katherine.ertell@pnl.gov
Meeting Schedule 2nd Wednesday of every month 8:30-10:30 AM

Other IRB Contacts

Battelle Office of Research Administration: Jan Jaeger
DOE/PNSO Human Subject Liaison: Julie K. Turner
PNNL Institutional Biosafety Committee: Roger Mitchell

The following "Field Advocates" have had prior experience in working with the IRB and human subject studies and are willing to advise their peers regarding human subject requirements as it relates to their particular field of expertise.

Fundamental/Biological Sciences: David G. Camp
Hanford Cultural Resources Laboratory (Oral History): Ellen Prendergast-Kennedy
Human Computer Interaction: Anne Schur
Biological Monitoring/Modeling: Karla Thrall
Classified Programs: Jesse Willett