Organizational Structure — Roles and Responsibilities

The protection of human subjects is a responsibility shared by the Institution, the IRB, Principal Investigators (PI or investigators) and their management, by sponsors and, to a certain extent, by the subjects themselves. To fulfill these responsibilities, each is responsible for familiarizing themselves with their particular roles and responsibilities. Every member of the workforce is responsible for reporting concerns, problems or suspected deviations from any approved protocol to the IRB. The IRB works closely with PNNL management and operational systems such as the Electronic Prep and Risk, EMSL proposal system, LDRD and contracts personnel, and participates on the Institutional Biosafety and Internal/External Survey Committees to locate and review human subject research identified by those systems.

Cancer patient imaging to determine uptake, biodistribution, retention, and clearance of a tracer-level of radio-labeled monoclonal antibody

Institution

As a component of Battelle Memorial Institute (BMI), the PNNL Human Research Protection Program (HRPP) is registered and assured under the BMI Department of Health and Human Services Federal Wide Assurance, FWA0004696 as Institutional Review Boards (IRB) No. 00000285 and IRB No. 00005670 and, in accordance with that agreement, is subject to yearly program assessments and continuing oversight by the BMI Office of Research Administration (ORA). The PNNL HRPP, which is delegated by the BMI Signatory Official to conduct all activities in accordance with the FWA, meets at least once a year with the BMI ORA official.

Institutional Official

The PNNL HRPP is located in the Legal Directorate and operates under delegation of the Laboratory Director who serves as the Institutional Official (IO). The IRB has direct access to the IO and to the Associate Laboratory Director for Operations who provides oversight and assistance on operational and administrative issues.

The PNNL Institutional Official has the following responsibilities:

Authority to act and speak for PNNL and assume obligations in the DHHS/BMI Federal Wide Assurance.
Create a culture that promotes and upholds the highest ethical and scientific principles in the review and conduct of human research.
Ensure the independence, authority and standing of the IRB within the institution to demonstrate a commitment to human subject protections.
Commit the institution to compliance with applicable regulations and local law for the protection of human subjects.
Ensure that the institution effectively fulfills its oversight function for all research involving human subjects performed under the auspices of the institution.
Ensure that no research is initiated without IRB approval.
Ensure the IRB is properly constituted and functions in full accordance with the regulations.
Provide sufficient resources, space, and staff to maintain the HRPP and assess resources on an annual basis.
Set standards for human subject education requirements.
Support IRB authority and decisions.
Ensure the IRB ready access to impartial legal counsel and to the highest officials of the institution, as necessary.

Institutional Review Board (IRB)

IRB Members

The IRB is responsible for identifying and reviewing all proposed and continuing human subject research submitted to the board, and for ensuring that all approved studies comply with the terms and conditions of their approval for the life of the project.

The IRB has the authority and responsibility to approve, require modification to, or disapprove research activities including proposed changes to previously approved research. It may suspend, place restrictions on, or terminate any previously approved research that has been associated with serious or unexpected harm to subjects or to others, or with continuing noncompliance. The IRB is responsible for conducting continuing review of approved research at intervals appropriate to the degree of risk, but not less than once per year.

To adequately review human subject research, IRB members must be familiar with the following:

The ethical principles of human subject research as set forth in the Belmont Report.
Applicable federal and state regulations including the BMI Federal Wide Assurance.
Institutional policies and procedures.
Levels of review.
Standard definitions and an effective working knowledge of:
- Basic requirements for informed consent.
- Subject populations, particularly vulnerable subjects.
- Institutional constraints.
- Differing legal requirements (HHS/FDA, federal and state).
- Other factors which might foreseeably contribute to a determination of risks and benefits to a subject and/or to the subject's informed consent.

Chair

The IRB Chair ensures that the IRB carries out its responsibilities. In addition to the duties common to all IRB members, the Chair also has the following responsibilities:

Assure that expedited reviews are conducted in a timely manner.
Keep the IO informed regarding issues related to human subject research.
Educate IRB members and investigators.
Sign off on all Full Board Review Approval letters, requests for use of Battelle staff as research subjects, and Unanticipated Problems and Noncompliance.
Report the following promptly to DOE/HQ, the PNNL IO, Battelle management and sponsors as appropriate:
- Any injuries to human subjects.
- Any unanticipated problems involving risks to human subjects or others.
- Any serious or continuing noncompliance with the requirements or determinations of the IRB.
- Any suspension or termination of IRB approval of research.
Ensure that DOE/HQ is notified of any new human subjects research involving:
- An institution without an established IRB.
- A foreign country.
- Potential for significant controversy, vulnerable subjects.
- The generation or use of classified or sensitive unclassified information.

Vice Chair and Chair-in-Training

The Vice Chair and Chair-in-Training are both delegated to act in the Chair's absence and, as Acting Chair, have signature authority for anything that must be processed or requires approval during that time. As a corporate attorney, the Vice Chair also renders legal opinions on matters related to human subject protection, interprets federal and state regulations and DOE directives, and advises the Board as needed. Both are voting members of the IRB.

Program Manager

The IRB Program Manager manages the day-to-day activities of the HRPP and the IRB, is a voting member of the IRB, and assumes the following responsibilities:

Is the Subject Matter Expert and Laboratory contact for all internal and external human subject activities.
Responds to and participates in internal and external audits.
Facilitates constructive and effective communication between the IRB, research and support staff, management, DOE, BMI, sponsors and collaborative institutions.
Is the IRB contact for subjects on all informed consents.
Makes preliminary determinations regarding exemptions and expedited review.
- Provides one-on-one consultation for investigators.
Coordinates, schedules, and facilitates all reviews.
Provides notice of continuing review to investigators. Reports promptly to the IO, the IRB Chair or Vice Chair, management and sponsoring department or agency head:
- Unanticipated problems involving risks to subjects or to others.
- Serious or continuing noncompliance with the regulations or the requirements of IRB approval.
- Suspension or termination of IRB approval.
Manages all administrative aspects of the IRB office including the program budget, meetings, distribution of materials, meeting minutes and record keeping.
- Reviews the program budget with management annually to ensure sufficient resources for the HRPP.
- Schedules and prepares for IRB meetings.
- Promptly conveys IRB decisions and requirements for modifications to investigators in writing.
- Maintains IRB records and arranges access to the records as requested by federal authorities.
Documents the IRB process, philosophy, policies and procedures.
Develops and maintains the HRPP website.
Develops and implements an education plan for the IRB and research staff.
- Maintains educational records.
- Notifies staff of retraining requirements.
Develops and maintains the HRPP Standards Based Management System (SBMS) (internal policies and procedures for investigators, management and research staff).
Develops and maintains the HRPP IRB website.
Represents PNNL on the DOE Human Subjects Working Group (HSWG), at annual national conferences, and on regional IRB Committees.
Represents PNNL at BMI Office of Research Administration meetings.
Stays current on regulations and pending changes that affect human subject protection and advises others as appropriate.
Prepares and submits the annual DOE Human Subjects Research Database report.

IRB Administrative Team

The IRB Administrative Team (IRB Team) which is made up of the Chair, Vice Chair, Chair-in-Training and Program Manager, meets regularly on an informal basis to discuss initial or expedited reviews, current or evolving issues, and develop policies and procedures. The IRB Team meets with researchers to assist in the initial assessment and design of their studies. Each member of the IRB Team is delegated to conduct expedited reviews but often obtains the concurrence of two or more members. The IRB Team is also responsible for the initial assessment of unanticipated problems and for determining the immediate required action and reporting requirements. Team members may call a meeting at any time for any reason.

Under certain circumstances, the IRB may delegate final approval authority to the IRB Team where, for instance, contingencies must be resolved before a protocol can be given final full-board approval to proceed.

Research and Line Management

Line managers are responsible for:

Promoting a culture of respect for human subjects and for the IRB process.
Maintaining an awareness of the human subject activities under their purview.
Evaluating the technical aspects and scientific merits of proposed research.
Validating the necessity of involving human subjects in proposed research.
Assuring that proposed research is consistent with research priorities and funding.
Confirming that the PI and project team possesses the necessary expertise and experience.
Supporting the IRB in its requirements and decisions.

Investigators

Principal Investigators have a legal and moral responsibility to protect the rights and welfare of the subjects they use to accomplish the goals of their research. The protection of human subjects in research is paramount — be it their physical or psychological well being, their right to privacy, or the protection of their social standing or employment status. Principal Investigators are expected to:

Document scientific peer review.
Protect the welfare and well being of the subjects who make their research possible by:
- Minimizing risks and maximizing benefits to them.
- Providing proper consent.
Understand and comply with the ethical standards, regulatory requirements and laws that govern human subject research, including those related to their profession.
Obtain IRB review and approval before initiating any human subject activity.
Conduct research according to the IRB-approved protocol and comply with all IRB determinations.
Obtain IRB approval for changes to the protocol, informed consent process, project management, and previously approved forms before initiating work that includes those changes.
Provide full and informed consent, ensuring subject understanding.
Provide each subject with a signed consent and Research Subject's Bill of Rights and Responsibilities.
Document human subject training for primary project staff.
Apply for continuation of the study on an annual basis, or as otherwise stipulated by the IRB. Report progress of approved research as often and in the manner prescribed by the IRB, no less than once per year.
Maintain appropriate project records for at least 3 years beyond project closure.
Participate in project conformance reviews as required by the IRB.
Provide a final report at project completion.
Principal Investigators and their project staff are expected to immediately report the following to the IRB.
- Unanticipated problems or noncompliance with the approved protocol or consent, including those that occur at collaborating institutions.
- Any change or new information that might impact the risk benefit ratio to subjects.
- Significant new findings that could affect a subject's willingness to continue their participation in the study.

Ref: Condensed Principal Investigator Responsibilities (.pdf) (SBMS Exhibit).

Subjects and the Community

As volunteers, human subjects have many rights, but they also assume a certain amount of responsibility for themselves and for others, including the study investigators. Investigators provide subjects with the Research Subject's Bill of Rights and Responsibilities (.pdf) which includes the responsibilities noted below. Subjects are responsible for:

Carefully reading all project materials, in particular the consent and the directions for participation and if they choose, taking the time to discuss their participation with their family or friends before making a final decision.
Asking questions to confirm their understanding of the circumstances of participation and ensuring they have enough information to freely volunteer or decline participation.
Disclosing any information that might affect their ability to participate fully in the research activities, such as:
- Exclusion or inclusion criteria that might apply.
- Family relationship to PNNL employees or potential conflicts of interest with the study.
- Scheduling problems, particularly if their involvement will take place over an extended period.
- Physical, social, or psychological limitations.
Asking questions throughout the process and making sure they understand the answers before signing the consent or any other document.
Abiding by the protocol.
Notifying project staff of new issues or concerns that might arise, for instance, if they are unable to meet the requirements of participation.
Suggesting changes to the study or informed consent, where appropriate.
Notifying project staff if they decide to discontinue their participation.
Contacting the IRB with unresolved issues.

The IRB interacts with the community on a casual basis, generally when invited to provide presentations regarding the HRPP or on more specific occasions such as meetings relating to Hanford Worker Health.

The HRPP Program Manager is listed as the contact to discuss problems, concerns and questions or accept input that may come from the community. If an initial conversation does not resolve the callers concerns, the HRPP PM will discuss the callers concerns with the IRB Chair and Vice Chair. If they cannot resolve the callers concerns, the IRB Chair will discuss them with the Institutional Official and, if considered serious enough by the IRB Administrative Team and the IO, with the convened Board.