HRPP HOME

Introduction

• Mission
• Program Overview
• Policies & Procedures

The Institutional Review Board (IRB)

• Independence, Authority & Jurisdiction
• Responsibilities
• Structure & Composition
• Membership
• Administration
• Contact Information

Governing Principles, Standards & Regulations

• The Belmont Report
• Standards
• Federal & State Regulations
• Institutional Policies
• Conflict of Interest
• Regulations that Do Not Apply

Defining Human Subject Research

• Is It Research
• Research Activities That Require IRB Review
• Activities That Do Not Require IRB Review
• Best Practices

Organizational Structure / Roles and Responsibilities

• Institution
• Institutional Official
• IRB
• Investigators
• Sponsors
• Subjects and the Community

Education & Training

• Research Management, Investigators & Support Staff
• IRB Members & Support Staff

The Informed Consent Process - Selecting, Recruiting, and Consenting Subjects

• Selecting Subjects
• Recruiting Subjects
• Consenting Subjects
• Writing Consent Forms (46, 116)
• Waiver or Alteration of Consent
• Waiver of Documentation of Consent
• Consent Obtained by Collaborating Institutions

Items for Consideration

• Table of Contents

IRB Review and Approval

• Proposal Development
• Criteria for IRB Approval
• Initiating IRB Review
• Levels of IRB Review
• Exempt
• Expedited
• Full Board
• Reviewing the Consent Process
• Determining Frequency of Review and Additional Monitoring
• Reporting IRB Approval to Clients

After Approval - Conducting Human Subject Research

• Forms & Directions
• Continuing Review
• Amendments, Modifications, Changes & New Findings
• Unanticipated Problems, Noncompliance, and Suspension or Termination of IRB Approval
• Additional Monitoring & Oversight
• Study Completion

Program Assessment & Oversight

Accreditation

Questions, Suggestions, and Concerns

New Information and Important Changes

• Office for Human Research Protections
• New EPA Rule - Pesticides, Pregnant Women & Children
• Tuskegee Syphilis Study

Other Sites of Interest

IRB Library

SBMS Subject Area Links

• SBMS Subject Area
• Definitions
• Exhibits
• Forms
• References

PNNL in the Community

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Assurance:
FWA00004696 - IRB00000285 - IRB00005670

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Introduction

It is both a privilege and a serious responsibility when humans volunteer to participate as research subjects for the advancement of science and everyone involved in the endeavor, including the institution, its management, investigators, and the Institutional Review Board (IRB), share equal responsibility for ensuring that the rights and welfare of those subjects are fully protected under the law.

The Pacific Northwest National Laboratory (PNNL) Human Research Protection Program (HRPP) strives to maintain the highest ethical standards and practices in its protection of human subjects and seeks to continually improve the efficiency and effectiveness of its methods for doing so. In support of those efforts, PNNL has applied for accreditation of its program with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).

Mission

The mission of the PNNL HRPP is to protect the dignity, welfare and rights of human research subjects by developing a fair and explicit process in which they, or those who speak for them, may voluntarily choose to participate in research based on an intelligent and knowledgeable assessment of the risks and benefits that may accrue to them or to society as a result of their participation in that research.

Program Overview

PNNL's HRPP was established over 30 years ago in response to concerns raised when the Laboratory assumed responsibility for a study involving prisoners. Since that time it has reviewed a broad and diverse range of human subject research conducted by PNNL investigators.

PNNL is unique in the sense that its human subject research is more diverse than what might ordinarily be expected, for example, at a university. It is not clinical and seldom social-behavioral in nature. Human subject-related research conducted at PNNL ranges all the way from oral history interviews with local Native Americans to demonstrations involving the use of "grid friendly" computer chips that are installed in home appliances, to the study of the actions of proteins in human cells, and research to advance homeland security. Other examples of the diversity of research conducted at PNNL includes telemedicine diagnostic systems; comparative proteomic characterization of human samples from normal and diseased subjects, including breast cancer and subjects infected with pathogens; holographic imaging of millimeter wave signals off the body; and analysis of cancer patient samples to determine the uptake, biodistribution, retention and clearance of tracer-level radio-labeled monoclonal antibodies; and, evaluating human exposure to volatile organic compounds in residential water. PNNL conducts usability testing of computer programs developed by the laboratory, in some instances videotaping or recording the results.

Currently, PNNL does not conduct research involving vulnerable subjects and does not conduct FDA-regulated research.

Absent from our client mix, at least in the area of human subjects research, is any work done for the FDA. Although some of PNNL's clients are working on medical drugs and devices (such as the development of tiny radioactive "seeds" for the treatment of prostate cancer), PNNL is not involved in the testing of such devices but only in tangential areas such as radioactive encapsulation and isotope purification. While it is possible that FDA-regulated human subjects research could be conducted at some point, it is not PNNL's intention to pursue any such opportunities for the foreseeable future, so the IRB and its policies and procedures are not set up to deal with such issues and applications.

PNNL does not meet the definition of a "covered entity" according to the requirements set forth under the Health Insurance and Portability Protection Act (HIPAA). In addition, PNNL does not currently conduct research involving the vulnerable subjects afforded special protections under 45 CFR 46, Subparts B, C, and D. While supporting information is provided in the HRPP regarding the protections that should be afforded vulnerable subjects, such research would not be allowed at PNNL unless and until specific policies and procedures could be established for the review and conduct of those activities.

To safeguard the rights and welfare of human subjects, the PNNL HRPP maintains two committees known as Institutional Review Boards (IRB). The IRBs are registered with, and assured by, the Department of Human Health Services (DHHS), Office of Human Research Protection (OHRP) under the Battelle Memorial Institute Federal Wide Assurance FWA00004696, (IRB00000285 and IRB00005670) and are delegated by the Laboratory Director and HRPP Institutional Official (IO), to perform their duties independently and free of outside influence. (See Michael Kluse's April 2 , 2007 all-staff memo (.pdf 284kb).)

Both IRBs can review any type of research. The "Cleared" IRB (CIRB) consists of members with necessary clearances to review sensitive or classified studies

Purpose

This website was developed to provide a basic understanding of the guiding ethical principles, federal and state regulations, and policies and procedures under which PNNL reviews and performs human subject research. The guidance provided applies to all research activities conducted under the auspices of the Battelle, Pacific Northwest Division and the Pacific Northwest National Laboratory which is operated by Battelle for the Department of Energy (DOE) regardless of the sponsor, funding source, or location. For the purpose of this website, the institution will, from here on out, be described as the Pacific Northwest National Laboratory, or PNNL. This web site is considered a "living" document that is subject to revision at any time to accommodate program assessments and changes to regulatory or institutional policies.

Policies and Procedures

Policies and Procedures specific to the IRB are included in this website.  Policies, procedures, forms and exhibits specific to Principal Investigators are located in the Human Subjects site in SBMS.