Governing Principles, Standards and Regulations

PNNL complies with a set of Federal laws [45 CFR 46, Subparts B, C and D] known as the "Common Rule" which are promulgated from the Belmont Report, the Nuremberg Code (.pdf 65kb), and the Declaration of Helsinki; documents that were created to guide researchers and physicians in the ethical conduct of research and treatment of human subjects. The Nuremberg Code, written in the 1940s in response to Nazi atrocities, was the first to require informed and voluntary consent. The Declaration of Helsinki, developed in 1964 by the World Medical Association, has undergone numerous revisions to address ethical problems associated with rapidly advancing medical research and technology. The basic ethical principals of the 1979 Belmont report, with which the "Common Rule" is most clearly associated, are described below.

The holographic imaging system's transceiver reflects a millimeter-wave signal off the body and any objects carried on it. Unlike current metal detectors, the system developed at PNNL detects all threats or contraband, including metal, plastic, liquids, drugs and ceramic weapons hidden under clothing.

Basic Ethical Principles of the Belmont Report

Respect for Persons
Beneficence
Justice

Respect for Persons (Autonomy)

Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents and second, that persons with diminished capacity are entitled to protection. The principle of respect requires that researchers obtain informed consent from the subjects they solicit to participate in research. The process of informed consent, which is the cornerstone for protection of human subjects, requires that potential subjects are provided with complete information in terms they understand and are given adequate time to make a decision to participate or not, without pressure or undue influence.

Because not every human being is capable of self-determination, respect may require that extra precautions are taken to protect those who are immature or incapacitated, such as children or mentally disabled persons, perhaps even to the extent of excluding them from participation in certain types of research. Respect also means honoring the privacy of individuals and maintaining confidentiality of their records.

Beneficence

Beneficence is an obligation to protect subjects from harm. The principle of beneficence requires that investigators minimize the probable risks of harm and maximize the potential for benefit to the subjects and/or to society as a whole in the importance of the knowledge that may result from the research. Before research is undertaken, a determination should be made that the risks to subjects are reasonable in relationship to the potential benefits that may be gained from their participation in that endeavor.

Justice

The principle of justice asks the question: who ought to receive the benefits of research and bear its burdens? Justice requires that the selection of human subjects and the risks and benefits of the research they participate in be distributed among them in a fair and equitable manner. Particular concern must be given to subjects whose personal status or condition (e.g., pregnant women, fetuses, children, prisoners, employees, patients, the impoverished or persons with diminished capacity) places them in a vulnerable or dependent status. Researchers should be aware of the fact that circumstances sometimes make the inclusion or exclusion of these particularly vulnerable populations unfair.

Subjects should be selected based on those factors that most effectively and soundly address the research problem, not simply on their ease of availability. For instance, investigators should be mindful of the fact that supervisors using subordinates for research may risk, at a minimum, the appearance of undue pressure or coercion.

Standards

PNNL acknowledges and accepts full responsibility for protecting the rights and welfare of human subjects when its researchers are engaged in research that is:

Sponsored by the institution (PNNL), or any other federal, state or private agency.
Conducted by, or under the direction of, any employee or agent of the institution in connection with his or her institutional responsibilities.
Conducted by, or under the direction of, any employee of the institution using any property or facility of the institution, including visiting scientists and students.
Conducted in collaboration with other institutions (with each institution being responsible for the activities performed by its employees).
Involved in the use of the institution's nonpublic information to use or contact subjects for the purpose of research.
Conducted in a foreign country - in accordance with 45 CFR 46.101(g)(h).

The policies and procedures contained in this web site and the Human Subjects SBMS site, which are very closely linked in purpose and intent, are provided in accordance with [45 CFR 46.103].

At PNNL, no human subject research may begin without (1) IRB approval to proceed and, (2) documentation of human subject training by key project staff, as required by the IRB.

Federal and State Regulations

PNNL complies with the "Common Rule" which was adopted in 1991 by sixteen federal agencies that support, conduct or otherwise regulate human subject research. For the U.S. Department of Health and Human Services (DHHS), the Common Rule is implemented at 45 CFR 46, Subpart A. Subparts B, C, and D include special provisions for the protection of vulnerable subjects including pregnant women, fetuses, prisoners, and children. See Items for Consideration for more detailed information on vulnerable subjects.

For the Department of Energy (DOE), the Common Rule is implemented at 10 CFR 745 (.pdf). DOE Policy (.pdf) and Order 443.1 (.pdf), Protection of Human Subjects, sets forth the procedures and responsibilities associated for implementing 10 CFR 745. DOE Order 481.1 applies to DOE Work for Others (Non-Department of Energy Funded Work). The DOE policy includes studies that use:

Identifiable or high risk data, including surveys, collected through direct intervention or interaction with individuals;
Private information readily identifiable with individuals, including genetic information and medical and exposure records, such as in worker surveillance studies;
Worker populations or subgroups;
Humans to test devices, products, or materials developed through research; to examine human-machine interfaces; or to evaluate environmental alterations; and,
Bodily materials such as cells, blood, tissues, or urine that are identifiable with individuals.

Also see Washington State Law Chapter 388-04 WAC which establishes rules implementing the department's policy for the protection of wards, clients, and employees who serve as human subjects in research and other related activities. Other Washington State Laws that might apply include Chapter 42.48 RCW, Release of Records for Research Purposes and Chapter 70.02 RCW, Medical Records, Health Care Information Access and Disclosure. These laws may exceed but do not supersede or limit the applicability of 45 CFR 46. Investigators may contact the IRB's legal counsel for assistance in applying laws other than Federal regulations to the conduct of human subject research.

Institutional Regulations and Policies

The PNNL IRB is registered and assured under the U.S. Department of Health and Human Services (DHHS) Federal Wide Assurance FWA00004696 (.pdf 893kb) (IRB00000285 and IRB00005670) awarded to Battelle Memorial Institute and, as such, is subject to the terms and conditions of that assurance, which is approved to May 23, 2008.

PNNL must also meet the requirements set forth in Battelle Corporate policies 1.1.1.6 and 1.1.1.7, "Human Subjects in Research." To prevent any actual or perceived appearance of coercion or undue influence, Corporate Policy 1.1.1.6 forbids the use of Battelle staff or their family members as subjects without approval by the IRB and the PNNL Institutional Official and then only for minimal, or less than minimal, risk studies. Directions for obtaining approval to use Battelle staff as subjects of research are located in SBMS.

Conflict of Interest

Investigators and IRB members are required to reveal any real or apparent conflict of interest that may apply to the work they are conducting or reviewing. Conflict of interest takes many forms. Investigators and IRB Members should be aware of the types that exist and report them properly to the IRB. In all instances the IRB has the authority to make the final determination and take appropriate action, particularly when the rights and welfare of subjects might be impacted by a conflict of interest. The requirements for reporting conflict of interest also apply to consultants to the IRB [45 CFR 46.107(e)]. Refer to Items for Consideration for more detailed information regarding conflict of interest.

Regulations that Do Not Currently Apply

PNNL does not conduct clinical research regulated by the Food and Drug Administration, and does not meet the definition of a "covered entity" under the Health Insurance and Portability and Accountability Act (HIPAA) of 1996, and is not, therefore, subject to either FDA regulations or the requirements of the HIPAA Privacy Act. The IRB does, however, require documentation of compliance by collaborating institutions covered by those regulations when appropriate. If an exception were ever to occur in the work conducted by PNNL, full compliance with the applicable regulations would be mandatory. Links to FDA and HIPAA can be found in Other Sites of Interest.