Federal Agency Survey on Policies and Procedures (Research Involving Human Participants V2)
Author(s): National Bioethics Advisory Commission Bethesda, Maryland
Introduction
In 1991, a single set of regulations, referred to as the Common Rule (The Federal Policy for the Protection of Human Subjects in Research), was published in the Federal Register and adopted independently by 16 federal departments and agencies (see Table 1).1 The adoption of this set of common regulations was a benchmark event in the United States for addressing concerns about the uniformity of the system of human subjects protection throughout the federal government. It represented the culmination of a 10-year effort to produce a single set of regulations, something that had been recommended by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1981.
In 1995, the final report of the Advisory Committee on Human Radiation Experiments expressed concerns about the adequacy and uniformity of the implementation of the regulations among the signatory agencies. In his 1995 Executive Order (12975) establishing the National Bioethics Advisory Commission (NBAC), President Clinton directed every federal department and agency that conducts, supports, or regulates research involving human subjects to report to NBAC regarding the protections afforded to human subjects by each department's or agency's existing policies and procedures. This analysis describes the final results of a data collection process conducted by NBAC staff and consultants over a three-year period to describe and assess federal policies and practices related to protecting human subjects in research. The data reported here reflect the status of agency activities as of February 2000. This report does not include descriptions of activities or changes in agency functions that have occurred since February 2000.2
Background on NBAC Data Collection Efforts
The initial responses by federal agencies to the President's 1995 request were variable. To follow up on the initial data provided, NBAC staff and consultants undertook an examination of each department's activities to protect human subjects in research and the structures, policies, and procedures in place for the review and oversight of human subjects protections. Each department head was contacted and invited to appoint a representative to discuss with NBAC all departmental activities, policies, and procedures involving the protection of human subjects in research.
A survey tool for "Phase I" of the data collection was developed as the basis for individual interviews that were conducted with each departmental representative. The survey was designed to assess both the department's level of compliance with the Common Rule, and, for those departments that were in compliance, any difficulties they encountered in adhering to the regulations. In addition, several questions solicited suggestions from the departments for the improvement of federal protections for human subjects. Both the questions and methods of the survey were reviewed by outside experts.3 After several pilot interviews, survey questions were added to include commonly mentioned topics, such as ethical issues in international research. Each interview included follow-up questions and department-specific discussions, which served to illuminate those practices unique to each institution.
The survey questions, along with an information sheet, were mailed to each departmental representative. NBAC staff arranged to meet, in person, with representatives from every department, including those departments that responded to the survey in writing. Interview notes were supplemented by departmental charts, written policies and regulations, and other materials collected at the meeting. Several departments found it difficult to provide a department-wide response to the survey; in such cases, the agencies within the department that sponsored research with human subjects were interviewed separately.
The major purpose of the Phase I survey was to examine what structures - i.e., organizational units, personnel, and written policies and procedures - were in place to protect human research subjects, especially those related to the Common Rule.
Staff and consultants then embarked on "Phase II" of the survey, the purpose of which was to examine, among those organizations with structures in place, what processes were followed to protect human subjects, particularly related to the Common Rule. The respondents were asked to respond to open-ended questions about their perceptions of policies and procedures in their agency. Phase II of the study was never completed; it was thought that the data from Phase I deserved a fuller evaluation before continuing with lengthy interviews.
Based on the data collected in Phase I (and only somewhat in Phase II), staff and consultants characterized the status of agency compliance with the regulations (at the time of NBAC's interview with each agency) of implementation of procedures and policies to protect human research subjects. Determinations of agency status were made based on staff/consultant interpretations of the data collected in the two phases of the survey. They are, in large part, based on staff assessments of what constitutes research, minimal risk, vulnerable subjects, and adequacy of structures and procedures in place. Out of these analyses a draft report was written and distributed to the federal agencies for comment. The report was also shared with NBAC.
On October 2, 1998, the Office of Science and Technology Policy sponsored a meeting with federal agency representatives, NBAC commissioners, and staff to discuss the draft report. Commissioners R. Alta Charo, James Childress, and Bette Kramer attended that meeting. In addition, an ongoing exchange of information occurred between NBAC staff and the agencies. At several meetings of the Human Subjects Research Subcommittee of the Committee on Science, National Science and Technology Council, NBAC staff briefed agency representatives on the status of NBAC's work. NBAC staff also invited agencies to submit, on an ongoing basis, information about changes in their human subjects protections policies and procedures. Thus, data have accumulated over time.
On May 4, 1999, NBAC Chairman, Harold T. Shapiro sent a memorandum to the President summarizing general concerns about human subjects protections that had been raised by these initial reviews. Areas of concerns were the following:
- Federal protections for persons serving as subjects in research do not yet extend to all Americans.
- Despite widespread implementation of federal regulations by those departments and agencies sponsoring substantial amounts of biomedical research, a number of departments and agencies that sponsor primarily nonbiomedical research or little research overall have failed to implement fully these federal protections.
- Federal protections do not always include specific provisions for especially vulnerable populations of research subjects.
- Many federal agencies find the interpretation and implementation of the Common Rule confusing and/or unnecessarily burdensome.
- Federal protections are difficult to enforce and improve effectively throughout the federal government, in part because no single authority or office oversees research protections across all government agencies and departments.
- New techniques are needed to ensure implementation at the local level.
Methods for Completing Data Collection and Analysis
In fall 1999, NBAC staff and consultants began to re-evaluate the data collected in Phase I of the study and concluded that these data provide a useful starting point for the Commission's assessment. The partial data collected in Phase II, however, are not particularly informative. It was decided that because significant time had been passed since the initial data collection, and because the evolving work of NBAC had raised new issues and concerns about human subjects protections, it would be necessary to collect more timely and complete data from the same set of agencies.
On November 12, 1999, Dr. Shapiro sent a letter to each of the agency representatives informing them of NBAC's intentions. The letter requested that the agencies provide NBAC with an update on any changes that have occurred in their human subjects protections policies and procedures since they last reviewed and approved the Phase I data. In December 1999, a questionnaire was sent to each department or agency head requesting a response by mid-February 2000 (see Appendix A). Sixteen agencies and their relevant subcomponents responded to the survey (see Table 2). As of October 1, 2000, the Department of Agriculture has not responded to this request. This report describes the results of the survey analysis.
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Survey Results
The Size and Scope of Human Subjects Research Supported by the Federal Government
All 16 federal departments and agencies responding to the survey conduct or support research involving human subjects, although some components within departments reported that they do not sponsor or conduct humans subjects research (e.g., the Administration on Aging in the Department of Health and Human Services [DHHS]). Each agency's human subjects research program is distinctive in terms of its size, scope, organization, and focus, all of which reflect the primary mission of the agency. The following examples illustrate the diverse types of research conducted and/or supported by the federal agencies:
- The Department of Defense (DOD) conducts biomedical and behavioral research involving human subjects within each of the military services and through several additional defense agencies, primarily in areas that support the mission of the department.
- The Veterans Administration (VA) operates inpatient medical centers - including short-term hospitals, psychiatric and rehabilitation facilities, and nursing homes - and domiciliary and outpatient facilities. The VA's largely intramural biomedical research program focuses on the health care needs of veterans.
- The Department of Energy (DOE) conducts and supports research involving human subjects that ranges from diagnostic and therapeutic applications in nuclear medicine to epidemiological and occupational health studies, and manages the National Laboratories, at which many other agencies sponsor biomedical and nonbiomedical research.
- The U.S. Coast Guard (Department of Transportation, or DOT) studies involving human subjects are currently limited to shipboard crew endurance efforts.
- The National Aeronautics and Space Administration (NASA) conducts ground-based and in-flight biomedical research involving human subjects related to space life.
- Research authorized by the Bureau of Prisons (Department of Justice, or DOJ) must be related to criminal justice or corrections, and must not involve medical experimentation, or pharmaceutical or drug testing.
- The Census Bureau (Department of Commerce, or DOC) conducts survey and census design, questionnaire development, geographic support, data collection, tabulation, analysis, and dissemination. The Census Bureau defines research as studies related to methodology (e.g., cognitive testing of survey questions, record linkage, disclosure limitation, sample estimation, time series analysis).
- Studies in the Human Factors Laboratory at the Federal Highway Administration (DOT) include investigations of driver's responses to highway design features and in-vehicle information systems.
- A major program of the Substance Abuse and Mental Health Services Administration (SAMHSA, in DHHS) develops knowledge about new ways to improve the prevention and treatment of substance abuse and mental illness, and to work with state and local governments, as well as providers, families, and consumers, to apply that knowledge effectively in everyday practice.
- The Health Care Financing Administration (HCFA, in DHHS) sponsors research designed to study or evaluate public benefit or service programs, such as Medicare/Medicaid, and the State Children's Health Insurance Program.
- In the area of infectious disease research, the Centers for Disease Control and Prevention (CDC, in DHHS) conducts ongoing, systematic collection, analysis, and interpretation of outcome-specific data, closely integrated with timely dissemination of these data to those responsible for preventing and controlling disease or injury.
- The Division of Behavioral and Cognitive Sciences of the National Science Foundation (NSF) supports research to develop and advance scientific knowledge focusing on human cognition, language, social behavior and culture, as well as research on the interactions between human societies and the physical environment.
- The Social Security Administration (SSA) supports a study to determine the number, characteristics, and activities of adults aged 18 to 69 who have disabilities severe enough to meet SSA eligibility criteria for disability benefits.
- The Department of Education (ED) supports, among many activities, action research, in which teachers are often part of the research team, and the team adopts a consensus approach to designing and carrying out projects in which they seek to find ways to create and improve their own educational practices.
- One activity supported by the Environmental Protection Agency (EPA) includes human exposure research, which involves the gathering of physiological measurements (e.g., monitoring a subject's cardiorespiratory performance) or the collection of body fluids, tissue, or expired air from subjects.
- As part of its HIV/AIDS & Pre-adolescent Awareness Programs in Africa, the U.S. Agency for International Development (USAID) supports activities to collect information about what is currently taking place in schools as well as information about student sexual awareness and sexual practices. Research efforts aim to demonstrate what kinds of risk behavior exists and how curriculum can be developed that will enable students to make informed decisions.
In the questionnaire NBAC suggested that agencies use the definition of "human subject" as provided at Section 102(f) of 45 CFR 46: "A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information..." This definition was uniformly applied in the agency responses. Only DOT indicated a divergence from this definition. DOT treats human cadavers as human subjects in safety research conducted by the agency.
Budget Data
Each agency was asked to provide estimates of total budgets, research budgets,4 and human subjects research budgets5 for Fiscal Year (FY) 1999 (see Table 3). Of the responding agencies, only the Central Intelligence Agency (CIA) was unable to provide budget data because it is classified.
These data were gathered to understand the relative resource allocations to research in each agency, that is 1) the proportion of the budget spent on research regardless of the type (e.g., human, animal, weapons), 2) the proportion of the research budget spent on research involving humans, and 3) the proportion of the human subjects research budget conducted within (intramural or in-house) the agency. Some departments provided detailed budget data by agency (e.g., DOJ provided budget data for its four divisions; see Table 2 for listing). Others aggregated all data into one overall figure.
The amount of funding devoted to research or human subjects research as a percent of total department funding varied enormously. For example, although the SSA had a budget of over $421 billion, it spent less than $30 million on human subjects research. Likewise, although DOD had the largest overall research budget (nearly $36 billion), only $37 million was allocated to human subjects research.
By far, DHHS is the largest federal sponsor of research involving human subjects, totaling nearly $9.3 billion in FY 1999, the largest portion of which is allocated to the National Institutes of Health (NIH) ($8.6 billion). NIH supports 82.8 percent of all federally funded human subjects research in the United States. Of note, NIH has a sophisticated system for assigning codes to research proposals involving human subjects, including exemption status, existence of assurances, and whether concerns about protections have been expressed by scientific or Institutional Review Boards (IRBs). This system provides relatively accurate real-time estimates of the amount of human subjects research currently supported.
In contrast to DHHS, some agencies dedicate relatively small amounts of their total budget to human subjects research. For example, DOJ spent less than one percent of the department's total budget on human subjects research in FY 1999.
In addition, NBAC asked for the percent of human subjects research conducted by agency employees or other staff (e.g., students) on site. With this question, NBAC was trying to determine where responsibility for IRB review of research studies lies, i.e., with an agency IRB versus a grantee's or contractor's IRB. Some agencies do not themselves conduct human subjects research, rather they support research conducted by contractors or grantees or through cooperative agreements (see Table 4). Of the agencies that do conduct research (thereby requiring some level of review by the agency), most have some mechanism for review of protocols by an IRB or similarly constituted body (see Exhibit A for some examples), although there were a few exceptions (EPA and SSA). Almost all federal agencies that conduct human subjects research within their own facilities have intramural IRBs whose members include agency staff and at least one member who is not affiliated with the agency.
Exhibit A: Distinctive Mechanisms for Review of In-House Research
Environmental Protection Agency
All human subject research studies supported by EPA must either be approved or be determined to be exempt research by the EPA Human Subjects Research Review Official before any contract, grant, cooperative agreement, or cooperative research and development agreement (CRADA), interagency agreement, or any formal agreement involving EPA support of such studies is awarded or entered into. All human research studies conducted by EPA also must be approved or determined to be exempt by the Review Official before work can start (EPA Order No. 1000.17 Change A1, July 30, 1999).
Indian Health Service
The Indian Health Service (IHS) has a two-tier IRB system. IHS is divided into 13 Areas or regions; each Area has its own IHS IRB. Each Area IRB is the IRB of record for research conducted in that area in which IHS is involved in any way. There is also a Headquarters IRB that oversees the IRB system; it reviews all research in which IHS is involved, including all research reviewed by one or more Area IRBs, as well as research that takes place at the national level.
U.S. Coast Guard
The infrastructure in place to monitor the human subject protections is a newly established Coast Guard Formal Review Board that reviews and approves all of the test procedures and documentation prior to every experiment.
Social Security Administration
SSA's extramural research is reviewed for compliance with the Common Rule's informed consent guidelines, as well as the Privacy Act and SSA privacy rules. Project and contract officers conduct this review, with advice from SSA's Privacy Officer in the Office of Disclosure Policy and the Office of General Counsel. For review of extramural biomedical or behavioral research, SSA relies on contractors' or grantees' IRBs and the existing DHHS Multiple Project Assurance (MPA) system. SSA's intramural research, which includes neither biomedical nor behavioral research, receives a similar review throughout each project's planning, conduct, and evaluation.
Table 4 displays the number of IRBs found at those agencies that conduct research and the number of protocols reviewed in FY 1999. The range of protocols reviewed was large. DOD, with 43 IRBs, reviewed more than 3,500 protocols in FY 1999 while the CIA's IRB reviewed just 2. Although the VA has 101 IRBs of record, there is no centralized system to tabulate the number of protocols reviewed in FY 1999. It is notable that a few agencies that conduct human subjects research have no constituted IRB available to review such research.
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Types of Sponsored Research
Of those agencies that sponsor human subjects research, most support more than one type (see Table 5). All agencies reported supporting social science/behavioral research. Nine of the 16 support clinical research. Some agencies predominately support one type of research. For example, DOT principally supports human factors research, and the Consumer Product Safety Commission (CPSC) primarily supports social science/behavioral research and consumer product testing. A few agencies receive funds from other agencies to conduct research. For example, in addition to conducting its own research, the Census Bureau is funded by Congress to conduct large population surveys, such as the Survey of Income and Program Participation, and also receives interagency transfers of funds to provide field collection, data processing, and analysis services for other federal agencies such as the Bureau of Labor Statistics, the Bureau of Justice Statistics, and ED.
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Research with Vulnerable Populations
Agencies were asked to respond to whether research is sponsored or conducted that targets vulnerable populations (as specified at Section 111(a)(3)). The responses to that question can be seen in Table 6. The large number of agencies responding positively to this question was unexpected. Upon follow-up with several of the agencies, it became clear that they understood the question to mean, "are members of vulnerable populations ever subjects in your research, in contrast to the targeted population of the research?" For example, ED indicated that it might conduct studies that inadvertently include pregnant women, although their pregnant condition is inconsequential to the research. In contrast, some agencies do target these populations, for example, the Department of Housing and Urban Development (HUD) conducts studies in economically disadvantaged neighborhoods to assess needs.
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Administrative Oversight of Human Subjects Research
NBAC asked a series of questions related to administrative roles and responsibilities related to oversight of human subjects research, ranging from decisionmaking regarding review to the size of the administrative unit(s) devoted to protections.
Determination of Need for Review
NBAC asked, "What are the policies and procedures of your agency for determining whether a particular activity constitutes human subjects research? Please describe agency procedures for making determinations for 1) research conducted by agency employees or other staff and 2) research conducted by grantees, contractors and other funded entities." Each federal department structures its program of administrative oversight of human subjects research somewhat differently, despite the fact that all operate under the requirements of the Common Rule. Some departments conduct reviews of research documentation out of one central departmental office, while others rely on local review (e.g., within an agency division or by a contractor's or grantee's IRB); some provide detailed interpretive guidance on human subjects protections to subsidiary intramural research offices, contractors, and grantees, while others simply reference the Common Rule; and some departments audit or review IRB performance routinely, while others conduct investigations only when problems emerge.
Many agencies have an officer, either full or part time with assigned duties in this area. Often, if the agency primarily or exclusively supports research conducted by grantees and contractors (i.e., not by federal employees), a high-ranking individual responsible for grants and contracts is charged with making decisions about which research involves human subjects and whether it is exempt. For example, the Director of Grants Policy and Oversight Staff at ED makes the final determinations regarding need for review. At EPA, such determinations are made by a Human Subjects Research Review Official. In some agencies, the Office of the General Counsel primarily is involved. For example, at DOJ, the OJP Office of the General Counsel works with the Human Subjects Protection Officer to make determinations of this kind. The Food and Drug Administration (FDA) Office of the Senior Advisor for Science in the Office of the Commissioner will be responsible for reviewing determinations of exemptions.
Technical officers at USAID, NASA, and the National Institute of Standards and Technology (NIST, in DOC), who might be involved in grantmaking or contracting activities, often make the determination in cooperation with legal counsel that human subjects are involved.
In general, agencies rely on the grantee or contracting institution to make the initial determination of whether human subjects are involved. For research conducted in-house, or intramurally, the process might be different. If an agency has one or more IRBs, often the Chair will make these determinations. This is the case at CIA, DOD, and VA, and components of DOJ.
As mentioned previously, a few agencies conduct research but have no IRB. In the cases of SSA and HUD, the agencies report that the research conducted qualifies for an exemption, therefore there is no need for an IRB. SSA recognizes, however, that the requirements for their DHHS MPA pre-empt that exemption.
Determination of Exempt Research
Agencies were asked about their policies and procedures for determining whether a human subjects research activity is exempt under Section 101 and were asked to estimate the percent of human subjects research determined to be exempt from the Common Rule. The responses to this question are summarized in Table 7. Many agencies reported that all or nearly all of their research is exempt. The most common exemption cited (14/16) was:
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
In general, agencies use the same mechanisms to determine exempt research as that used to determine whether human subjects are involved - that is the IRB Chair for in-house research and a combination of technical and legal staff for grantees and contractors. For example, the Chair of the CPSC Human Subjects Committee, in consultation with the Office of General Counsel, determines whether the proposed activity is exempt under Section 101.
Some agencies have customized administrative mechanisms for making these determinations to meet their statutory and mission-related requirements. For example, the Census Department considers all of its research to be exempt under Federal Policy 15 CFR 27.101(b)(3)(ii) which exempts survey procedures if "federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and hereafter." However, privacy and confidentiality issues that relate to human subjects are brought to the Census Bureau's Policy Office. The Disclosure Review Board has primary responsibility for ensuring confidentiality in published reports and data products.
As mentioned above, SSA does not have an IRB, because it claims all research is exempt. This exemption took effect on April 4, 1983, as a result of a final DHHS rule published on March 4, 1983 (FR 9266). Research carried out under section 1110(b) of the Social Security Act, however, remains subject to the Common Rule's informed consent requirements. The 1983 notice states that "In order to insure the continued protection of human subjects participating in such [otherwise exempt] research activity, the Department is adding a specific requirement of written, informed consent in any instance, not reviewed by an IRB, in which the Secretary determines that the research activity presents a danger to the physical, mental, or emotional well-being of a participant." In the case of biomedical and behavioral research, in the 1983 Federal Register notice, DHHS makes clear the need for IRB review, but states such review would be "unnecessary and burdensome in the context of research under the Social Security Act and otherwise." DHHS discusses, but rejects, several proposals for IRB review of research and demonstrations to support public benefit or service programs and concluded that "ethical and other problems raised by research in benefit programs will be addressed by the officials who are familiar with the programs and responsible for their successful operations under state and federal law." SSA has reviewed the 1983 regulation with the Office for Protection from Research Risks (OPRR, now the Office for Human Research Protections [OHRP]) and has concluded that it continues to apply to SSA research and demonstrations. In 1999, SSA did not conduct any extramural human subjects research or demonstrations under section 1110(b).
The Health Resources and Services Administration (HRSA, in DHHS) reported that practically all of its research activity comprises program evaluation or evaluation of demonstration projects. All such evaluations are technically exempt under the public "benefit and service" criterion. However, HRSA Policy 96.05 requires such a claim of exemption to be approved by the HRSA Human Subjects Committee; otherwise IRB oversight is required.
Qualifications for IRBs
Clearly, local review is a key component of the oversight system. The Common Rule requires IRB review and approval prior to the granting of federal funding for research on human subjects. Agencies that conduct human subjects research and that are signatories to the Common Rule should have an IRB or IRB-like body to review its research. The systems by which IRBs are formed are relatively uniform across those agencies that have one - that is, they are formed and charged according to the requirements of the Common Rule. In general, a high-ranking official makes the determinations about IRB members. For example:
- At the FBI, the General Counsel determines the composition of IRB: at NASA the Cognizant Center Director makes the determination.
- At VA, the Chief Research and Development Officer and the Chief Officer, Office of Research Compliance and Assurance make the final determinations.
- At ED, the Chief Financial Officer is responsible for ensuring that the IRB membership is qualified to review intramural research protocols.
- At DOD, the commander of the military facility where the IRB is located is the sole authority for appointing the membership of the IRB and for approving the results of their deliberations.
Many agencies have policy directives and manuals that supplement the Common Rule, specifying in greater detail the required composition of the IRB. For example, at the Bureau of Prisons (DOJ), a majority of the members must be from outside the Bureau and must include a prisoner representative. The members are appointed by the Bureau Director, who must give final approval to IRB decisions.
Sizes and Functions of Administrative Units
In overseeing human subjects research conducted in-house or supported extramurally, federal agencies assume the following responsibilities:
- communication of practice guidelines to research institutions and IRBs based on the policies of the Common Rule;
- establishment of a structure whereby research proposals involving human subjects are peer reviewed for scientific merit as well as for IRB approval and the adequacy of subject protections;
- negotiation of assurances with research institutions that ensure that adequate protections will be in place for research subjects;
- verification that institutions, their IRBs, and researchers are complying with the federal human subjects regulations; and
- investigation of complaints of noncompliance and adverse outcomes for subjects of research.
The method, intensity, and frequency of research oversight and inspection activities may depend on how much staff and budget an agency allots them. Agencies were asked about the size of the administrative unit dedicated to human subjects protections (see Table 8). Many agencies had difficulty answering this question because duties are shared in part across many individuals. The range for full-time equivalents (FTEs) devoted to human subjects protections was large, from none to 60. FDA responded that it has 287 FTEs dedicated to human subjects protections, because of its mission to monitor and oversee the conduct of clinical trials.
Assurances of Compliance
Many agencies issue their own assurances of compliance (see Table 8). In addition, most rely as well on assurances provided by then OPRR through MPAs with large research institutions that perform a significant amount of research funded by DHHS. If an institution is awarded an MPA by OHRP, the federal agency funding the research must accept that institution's assurance of compliance with federal requirements and may not impose additional assurance requirements on the institution. This provision is intended to avoid duplicative and potentially contradictory enforcement of the federal protections. A few agencies reported that they do not issue their own assurances of compliance, nor do they rely on those issued by OPRR through DHHS (see Table 8).
Investigating and Acting on Noncompliance
In the event that the Common Rule is violated in the conduct of federally sponsored research involving human subjects, there are various responses that can affect both investigators and grantee institutions, such as withdrawal or restriction of an institution's or project's assurance and, with that action, of research funding and suspension or termination of IRB approval of the research. In addition, an IRB is authorized by the Common Rule to suspend or terminate its approval of research that fails to comply with the IRB's requirements or when a research subject suffers an adverse event. No federal department or agency may continue to fund a project from which IRB approval has been withdrawn or at an institution whose assurance has been withdrawn.
OPRR, in overseeing human subjects protections for DHHS-funded research and for all institutions to which it has issued an assurance, generally investigates the conduct of research only in cases where a complaint has been filed; where an institution, IRB, or researcher has reported a problem or adverse outcome; where a problematic audit finding has been referred to it by the FDA or a DHHS funding agency; or where published research raises concern among OPRR compliance staff.
The FDA, in its role regulating new drugs, biologics, and devices for marketing, enforces the somewhat similar requirements for human subjects protections defined in the Food, Drug, and Cosmetic Act through periodic on-site investigations of research institutions (e.g., pharmaceutical firms, university-based research facilities funded by pharmaceutical firms, independent testing laboratories) and their IRBs, as well as clinical investigators, sponsors, monitors, and contract research organizations.
In most agencies, cases of noncompliance would be referred to a high-ranking or fiscally responsible official (the Assistant Attorney General or Legal Counsel, the contracting officer or component director, the Cognizant Human Subjects Officer).
The most common responses to the question about sanctions applied in the case of noncompliance were:
- Suspension or termination of funds.
- Suspension or restriction of assurance.
- Requirement that investigators receive appropriate education.
- Notification of peer review groups of an institution's or investigator's noncompliance.
- Debarment.
- Closing of the site.
- Stopping of accrual or trial.
- Disciplinary actions against employees.
At the time of this survey, VA had a Rapid Response Team, a group of experts who are dispatched to conduct site visits at any facility where there may be an indication that the research is not being conducted in compliance with regulations. The Chief Research and Development Officer and the Chief Officer, Office of Research Compliance and Assurance, make the final determination regarding noncompliance.
At ED, the Director of the Grants Policy and Oversight Staff Education is authorized to investigate allegations of noncompliance with the regulations in extramural research.
Federal agencies may also take disciplinary action against employees involved in human subjects research for failure to follow human subjects protection rules. For example, DOD sanctions for noncompliance by intramural researchers include loss of investigator privileges. For military personnel, potential sanctions are letters of reprimand, nonjudicial punishment, and sanctions under the Military Code of Justice; for civilian DOD personnel, sanctions include reprimands, suspension, or termination of employment. The commander of the military facility is authorized to make final determinations about noncompliance. Depending on the nature of the infraction, the case could result in a general court martial.
At NSF, the Office of the Inspector General investigates allegations of noncompliance.
Human subjects site reviews are conducted at all major DOE laboratories on a "not-for-cause" basis. The DOE Human Subjects Program Manager makes the final determination of noncompliance.
Additional Policies, Statutes, and Regulations
Many agencies must comply with additional requirements as codified in statute or law. In addition, several agencies have imposed additional requirements beyond those specified in the Common Rule. A listing of these requirements appears in Table 9.
Some agencies have to comply with statutes that provide similar, parallel, or somewhat different approaches to subject protection than those that are provided by the Common Rule. For example, NIH has imposed additional guidelines for inclusion of women and children in research. The IHS has requirements about tribal consultation in research activities.
The Privacy Act allows several agencies to disclose research information about individuals under certain conditions. For example, the Privacy Act permits HCFA to disclose information without individual's consent if the data is to be used for a purpose that is compatible with the purposes for which it was collected. This is known as routine use, as identified in a System of Record notice. Routine use permits recipients of the information to use data in connection with a matter relating to one of HCFA's programs. Specifically, HCFA may release data under the routine use for research to an individual or organization for research, evaluation, or epidemiological project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. The Privacy Officer is the point of contact for Privacy Act data requests. Those using data must sign a Data Use Agreement, a legally binding agreement between the requestor of the data and HCFA to ensure the protection of the data. HCFA's Data Disclosure Review Board is responsible for refining and updating HCFA-wide policies that evaluate access to individually identifiable information, while at the same time ensuring its confidentiality, as well as the privacy of individuals.
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Educational Activities
Activities undertaken by agencies to improve staff and grantee/contractor awareness about the system of human subjects protections are listed in Table 10. Activities range from passive dissemination of relevant information about the Common Rule to aggressive requirements that training occur before research is conducted. For example, for its intramural researchers, NIH has a computer-based training program on the protection of human subjects that explains major requirements of its MPA. Registered completion is required of all staff conducting or supporting research involving human subjects and all newly employed NIH researchers. Since 1995, over 4,000 NIH employees have registered completion. DOE has an extensive education program that includes brochures, booklets on special research topics, a handbook for IRBs, large-scale interagency meetings, and a well-used website with information pertaining to human subjects protections.
Emerging Issues and Suggestions for Change
NBAC asked the federal agencies to identify emerging issues that might affect the landscape of human subjects protections in the future. Responses are shown in Table 11. Suggestions for NBAC to consider as it conducts its analysis over the next year are summarized in Table 12.
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Conclusions
Several issues are raised by these data. First, many agencies report significantly increased activity in the areas of human subjects protections since they last reported to NBAC in 1996 and 1997. These improvements have ranged from new agency policies and procedures clarifying or enhancing protections, additional staff, establishment of IRBs and other review mechanisms to evaluate research being conducted by agency employees, and increased educational and training activities to educate employees, grantees, and contractors about the federal requirements and the specific policies and procedures of the agency or department.
However, some problems remain, most particularly in inadequacies of review mechanisms, insufficient administrative support, and lack of an assurance process. More generally, the applicability of the Common Rule and its problematic interpretation by some agencies is a central issue that must be addressed. Each of these issues is addressed below.
Appropriateness of the Common Rule
Table 5 shows the wide range of research supported by most federal agencies. Of note, all but one report that they support social science and/or behavioral research. A majority report supporting operational, health services, and education research. This is notable because it is the "nonclinical, nonmedical" research communities that most often report the greatest difficulty in interpreting and applying the language of the Common Rule, especially as it applies to defining minimal risk. This leads to a question rather than a conclusion: Because so many agencies support nonclinical research, and because it is these types of research that challenge the paradigm of the Common Rule, is it necessary to consider whether the Common Rule as currently written addresses the unique concerns raised by, for example, behavioral, social science, or educational research.
Subparts B, C, and D of 45 CFR 46
Nearly all agencies reported conducting research that involves vulnerable populations (see Table 6). It is not clear whether these populations are targeted for the research or whether they happen to be subjects in ongoing research focused on a more general population. Of note, all DHHS agencies have adopted Subparts B, C, and D of 45 CFR 46 for funded or intramural research. Nonetheless, most agencies have not adopted Subparts B,C, and D of 45 CFR 46, pertaining to additional protections pertaining to research, development, and related activities involving fetuses, pregnant women, human in vitro fertilization, prisoners, and children. Based on this survey data alone, the implications of this are not clear, but they certainly deserve further consideration.
Lack of an IRB
Much of the success or failure of the federal regulations governing human subjects research depends on the effectiveness of IRBs in carrying out their responsibilities, which include assessing research proposals prior to their funding; stipulating changes in the research protocol or informed consent procedure that strengthen the protections afforded the subjects; disapproving excessively risky research proposals; minimizing risks to subjects; reviewing ongoing research; and taking action quickly to correct or remove threats to subjects' rights and welfare.
Most agencies have constituted an IRB to review human subjects research conducted by employees or contractors within their purview (i.e., not covered by an IRB at a grantee or contractor institution). However, a few agencies that reported conducting human subjects research in-house have not done so (see Table 4), raising concerns about the processes by which decisions about, for example, exemption or waiver of consent are made, not to mention ensuring adequate protection of the human subjects involved.
Determining Exemptions
Who determines which research is exempt from the federal policy and how the exemptions cited at 46.101(b) are interpreted varies across the agencies. In general, agencies with one or more IRBs or dedicated human subjects protections staff appear to have systems by which such exemptions are determined in a systematic manner. Although the regulations state that "Department or Agency heads retain final judgment as to whether a particular activity is covered by this policy" (46.101(c)), the process by which such determinations are made should be more carefully examined. Some might find it problematic when one individual unilaterally makes a recommendation that research is exempt (even if the recommendation must be accepted by the Department head), given that the individual might be biased, conflicted, or misguided about the meaning of the language.
In addition, it appears that some agencies broadly interpret what is included under the exemptions. Although this does not necessarily indicate a problem, it should suggest that the language and use of the exemptions deserve further consideration.
Assurances
In the past, OPRR was the principal entity responsible for negotiating MPAs with large research institutions that perform a significant amount of research funded by DHHS. If an institution is awarded an MPA by OPRR, the federal agency funding the research must accept that institution's assurance of compliance with federal requirements and may not impose additional assurance requirements on the institution. This provision is intended to avoid duplicative and potentially contradictory enforcement of the federal protections. Many departments indicated that they rely on the DHHS assurance, and in some cases negotiate their own assurance. However, a few agencies appear to have no mechanism in place for issuing assurances (see Table 8). It is not clear from the data whether other mechanisms are in place to offer such assurances.
The implications of this are important in one respect. OPRR (now OHRP), in overseeing human subjects protections for DHHS-funded research and for all institutions to which it has issued an assurance, generally investigates the conduct of research in cases in which a complaint has been filed; in which an institution, IRB, or researcher has reported a problem or adverse outcome; or in which a problematic audit finding has been referred to it by the FDA. In the absence of such an assurance, it is not clear how such an investigation could be conducted by a disinterested party.
Adequacy of Administrative Structures
The adequacy of research oversight and inspection activities at the federal level are likely to depend on how much staff and budget an agency allots them. In overseeing human subjects research conducted by employees or supported extramurally or through contracts, federal agencies have the following responsibilities:
- Communicating policies and practice guidelines to relevant research institutions and IRBs based on the policies of the Common Rule;
- Establishing a structure whereby research proposals involving human subjects are peer reviewed for scientific merit as well as for IRB approval and the adequacy of subject protections;
- Negotiating assurances with research institutions that make certain that adequate protections will be in place for human subjects;
- Verifying that institutions, their IRBs, and researchers are complying with the federal regulations; and
- Investigating and following up on complaints of noncompliance.
Agencies that conduct and/or support a large portfolio of human subjects research should have sufficient staffing and resources to assure that these responsibilities are met. Although the data collected in the survey are incomplete and somewhat imperfect, it would appear that some agencies clearly do not devote sufficient resources to these efforts (see Table 8). There is no formula for determining what is adequate for a given agency, but when there are no staff or resources devoted to these activities, one can assume an inadequacy exists.
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Footnotes
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Appendix A
National Bioethics Advisory Commission
Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research December 21, 1999
- Does your agency (i) support, (ii) conduct, or (iii) regulate human subjects research? ____Yes ____No
- What was your agency's total budget appropriation for FY 1999? __________________________________
In Questions 3-5, NBAC is attempting to get an idea of (1) the proportion of your budget spent on research regardless of the type (e.g., human, animal, weapons) your agency conducts, (2) the proportion of your research budget spent on research involving humans, and (3) the proportion of your human subjects research budget that is conducted within (intramural or in-house) your agency.
- Approximately what percent of your agency's FY 1999 budget appropriation was dedicated to research activities? (round estimate to nearest ten percent) ___________% If you prefer to provide a dollar amount instead of a percent, please do so here: ___________
- Please provide a best estimate. NBAC will use the information to describe your research portfolio in terms of a proportion of your total budget. We suggest that the definition of research cited at Section 102(d)1 be used as a starting point, "Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." If your agency uses a different definition, please note the definition and include the research activities in your estimate.
- In estimating agency expenditures for research, include all costs to your agency for the support of research, such as funds expended through grants, contracts, cooperative agreements and other funding mechanisms; salaries for in-house staff including, program and administrative staff; and other indirect costs.
- If appropriate, please describe any limitations or factors that would influence the interpretation of the estimate. (Please note: you will have the opportunity to review NBAC drafts that use these data to ensure that they are not misinterpreted.)
- Of the percent provided in your response to Question #3, approximately what percent of the research budget involved human subjects (including exempt research)? (round estimate to nearest ten percent) ___________%. If you prefer to provide a dollar amount instead of a percent, please do so here: _________
- We refer you to the definition of "human subject" provided at Section 102(f): "A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information..."
- If appropriate, please describe any limitations or factors that would influence the interpretation of the estimate. (Please note: you will have the opportunity to review NBAC drafts that use these data to ensure that they are not misinterpreted.)
- 1 Please note that throughout this document we refer only to the relevant section of the Federal Policy for the Protection of Human Subjects, since agencies use different numbers in referring to the relevant Title of the Code of Federal Regulations.
- Of the percent provided in your response to Question #4, approximately what percent of your agency's human subjects research budget was conducted by agency employees or other staff (e.g., students) on-site (i.e., in-house or intramural?) (round estimate to nearest ten percent). ___________% If you prefer to provide a dollar amount instead of a percent, please do so here: ___________
- With this question NBAC is trying to determine where responsibility for IRB review of research studies lies, i.e., with an agency IRB versus a grantee's or contractor's IRB.
- What are the policies and procedures of your agency for determining whether a particular activity constitutes human subjects research? Please describe agency procedures for making determinations for (1) research conducted by agency employees or other staff and (2) research conducted by grantees, contractors and other funded entities. Provide a brief description here or attach policies and procedures (please note if they already have been provided to NBAC).
- What are the policies and procedures of your agency for determining whether a human subjects research activity is exempt under Section 101 and who makes the determination? Please describe agency procedures for making determinations for research conducted by agency employees or other staff and for research conducted by grantees, contractors and other funded entities. Provide a brief description here, or attach relevant policies and procedures (please note if they already have been provided to NBAC).
- a. Approximately what percent of your human subjects research portfolio is determined to be exempt from the Common Rule?
- __________% for human subjects research performed by employees or other staff
- __________% for human subjects research performed by grantees or contractors or other funded entities
- b. In general, of the six categories of research that may be exempt, which categories, if any, does your agency use? Check each category used. (See Section 101(b).)
- _________ "Research conducted in established or commonly accepted educational settings..."
- _________ "Research involving the use of educational tests, survey procedures, interview procedures or observations of public behavior, ..."
- _________ "Research involving the use of educational tests, survey procedures...that is not exempt under the (b)(2)..."
- _________ "Research involving the collection or study of existing data..."
- _________ "Research and demonstration projects ..."
- _________ "Taste and food quality evaluation and consumer acceptance studies..."
- How many IRBs does your agency have? ___________
- a. Approximately how many protocols did your IRB(s) review in FY 1999? ___________
- b. What criteria are applied, and by whom, to determine that the IRB(s) is/are qualified to review and approve your organization's intramural/in-house research? Provide brief description here or attach criteria and procedures (please note if they have already been provided to NBAC).
- What is the nature of the human subjects research sponsored by your agency? (Check all that apply) If the categories below do not describe the types of human subjects research conducted by your agency, please provide a listing of categories relevant to your agency, use additional lines below. Add categories if needed.
- a. ________ social science (behavioral) experiments
- b. ________ social science research, not experimental
- c. ________ clinical research, experimental (e.g., clinical trials)
- d. ________ epidemiologic research (excluding clinical trials)
- e. ________ large population surveys of demographic and other personal data
- f. ________ development of new tools or methods to be used in human subjects research
- g. ________ health services research
- h. ________ operational, operations, organizational, or management assessments
- i. ________ demonstration projects
- j. ________ educational research
- k. ________ community-based intervention research
- l. ________ human factors research
- Does your agency sponsor or conduct research that targets vulnerable populations (as specified at Section 111(a)(3))? Please check all those that apply.
- a. ________ children
- b. ________ prisoners
- c. ________ pregnant women
- d. ________ fetuses
- e. ________ mentally disabled persons
- f. ________ economically disadvantaged persons
- g. ________ educationally disadvantaged persons
- h. ________ other (please specify)
- .Does your agency have an administrative unit dedicated to implementing human subjects protections?
- _____Yes _____No
- a. If so, how many FTEs are working in that unit? ____________
- b. If so, what was the FY 1999 budget for that unit? ____________
- Does your agency comply with additional regulations, policies, or procedures (whether mandated or self-imposed) relevant to the protection of human subjects in research? (apart from implementation of the Federal Policy for the Protection of Human Subjects, 56 Fed. Reg. 28003 (June 18, 1991) (Common Rule)).
- _____Yes _____No
- If yes, please provide copies of regulations, policies or procedures to NBAC if you have not already done so. If already provided, please note here.
- Does your agency issue assurances of compliance?
- _____Yes _____No
- If yes, please provide copies of "sample" documents to NBAC. If copies have already been provided to NBAC, please note so here.
- a. Who, in your agency, is authorized to negotiate an assurance? (provide title, not name) ______________________________________________________ ______________________________
- b. Does your agency rely on other agency assurances, such as the DHHS Multiple Project Assurance? _____Yes _____No
- If yes, please indicate which agency (or agencies) and what type(s) of assurances?
- Please describe the policies and procedures, if any, your agency uses to investigate allegations that human subjects research conducted or supported by your agency has not been conducted in compliance with the regulations. Provide a brief description here or attach policies and procedures or note that they have already been provided to NBAC.
- a. Who in your organization is authorized to make a final determination about noncompliance? (provide title, not name) ______________________________________________________ _________________
- b. What sanctions, if any, are available to your agency to impose on individuals or institutions found in violation of the laws, regulations, policies, or procedures for the protection of human subjects in research? Who imposes such sanctions? Provide a brief description here, or attach policies and procedures. (Please note whether they have already been provided to NBAC).
- Describe any educational or outreach activities undertaken by your agency to inform investigators, institutions, and/or IRBs about the Common Rule. Provide a brief description here or attach descriptions or note that they have already been provided to NBAC
- If applicable, please describe emerging research issues that are likely to influence human subjects protection.
- Please provide NBAC with a description of any changes in policies or procedures that have been implemented by your agency since it initially responded to Executive Order 12975. If this information has already been provided to NBAC, please note so here.
- Please provide NBAC with suggestions for changes in the government-wide human subjects protection system, including, but not limited to, changes in or revisions to the Common Rule.
- Please respond by February 15, 2000.
- Thank you for your assistance.
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Table 1: Federal Signatories* to the Common Rule**
| Relevant Section of Code of Federal Regulations (CFR) |
Department/Agency |
| 45 CFR Part 46 |
Department of Health and Human Services2 |
| 10 CFR Part 745 |
Department of Energy |
| 14 CFR Part 1230 |
National Aeronautics and Space Administration |
| 15 CFR Part 27 |
Department of Commerce |
| 16 CFR Part 1028 |
Consumer Product Safety Commission |
| 22 CFR Part 225 |
International Development Cooperation Agency, Agency for International Development |
| 24 CFR Part 60 |
Department of Housing and Urban Development |
| 28 CFR Part 46 |
Department of Justice |
| 32 CFR Part 219 |
Department of Defense |
| 34 CFR Part 97 |
Department of Education |
| 38 CFR Part 16 |
Department of Veteran Affairs |
| 40 CFR Part 26 |
Environmental Protection Agency |
| 45 CFR Part 690 |
National Science Foundation |
| 49 CFR Part 11 |
Department of Transportation |
| Not codified in regulation |
Office of Science and Technology Policy |
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Table 2: Federal Agencies Responding to December 1999 NBAC Survey (Acronyms)
| Agency Name |
Acronym |
| Central Intelligence Agency |
CIA |
| Department of Commerce |
DOC |
| National Telecommunications and Information Administration |
NTIA |
| National Institute of Standards and Technology |
NIST |
| Department of Defense |
DOD |
| Department of Education |
ED |
| Department of Energy |
DOE |
| Department of Health and Human Services |
DHHS |
| Centers for Disease Control and Prevention |
CDC |
| Department of Housing and Urban Development |
HUD |
| Department of Justice |
DOJ |
| Community-Oriented Policing Services |
COPS |
| Department of Transportation |
DOT |
| National Highway Traffic Safety Administration |
NHTSA |
| Department of Veterans Affairs |
VA |
| National Aeronautics and Space Administration |
NASA |
| National Science Foundation |
NSF |
| Social Security Administration |
SSA |
| U.S. Agency for International Development |
AID |
| U.S. Consumer Product Safety Commission |
CPSC |
| U.S. Environmental Protection Agency |
EPA |
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Table 3: Agency Budget Data, FY 1999 ($ in thousands)
| Agency |
Total Budget |
Amount Research |
Amount Human Subjects Research |
| CIA |
classified |
classified |
classified |
| Commerce |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -NTIA |
66,765 |
17,600 |
17,600 |
| -NIST |
641,000 |
410,240 |
41,024 |
| -CEN |
317,00011 |
317,000 |
158,500 |
| Defense |
252,300,000 |
35,915,600 |
37,100 |
| Education |
39,000,000 |
143,000 |
50,000 |
| Energy |
18,000,000 |
4,000,000 |
27,000 |
| DHHS |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -ACF |
NA/Unknown |
30,000 |
30,000 |
| -AHRQ |
170,955 |
136,764 |
109,411 |
| -CDC |
2,638,981 |
433,307 |
167,465 |
| -ATSDR |
76,000 |
7,600 |
4,560 |
| -FDA |
1,132,974 |
113,297 |
11,329 |
| -HCFA |
1,946,00022 |
50,000 |
15,000 |
| -HRSA |
4,353,564 |
130,793 |
75,908 |
| -IHS |
2,240,000 |
22,400 |
22,400 |
| -NIH |
15,602,7003 |
15,600,000 |
8,580,000 |
| -SAMHSA |
2,486,787 |
338,344 |
338,344 |
| Housing and Urban |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| Development |
24,500,000 |
55,000 |
11,000 |
| Justice |
18,450,850 |
184,508 |
110,705 |
| Transportation |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -FAA |
9,750,000 |
150,000 |
25,000 |
| -USCG |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -FHA |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -NHTSA |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| Veterans Affairs |
42,625,029 |
316,000 |
175,600 |
| NASA |
13,652,000 |
5,654,000 |
20,000 |
| NSF |
3,737,000 |
2,506,000 |
150,360 |
| Social Security |
421,000,000 |
68,00043 |
40,000 |
| EPA |
7,600,000 |
760,000 |
76,000 |
| AID |
8,342,000 |
200,000 |
60,000 |
| Consumer Product |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| Safety Commission |
47,000 |
N/A |
100 |
| TOTAL |
NA/Unknown |
NA/Unknown |
10,354,406 |
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Table 4: Review of "In-House" Research at Federal Agencies
| Agency |
PHS1 |
Number of IRBs |
Number of Protocols FY 1999 |
| Department of Health and Human Services |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -ACF |
0 |
0 |
0 |
| -AHRQ |
25 |
0 (planned) |
0 |
| -CDC |
23 |
6 |
1,031 |
| -FDA |
<1 |
1 |
14 |
| -HCFA |
0 |
02 |
0 |
| -HRSA |
<1 |
03 |
0 |
| -IHS |
50 |
13 |
200 |
| -NIH |
10 |
14 |
1,337 |
| -SAMHSA |
0 |
0 |
0 |
| Department of Energy |
0 |
0 |
0 |
| Central Intelligence Agency |
0 |
1 |
2 |
| National Aeronautics and Space Administration |
50 |
5 |
200 |
| Department of Commerce |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -NTIA |
0 |
0 |
0 |
| -NIST |
10 |
1 |
37 (including exempt) |
| -Census |
100 |
0 |
0 |
| Consumer Product Safety Commission |
<10 |
1 |
4 |
| Agency for International Development |
0 |
0 |
0 |
| Department of Housing and Urban Development |
30 |
0 |
0 |
| Department of Justice |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -FBI |
0-3 |
1 |
10 |
| -BOJP |
0-3 |
1 |
0 |
| -BOP |
0-3 |
1 |
50 |
| Department of Defense |
45-100 |
43 |
3,572 |
| Department of Education |
0 |
1 |
0 |
| Department of Veterans Affairs |
100 |
101 |
? |
| Environmental Protection Agency |
30 |
0 |
0 |
| National Science Foundation |
0 |
0 |
0 |
| Department of Transportation |
0-40 (FAA) |
FAA 2 |
40 |
| Social Security Administration |
~66 |
0 |
0 |
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Table 5: What is the Nature of Human Subject Research by your Agency?
| Agency |
Social Science/Behavior |
Social Science/Research |
Clinical Research |
Epidemiology |
Large Population on Surveys |
Development Tools/Methods |
Health Services |
Operational |
Demonstration |
Education |
Community Based |
Human Factors |
| CIA |
Y |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
| DOC |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
| -NTIA |
Y |
Y |
Y |
Y |
Y |
N |
Y |
Y |
Y |
N |
Y |
N |
| -NIST |
N |
N |
Y |
N |
N |
N |
Y |
Y |
Y |
Y |
N |
Y |
| -CEN |
N |
Y |
N |
N |
Y |
Y |
N |
N |
N |
N |
N |
Y |
| DOD |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
| ED |
Y |
Y |
Y |
N |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
| DOE |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
| DHHS |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
| -ACF |
NP |
NP |
NP |
NP |
NP |
NP |
NP |
NP |
NP |
NP |
NP |
NP |
| -AHRQ |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
N |
| -CDC |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
N |
| -FDA |
N |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
N |
N |
| -HCFA |
N |
N |
N |
N |
Y |
N |
Y |
N |
Y |
N |
N |
N |
| -HRSA |
N |
Y |
N |
Y |
Y |
N |
Y |
Y |
Y |
N |
Y |
N |
| -IHS |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
| -NIH |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
| -OPRR |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
| -SAMHS |
Y |
N |
N |
Y |
Y |
Y |
Y |
Y |
Y |
N |
Y |
Y |
| HUD |
N |
N |
N |
N |
Y |
N |
N |
N |
Y |
N |
N |
N |
| DOJ |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
| -OJP |
Y |
Y |
N |
N |
Y |
Y |
N |
Y |
Y |
N |
Y |
N |
| -COPS |
Y |
N |
N |
N |
Y |
N |
N |
Y |
Y |
N |
Y |
N |
| -BOP |
N |
Y |
N |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
N |
| -FBI |
Y |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
| DOT |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
| -FAA |
Y |
Y |
N |
N |
Y |
Y |
N |
Y |
N |
N |
N |
Y |
| -USCG |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Y |
| -FHA |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Y |
| -NHTSA |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Y |
| VA |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
| NASA |
Y |
N |
Y |
Y |
N |
Y |
Y |
Y |
N |
N |
N |
Y |
| NSI |
Y |
Y |
N |
N |
Y |
N |
N |
N |
N |
Y |
N |
Y |
| SSA |
N |
Y |
N |
Y |
Y |
N |
N |
Y |
Y |
N |
N |
N |
| AID |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
N |
| CPSC* |
Y |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Y |
| EPA |
Y |
Y |
Y |
Y |
N |
Y |
N |
N |
Y |
N |
Y |
N |
| Totals |
14/16 |
12/16 |
9/16 |
10/16 |
12/16 |
11/16 |
9/16 |
11/16 |
11/16 |
9/16 |
9/16 |
10/16 |
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Table 6: Agencies that Sponsor or Conduct Research That Targets Vulnerable Populations
| Agency |
Children |
Prisoners |
Pregnant Women |
Fetuses |
Mentally Disabled Persons |
Economically Disadvantaged Persons |
Educationally Disadvantaged Persons |
Others |
| CIA |
N |
N |
N |
N |
N |
N |
N |
N |
| DOC |
N |
N |
N |
N |
N |
N |
N |
N |
| -NTIA |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
N |
| -NISI |
Y |
Y |
N |
N |
N |
N |
N |
N |
| -CEN |
N |
Y |
N |
N |
N |
N |
N |
N |
| DOD |
Y |
Y |
Y |
N |
Y |
N |
Y |
Military Students |
| ED |
Y |
Y |
Y |
N |
Y |
Y |
Y |
N |
| DHHS |
N |
N |
N |
N |
N |
N |
N |
N |
| -ACF |
Y |
N |
Y |
N |
N |
Y |
Y |
N |
| -AHRQ |
Y |
N |
Y |
N |
Y |
Y |
Y |
N |
| -CDC |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
N |
| -FDA |
Y |
N |
Y |
N |
Y |
N |
N |
N |
| -HCFA |
Y |
N |
Y |
N |
Y |
N |
N |
Elderly |
| -HRSA |
Y |
N |
Y |
N |
N |
Y |
N |
N |
| -IHS |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
| -NIH |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
| -OPRR |
N |
N |
N |
N |
N |
N |
N |
N |
| -SAMHSA |
Y |
Y |
Y |
N |
Y |
Y |
Y |
N |
| HUD |
Y |
N |
N |
N |
N |
C |
N |
N |
| DOJ |
N |
N |
N |
N |
N |
N |
N |
N |
| -OJP |
Y |
Y |
Y |
N |
Y |
Y |
Y |
N |
| -COPS |
N |
Y |
N |
N |
Y |
Y |
Y |
N |
| -BOP |
N |
Y |
N |
N |
Y |
Y |
Y |
N |
| -FBI |
N |
Y |
N |
N |
N |
N |
N |
N |
| DOT |
N |
N |
N |
N |
N |
N |
N |
N |
| -FAA |
N |
N |
N |
N |
N |
N |
N |
N |
| -USCG |
N |
N |
N |
N |
N |
N |
N |
N |
| -FHA |
N |
N |
N |
N |
N |
N |
N |
N |
| -NHTSA |
N |
N |
N |
N |
N |
N |
N |
N |
| VA |
Y |
N |
Y |
Y |
Y |
Y |
Y |
Veterans, Employees |
| NASA |
N |
N |
N |
N |
N |
N |
N |
Empolyees |
| NSF |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
N |
| SSA |
Y |
N |
N |
N |
Y |
Y |
Y |
N |
| AID |
Y |
N |
Y |
N |
N |
Y |
Y |
NA/Unknown |
| CPSC |
Y |
N |
N |
N |
N |
N |
N |
N |
| EPA |
Y |
N |
N |
N |
N |
Y |
Y |
N |
| Totals |
13/16 |
6/16 |
8/16 |
4/16 |
9/16 |
10/16 |
10/16 |
NA |
Back to Top
Table 7: Exemptions According to Section 101
| Agency |
Estimated percent of human subjects research deemed exempt |
Educational Settings |
| DOJ |
0-80 |
Y |
| HUD |
40 |
N |
| AID |
50 |
N |
| CIA |
0 |
N |
| EPA |
3-5 |
N |
| DOC |
60-100 |
Y |
| NASA |
0 |
N |
| VA |
unknown |
Y |
| CPSC |
50-100 |
N |
| ED |
60 |
Y |
| SSA |
100 |
N |
| DOD |
80 |
Y |
| DOT |
5 |
N |
| NSF |
80-100 |
Y |
| DOE |
unknown |
Y |
| DHHS |
NA |
NA |
| -ACF |
0 |
Y |
| -AHRQ |
20-90 |
Y |
| -CDC |
10 |
Y |
| -FDA |
<10 |
Y |
| -HCFA |
100 |
N |
| -HRSA |
100 |
N |
| -IHS |
20 |
Y |
| -NIH |
<10 |
Y |
| -OPRR |
? |
? |
| -SAMHSA |
0-100 |
N |
Back to Top
Table 8: Administrative Aspects of Agency Human Subjects Protection Activities
| Agency |
Dedicated Administrative Unit |
Budget |
Issue Assurances of Compliance |
Rely on Other Agency Assurances |
| DOJ |
Yes, Two part time FTEs |
N/A |
Some components |
DHHS |
| HUD |
No (Office of Lead Hazard Control's Planning and Standards Division) |
NA/Unknown |
No |
NA/Unknown |
| AID |
Yes, Cognizant Human Subjects Officers |
NA/Unknown |
Yes |
DHHS, DOD |
| CIA |
Yes, Chief of Human Subjects Research Panel and Contracting Officer's Technical Representatives |
NA/Unknown |
No |
No |
| EPA |
No |
NA/Unknown |
Yes |
DHHS |
| DOC |
NA/Unknown |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -NTIA |
No |
NA/Unknown |
No |
No |
| -NIST |
Personnel in Deputy Chief Counsel's office and elsewhere |
NA/Unknown |
Yes |
DHHS |
| -CEN |
No |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| NASA1. |
Yes, 5.9 FTEs |
$625,000 |
Yes |
DHHS |
| VA |
Yes, 3 units, 3 FTEs |
NA/Unknown |
Yes |
DHHS |
| CPSC |
No |
NA/Unknown |
Yes |
DHHS |
| ED |
Yes, 1.5 FTEs |
$200,000 |
Yes |
DHHS |
| SSA |
No |
NA/Unknown |
No |
DHHS |
| SSA |
No |
NA/Unknown |
No |
DHHS |
| DOD |
Yes, 60 FTEs |
$3,500,000 |
Yes |
DHHS |
| NSF |
Yes, part time FTE |
NA/Unknown |
Yes |
Yes |
| DOT |
No |
NA/Unknown |
No |
DHHS |
| DOE |
Yes, 2 FTE |
$425,000 |
Yes |
DHHS |
| DHHS |
NA/Unknown |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -ACF |
No |
NA/Unknown |
NA/Unknown |
DHHS |
| -AHRQ |
No |
NA/Unknown |
NA/Unknown |
DHHS |
| -CDC |
Yes, 6 FTEs |
$651,505 |
NA/Unknown |
DHHS |
| -FDA |
Yes, ~287 FTEs2 |
~$37,000,000 |
NA/Unknown |
DHHS |
| -HCFA |
Yes, 6 FTEs |
NA/Unknown |
NA/Unknown |
NA/Unknown |
| -HRSA |
No |
NA/Unknown |
NA/Unknown |
DHHS |
| IHS |
Yes, 4.7 FTEs |
$1,000,000 |
NA/Unknown |
DHHS |
| -NIH |
Yes, 4FTEs in Office of Human Subjects Research, another 10.73 in institute's administrative units, 19 FTEs in OPRR |
$480,000 for Office of HSR, $334,965 for administrative units, $2,700,000 for OPRR |
NA/Unknown |
DHHS |
| -SAMHSA |
No |
NA/Unknown |
NA/Unknown |
DHHS |
Back to Top
Table 9: Additional Regulations, Policies, or Procedures Relevant to Human Subjects Protections
Agency/Department Relevant controlling authorities and directives
- Department of Justice
- Agency for International Development
- Central Intelligence Agency
- Environmental Protection Agency
- Department of Commerce
- National Aeronautics and Space Administration
- Department of Veterans Affairs
- Consumer Product Safety Commission
- Department of Education
- OJP Instruction for the Protection of Human Subjects of Research and Statistical Activities (I 1564.1)
- 42 USC section 3789g and 28 CFR Parts 22 and 46 - Confidentiality of Identifiable Research and Statistical Information (privacy certificate available)(special protections for prisoners)
- Protection of Human Subjects and Privacy Certificate Requirements (11/9/99)
- Program Statement 512.10 (5/12/99) specifies additional requirements for researchers to obtain approval to conduct research within the Bureau of Prisons
- Administrative Law Unit: Establishment of FBI Policy Regarding Human Subject Research and an FBI Institutional Review Board (11/05/98)
- Procedures for Protection of Human Subjects in Research Supported by AID
- How to Interpret the Federal Policy for the Protection of Human Subjects or "Common Rule" (Part A)
- Standard Contract Clause of Human Subjects Research
- Executive Order 12333 and HR 7-1 (establishes Human Subjects Research Panel)
- Employee Bulletin No. 98-008 (5/22/98), Agency-Sponsored Research Using Human Subjects
- EPA Order 1000.17, Change A1, Policy and Procedures on Protection of Human Research Subjects in EPA Conducted or Supported Research (7/30/99)
- NIST Administrative Manual
- Title 13 USC, the Census Law protects individual data and sets standards for informed consent
- The Privacy Act of 1974 provides legal exemptions and cites requirements on uses of personal data for statistical research at the Census Bureau
- NASA Policy Directive 7100.8C (1/1/1999), Protection of Human Subjects
- 42 USC 2473 (c)(1), Section 203 (c)(1), The National Aeronautics and Space Act of 1958, as amended
- Interim Policy Memorandum 8900-2, Astronaut Health Care and Biomedical Research OLMSA Supplemental Guidance to NMI 8900.3D and NPD 7100.8A (2/9/1999)
- NPD 8621.1 NASA Mishap Reporting and Investigating Policy
- NPG 1441.1 NASA Records Retention Schedules
- 38 CFR Part 17, Treatment of Research-Related Injuries to Human Subjects (April 1998)
- M-3, Part 1, Chapter 15 (Scientific Misconduct)
- M-3, Part 1, chapter 9 (Requirements for the Protection of Human Subjects)
- VA Multiple Project Assurance Contract
- CPSC Order 0620.1, Protection of Human Subjects in Research
- Subpart D, Additional Protections for Children
- The Protection of Pupil Rights Amendment, 34 CFR Part 98
- Family Education Rights and Privacy Act, 34 CFR Part 99
- 34 CFR 350.4(c) and 34 CFR 356.3(c), additional IRB membership requirements
- National Center for Educational Statistics Confidentiality Statute
- ED Directive A:CFO/CIO:1-105, The Protection of Human Subjects in Research: Ethical Principles and ED Policies, Intramural Research Involving Human Subjects, and the ED Institutional Review Board (8/18/98)
- ED Directive A:CFO/CIO:1-106, Protection of Human Subjects in Research: Extramural Research (2/2/1999)
- Social Security Administration
- Department of Defense
- Department of Transportation
- Department of Energy
- Department of Health and Human Services
- Social Security Independence and Program Improvements Act (P.L. 103-296)
- Privacy Act of 1974
- Freedom of Information Act
- Section 1106, Social Security Act (legal authority to disclose)
- Section 6103 Internal Revenue Code (26 USC 6103)
- DOD Directive 3216.2, Protection of Human Subjects in DOD Sponsored Research
- Air Force Instruction 40-402, Using Human Subjects in Research, Development, Test, and Evaluation
- Army Regulation 70-25 Use of Volunteers as Subjects of Research
- Secretary of the Navy Instruction 3900.39B, Protection of Human Subjects
- Office of Naval Research Instruction 3900.34A, Protection of Human Subjects
- Naval Medical Research and Development Command Instruction 3900.2, Protection of Human Research Volunteers from Research Risk
- Uniformed Services University of the Health Sciences Instruction 3201, Human Subjects Research at USUHS
- DODD 3216.2, DODD 6000.8, Funding and Administration of Clinical Investigations Programs
- AFI 40-403, Clinical Investigations in Medical Research
- AR40-38, Clinical Investigations Program
- Bureau of Medicine and Surgery Instruction 6000.12, Clinical Investigation Program
- Naval School of Health Sciences Instruction 6000.41A, Clinical Investigation Program
- 10 USC 980
- DODD 5500.7, Standards of Conduct
- DODD 6025.13, Clinical Quality Management Program in the Military Health Services System
- AFI 44-119, Medical Service Clinical Quality Management
- FAA Order 9500.25, Protection of Human Research Subjects
- DOE Order 443.1, Protection of Human Subjects (5/15/2000)
- Human Subjects Research Handbook
- DOE Secretarial Memo, Policy Update on Protection of Human Research Subjects (1/98)
- SAMHSA has requirements for confidentiality certificates and Protection and Advocacy for persons with mental illness (EP 98-01)
- AHRQ Standard Operating Procedure, Assurance of Human Subject Certification
- HCFA's Data Use Policies and Procedures Handbook
- Privacy Act
- In addition to complying with 21 CFR Parts 50 and 56, FDA complies with 45 CFR 46, Subparts B, C, and D, 21 and the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
- HRSA Policy Circular 96.05, Protection of Participants in HRSA Research Programs
- NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
- NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects
- NIH Guidelines for Research Involving Recombinant DNA Molecules
- The Indian Health Service requires that all research be approved by the relevant tribal government
- IHS Guidelines for Implementing and Complying with HIS Policy on Specimens (9/18/1998)
- CDC complies with Subparts B, C, and D of 45 CFR 46
Back to Top
Table 10: Human Subjects Protections Education and Training Activities
- Training for staff and funding recipients
- Use of the agency website
- Via program announcements, solicitations, and application kits
- CD-ROMs
- Institutional Review Board training
- Site visits
- Regular briefings
- Lecture and compulsory courses for project officers
- Satellite broadcasts
- Interagency meetings
- Newsletters
- Attendance at Arena and Public Responsibility in Medicine and Research (PRIM&R) meetings
- Agency work groups
- Informational publications and handbooks
Back to Top
Table 11: Some Emerging Research Issues Likely to Influence Human Subjects Protection (as Reported by Agencies)
Substantive
- Cyber-research
- Action (or participatory) research
- Genetics research
- Health effects studies in the workplace
- Stem cell research
- Telemedicine and electronic medical records research
- International research
- Potential harms and benefits to communities
Procedural
- Research using public use and restricted data sets
- Use of employees in research
- Conflicts of interest for investigators and institutions
- Reimbursement for medical expenses incurred by subjects during research
- Consumer demands for investigational new agents
Back to Top
Table 12: Suggested Changes in the Government-Wide Human Subjects Protection System
- Clarify requirements for protection for disease surveillance activities versus research.
- Clarify the concept of minimal risk in social science research.
- Develop a means to triage the system to determine risk - e.g., full IRB review for protected classes, full IRB review not involving protected classes, expedited review, exempt projects.
- Improve the competencies of IRBs.
- Coordinate/streamline differences between federal agency policies and practices, specifically between NIH and FDA.
- Refine the definition of research.
- Clarify when consent by third parties is appropriate.
- Protect subjects in privately funded research.
- Extend the protection system to all federal agencies.
- Enact administrative reforms (compliance, flexibility, costs).
- Enact educational reforms (requirements, programs, public).
- Develop a better definition of what constitutes exempt research.
- Improve the definition of human subject.
- Refine the definition of vulnerable populations.
- Encourage adoption of Subparts B, C, and D by all agencies.
Cite this page:
"Federal Agency Survey on Policies and Procedures (Research Involving Human Participants V2)"
Online Ethics Center for Engineering
5/25/2007
National Academy of Engineering
Accessed: Wednesday, February 08, 2012
<www.onlineethics.org/Topics/RespResearch/ResResources/nbacindex/nbachindex/hnbac.aspx>