Environmental Protection Agency Pt. 26 PART 26—PROTECTION OF HUMAN SUBJECTS Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Con- ducted or Supported by EPA Sec. 26.101 To what does this policy apply? 26.102 Definitions. 26.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal Department or Agency. 26.104–26.106 [Reserved] 26.107 IRB membership. 26.108 IRB functions and operations. 26.109 IRB review of research. 26.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk, and for minor changes in approved research. 26.111 Criteria for IRB approval of research. 26.112 Review by institution. 26.113 Suspension or termination of IRB ap- proval of research. 26.114 Cooperative research. 26.115 IRB records. 26.116 General requirements for informed consent. 26.117 Documentation of informed consent. 26.118 Applications and proposals lacking definite plans for involvement of human subjects. 26.119 Research undertaken without the in- tention of involving human subjects. 26.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or supported by a Federal De- partment or Agency. 26.121 [Reserved] 26.122 Use of Federal funds. 26.123 Early termination of research sup- port: Evaluation of applications and pro- posals. 26.124 Conditions. Subpart B—Prohibition of Research Con- ducted or Supported by EPA Involving Intentional Exposure of Human Sub- jects who are Children or Pregnant or Nursing Women 26.201 To what does this subpart apply? 26.202 Definitions. 26.203 Prohibition of research conducted or supported by EPA involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child. Subpart C—Observational Research: Addi- tional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA 26.301 To what does this subpart apply? 26.302 Definitions. 26.303 Duties of IRBs in connection with ob- servational research involving pregnant women and fetuses. 26.304 Additional protections for pregnant women and fetuses involved in observa- tional research. 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material. Subpart D—Observational Research: Addi- tional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA 26.401 To what does this subpart apply? 26.402 Definitions. 26.403 IRB duties. 26.404 Observational research not involving greater than minimal risk. 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the indi- vidual subjects. 26.406 Requirements for permission by par- ents or guardians and for assent by chil- dren. Subparts E–J [Reserved] Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pes- ticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults 26.1101 To what does this subpart apply? 26.1102 Definitions. 26.1103–26.1106 [Reserved] 26.1107 IRB membership. 26.1108 IRB functions and operations. 26.1109 IRB review of research. 26.1110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk, and for minor changes in approved research. 26.1111 Criteria for IRB approval of re- search. 26.1112 Review by institution. 26.1113 Suspension or termination of IRB approval of research. 26.1114 Cooperative research. 26.1115 IRB records. 26.1116 General requirements for informed consent. 26.1117 Documentation of informed consent. 281 § 26.101 26.1118–26.1122 [Reserved] 26.1123 Early termination of research. 26.1124 [Reserved] 26.1125 Prior submission of proposed human research for EPA review. Subpart L—Prohibition of Third-Party Re- search for Pesticides Involving Inten- tional Exposure of Human Subjects who are Children or Pregnant or Nurs- ing Women 26.1201 To what does this subpart apply? 26.1202 Definitions. 26.1203 Prohibition of research involving in- tentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research 26.1301 To what does this subpart apply? 26.1302 Definitions. 26.1303 Submission of information per- taining to ethical conduct of completed human research. Subpart N [Reserved] Subpart O—Administrative Actions for Noncompliance 26.1501 To what does this subpart apply? 26.1502 Lesser administrative actions. 26.1503 Disqualification of an IRB or an in- stitution. 26.1504 Public disclosure of information re- garding revocation. 26.1505 Reinstatement of an IRB or an insti- tution. 26.1506 Debarment. 26.1507 Actions alternative or additional to disqualification. Subpart P—Review of Proposed and Completed Human Research 26.1601 EPA review of proposed human re- search. 26.1602 EPA review of completed human re- search. 26.1603 Operation of the Human Studies Re- view Board. Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions 26.1701 To what does this subpart apply? 26.1702 Definitions. 26.1703 Prohibition of reliance on research involving intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or children. 40 CFR Ch. I (7–1–11 Edition) 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults conducted before April 7, 2006. 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non- nursing adults conducted after April 7, 2006. 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable research. AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42 U.S.C. 300v–1(b). SOURCE: 56 FR 28012, 28022, June 18, 1991, unless otherwise noted. Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.101 To what does this policy apply? (a) Except as provided in paragraph (b) of this section, this policy applies to all research involving human sub- jects conducted, supported or otherwise subject to regulation by any Federal department or agency which takes ap- propriate administrative action to make the policy applicable to such re- search. This includes research con- ducted by Federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise sub- ject to regulation by the Federal Gov- ernment outside the United States. (1) Research that is conducted or sup- ported by a Federal department or agency, whether or not it is regulated as defined in § 26.102(e), must comply with all sections of this policy. (2) Research that is neither con- ducted nor supported by a Federal de- partment or agency but is subject to regulation as defined in § 26.102(e) must be reviewed and approved, in compli- ance with § 26.101, § 26.102, and § 26.107 through § 26.117 of this policy, by an in- stitutional review board (IRB) that op- erates in accordance with the pertinent requirements of this policy. (b) Unless otherwise required by de- partment or agency heads, research ac- tivities in which the only involvement 282 Environmental Protection Agency § 26.101 of human subjects will be in one or more of the following categories are exempt from this policy: (1) Research conducted in established or commonly accepted educational set- tings, involving normal educational practices, such as (i) research on reg- ular and special education instruc- tional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, cur- ricula, or classroom management methods. (2) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey proce- dures, interview procedures or observa- tion 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 sub- jects’ 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. (3) Research involving the use of edu- cational tests (cognitive, diagnostic, aptitude, achievement), survey proce- dures, interview procedures, or obser- vation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) The human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) with- out exception that the confidentiality of the personally identifiable informa- tion will be maintained throughout the research and thereafter. (4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or di- agnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be iden- tified, directly or through identifiers linked to the subjects. (5) Research and demonstration projects which are conducted by or sub- ject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise exam- ine: (i) Public benefit or service pro- grams; (ii) Procedures for obtaining benefits or services under those programs; (iii) Possible changes in or alter- natives to those programs or proce- dures; or (iv) Possible changes in methods or levels of payment for benefits or serv- ices under those programs. (6) Taste and food quality evaluation and consumer acceptance studies, (i) If wholesome foods without addi- tives are consumed or (ii) If a food is consumed that con- tains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environ- mental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agri- culture. (c) Department or agency heads re- tain final judgment as to whether a particular activity is covered by this policy. (d) Department or agency heads may require that specific research activities or classes of research activities con- ducted, supported, or otherwise subject to regulation by the department or agency but not otherwise covered by this policy, comply with some or all of the requirements of this policy. (e) Compliance with this policy re- quires compliance with pertinent Fed- eral laws or regulations which provide additional protections for human sub- jects. (f) This policy does not affect any State or local laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. (g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and which pro- vide additional protections to human subjects of research. (h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies 283 § 26.102 with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a department or agency head determines that the proce- dures prescribed by the institution af- ford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the proce- dural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the de- partment or agency head, notices of these actions as they occur will be pub- lished in the FEDERAL REGISTER or will be otherwise published as provided in department or agency procedures. (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific re- search activities or classes of research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the de- partment or agency head shall forward advance notices of these actions to the Office for Human Research Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office, and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in de- partment or agency procedures. 1 [56 FR 28012, 28022, June 18, 1991, 56 FR 29756, June 28, 1991, as amended at 70 FR 36328, June 23, 2005] 1 Institutions with HHS-approved assur- ances on file will abide by provisions of title 45 CFR part 46 subparts A–D. Some of the other Departments and Agencies have incor- porated all provisions of title 45 CFR part 46 into their policies and procedures as well. However, the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research in- volving observations of public behavior when the investigator(s) do not participate in the activities being observed. 40 CFR Ch. I (7–1–11 Edition) § 26.102 Definitions. (a) Department or agency head means the head of any Federal department or agency and any other officer or em- ployee of any department or agency to whom authority has been delegated. (b) Institution means any public or private entity or agency (including Federal, State, and other agencies). (c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the procedure(s) involved in the research. (d) Research means a systematic in- vestigation, including research devel- opment, testing and evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this definition constitute re- search for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (e) Research subject to regulation, and similar terms are intended to encom- pass those research activities for which a Federal department or agency has specific responsibility for regulating as a research activity, (for example, In- vestigational New Drug requirements administered by the Food and Drug Ad- ministration). It does not include re- search activities which are inciden- tally regulated by a Federal depart- ment or agency solely as part of the de- partment’s or agency’s broader respon- sibility to regulate certain types of ac- tivities whether research or non-re- search in nature (for example, Wage and Hour requirements administered by the Department of Labor). (f) Human subject means a living indi- vidual about whom an investigator (whether professional or student) con- ducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. Intervention includes both physical pro- cedures by which data are gathered (for 284 Environmental Protection Agency § 26.103 example, venipuncture) and manipula- tions of the subject or the subject’s en- vironment that are performed for re- search purposes. Interaction includes communication or interpersonal con- tact between investigator and subject. ‘‘Private information’’ includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably expect that no observation or recording is taking place, and informa- tion which has been provided for spe- cific purposes by an individual and which the individual can reasonably expect will not be made public (for ex- ample, a medical record). Private infor- mation must be individually identifi- able (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the in- formation) in order for obtaining the information to constitute research in- volving human subjects. (g) IRB means an institutional review board established in accord with and for the purposes expressed in this pol- icy. (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and may be con- ducted at an institution within the constraints set forth by the IRB and by other institutional and Federal re- quirements. (i) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of rou- tine physical or psychological exami- nations or tests. (j) Certification means the official no- tification by the institution to the sup- porting department or agency, in ac- cordance with the requirements of this policy, that a research project or activ- ity involving human subjects has been reviewed and approved by an IRB in ac- cordance with an approved assurance. § 26.103 Assuring compliance with this policy—research conducted or sup- ported by any Federal Department or Agency. (a) Each institution engaged in re- search which is covered by this policy and which is conducted or supported by a Federal department or agency shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements set forth in this policy. In lieu of re- quiring submission of an assurance, in- dividual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for federalwide use by that office. When the existence of an HHS-approved as- surance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protec- tions, HHS, or any successor office. (b) Departments and agencies will conduct or support research covered by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB pro- vided for in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum include: (1) A statement of principles gov- erning the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regu- lation. This may include an appro- priate existing code, declaration, or statement of ethical principles, or a statement formulated by the institu- tion itself. This requirement does not preempt provisions of this policy appli- cable to department- or agency-sup- ported or regulated research and need not be applicable to any research ex- empted or waived under § 26.101 (b) or (i). (2) Designation of one or more IRBs established in accordance with the re- quirements of this policy, and for which provisions are made for meeting space and sufficient staff to support the IRB’s review and recordkeeping duties. 285 § 26.103 (3) A list of IRB members identified by name; earned degrees; representa- tive capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each mem- ber’s chief anticipated contributions to IRB deliberations; and any employ- ment or other relationship between each member and the institution; for example: full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant. Changes in IRB member- ship shall be reported to the depart- ment or agency head, unless in accord with § 26.103(a) of this policy, the exist- ence of an HHS-approved assurance is accepted. In this case, change in IRB membership shall be reported to the Office for Human Research Protec- tions, HHS, or any successor office. (4) Written procedures which the IRB will follow (i) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) for determining which projects re- quire review more often than annually and which projects need verification from sources other than the investiga- tors that no material changes have oc- curred since previous IRB review; and (iii) for ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for ensuring that such changes in approved research, during the period for which IRB ap- proval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject. (5) Written procedures for ensuring prompt reporting to the IRB, appro- priate institutional officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or deter- minations of the IRB and (ii) any sus- pension or termination of IRB ap- proval. (c) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations im- posed by this policy and shall be filed 40 CFR Ch. I (7–1–11 Edition) in such form and manner as the depart- ment or agency head prescribes. (d) The department or agency head will evaluate all assurances submitted in accordance with this policy through such officers and employees of the de- partment or agency and such experts or consultants engaged for this purpose as the department or agency head de- termines to be appropriate. The depart- ment or agency head’s evaluation will take into consideration the adequacy of the proposed IRB in light of the an- ticipated scope of the institution’s re- search activities and the types of sub- ject populations likely to be involved, the appropriateness of the proposed ini- tial and continuing review procedures in light of the probable risks, and the size and complexity of the institution. (e) On the basis of this evaluation, the department or agency head may approve or disapprove the assurance, or enter into negotiations to develop an approvable one. The department or agency head may limit the period dur- ing which any particular approved as- surance or class of approved assurances shall remain effective or otherwise condition or restrict approval. (f) Certification is required when the research is supported by a Federal de- partment or agency and not otherwise exempted or waived under § 26.101 (b) or (i). An institution with an approved as- surance shall certify that each applica- tion or proposal for research covered by the assurance and by § 26.103 of this Policy has been reviewed and approved by the IRB. Such certification must be submitted with the application or pro- posal or by such later date as may be prescribed by the department or agen- cy to which the application or proposal is submitted. Under no condition shall research covered by § 26.103 of the Pol- icy be supported prior to receipt of the certification that the research has been reviewed and approved by the IRB. In- stitutions without an approved assur- ance covering the research shall certify within 30 days after receipt of a request for such a certification from the de- partment or agency, that the applica- tion or proposal has been approved by the IRB. If the certification is not sub- mitted within these time limits, the 286 Environmental Protection Agency § 26.109 application or proposal may be re- turned to the institution. (Approved by the Office of Management and Budget under Control Number 0990–0260) [56 FR 28012, 28022, June 18, 1991, 56 FR 29756, June 28, 1991, as amended at 70 FR 36328, June 23, 2005] §§ 26.104–26.106 [Reserved] § 26.107 IRB membership. (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly con- ducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as com- munity attitudes, to promote respect for its advice and counsel in safe- guarding the rights and welfare of human subjects. In addition to pos- sessing the professional competence necessary to review specific research activities, the IRB shall be able to as- certain the acceptability of proposed research in terms of institutional com- mitments and regulations, applicable law, and standards of professional con- duct and practice. The IRB shall there- fore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handi- capped or mentally disabled persons, consideration shall be given to the in- clusion of one or more individuals who are knowledgeable about and experi- enced in working with these subjects. (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and who is not part of the immediate family of a person who is affiliated with the insti- tution. (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any project in which the member has a conflicting interest, except to provide information re- quested by the IRB. (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. § 26.108 IRB functions and operations. In order to fulfill the requirements of this policy each IRB shall: (a) Follow written procedures in the same detail as described in § 26.103(b)(4) and, to the extent required by, § 26.103(b)(5). (b) Except when an expedited review procedure is used (see § 26.110), review proposed research at convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a ma- jority of those members present at the meeting. § 26.109 IRB review of research. (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure approval), or dis- approve all research activities covered by this policy. (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in accordance with § 26.116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in § 26.116, be given to the subjects when in the IRB’s judg- ment the information would meaning- fully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documenta- tion of informed consent or may waive documentation in accordance with § 26.117. 287 § 26.110 (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica- tion a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research covered by this pol- icy at intervals appropriate to the de- gree of risk, but not less than once per year, and shall have authority to ob- serve or have a third party observe the consent process and the research. (Approved by the Office of Management and Budget under Control Number 0990–0260) [56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 2005] § 26.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for minor changes in approved re- search. (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor of- fice. (b) An IRB may use the expedited re- view procedure to review either or both of the following: (1) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to involve no more than mini- mal risk, (2) Minor changes in previously ap- proved research during the period (of one year or less) for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more ex- perienced reviewers designated by the chairperson from among members of 40 CFR Ch. I (7–1–11 Edition) the IRB. In reviewing the research, the reviewers may exercise all of the au- thorities of the IRB except that the re- viewers may not disapprove the re- search. A research activity may be dis- approved only after review in accord- ance with the non-expedited procedure set forth in § 26.108(b). (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of re- search proposals which have been ap- proved under the procedure. (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institu- tion’s or IRB’s use of the expedited re- view procedure. [56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 2005] § 26.111 Criteria for IRB approval of research. (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the following require- ments are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are con- sistent with sound research design and which do not unnecessarily expose sub- jects to risk, and (ii) whenever appro- priate, by using procedures already being performed on the subjects for di- agnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distin- guished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long- range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of 288 Environmental Protection Agency § 26.115 the special problems of research in- volving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economi- cally or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representa- tive, in accordance with, and to the ex- tent required by § 26.116. (5) Informed consent will be appro- priately documented, in accordance with, and to the extent required by § 26.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to en- sure the safety of subjects. (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the con- fidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been in- cluded in the study to protect the rights and welfare of these subjects. § 26.112 Review by institution. Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB. § 26.113 Suspension or termination of IRB approval of research. An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head. (Approved by the Office of Management and Budget under Control Number 0990–0260) [56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 2005] § 26.114 Cooperative research. Cooperative research projects are those projects covered by this policy which involve more than one institu- tion. In the conduct of cooperative re- search projects, each institution is re- sponsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the department or agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoid- ing duplication of effort. § 26.115 IRB records. (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and reports of injuries to sub- jects. (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings; actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the discussion of controverted issues and their resolution. (3) Records of continuing review ac- tivities. (4) Copies of all correspondence be- tween the IRB and the investigators. (5) A list of IRB members in the same detail as described is § 26.103(b)(3). (6) Written procedures for the IRB in the same detail as described in § 26.103(b)(4) and § 26.103(b)(5). (7) Statements of significant new findings provided to subjects, as re- quired by § 26.116(b)(5). 289 § 26.116 (b) The records required by this pol- icy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be acces- sible for inspection and copying by au- thorized representatives of the depart- ment or agency at reasonable times and in a reasonable manner. (Approved by the Office of Management and Budget under Control Number 0990–0260) [56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 2005] § 26.116 General requirements for in- formed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the inves- tigator has obtained the legally effec- tive informed consent of the subject or the subject’s legally authorized rep- resentative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient oppor- tunity to consider whether or not to participate and that minimize the pos- sibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the sub- ject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the rep- resentative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the insti- tution or its agents from liability for negligence. (a) Basic elements of informed con- sent. Except as provided in paragraph (c) or (d) of this section, in seeking in- formed consent the following informa- tion shall be provided to each subject: (1) A statement that the study in- volves research, an explanation of the purposes of the research and the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed, and identification of any procedures which are experi- mental; 40 CFR Ch. I (7–1–11 Edition) (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the research; (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that might be advan- tageous to the subject; (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they consist of, or where further information may be ob- tained; (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements of in- formation shall also be provided to each subject: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may be- come pregnant) which are currently unforeseeable; (2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s con- sent; (3) Any additional costs to the sub- ject that may result from participation in the research; (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject; 290 Environmental Protection Agency § 26.117 (5) A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and (6) The approximate number of sub- jects involved in the study. (c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the ele- ments of informed consent set forth above, or waive the requirement to ob- tain informed consent provided the IRB finds and documents that: (1) The research or demonstration project is to be conducted by or subject to the approval of State or local gov- ernment officials and is designed to study, evaluate, or otherwise examine: (i) Public benefit of service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and (2) The research could not prac- ticably be carried out without the waiver or alteration. (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the ele- ments of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: (1) The research involves no more than minimal risk to the subjects; (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) The research could not prac- ticably be carried out without the waiver or alteration; and (4) Whenever appropriate, the sub- jects will be provided with additional pertinent information after participa- tion. (e) The informed consent require- ments in this policy are not intended to preempt any applicable Federal, State, or local laws which require addi- tional information to be disclosed in order for informed consent to be le- gally effective. (f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State, or local law. (Approved by the Office of Management and Budget under Control Number 0990–0260) [56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 2005] § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representa- tive. A copy shall be given to the per- son signing the form. (b) Except as provided in paragraph (c) of this section, the consent form may be either of the following: (1) A written consent document that embodies the elements of informed consent required by § 26.116. This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it before it is signed; or (2) A short form written consent doc- ument stating that the elements of in- formed consent required by § 26.116 have been presented orally to the sub- ject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the rep- resentative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form. (c) An IRB may waive the require- ment for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting 291 § 26.118 from a breach of confidentiality. Each subject will be asked whether the sub- ject wants documentation linking the subject with the research, and the sub- ject’s wishes will govern; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally re- quired outside of the research context. In cases in which the documentation requirement is waived, the IRB may re- quire the investigator to provide sub- jects with a written statement regard- ing the research. (Approved by the Office of Management and Budget under Control Number 0990–0260) [56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 2005] § 26.118 Applications and proposals lacking definite plans for involve- ment of human subjects. Certain types of applications for grants, cooperative agreements, or con- tracts are submitted to departments or agencies with the knowledge that sub- jects may be involved within the period of support, but definite plans would not normally be set forth in the applica- tion or proposal. These include activi- ties such as institutional type grants when selection of specific projects is the institution’s responsibility; re- search training grants in which the ac- tivities involving subjects remain to be selected; and projects in which human subjects’ involvement will depend upon completion of instruments, prior ani- mal studies, or purification of com- pounds. These applications need not be reviewed by an IRB before an award may be made. However, except for re- search exempted or waived under § 26.101 (b) or (i), no human subjects may be involved in any project sup- ported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the in- stitution, to the department or agency. § 26.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later pro- posed to involve human subjects in the 40 CFR Ch. I (7–1–11 Edition) research, the research shall first be re- viewed and approved by an IRB, as pro- vided in this policy, a certification sub- mitted, by the institution, to the de- partment or agency, and final approval given to the proposed change by the de- partment or agency. § 26.120 Evaluation and disposition of applications and proposals for re- search to be conducted or sup- ported by a Federal Department or Agency. The department or agency head will evaluate all applications and proposals involving human subjects submitted to the department or agency through such officers and employees of the depart- ment or agency and such experts and consultants as the department or agen- cy head determines to be appropriate. This evaluation will take into consid- eration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the re- search to the subjects and others, and the importance of the knowledge gained or to be gained. (b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one. § 26.121 [Reserved] § 26.122 Use of Federal funds. Federal funds administered by a de- partment or agency may not be ex- pended for research involving human subjects unless the requirements of this policy have been satisfied. § 26.123 Early termination of research support: Evaluation of applications and proposals. (a) The department or agency head may require that department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy. (b) In making decisions about sup- porting or approving applications or proposals covered by this policy the de- partment or agency head may take into account, in addition to all other 292 Environmental Protection Agency § 26.301 eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termi- nation or suspension under paragraph (a) of this section and whether the ap- plicant or the person or persons who would direct or has have directed the scientific and technical aspects of an activity has have, in the judgment of the department or agency head, mate- rially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to Federal regulation). § 26.124 Conditions. With respect to any research project or any class of research projects the de- partment or agency head may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head addi- tional conditions are necessary for the protection of human subjects. Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Ex- posure of Human Subjects who are Children or Pregnant or Nursing Women SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.201 To what does this subpart apply? (a) This subpart applies to all re- search involving intentional exposure of any human subject who is a preg- nant woman (and her fetus) or a child conducted or supported by the Environ- mental Protection Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA employ- ees. (b) The requirements of this subpart are in addition to those imposed under the other subparts of this part. § 26.202 Definitions. The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart. (a) Research involving intentional expo- sure of a human subject means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study. (b) A child is a person who has not at- tained the age of 18 years. § 26.203 Prohibition of research con- ducted or supported by EPA involv- ing intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child. Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. [71 FR 36175, June 23, 2006] Subpart C—Observational Re- search: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.301 To what does this subpart apply? (a) Except as provided in paragraph (b) of this section, this subpart applies to all observational research involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the Environ- mental Protection Agency (EPA). This includes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA employ- ees. (b) The exemptions at § 26.101(b)(1) through (b)(6) are applicable to this subpart. (c) The provisions of § 26.101(c) through (i) are applicable to this sub- part. References to State or local laws in this subpart and in § 26.101(f) are in- tended to include the laws of federally 293 § 26.302 recognized American Indian and Alas- ka Native Tribal Governments. (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part. § 26.302 Definitions. The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition, observational research means any human research that does not meet the definition of research in- volving intentional exposure of a human subject in § 26.202(a). § 26.303 Duties of IRBs in connection with observational research involv- ing pregnant women and fetuses. The provisions of 45 CFR 46.203 are applicable to this section. § 26.304 Additional protections for pregnant women and fetuses in- volved in observational research. The provisions of 45 CFR 46.204 are applicable to this section. § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material. The provisions of 45 CFR 46.206 are applicable to this section. Subpart D—Observational Re- search: Additional Protections for Children Involved as Sub- jects in Observational Re- search Conducted or Sup- ported by EPA SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.401 To what does this subpart apply? (a) This subpart applies to all obser- vational research involving children as subjects, conducted or supported by EPA. References to State or local laws in this subpart and in § 26.101(f) are in- tended to include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. This in- cludes research conducted in EPA fa- cilities by any person and research con- ducted in any facility by EPA employ- ees. (b) Exemptions at § 26.101(b)(1) and (b)(3) through (b)(6) are applicable to 40 CFR Ch. I (7–1–11 Edition) this subpart. The exemption at § 26.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at § 26.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not apply to research cov- ered by this subpart, except for re- search involving observation of public behavior when the investigator(s) do not participate in the activities being observed. (c) The exceptions, additions, and provisions for waiver as they appear in § 26.101(c) through (i) are applicable to this subpart. § 26.402 Definitions. The definitions in § 26.102 shall be ap- plicable to this subpart as well. In ad- dition, the following terms are defined: (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been delegated by the Administrator. (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, ab- sent affirmative agreement, be con- strued as assent. (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in research. (d) Parent means a child’s biological or adoptive parent. (e) Guardian means an individual who is authorized under applicable State, Tribal, or local law to consent on be- half of a child to general medical care. (f) Observational research means any research with human subjects that does not meet the definition of re- search involving intentional exposure of a human subject in § 26.202(a). (g) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of rou- tine physical or psychological exami- nations or tests. § 26.403 IRB duties. In addition to other responsibilities assigned to IRBs under this part, each 294 Environmental Protection Agency § 26.406 IRB shall review observational re- search covered by this subpart and ap- prove only research that satisfies the conditions of all applicable sections of this subpart. § 26.404 Observational research not in- volving greater than minimal risk. EPA will conduct or fund observa- tional research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in § 26.406. § 26.405 Observational research involv- ing greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. If the IRB finds that an intervention or procedure presents more than mini- mal risk to children, EPA will not con- duct or fund observational research that includes such an intervention or procedure unless the IRB finds and doc- uments that: (a) The intervention or procedure holds out the prospect of direct benefit to the individual subject or is likely to contribute to the subject’s well-being; (b) The risk is justified by the antici- pated benefit to the subjects; (c) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects as that presented by available alternative approaches; and (d) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 26.406. § 26.406 Requirements for permission by parents or guardians and for as- sent by children. (a) In addition to the determinations required under other applicable sec- tions of this subpart, the IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of pro- viding assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be in- volved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB deter- mines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure in- volved in the observational research holds out a prospect of direct benefit that is important to the health or well- being of the children and is available only in the context of the research, the assent of the children is not a nec- essary condition for proceeding with the observational research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with § 26.116(d). (b) In addition to the determinations required under other applicable sec- tions of this subpart, the IRB shall de- termine, in accordance with and to the extent that consent is required by § 26.116, that adequate provisions are made for soliciting the permission of each child’s parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under § 26.404 or § 26.405. (c) In addition to the provisions for waiver contained in § 26.116, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guard- ian permission is not a reasonable re- quirement to protect the subjects (for example, neglected or abused children), it may replace the consent require- ments in subpart A of this part and paragraph (b) of this section with pro- vided an appropriate, equivalent mech- anism for protecting the children who will participate as subjects in the re- search is substituted, and provided fur- ther that the waiver is not inconsistent with Federal, State, or local law. The choice of an appropriate, equivalent mechanism would depend upon the na- ture and purpose of the activities de- scribed in the protocol, the risk and anticipated benefit to the research sub- jects, and their age, maturity, status, and condition. 295 § 26.1101 (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent required by § 26.117. (e) When the IRB determines that as- sent is required, it shall also determine whether and how assent must be docu- mented. Subparts E–J [Reserved] Subpart K—Basic Ethical Require- ments for Third-Party Human Research for Pesticides In- volving Intentional Exposure of Non-pregnant, Non-nursing Adults SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.1101 To what does this subpart apply? (a) Except as provided in paragraph (b) of this section, subpart K of this part applies to all research initiated after April 7, 2006 involving intentional exposure of a human subject if, at any time prior to initiating such research, any person who conducted or supported such research intended: (1) To submit results of the research to EPA for consideration in connection with any action that may be performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or (2) To hold the results of the research for later inspection by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a). (b) Unless otherwise required by the Administrator, research is exempt from this subpart if it involves only the collection or study of existing data, documents, records, pathological speci- mens, or diagnostic specimens from previously conducted studies, and if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 40 CFR Ch. I (7–1–11 Edition) (c) The Administrator retains final judgment as to whether a particular activity within the scope of paragraphs (a) and (b) of this section is covered by this subpart. (d) Compliance with this subpart re- quires compliance with pertinent Fed- eral laws or regulations which provide additional protections for human sub- jects. (e) This subpart does not affect any State or local laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. Reference to State or local laws in this subpart is intended to include the laws of federally recog- nized American Indian and Alaska Na- tive Tribal Governments. (f) This subpart does not affect any foreign laws or regulations which may otherwise be applicable and which pro- vide additional protections to human subjects of research. (g) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may consider any available information relevant to de- termining the intent of a person who conducts or supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume such intent existed if: (1) The person or the person’s agent has submitted or made available for in- spection the results of such research to EPA; or (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of people, products, or ac- tivities. § 26.1102 Definitions. (a) For purposes of this subpart, Ad- ministrator means the Administrator of the Environmental Protection Agency (EPA) and any other officer or em- ployee of EPA to whom authority has been delegated. (b) Institution means any public or private entity or agency (including Federal, State, and other agencies). 296 Environmental Protection Agency § 26.1107 (c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the procedure(s) involved in the research. (d) Research means a systematic in- vestigation, including research, devel- opment, testing and evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities which meet this definition constitute re- search for purposes of this subpart, whether or not they are considered re- search for other purposes. For example, some demonstration and service pro- grams may include research activities. (e) Human subject means a living indi- vidual about whom an investigator (whether professional or student) con- ducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. (3) ‘‘Intervention’’ includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are per- formed for research purposes. Inter- action includes communication or interpersonal contact between investi- gator and subject. ‘‘Private informa- tion’’ includes information about be- havior that occurs in a context in which an individual can reasonably ex- pect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the indi- vidual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the iden- tity of the subject is or may readily be ascertained by the investigator or asso- ciated with the information) in order for obtaining the information to con- stitute research involving human sub- jects. (f) IRB means an institutional review board established in accord with and for the purposes expressed in this part. (g) IRB approval means the deter- mination of the IRB that the research has been reviewed and may be con- ducted at an institution within the constraints set forth by the IRB and by other institutional and Federal re- quirements. (h) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of rou- tine physical or psychological exami- nations or tests. (i) Research involving intentional expo- sure of a human subject means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study. (j) Person means any person, as that term is defined in FIFRA section 2(s) (7 U.S.C. 136), except: (1) A federal agency that is subject to the provisions of the Federal Policy for the Protection of Human Subjects of Research, and (2) A person when performing human research supported by a federal agency covered by paragraph (j)(1) of this sec- tion. §§ 26.1103–26.1106 [Reserved] § 26.1107 IRB membership. (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities which are pre- sented for its approval. The IRB shall be sufficiently qualified through the experience and expertise of its mem- bers, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensi- tivity to such issues as community at- titudes, to promote respect for its ad- vice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the profes- sional competence necessary to review specific research activities, the IRB shall be able to ascertain the accept- ability of proposed research in terms of institutional commitments and regula- tions, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB 297 § 26.1108 regularly reviews research that in- volves a vulnerable category of sub- jects, such as prisoners or handicapped or mentally disabled persons, consider- ation shall be given to the inclusion of one or more individuals who are knowl- edgeable about and experienced in working with these subjects. (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s con- sideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (d) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and who is not part of the immediate family of a person who is affiliated with the insti- tution. (e) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any project in which the member has a conflicting interest, except to provide information re- quested by the IRB. (f) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. § 26.1108 IRB functions and oper- ations. In order to fulfill the requirements of this subpart each IRB shall: (a) Follow written procedures: (1) For conducting its initial and con- tinuing review of research and for re- porting its findings and actions to the investigator and the institution; (2) For determining which projects require review more often than annu- ally and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review; 40 CFR Ch. I (7–1–11 Edition) (3) For ensuring prompt reporting to the IRB of proposed changes in re- search activity; and (4) For ensuring that changes in ap- proved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent imme- diate hazards to the human subjects. (b) Follow written procedures for en- suring prompt reporting to the IRB, appropriate institutional officials, and the Environmental Protection Agency of: (1) Any unanticipated problems in- volving risks to human subjects or oth- ers; (2) Any instance of serious or con- tinuing noncompliance with this sub- part of the requirements or determina- tions of the IRB; or (3) Any suspension or termination of IRB approval. (c) Except when an expedited review procedure is used (see § 26.1110), review proposed research at convened meet- ings at which a majority of the mem- bers of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a ma- jority of those members present at the meeting. § 26.1109 IRB review of research. (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure approval), or dis- approve all research activities covered by this subpart. (b) An IRB shall require that infor- mation given to subjects as part of in- formed consent is in accordance with § 26.1116. The IRB may require that in- formation, in addition to that specifi- cally mentioned in § 26.1116 be given to the subjects when, in the IRB’s judg- ment, the information would meaning- fully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documenta- tion of informed consent in accordance with § 26.1117. 298 Environmental Protection Agency § 26.1111 (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica- tion a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research covered by this sub- part at intervals appropriate to the de- gree of risk, but not less than once per year, and shall have authority to ob- serve or have a third party observe the consent process and the research. § 26.1110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for minor changes in approved re- search. (a) The Secretary, HHS, has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the FEDERAL REG- ISTER. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor of- fice. (b)(1) An IRB may use the expedited review procedure to review either or both of the following: (i) Some or all of the research ap- pearing on the list and found by the re- viewer(s) to involve no more than mini- mal risk, (ii) Minor changes in previously ap- proved research during the period (of 1 year or less) for which approval is au- thorized. (2) Under an expedited review proce- dure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the re- search. A research activity may be dis- approved only after review in accord- ance with the non-expedited procedure set forth in § 26.1108(b). (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of re- search proposals which have been ap- proved under the procedure. (d) The Administrator may restrict, suspend, or terminate, an institution’s or IRB’s use of the expedited review procedure for research covered by this subpart. § 26.1111 Criteria for IRB approval of research. (a) In order to approve research cov- ered by this subpart the IRB shall de- termine that all of the following re- quirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treat- ment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distin- guished from risks and benefits sub- jects would receive even if not partici- pating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the re- search (for example, the possible ef- fects of the research on public policy) as among those research risks that fall within the purview of its responsi- bility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research in- volving vulnerable populations, such as prisoners, mentally disabled persons, or economically or educationally dis- advantaged persons. 299 § 26.1112 (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representa- tive, in accordance with, and to the ex- tent required by § 26.1116. (5) Informed consent will be appro- priately documented, in accordance with, and to the extent required by § 26.1117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to en- sure the safety of subjects. (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the con- fidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as prisoners, mentally disabled persons, or economi- cally or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these sub- jects. § 26.1112 Review by institution. Research covered by this subpart that has been approved by an IRB may be subject to further appropriate re- view and approval or disapproval by of- ficials of the institution. However, those officials may not approve the re- search if it has not been approved by an IRB. § 26.1113 Suspension or termination of IRB approval of research. An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and the Administrator of EPA. § 26.1114 Cooperative research. In complying with this subpart, spon- sors, investigators, or institutions in- volved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or 40 CFR Ch. I (7–1–11 Edition) similar arrangements aimed at avoid- ance of duplication of effort. § 26.1115 IRB records. (a) An IRB shall prepare and main- tain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the proposals, ap- proved sample consent documents, progress reports submitted by inves- tigators, and reports of injuries to sub- jects. (2) Minutes of IRB meetings which shall be in sufficient detail to show at- tendance at the meetings; actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the discussion of controverted issues and their resolution. (3) Records of continuing review ac- tivities. (4) Copies of all correspondence be- tween the IRB and the investigators. (5) A list of IRB members identified by name; earned degrees; representa- tive capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each mem- ber’s chief anticipated contributions to IRB deliberations; and any employ- ment or other relationship between each member and the institution, for example, full-time employee, a member of governing panel or board, stock- holder, paid or unpaid consultant. (6) Written procedures for the IRB in the same detail as described in § 26.1108(a) and § 26.1108(b). (7) Statements of significant new findings provided to subjects, as re- quired by § 26.1116(b)(5). (b) The records required by this sub- part shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be acces- sible for inspection and copying by au- thorized representatives of EPA at rea- sonable times and in a reasonable man- ner. 300 Environmental Protection Agency § 26.1116 § 26.1116 General requirements for in- formed consent. No investigator may involve a human being as a subject in research covered by this subpart unless the investigator has obtained the legally effective in- formed consent of the subject or the subject’s legally authorized representa- tive. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to partici- pate and that minimize the possibility of coercion or undue influence. The in- formation that is given to the subject or the representative shall be in lan- guage understandable to the subject or the representative. No informed con- sent, whether oral or written, may in- clude any exculpatory language through which the subject or the rep- resentative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the insti- tution or its agents from liability for negligence. (a) Basic elements of informed con- sent. In seeking informed consent the following information shall be provided to each subject: (1) A statement that the study in- volves research, an explanation of the purposes of the research and the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed, and identification of any procedures which are experi- mental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may rea- sonably be expected from the research; (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that might be advan- tageous to the subject; (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they consist of, or where further information may be ob- tained; (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements of in- formation shall also be provided to each subject: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject may become pregnant) which are currently unfore- seeable; (2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s con- sent; (3) Any additional costs to the sub- ject that may result from participation in the research; (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue par- ticipation will be provided to the sub- ject; and (6) The approximate number of sub- jects involved in the study. (c) The informed consent require- ments in this subpart are not intended to preempt any applicable Federal, State, or local laws which require addi- tional information to be disclosed in order for informed consent to be le- gally effective. (d) Nothing in this subpart is in- tended to limit the authority of a phy- sician to provide emergency medical 301 § 26.1117 care, to the extent the physician is per- mitted to do so under applicable Fed- eral, State, or local law. (e) If the research involves inten- tional exposure of subjects to a pes- ticide, the subjects of the research must be informed of the identity of the pesticide and the nature of its pes- ticidal function. § 26.1117 Documentation of informed consent. (a) Informed consent shall be docu- mented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form. (b) The consent form may be either of the following: (1) A written consent document that embodies the elements of informed consent required by § 26.1116. This form may be read to the subject or the sub- ject’s legally authorized representa- tive, but in any event, the investigator shall give either the subject or the rep- resentative adequate opportunity to read it before it is signed; or (2) A short form written consent doc- ument stating that the elements of in- formed consent required by § 26.1116 have been presented orally to the sub- ject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the rep- resentative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form. §§ 26.1118–26.1122 [Reserved] § 26.1123 Early termination of re- search. The Administrator may require that any project covered by this subpart be 40 CFR Ch. I (7–1–11 Edition) terminated or suspended when the Ad- ministrator finds that an IRB, investi- gator, sponsor, or institution has mate- rially failed to comply with the terms of this subpart. § 26.1124 [Reserved] § 26.1125 Prior submission of proposed human research for EPA review. Any person or institution who in- tends to conduct or sponsor human re- search covered by § 26.1101(a) shall, after receiving approval from all appro- priate IRBs, submit to EPA prior to initiating such research all informa- tion relevant to the proposed research specified by § 26.1115(a), and the fol- lowing additional information, to the extent not already included: (a) A discussion of: (1) The potential risks to human sub- jects; (2) The measures proposed to mini- mize risks to the human subjects; (3) The nature and magnitude of all expected benefits of such research, and to whom they would accrue; (4) Alternative means of obtaining in- formation comparable to what would be collected through the proposed re- search; and (5) The balance of risks and benefits of the proposed research. (b) All information for subjects and written informed consent agreements as originally provided to the IRB, and as approved by the IRB. (c) Information about how subjects will be recruited, including any adver- tisements proposed to be used. (d) A description of the cir- cumstances and methods proposed for presenting information to potential human subjects for the purpose of ob- taining their informed consent. (e) All correspondence between the IRB and the investigators or sponsors. (f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that re- search involving human subjects has been reviewed and approved by an IRB. 302 Environmental Protection Agency § 26.1303 Subpart L—Prohibition of Third- Party Research for Pesticides Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nurs- ing Women SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.1201 To what does this subpart apply? Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human subject in- tended: (1) For submission to EPA for consid- eration in connection with any action that may be performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or (2) To be held for later inspection by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 346a). (b) For purposes of determining a person’s intent under paragraph (a) of this section, EPA may consider any available information relevant to de- termining the intent of a person who conducts or supports research with human subjects after the effective date of the rule. EPA shall rebuttably pre- sume such intent existed if: (1) The person or the person’s agent has submitted or made available for in- spection the results of such research to EPA; or (2) The person is a member of a class of people who, or whose products or ac- tivities, are regulated by EPA under FIFRA or the FFDCA and, at the time the research was initiated, the results of the research would be relevant to EPA’s exercise of its authority under FIFRA or the FFDCA with respect to that class of people, products, or ac- tivities. § 26.1202 Definitions. The definitions in § 26.1102 shall be applicable to this subpart as well. In addition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart. In addition, a child is a person who has not attained the age of 18 years. § 26.1203 Prohibition of research in- volving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support re- search covered by § 26.1201 that involves intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. [71 FR 36175, June 23, 2006] Subpart M—Requirements for Sub- mission of Information on the Ethical Conduct of Com- pleted Human Research SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.1301 To what does this subpart apply? This subpart applies to any person who submits a report containing the results of any human research if: (a) The report is submitted after April 7, 2006, and (b) The report is submitted for con- sideration in connection with any ac- tion that may be performed by EPA under the Federal Insecticide, Fun- gicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a). § 26.1302 Definitions. The definitions in § 26.102 shall apply to this subpart as well. § 26.1303 Submission of information pertaining to ethical conduct of completed human research. Any person who submits to EPA data derived from human research covered by this subpart shall provide at the time of submission information con- cerning the ethical conduct of such re- search. To the extent available to the submitter and not previously provided 303 § 26.1501 to EPA, such information should in- clude: (a) Copies of all of the records rel- evant to the research specified by § 26.1115(a) to be prepared and main- tained by an IRB. (b) Copies of all of the records rel- evant to the information identified in § 26.1125(a) through (f). (c) Copies of sample records used to document informed consent as speci- fied by § 26.1117, but not identifying any subjects of the research. (d) If any of the information listed in paragraphs (a) through (c) of this sec- tion is not provided, the person shall describe the efforts made to obtain the information. Subpart N [Reserved] Subpart O—Administrative Actions for Noncompliance SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.1501 To what does this subpart apply? This subpart applies to any human research subject to subparts A through L of this part. References to State or local laws in this subpart are intended to include the laws of federally recog- nized American Indian and Alaska Na- tive Tribal Governments. § 26.1502 Lesser administrative ac- tions. (a) If apparent noncompliance with the applicable regulations in subparts A through L of this part concerning the operation of an IRB is observed by an officer or employee of EPA or of any State duly designated by the Adminis- trator during an inspection. EPA may send a letter describing the noncompli- ance to the IRB and to the parent in- stitution. The agency will require that the IRB or the parent institution re- spond to this letter within a reasonable time period specified by EPA and de- scribe the corrective actions that will be taken by the IRB, the institution, or both to achieve compliance with these regulations. (b) On the basis of the IRB’s or the institution’s response, EPA may sched- ule a reinspection to confirm the ade- 40 CFR Ch. I (7–1–11 Edition) quacy of corrective actions. In addi- tion, until the IRB or the parent insti- tution takes appropriate corrective ac- tion, the Agency may: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB; (2) Direct that no new subjects be added to ongoing studies subject to this part; (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or (4) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, notify relevant State and Federal regu- latory agencies and other parties with a direct interest of the deficiencies in the operation of the IRB. (c) The parent institution is pre- sumed to be responsible for the oper- ation of an IRB, and EPA will ordi- narily direct any administrative action under this subpart against the institu- tion. However, depending on the evi- dence of responsibility for deficiencies, determined during the investigation, EPA may restrict its administrative actions to the IRB or to a component of the parent institution determined to be responsible for formal designation of the IRB. § 26.1503 Disqualification of an IRB or an institution. (a) Whenever the IRB or the institu- tion has failed to take adequate steps to correct the noncompliance stated in the letter sent by the Agency under § 26.1502(a) and the EPA Administrator determines that this noncompliance may justify the disqualification of the IRB or of the parent institution, the Administrator may institute appro- priate proceedings. (b) The Administrator may disqualify an IRB or the parent institution from studies subject to this part if the Ad- ministrator determines that: (1) The IRB has refused or repeatedly failed to comply with any of the regu- lations set forth in this part, and (2) The noncompliance adversely af- fects the rights or welfare of the human subjects of research. (c) If the Administrator determines that disqualification is appropriate, 304 Environmental Protection Agency § 26.1601 the Administrator will issue an order that explains the basis for the deter- mination and that prescribes any ac- tions to be taken with regard to ongo- ing human research, covered by sub- parts A through L of this part, con- ducted under the review of the IRB. EPA will send notice of the disquali- fication to the IRB and the parent in- stitution. Other parties with a direct interest, such as sponsors and inves- tigators, may also be sent a notice of the disqualification. In addition, the agency may elect to publish a notice of its action in the FEDERAL REGISTER. (d) EPA may refuse to consider in support of a regulatory decision the data from human research, covered by subparts A through L of this part, that was reviewed by an IRB or conducted at an institution during the period of disqualification, unless the IRB or the parent institution is reinstated as pro- vided in § 26.1505, or unless such re- search is deemed scientifically sound and crucial to the protection of public health, under the procedure defined in § 26.1706. § 26.1504 Public disclosure of informa- tion regarding revocation. A determination that EPA has dis- qualified an institution from studies subject to this part and the adminis- trative record regarding that deter- mination are disclosable to the public under 40 CFR part 2. § 26.1505 Reinstatement of an IRB or an institution. An IRB or an institution may be re- instated to conduct studies subject to this part if the Administrator deter- mines, upon an evaluation of a written submission from the IRB or institution that explains the corrective action that the institution or IRB has taken or plans to take, that the IRB or insti- tution has provided adequate assurance that it will operate in compliance with the standards set forth in this part. No- tification of reinstatement shall be provided to all persons notified under § 26.1502(c). § 26.1506 Debarment. If EPA determines that an institu- tion or investigator repeatedly has not complied with or has committed an egregious violation of the applicable regulations in subparts A through L of this part, EPA may recommend that institution or investigator be declared ineligible to participate in EPA-sup- ported research (debarment). Debar- ment will be initiated in accordance with procedures specified at 2 CFR part 1532. [71 FR 6168, Feb. 6, 2006, as amended at 72 FR 2427, Jan. 19, 2007] § 26.1507 Actions alternative or addi- tional to disqualification. Disqualification of an IRB or of an institution is independent of, and nei- ther in lieu of nor a precondition to, other statutorily authorized pro- ceedings or actions. EPA may, at any time, on its own initiative or through the Department of Justice, institute any appropriate judicial proceedings (civil or criminal) and any other appro- priate regulatory action, in addition to or in lieu of, and before, at the time of, or after, disqualification. The Agency may also refer pertinent matters to an- other Federal, State, or local govern- ment agency for any action that that agency determines to be appropriate. Subpart P—Review of Proposed and Completed Human Research SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.1601 EPA review of proposed human research. (a) EPA shall review all protocols submitted under § 26.1125 in a timely manner. With respect to any research or any class of research, the Adminis- trator may recommend additional con- ditions which, in the judgment of the Administrator, are necessary for the protection of human subjects. (b) In reviewing proposals covered by this subpart, the Administrator may take into account factors such as whether the applicant has been subject to a termination or suspension under § 26.123(a) or § 26.1123 and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the Administrator, materially failed to 305 § 26.1602 discharge responsibility for the protec- tion of the rights and welfare of human subjects (whether or not the research was subject to Federal regulation). (c) When research covered by subpart K takes place in foreign countries, pro- cedures normally followed in the for- eign countries to protect human sub- jects may differ from those set forth in subpart K. (An example is a foreign in- stitution which complies with guide- lines consistent with the World Med- ical Assembly Declaration of Helsinki, issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.) In these circumstances, if the Administrator de- termines that the procedures pre- scribed by the institution afford pro- tections that are at least equivalent to those provided in subpart K, the Ad- ministrator may approve the substi- tution of the foreign procedures in lieu of the procedural requirements pro- vided in subpart K. (d) Following initial evaluation of the protocol by Agency staff, EPA shall submit the protocol and all sup- porting materials, together with the staff evaluation, to the Human Studies Review Board. (e) EPA shall notify the submitter of the proposal of the results of the EPA and Human Studies Review Board re- views. § 26.1602 EPA review of completed human research. (a) When considering data under FIFRA or FFDCA from research in- volving intentional exposure of hu- mans, EPA shall review the material submitted under § 26.1303 and other available, relevant information and document its conclusions regarding the scientific and ethical conduct of the re- search. (b) EPA shall submit its review of data from human research covered by subpart Q, together with the available supporting materials, to the Human Studies Review Board if EPA decides to rely on the data and: (1) The data are derived from re- search initiated after April 7, 2006, or (2) The data are derived from re- search initiated before April 7, 2006, and the research was conducted for the 40 CFR Ch. I (7–1–11 Edition) purpose of identifying or measuring a toxic effect. (c) In its discretion, EPA may submit data from research not covered by paragraph (b) of this section to the Human Studies Review Board for their review. (d) EPA shall notify the submitter of the research of the results of the EPA and Human Studies Review Board re- views. § 26.1603 Operation of the Human Studies Review Board. EPA shall establish and operate a Human Studies Review Board as fol- lows: (a) Membership. The Human Studies Review Board shall consist of members who are not employed by EPA, who meet the ethics and other requirements for special government employees, and who have expertise in fields appro- priate for the scientific and ethical re- view of human research, including re- search ethics, biostatistics, and human toxicology. (b) Responsibilities. The Human Stud- ies Review Board shall comment on the scientific and ethical aspects of re- search proposals and reports of com- pleted research with human subjects submitted by EPA for its review and, on request, advise EPA on ways to strengthen its programs for protection of human subjects of research. Subpart Q—Ethical Standards for Assessing Whether To Rely on the Results of Human Re- search in EPA Actions SOURCE: 71 FR 6168, Feb. 6, 2006, unless oth- erwise noted. § 26.1701 To what does this subpart apply? This subpart applies to EPA’s deci- sions whether to rely in its actions taken under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) on scientifically valid and relevant data from research involv- ing intentional exposure of human sub- jects. 306 Environmental Protection Agency Pt. 27 § 26.1702 Definitions. The definitions in § 26.1102 and § 26.1202 shall apply to this subpart as well. § 26.1703 Prohibition of reliance on re- search involving intentional expo- sure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or children. Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701 EPA shall not rely on data from any re- search involving intentional exposure of any human subject who is a preg- nant woman (and therefore her fetus), a nursing woman, or a child. [71 FR 36175, June 23, 2006] § 26.1704 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con- ducted before April 7, 2006. Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on data from any re- search initiated before April 7, 2006, if there is clear and convincing evidence that the conduct of the research was fundamentally unethical (e.g., the re- search was intended to seriously harm participants or failed to obtain in- formed consent), or was significantly deficient relative to the ethical stand- ards prevailing at the time the re- search was conducted. This prohibition is in addition to the prohibition in § 26.1703. § 26.1705 Prohibition of reliance on un- ethical human research with non- pregnant, non-nursing adults con- ducted after April 7, 2006. Except as provided in § 26.1706, in ac- tions within the scope of § 26.1701, EPA shall not rely on data from any re- search initiated after April 7, 2006, un- less EPA has adequate information to determine that the research was con- ducted in substantial compliance with subparts A through L of this part, or if conducted in a foreign country, under procedures at least as protective as those in subparts A through L of this part. This prohibition is in addition to the prohibition in § 26.1703. § 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unaccept- able research. This section establishes the exclusive criteria and procedure by which EPA may decide to rely on data from re- search that is not acceptable under the standards in §§ 26.1703 through 26.1705. EPA may rely on such data only if all the conditions in paragraphs (a) through (d) of this section are satisfied: (a) EPA has obtained the views of the Human Studies Review Board con- cerning the proposal to rely on the oth- erwise unacceptable data, (b) EPA has provided an opportunity for public comment on the proposal to rely on the otherwise unacceptable data, (c) EPA has determined that relying on the data is crucial to a decision that would impose a more stringent regu- latory restriction that would improve protection of public health, such as a limitation on the use of a pesticide, than could be justified without relying on the data, and (d) EPA publishes a full explanation of its decision to rely on the otherwise unacceptable data, including a thor- ough discussion of the ethical defi- ciencies of the underlying research and the full rationale for finding that the standard in paragraph (c) of this sec- tion was met. PART 27—PROGRAM FRAUD CIVIL REMEDIES Sec. 27.1 Basis and purpose. 27.2 Definitions. 27.3 Basis for civil penalties and assess- ments. 27.4 Investigation. 27.5 Review by the reviewing official. 27.6 Prerequisites for issuing a complaint. 27.7 Complaint. 27.8 Service of complaint. 27.9 Answer. 27.10 Default upon failure to file an answer. 27.11 Referral of complaint and answer to the presiding officer. 27.12 Notice of hearing. 27.13 Parties to the hearing. 27.14 Separation of functions. 27.15 Ex parte contacts. 27.16 Disqualification of the reviewing offi- cial or presiding officer. 27.17 Rights of parties. 307