22VAC30-40 Protection of Participants in Human Research

REGULATIONS

Vol. 25 Iss. 21 - June 22, 2009

TITLE 22. SOCIAL SERVICES

DEPARTMENT OF REHABILITATIVE SERVICES

Chapter 40

Final Regulation

Title of Regulation: 22VAC30-40. Protection of Participants in Human Research (amending 22VAC30-40-10 through 22VAC30-40-150; adding 22VAC30-40-160).

Statutory Authority: § 51.5-5.1 of the Code of Virginia.

Effective Date: July 22, 2009.

Agency Contact: Vanessa S. Rakestraw, Policy Analyst, Department of Rehabilitative Services, 8004 Franklin Farms Drive, Richmond, VA 23229, telephone [phone], FAX [phone], TTY [phone], or email [e-mail].

Summary:

These regulations provide a basis for the Department of Rehabilitative Services (DRS) to oversee human subjects research involving the Department of Rehabilitative Services, the Woodrow Wilson Rehabilitation Center, sheltered workshops, and independent living centers. The amendments: (i) make minor changes in language to ensure consistency with 45 CFR 46.101 et seq.; (ii) change the definition of sheltered workshop so that only those vocational rehabilitation service programs that have a vendor relationship with the department and are not operated by a community services board are covered by this regulation; (iii) provide that independent living centers and sheltered workshops no longer have the option to establish their own human research review committee or to affiliate with other centers or workshops to establish a central human research committee but are required to affiliate with the DRS human research review committee; (iv) change the procedures for obtaining the informed written consent of prospective research subjects to ensure consistency with the requirements of federal regulations; (v) change the composition of the human research review committee that reviews research proposals to determine if they meet the requirements of this regulation to ensure consistency with federal requirements; (vi) add a new section that governs the inclusion of minors as research subjects; and (vii) change procedures for expedited review and the description of research that may receive expedited review to reflect existing federal regulations.

Summary of Public Comments and Agency's Response: No public comments were received by the promulgating agency.

22VAC30-40-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Affiliated with the institution covered entity" means employed by the institution covered entity or a member of a household containing an employee of the institution covered entity.

"Agent" means any individual performing department-designated activities or exercising department-delegated authority or responsibility.

"Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

"Commissioner" means the Commissioner of the Department of Rehabilitative Services.

"Covered entity" means the Department of Rehabilitative Services, Woodrow Wilson Rehabilitation Center, sheltered workshops, or independent living centers.

"Department" means the Department of Rehabilitative Services.

"Guardian" means an individual who is authorized under applicable state or local law to consent on behalf of a minor to general medical care.

"Human Research Review Committee" or "HRRC" means the committee established in accordance with and for the purposes expressed in this chapter.

"HRRC approval" means the determination of the HRRC that the research has been reviewed and may be conducted within the constraints set forth by the HRRC and by other department, state and federal requirements.

"Human participant or human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains:

(i) data 1. Data through intervention or interaction with the individual; or

(ii) identifiable 2. Identifiable private information.

"Human research" means any systematic investigation which utilizes human participants who may be exposed to physical or psychological injury as a consequence of participation and which departs from the application of established and accepted therapeutic methods appropriate to meet the participant's needs.

"Human subject research" means a systematic investigation, experiment, study, evaluation, demonstration or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) in which a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information.

"Identifiable private information" means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record, social security number). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) to constitute research involving human subjects.

"Independent living center" means a consumer-controlled, community-based, cross disability, nonresidential private nonprofit agency that:

1. Is designed and operated within a local community by individuals with disabilities; and

2. Provides an array of independent living services.

"Informed consent" means a process by which the investigator fully explains the research activities, ensures that the prospective subject has sufficient opportunity to ask questions, and has sufficient time to make a decision whether or not to participate in the research prior to signing the HRRC-approved written consent document. Informed consent must be prospectively obtained without coercion, include all of the basic elements of informed consent as specified in 22VAC30-40-100 B, be legally effective, contain no exculpatory language, and as required, include the additional elements of informed consent specified in 22VAC30-40-100 C.

"Institution" means the department, any center of independent living, sheltered workshop, the Woodrow Wilson Rehabilitation Center, or any facility or program operated, funded, or licensed by the department any public or private entity or agency (including federal, state, and other agencies).

"Interaction" includes means communication or interpersonal contact between investigator and participant subject.

"Intervention" includes means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant subject or participant's subject's environment that are performed for research purposes.

"Investigator" means the person, whether professional or student, who conducts the research.

"Legally authorized representative," as defined in § 32.1-162.16 of the Code of Virginia, means the, in the following specified order of priority:

1. The parent or parents having custody of a prospective participant, the subject who is a minor;

2. The agent appointed under an advance directive, as defined in § 54.1-2982 of the Code of Virginia, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's participation in human research;

3. The legal guardian of a prospective participant, subject;

4. The spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final;

5. An adult child of the prospective subject;

6. A parent of the prospective subject when the subject is an adult;

7. An adult brother or sister of the prospective subject; or

any 8. Any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective participant subject to such person's subject's participation in the particular human research.

For the purposes of this definition, any person authorized by law or regulation to consent on behalf of a prospective participant subject to his such subject's participation in the particular human research shall include an attorney-in-fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney-in-fact shall not be employed by the person, institution or agency conducting the human research and shall not be authorized to consent to nontherapeutic medical research. No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.

"Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

"Minor," as defined in § 1-207 of the Code of Virginia, means an individual who is less than 18 years of age.

"Nontherapeutic research" means human subject research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the participant subject.

"Parent" means a minor's biological or adoptive parent.

"Permission" means the agreement of parent(s) or a legally authorized representative to the participation of their minor or ward in research.

"Private information" includes means information about the human participant's behavior that occurs when in a context in which an individual can reasonably expect that no observation or recording is taking place, and or information which that has been provided for specific purposes by the human participant which an individual and that the participant individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the human participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.

"Research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to general generalizable knowledge (basic research) or specific knowledge (applied research). Activities which that meet this definition constitute research for purposes of this chapter, whether or not they are supported or funded under a program which that is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities.

"Research investigator" means the person, whether professional or student, who conducts the research.

"Sheltered workshop" means a facility-based community rehabilitation a program that (i) provides directly or facilitates the provision of one or more of the following vocational rehabilitation services enumerated in 34 CFR 361.5(b)(9)(i) to individuals with disabilities to enable them to maximize their opportunities for employment, including career advancement:; (ii) has a vendor relationship with the department; and (iii) is not operated by a community services board.

1. Medical, psychiatric, psychological, social, and vocational services that are provided under one management;

2. Testing, fitting, or training in the use of prosthetic and orthotic devices;

3. Recreational therapy;

4. Physical and occupational therapy;

5. Speech, language, and hearing therapy;

6. Psychiatric, psychological, and social services, including positive behavior management;

7. Assessment for determining eligibility and vocational rehabilitation needs;

8. Rehabilitation technology;

9. Job development, placement, and retention services;

10. Evaluation or control of specific disabilities;

11. Orientation and mobility services for individuals who are blind;

12. Extended employment;

13. Psycho-social rehabilitation services;

14. Supported employment services and extended services;

15. Services to family members when necessary to the vocational rehabilitation of the individual;

16. Personal assistance services; or

17. Services similar to the services described in subdivisions 1 through 16.

"Voluntary informed consent" means the knowing, written consent of an individual, or the individual's legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion. With regard to the conduct of human research, the basic elements of information necessary to such consent shall include in writing:

1. A statement that the study involves research, and a reasonable and comprehensible explanation to the human participant of the procedures that the researcher will follow and their purposes, including identification of any procedures which are experimental; the expected duration of the human participant's participation; and a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained, and if any data from this study are published, the individual will not be identified without his written permission;

2. A description of any attendant discomforts and risks to the human participant which may reasonably be expected and a statement that there may be other risks not yet identified;

3. A description of any benefits to the human participant or to others which may reasonably be expected;

4. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the human participant;

5. An offer to answer and answers to any inquiries by any individual concerning the procedure;

6. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the human participant is otherwise entitled, and the human participant may discontinue participation at any time without penalty or loss of benefits to which he is otherwise entitled;

7. An explanation of who to contact for answers to pertinent questions about the research and human research participants' rights, and who to contact in the event of a research related injury;

8. For research involving more than minimal risk, an explanation as to whether any compensation or medical care is available if injury occurs and, if so, what it consists of or where further information may be obtained; and

9. An explanation of any costs or compensation which may accrue to the person and, if applicable, the availability of third party reimbursement for the proposed procedures or protocols.

22VAC30-40-30. Applicability.

This chapter shall apply to the Department of Rehabilitative Services, Woodrow Wilson Rehabilitation Center, any sheltered workshop or workshops and independent living center centers, and any facility operated, funded or licensed by the department which conducts or which proposes to conduct or authorize research which uses human participants known as covered entities.

22VAC30-40-40. Policy General provisions for conducting human subjects research.

A. No human subjects research may be conducted by a covered entity without the voluntary informed consent of the participant subject or his the subject's legally authorized representative. The required elements of informed consent are provided in 22VAC30-40-100. The consent of the participant human subject or his the human subject's legally authorized representative to participate in the research must be documented in writing and supported by the signature of a witness not involved in the conduct of the research, except as provided for in 22VAC30-40-100 F J. The research investigator shall sign ensure that a knowledgeable member of the research team signs and provide participants provides human subjects of a research study project with a copy of the written, voluntary informed consent statement document as defined in 22VAC30-40-10 22VAC30-40-100 B. The investigator shall make arrangements for those who need special assistance in understanding the consequences of participating in the research.

B. Each human subjects research study project shall be approved by a committee composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities the department's HRRC. An institution may establish its own research review committee, it may work with other institutions to establish a single committee, or it may use the department's established committee.

C. Nontherapeutic research using institutionalized participants is prohibited unless the research review committee HRRC determines that such nontherapeutic research will not present greater than minimal risk to the human participant subjects.

D. The research investigator shall be required to notify all human participants in research subjects of the risks caused by the research which that are discovered after the research has concluded.

E. 22VAC30-40-160 applies to all research involving minors as subjects conducted or supported by the covered entity. In addition to other responsibilities assigned to the HRRC under 22VAC30-40-160, the HRRC shall review research covered by 22VAC30-40-160 and approve only research that satisfies the conditions of all applicable sections of this chapter. Exemptions in subdivisions 1 and 3 through 6 of 22VAC30-40-80 are applicable to 22VAC30-40-160. The exemption in subdivision 2 of 22VAC30-40-80 regarding educational tests is also applicable to 22VAC30-40-160. However, the exemption in subdivision 2 of 22VAC30-40-80 for research involving survey or interview procedures or observations of public behavior does not apply to research covered by 22VAC30-40-160, except for research involving observation of public behavior when the investigator or investigators do not participate in the activities being observed.

F. Cooperative research projects are those projects covered by this chapter that involve a covered entity in conjunction with an institution(s). In the conduct of cooperative research projects, the covered entity and each institution are responsible for safeguarding the rights and welfare of human subjects and for complying with this chapter. With the approval of the commissioner, a covered entity participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified institutional review board (IRB), or make similar arrangements for avoiding duplication of effort.

G. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by the HRRC, as provided in this chapter, a certification submitted by the covered entity to the commissioner, and final approval given to the proposed change by the commissioner.

H. With respect to any research project or any class of research projects, the commissioner may impose additional conditions prior to or at the time of approval when, in the judgment of the commissioner, additional conditions are necessary for the protection of human subjects.

I. In reviewing proposed research projects, the HRRC shall consider the requirements of review stated in 22VAC30-40-70.

22VAC30-40-50. Certification process.

A. Institutions seeking to conduct or sponsor human research are required to submit statements to the research review committee assuring that all human research activities will be reviewed and approved by a research review committee. Institutions shall report annually No later than 45 days after the end of each state fiscal year, Woodrow Wilson Rehabilitation Center, sheltered workshops and independent living centers shall send a written report to the commissioner giving assurance that a committee exists and is functioning. These reports should include a list of committee members, their qualifications for service on the committee, their institutional affiliation and a copy of the minutes of committee meetings either all human subjects research conducted during the fiscal year was reviewed and approved by the department's HRRC prior to implementation of that research or that no human subjects research was conducted during that state fiscal year.

B. Prior to the initiation of a human research project, institutions At the time that the research is approved by the HRRC, the HRRC chairperson shall also send to the commissioner a description of the research project to be undertaken, which shall include a statement of the criteria for inclusion of a participant prospective human subjects in the research project, a description of what will be done to the prospective human participants subjects, and a copy of the informed consent statement the type of review performed by the HRRC.

C. The commissioner may inspect the records of the research committee department's HRRC.

D. The chairman of the research committee shall report as soon as possible to the head of the institution and to the commissioner any violation of the research protocol which led the committee to either suspend or terminate the research. The HRRC shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the HRRC's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the HRRC's action and shall be reported promptly to the research investigator, the commissioner, the head(s) of other appropriate covered entities, and in the case of cooperative research, the institutional officials responsible for human subjects research.

E. Research covered by this chapter that has been approved by the HRRC may be subject to further appropriate review and approval or disapproval by officials of the covered entities. However, those officials may not approve the research if it has not been approved by the HRRC.

22VAC30-40-60. Composition of research review committees the HRRC.

A. Each research committee The HRRC shall have at least five members, appointed by the head of the institution or department commissioner, with varying backgrounds to provide promote complete and adequate review of activities research projects commonly conducted by the institution covered entities. The committee HRRC shall be sufficiently qualified through the research experience, and expertise, and diversity of its members, and the diversity of the members, including consideration of race, gender, and cultural background, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of participants in human research subjects. In addition to possessing the professional competence necessary to review specific activities research projects, the committee must HRRC shall be able to ascertain the acceptability of applications and proposals proposed research in terms of institutional the department's commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. If a committee the HRRC regularly reviews research that has an impact on an institutionalized or other involves a vulnerable category of participants subjects, including residents of mental health or mental retardation facilities, the committee shall have in its membership one or more individuals who are primarily concerned with the welfare of these participants and who have appropriate experience to serve in that capacity such as children, pregnant women, or persons with mental disabilities, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. Additional membership requirements may be imposed on the HRRC by 34 CFR 350.4(c) and 356.3(c) for research sponsored by the National Institute on Disability and Rehabilitation Research. When minors with disabilities or persons with mental disabilities are purposefully included as research subjects, the HRRC's membership must include at least one person who is primarily concerned with the welfare of these research subjects.

B. No committee shall Every nondiscriminatory effort will be made to ensure that the HRRC does not consist entirely of men or entirely of women, or including the department's consideration of qualified persons of both sexes, so long as no selection is made to the HRRC on the basis of gender. The HRRC may not consist entirely of members of one profession.

C. Each committee The HRRC shall include at least one of the following:

1. One At least one member whose primary concerns are in nonscientific areas (e.g., lawyers, ethicists, members of the clergy);

2. One At least one member who is not otherwise affiliated with the institution any covered entity and who is not part of the immediate family of a person who is affiliated with the institution covered entity; and

3. One consumer; and

4. One 3. At least one member whose primary concerns are in the scientific areas.

D. No member of a committee The HRRC shall not have a member participate in the committee's HRRC's initial or continuing review of any project in which the member is directly involved or for which he has administrative approval authority has a conflicting interest, except to provide information requested by the committee HRRC. The committee HRRC has responsibility for determining whether a member has a conflict of conflicting interest with any study. The committee HRRC member shall be replaced in the case of a conflict of conflicting interest resulting in a decrease of the committee HRRC below five persons members.

E. A committee The HRRC may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the committee HRRC. These individuals may not vote with the committee.

F. A quorum of the committee HRRC shall consist of a majority of its members including at least one member whose primary concerns are in nonscientific areas. Except when exempt or expedited review procedures are used, proposed research shall be reviewed at convened meetings at which a majority of members is 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 majority of those members present at the meeting.

G. The committee HRRC and the institution department shall establish procedures and rules of operation necessary to fulfill the requirements of these regulations.

22VAC30-40-70. Elements of each committee's the HRRC's review process.

A. No human research shall be conducted or authorized by the Department of Rehabilitative Services, any independent living center, any sheltered workshop, or the Woodrow Wilson Rehabilitation Center unless the committee has reviewed and approved the proposed human research project giving consideration to: The HRRC shall review and have authority to approve, require modifications in, or disapprove all research activities covered by this chapter.

1. The adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the research;

2. The degree of the risk, and, if the research is nontherapeutic, whether it presents greater than minimal risk;

3. Whether the rights and welfare of the participants are adequately protected;

4. Whether the risks to the participants are outweighed by the potential benefits to them;

5. Whether the voluntary informed consent is to be obtained by methods that adequately and appropriately fulfill the requirements of these regulations and whether the written consent form is adequate and appropriate in both content and language for the particular research and for the particular participants of the research;

6. Whether the research investigators proposing to supervise or conduct the particular human research are appropriately competent and qualified;

7. Whether criteria for selection of participants are equitable, especially in research regarding the future development of mental or physical illness;

8. Whether the research conforms with such other requirements as the department may establish; and

9. Whether appropriate studies in nonhuman systems have been conducted prior to the involvement of human participants.

B. The committee shall review, at least annually, approved projects to ensure conformity with the approved proposal. The HRRC shall require that information given to prospective subjects as part of the informed consent process is in accordance with 22VAC30-40-100. The HRRC may require that information, in addition to that specifically mentioned in 22VAC30-40-100, be given to prospective subjects when, in the HRRC's judgment, the information would meaningfully add to the protection of the rights and welfare of subjects.

C. Research must be approved by the committee which has jurisdiction over the participant. When cooperating institutions conduct some or all of the research involving some or all of the participants, each cooperating institution is responsible for safeguarding the rights and welfare of human participants and for complying with this chapter, except that in complying with this chapter institutions may enter into joint review, rely upon the review of another qualified committee, or make similar arrangements aimed at avoiding duplication of effort. The committee chairperson may make such arrangements with the approval of a majority of the members present at a meeting of the committee. The HRRC shall require documentation of informed consent or may waive documentation in accordance with 22VAC30-40-100 J.

D. The committee HRRC shall consider research proposals within 45 days after submission of a complete application to the committee's chairman HRRC's chairperson. In order for the research to be approved, it shall receive the approval of a majority of those members present at a meeting in which a quorum exists. A committee The HRRC shall notify research investigators and the institution covered entity in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure committee HRRC approval.

E. The committee HRRC shall develop a written complaint description of the procedure procedures to be followed by a human participant subject who has a complaint concern(s) about a research project in which he is participating or has participated.

F. Any participant who has a complaint about a research project in which he is participating or has participated shall be referred to the chairperson of the committee HRRC who shall refer it to the committee HRRC to determine if there has been a violation of the research protocol as approved by the HRRC.

G. The committee shall require periodic reports. The frequency of such reports should reflect the nature and degree of risk of each research project.

H. If the HRRC decides to disapprove a research application, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

I. The HRRC shall conduct continuing review of research covered by this chapter at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

J. In order to approve research covered by this chapter, the HRRC shall determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized:

a. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk; and

b. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic 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 HRRC should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The HRRC 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 HRRC 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 involving vulnerable populations, such as children, pregnant women, persons with mental disabilities, or economically or educationally disadvantaged persons.

4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative in accordance with and to the extent required by 22VAC30-40-100.

5. Informed consent will be appropriately documented in accordance with and to the extent required by 22VAC30-40-100.

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, pregnant women, persons with mental disabilities, or economically or educationally disadvantaged persons, additional safeguards have been included in the project to protect the rights and welfare of these subjects.

22VAC30-40-80. Kinds of research exempt from committee review.

Research activities in which the only involvement of human participants will be in one or more of the following categories are exempt from these regulations unless the research is covered by other sections of this chapter. The HRRC shall determine whether the proposed research project satisfies at least one exemption category in this section before the research can be conducted:

1. Research conducted in established or commonly accepted educational settings, involving commonly used normal educational practices, such as:

a. Research on regular and special education instructional strategies; or

b. Research on the effectiveness of or the comparison among instructional techniques, curriculum or classroom management methods.

2. Research involving solely the use and analysis of the results of standardized psychological, educational, diagnostic, aptitude, or achievement tests, if information taken from these sources is recorded in such a manner that participants cannot be reasonably identified, directly or through identifiers linked to the participants. of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

b. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

3. Research involving survey or interview procedures, unless responses are recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants, and either: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under subdivision 2 of 22VAC30-40-80 if:

a. The participant's responses, if they became known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation The human subjects are elected or appointed public officials or candidates for public office; or

b. The research deals with sensitive aspects of the participant's own behavior, such as sexual behavior, drug or alcohol use, illegal conduct, or family planning. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving solely the observation (including observation by participants) of public behavior, unless observations are recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants, and either:

a. The observations recorded about the individual, if they became known outside the research, could reasonably place the human participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation; or

b. The research deals with sensitive aspects of the participant's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.

5. 4. Research involving solely the collection or study of existing data, documents, records, or pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information taken from these sources is recorded by the investigator in such a manner that participants subjects cannot be identified, directly or through identifiers linked to the participants subjects.

5. Research and demonstration projects that are conducted by or subject to the approval of the commissioner, and that are designed to study, evaluate, or otherwise examine:

a. Public benefit or service programs;

b. Procedures for obtaining benefits or services under those programs;

c. Possible changes in or alternatives to those programs or procedures; or

d. Possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies:

a. If wholesome foods without additives are consumed; or

b. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental 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 Agriculture.

22VAC30-40-90. Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

A. The committee may conduct an expedited review of a human research project which involves no more than minimal risk to the participants if (i) another institution's or agency's human research review committee has reviewed and approved the project or (ii) the review involves only minor changes in previously approved research and the changes occur during the approved project period. The HRRC may use the expedited review procedure for categories of research that are listed in 63 FR 60364-60367 where either or both of the following apply:

1. Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk.

2. Minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Under an expedited review procedure, the committee review may be carried out by the HRRC chairperson and one or by one or more experienced reviewers designated by the chairperson from among members of the committee may carry out the review HRRC. In reviewing the research, the reviewers may exercise all of the authorities of the committee HRRC except that the reviewers may not disapprove the research. A research activity proposal may be disapproved only after review in accordance with the nonexpedited by a convened meeting of the HRRC in which a quorum is present and in accordance with procedure set forth in 22VAC30-40-70.

B. Each committee which uses When an expedited review procedure is used, the HRRC shall adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure.

C. Research activities involving no more than minimal risk and in which the only involvement of human participants will be in one or more of the categories referred to in 34 CFR 97.110. The commissioner may restrict, suspend, terminate, or choose not to authorize the HRRC's use of the expedited review procedure.

22VAC30-40-100. Informed consent.

A. No human research may be conducted in the department, any independent living center, any sheltered workshop, or the Woodrow Wilson Rehabilitation Center or approved by the research committee in the absence of voluntary informed, written consent. If the participant is competent at the time the consent is required, then the consent must be subscribed to in writing by the participant and witnessed. If the participant is not competent at the time the consent is required, then the consent shall be subscribed to in writing by the participant's legally authorized representative and witnessed except as provided for in subsection F of this section. If the participant is a minor otherwise capable of rendering voluntary informed consent, the consent must be subscribed to in writing by both the minor and his legally authorized representative and witnessed. A research Except as provided elsewhere in this chapter, no investigator may involve a human being as a subject in research covered by this chapter unless the investigator has obtained the legally effective informed consent of the prospective subject or the prospective subject's legally authorized representative in accordance with this chapter. The investigator shall seek such consent only under circumstances that provide the prospective human participant or the representative prospective human participant's legally authorized representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the prospective human participant or the prospective human participant's legally authorized representative shall be in language understandable to the prospective human participant or the prospective human participant's legally authorized representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the legally authorized representative 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 covered entity, or its agents from liability for negligence.

B. No individual shall participate in research unless this requirement is met for each individual. The giving of consent by a legally authorized representative shall be subject to the provisions of subsection C of this section. No voluntary informed consent shall include any language through which the participant waives or appears to waive any of his legal rights, including any release of any individual, institution or agency or any agents thereof from liability for negligence. Notwithstanding consent by a legally authorized representative, no person shall be forced to participate in any human research. Each human participant shall be given a copy of the signed consent form required by 22VAC30-40-40 A, except as provided for in 22VAC30-40-100 F. In seeking informed consent, the following basic elements shall be provided to each prospective subject or legally authorized representative:

1. A statement that the project involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

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 that may reasonably be expected from the research;

4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

5. A statement describing the extent, 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 explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

7. An explanation of who to contact for answers to pertinent questions about the research and research subject's rights, and who 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 participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

C. No legally authorized representative may consent to nontherapeutic research unless the committee determines that such nontherapeutic research will present no more than a minor increase over minimal risk to the participant. No nontherapeutic research shall be performed without the consent of the human participant. When the HRRC determines that it is appropriate, one or more of the following additional elements of informed consent 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 become pregnant) that are currently unforeseeable;

2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

3. Any additional costs to the subject 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 that may relate to the subject's willingness to continue participation will be provided to the subject; and

6. The approximate number of subjects involved in the project.

D. The committee HRRC may approve a consent procedure which that does not include or which alters some or all of the elements of informed consent set forth in 22VAC30-40-10. The committee may this section, or waive the requirements requirement to obtain some or all informed consent provided the committee HRRC finds and documents that:

1. The research involves no more than minimal risk to the human participants; or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

a. Public benefit or service programs;

b. Procedures for obtaining benefits or services under those programs;

c. Possible changes in or alternatives to those programs or procedures; or

d. Possible changes in methods or levels of payment for benefits or services under those programs; and

2. The waiver or alteration will not adversely affect the rights and welfare of the human participants;

3. 2. The research could not practicably be carried out without the waiver or alteration; and.

4. Whenever appropriate, the human participants will be provided with additional pertinent information after participation.

E. Except as provided in subsection F of this section, the consent form may be either of the following: The HRRC may approve a consent procedure that does not include or that alters some or all of the elements of informed consent set forth in subsection B of this section, or waive the requirements to obtain informed consent provided the HRRC finds and documents that:

1. A written consent document that embodies the elements of informed consent required by 22VAC30-40-10. This form may be read to the participant or the participant's legally authorized representative, but in any event, the investigator shall give either the participant or the representative adequate opportunity to read it before it is signed; or

2. A short form written consent document stating that the elements of informed consent required by 22VAC30-40-10 have been presented orally to the participant or the participant's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the committee shall approve a written summary of what is to be said to the participant or the representative. Only the short form itself is to be signed by the participant 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 human participant or the representative, in addition to a copy of the short form.

1. The research involves no more than minimal risk to the subject;

2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;

3. The research could not practicably be carried out without the waiver or alteration; and

4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

F. The committee may waive the requirement for the research investigator to obtain a signed consent form for some or all participants if it finds that the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality and there is no greater than a minimal risk of physical or mental harm to the human participant. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern. In cases where the documentation requirement is waived, the committee may require the investigator to provide participants with a written statement regarding the research. The informed consent requirements in this chapter are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed in order for informed consent to be legally effective.

G. Nothing in this chapter 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 or state law, or local ordinance.

H. Notwithstanding consent by a legally authorized representative, no person shall be forced to participate in any human subjects research. Each human subject shall be given a copy of the signed consent form required by this section, except as provided for in subsection J of this section.

I. No legally authorized representative may consent to nontherapeutic research unless the HRRC determines that such nontherapeutic research will present no more than a minor increase over minimal risk to the prospective subject. No nontherapeutic research shall be performed without the consent of the human subject.

J. Documentation of informed consent.

1. Except as provided in subdivision 3 of this subsection, informed consent shall be documented by the use of a written consent form approved by the HRRC and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

2. Except as provided in subdivision 3 of this subsection, the consent form may be either of the following:

a. A written consent document that embodies the elements of informed consent required in subsection B of this section. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read it before it is signed; or

b. A short form written consent document stating that the elements of informed consent required in subsection B of this section have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the HRRC shall approve a written summary of what is to be said to the subject or the representative. 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 legally authorized representative, in addition to a copy of the short form.

3. The HRRC may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

a. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the HRRC may require the investigator to provide subjects with a written statement regarding the research.

22VAC30-40-110. Committee HRRC records.

A. An institution, or when appropriate a committee, The HRRC shall prepare and maintain adequate documentation of committee HRRC activities, including the following:

1. Copies of all research proposals applications reviewed, scientific evaluations, if any, that accompany the proposals applications, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to participants subjects;

2. Minutes of committee HRRC meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the committee HRRC; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;

3. Records of continuing review activities;

4. Copies of all correspondence between the committee HRRC and the research investigators;

5. A list of all committee HRRC members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to HRRC deliberations; and any employment or other relationship between each member and the covered entity, for example: full-time employee, part-time employee, member of governing panel or board, or paid or unpaid consultant;

6. Written procedures for the committee Statements of significant new findings provided to participants; and

7. Statements of significant new findings provided to participants. Written procedures for the HRRC that shall include:

a. Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the department;

b. Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous HRRC review;

c. Ensuring prompt reporting to the HRRC of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which HRRC approval has already been given, may not be initiated without HRRC review and approval except when necessary to eliminate apparent immediate hazards to the subject; and

d. Ensuring prompt reporting to the HRRC and the commissioner of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the HRRC and (ii) any suspension or termination of HRRC approval.

B. The records required by this chapter shall be retained for at least three years, and records relating to research which is conducted shall be retained for at least three years after completion of the research. All records shall be accessible for inspection and copying by authorized employees or agents of the department or federal agency at reasonable times and in a reasonable manner.

C. The HRRC shall ensure that an overview of approved human subject research projects and the results of such projects are made public on the department's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

22VAC30-40-120. Mandatory reporting.

Each research review committee The HRRC shall submit to the Governor, the General Assembly, and the commissioner or his designee at least annually a report on the human subjects research projects reviewed and approved by the committee HRRC, including any significant deviations from the proposals as approved.

22VAC30-40-130. Role of the department and the commissioner.

A. The commissioner shall establish and maintain records of institutional federal assurances, annual reports, and summary descriptions of research projects.

B. The commissioner shall review communications from committees the HRRC reporting violations of research protocols which led to suspension or termination of the research to ensure that appropriate steps have been taken for the protection of the rights of human research participants subjects.

C. The commissioner shall arrange for the printing and dissemination of copies of these regulations.

22VAC30-40-140. Applicability of state policies.

Nothing in this chapter shall be construed as limiting in any way the rights of participants human subjects in research under regulations promulgated in response to §§ 32.1-162.19 and 37.1-84.1 Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia.

22VAC30-40-150. Applicability of federal policies.

Human research at institutions which The conduct of human subjects research that is subject to policies and regulations for the protection of human participants subjects promulgated by any agency of the federal government shall be exempt from requirements of this chapter. Such institutions When the HRRC reviews or approves federally funded or sponsored human research proposals, the HRRC shall notify the commissioner at least annually of their its compliance with the federal policies and regulations of federal agencies for the protection of human research subjects.

22VAC30-40-160. Additional protection for minors involved as subjects in research.

A. Research not involving greater than minimal risk. The covered entity may conduct or fund research in which the HRRC finds that no greater than minimal risk to minors is presented, only if the HRRC finds that adequate provisions are made for soliciting the assent of the minors and the permission of their parents or guardians, pursuant to subsection E of this section.

B. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. The covered entity may conduct or fund research in which the HRRC finds that more than minimal risk to minors is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the HRRC finds that:

1. The risk is justified by the anticipated benefit to the subjects;

2. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

3. Adequate provisions are made for soliciting the assent of the minors and permission of their parents or guardians, pursuant to subsection E of this section.

C. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. The covered entity may conduct or fund research in which the HRRC finds that more than minimal risk to minors is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is not likely to contribute to the well-being of the subject, only if the HRRC finds that:

1. The risk represents a minor increase over minimal risk;

2. The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

3. The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition that is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

4. Adequate provisions are made for soliciting assent of the minors and permission of their parents or guardians, pursuant to subsection E of this section.

D. Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of minors. The covered entity may conduct or fund research that the HRRC does not believe meets the requirements pursuant to subsection A, B, or C of this section only if:

1. The HRRC finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of minors; and

2. The Secretary of the United States Department of Education, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either that:

a. The research in fact satisfies the conditions pursuant to subsection A, B, or C of this section, as applicable; or

b. (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of minors; (ii) the research will be conducted in accordance with sound ethical principles; and (iii) adequate provisions are made for soliciting the assent of minors and the permission of their parents or guardians, pursuant to subsection E of this section.

E. Requirements for permission by parents or guardians and for assent by minors.

1. In addition to the determinations required under other applicable subsections of this section, the HRRC shall determine that adequate provisions are made for soliciting the assent of the minors, if in the judgment of the HRRC the minors are capable of providing assent. In determining whether minors are capable of assenting, the HRRC shall take into account the ages, maturity, and psychological state of the minors involved. This judgment may be made for all minors to be involved in research under a particular protocol, or for each minor, as the HRRC deems appropriate. If the HRRC determines that the capability of some or all of the minors is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the minors and is available only in the context of the research, the assent of the minors is not a necessary condition for proceeding with the research. Even if the HRRC determines that the subjects are capable of assenting, the HRRC may still waive the assent requirement under circumstances in which consent may be waived in accord with 22VAC30-40-100.

2. In addition to the determinations required under other applicable subsections of this section, the HRRC shall determine, in accordance with and to the extent that consent is required by 22VAC30-40-100, that adequate provisions are made for soliciting the permission of each minor's parent(s) or guardian(s). If parental permission is to be obtained, the HRRC may find that the permission of one parent is sufficient for research to be conducted pursuant to subsection A or B of this section. If research is covered pursuant to subsections C and D of this section and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal responsibility for the care and custody of the minor. Only the legal custodial parent can give informed consent.

3. In addition to the provisions for waiver contained in 22VAC30-40-100, if the HRRC determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused minors), it may waive the consent requirements in 22VAC30-40-100 and subdivision 2 of this subsection, provided an appropriate mechanism for protecting the minors who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism depends upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

4. Permission by parents or guardians must be documented in accordance with and to the extent required by 22VAC30-40-100 J.

5. If the HRRC determines that assent is required, it shall also determine whether and how assent must be documented.

F. Wards.

1. Minors who are wards of the state or any other agency, institution, or entity may be included in research approved under subsection C or D of this section only if that research is:

a. Related to their status as wards; or

b. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of minors involved as subjects are not wards.

2. If research is approved under subdivision 1 of this subsection, the HRRC shall require appointment of an advocate for each minor who is a ward, in addition to any other individual acting on behalf of the minor as guardian or in loco parentis. One individual may serve as advocate for more than one minor. The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the minor for the duration of the minor's participation in the research and who is not associated in any way (except in the role as advocate or member of the HRRC) with the research, the investigator or investigators, or the guardian organization.

VA.R. Doc. No. R07-294; Filed May 28, 2009, 11:18 a.m.