6VAC15-26 Regulations for Human Subject Research

REGULATIONS

Vol. 29 Iss. 4 - October 22, 2012

TITLE 6. CRIMINAL JUSTICE AND CORRECTIONS

DEPARTMENT OF CORRECTIONS

Chapter 26

Proposed Regulation

Title of Regulation: 6VAC15-26. Regulations for Human Subject Research (amending 6VAC15-26-10, 6VAC15-26-20, 6VAC15-26-30, 6VAC15-26-50, 6VAC15-26-120, 6VAC15-26-130; adding 6VAC15-26-61, 6VAC15-26-71, 6VAC15-26-81, 6VAC15-26-91, 6VAC15-26-101, 6VAC15-26-102; repealing 6VAC15-26-40, 6VAC15-26-60, 6VAC15-26-70, 6VAC15-26-80, 6VAC15-26-90, 6VAC15-26-100, 6VAC15-26-110, 6VAC15-26-140).

Statutory Authority: §§ 53.1-5 and 53.1-5.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 21, 2012.

Agency Contact: John Britton, Director, Research and Management Services, Department of Corrections, 6900 Atmore Drive, Richmond, VA 23225, telephone [phone] ext. 1241, FAX [phone], or email [e-mail].

Basis: Section 53.1-5 of the Code of Virginia authorizes the Board of Corrections to make, adopt and promulgate such rules and regulations as may be necessary to carry out the provisions of Title 53.1 of the Code of Virginia and other laws of the Commonwealth pertaining to local, regional and community correctional facilities.

Section 53.1-5.1 of the Code of Virginia requires the board to promulgate regulations pursuant to the Administrative Process Act (§ 2.2-4000 et seq.) to effectuate the provisions of Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia for human research.

Purpose: These regulations establish conditions, standards, and procedures that facilitate the Department of Corrections' review and approval of human research, on an informed consent basis, of offenders and employees. These regulations apply to any individual, group, or agency conducting research using human participants within the Virginia Department of Corrections, including any facility, program, or organization owned, operated, funded, or licensed by the department. The provisions protect the health, safety, and welfare of participants in human research.

Substance: 6VAC15-26-10 Definitions: Definitions have been inserted or amended to address the amendments and additions of specific information within the regulation, including "Human Subject Research Review Committee" or "HSRRC," "Organizational work unit," "Research Agreement," "Research Proposal," and "Voluntary informed consent."

6VAC15-26-30 Policy: Adding and amending requirements that all participation in human subject research is voluntary, precautions will be exercised to avoid any known risk to participants, and that such research shall not be conducted without documentation of appropriate review and approval.

6VAC15-26-40 Certification process: Repealing section.

6VAC15-26-50 Composition: Amending to set the composition and functions of the HSRRC.

6VAC15-26-60 Elements of each committee's review process: Repealing section; requirements incorporated into 6VAC15-26-61.

6VAC15-26-61 Duties and responsibilities: Adding section to set the duties and responsibilities of the HSRRC including requirements of 6VAC15-26-60.

6VAC15-26-70 Kinds of research exempt from committee review: Repealing section; requirements moved to 6VAC15-26-101.

6VAC15-26-71 Reports: Adding section to require interim and final reports from the researcher to the HSRRC; reporting requirements previously in 6-VAC15-26-60.

6VAC15-26-80 Expedited review procedures for certain kinds of research involving no more than minimal risk: Repealing section; no longer applicable.

6VAC15-26-81 Records maintenance: Adding section requiring maintenance of certain records by the principal researcher.

6VAC15-26-90 Informed consent: Repealing section; some requirements moved to 6VAC15-26-102, other requirements duplicate 6VAC15-26-30.

6VAC15-26-91 Publication rights: Adding section setting the rights of the researcher, the HSRRC, and the Department of Corrections to access, use, and disseminate research findings.

6VAC15-26-100 Committee records: Repealing section; requirements moved to 6VAC15-26-61.

6VAC15-26-101 Research exempt from HSRRC review: New section; updates the requirements of 6VAC15-26-70.

6VAC15-26-102 Waiver of signed voluntary informed consent form: New section; sets the requirements and conditions when signed informed consent forms are not needed.

6VAC15-26-110 Mandatory reporting: Repealing section.

6VAC15-26-130 Applicability of state and federal policies: Moves exemption for research studies subject to federal regulation from 6VAC15-26-140.

6VAC15-26-140 Applicability of federal policies: Repealing section; requirements moved to 6VAC15-26-130.

Issues: This action poses no disadvantages to the public or the Commonwealth. The amendments affect internal operational practices, and serve to protect research subjects, the Department of Corrections, and researchers. These regulations should prove advantageous by providing the opportunity to gather and develop knowledge to advance correctional and social sciences.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Corrections proposes to 1) reduce the number of the Human Subject Research Review Committee (HSRRC) members from five to three and 2) require that all research proposals, research agreements, accompanying documentation and reports must be submitted to HSRRC electronically.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. These regulations establish rules for research projects involving the offenders housed by and the employees working for the Virginia Department of Corrections (DOC). These rules apply to any individual, group, or agency conducting research using human participants within the DOC, including any facility, program, or organization owned, operated, funded, or licensed by DOC.

One of the proposed changes will reduce the number of the HSRRC members from five to three. The members of HSRRC do not receive any compensation and perform their duties as a professional courtesy. DOC has had some difficulty finding enough volunteers to serve on this committee. Thus, the proposed changes will reduce the number of members that make up the committee from five to three. While this change is procedurally significant, no significant economic effect is expected.

Another proposed change will require that all research proposals, research agreements, accompanying documentation, and reports must be submitted to HSRRC electronically. DOC Economic impact of 6VAC15-26 2 notes that the current state of the communication technology makes it much easier to transfer information electronically compared to 1994 when these regulations were drafted. As a result the Board of Corrections proposes that all documents involving human subject research projects are communicated through electronic means. According to DOC, approximately 15 to 20 research proposals are received per year primarily from students or faculty associated with institutions of higher learning. The provision for electronic submission of research proposal documents is expected to reduce printing, handling, and postage costs that would have otherwise been incurred by the researchers in dealing with the paper copies.

According to DOC, all of the remaining changes merely clarify the practices already followed under these regulations. Since the remaining changes are not expected to affect the way these regulations are currently enforced, no significant economic effect is expected other than improving the clarity of the regulations.

Businesses and Entities Affected. DOC receives approximately 15 to 20 research proposals per year almost all of which are from students or faculty associated with institutions of higher learning.

Localities Particularly Affected .The proposed changes apply throughout the Commonwealth.

Projected Impact on Employment. No significant impact on employment is expected.

Effects on the Use and Value of Private Property. No significant impact on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. The proposed changes do not impose cost or other effects on small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed changes do not impose adverse impact on small businesses.

Real Estate Development Costs. No significant impact on real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 107 (09). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency Response to Economic Impact Analysis: The Department of Corrections concurs with the economic impact analysis prepared by the Virginia Department of Planning and Budget regarding the proposed amendments to 6VAC15-26, Regulations for Human Subject Research.

Summary:

The proposed amendments update the regulations governing the form and review process for research to be conducted on human subjects with the Department of Corrections. The proposed amendments define the proposed research project information for the researcher to submit, the review process for approval, the agreements and conditions required for conducting an approved research project, the consent required from research subjects, the security of data collected, and the use of research findings.

The proposed amendments also reduce the number of Human Subject Research Review Committee(HSRRC) members from five to three and establish and define the HSRRC as the Department of Corrections committee responsible for (i) reviewing all submitted research projects for completeness and compliance with the Regulations for Human Subject Research, with all applicable Department of Corrections' operating procedures, and with all applicable state and federal regulations pertaining to human subject research; (ii) approving or denying submitted research proposals; (iii) monitoring all approved research projects for adherence to the scope of the research that was approved; and (iv) reporting on all research projects approved, all research projects denied and the findings of all approved research projects.

Part I
General Provisions

6VAC15-26-10. Definitions.

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

"Board" means the Board of Corrections.

"Department" means the Department of Corrections.

"Director" means the Director of the Department of Corrections.

"Human research" means any systematic investigation utilizing human subjects which may expose such human subjects to physical or psychological injury as a consequence of participation as subjects and which departs from the application of established and accepted therapeutic methods appropriate to meet the subjects' needs.

"Human Subject Research Review Committee" or "HSRRC" means the Department of Corrections committee responsible for (i) reviewing all submitted research projects for completeness and compliance, with the Regulations for Human Subject Research, with all applicable Department of Corrections operating procedures, and with all applicable state and federal regulations pertaining to human subject research; (ii) approving or denying submitted research proposals; (iii) monitoring all approved research projects for adherence to the scope of the research that was approved; and (iv) reporting on all research projects approved, all research projects denied and the findings of all approved research projects. The composition of the HSRRC and its responsibilities shall be as stated in Part II (6VAC15-26-50 et seq.) of this chapter.

"Legally authorized representative" means (i) the parent or parents having custody of a prospective subject, (ii) the legal guardian of a prospective subject, or (iii) any person or judicial body authorized by law or regulation to consent on behalf of a prospective subject to such 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 to his 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, organizational unit or agency conducting the human research and shall not be authorized to consent to nontherapeutic medical research. No official or employee of the organizational unit 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, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

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

"Organizational work unit" means any unit, facility, office, or district within the Department of Corrections, such as prisons, correctional centers, correctional field units, correctional work centers, probation and parole districts or offices, detention centers, diversion centers, or units supervised by a manager who reports directly to the Deputy Director of Administration. Each organizational work unit is managed by an organizational unit head such as a warden, superintendent, chief probation and parole officer, or manager.

"Participant" or "human participant" means a living individual whether personnel or inmate, probationer, or parolee employee or offender about whom an investigator a researcher (whether professional or student) conducting research obtains (i) data through intervention or interaction with the individual, or (ii) identifiable private information. "Intervention" includes both physical procedures by which data are gathered and manipulations of the participant or participant's environment that are performed for research purposes. "Interaction" includes communication or interpersonal contact between investigator researcher and participant.

"Private information" includes 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable in order for obtaining the information to constitute research involving human participants.

"Research" means the systematic development of knowledge essential to effective planning and rational decision making. It involves the assessment of current knowledge on conceptual problems selected, statement of those problems in researchable format, design of methodologies appropriate to the problems, and the application of appropriate analytical techniques to the data. Research findings should provide valuable information to management for policy options.

"Research agreement" means the document signed by the principal researcher, research project supervisor, or advisor and the HSRRC indicating the principal researcher and research project supervisor or advisor agree to conduct their research project in the manner in which the research project was approved by the HSRRC, including compliance with this chapter, all applicable Department of Corrections' operating procedures, all applicable state and federal laws and regulations, the research project timeline, and any conditions imposed by the HSRRC. The research agreement is governed by and must comply with the provisions of this chapter.

"Researcher" means an individual who has professional standing in the pertinent field or is supervised directly by such an individual.

"Research project" means the systematic collection of information, analysis of data, and preparation of a report of findings.

"Research proposal" means the document or documents completed by the principal researcher outlining: (i) information about the researchers, including contact information, affiliations, and funding sources; (ii) the human research to be performed, including purpose, methodology, informed consent, time frame, and Department of Corrections resources required; and (iii) any endorsements. The research proposal must be submitted to and approved by the HSRRC. Research proposals are to be limited to twenty pages (not including bibliographies, curriculum vitae, letters of endorsement, copies of surveys or instruments to be used, copies of external Institutional Review board approvals, and voluntary informed consent forms.) A suggested template for a research proposal is incorporated by reference with this chapter.

"Voluntary informed consent" means the knowing consent of an individual 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. Voluntary informed consent forms shall not include any language through which the human subject waives or appears to waive any of his legal rights, including any release of any individual, facility, agency, or agents thereof, from liability or negligence. The human participant shall sign all voluntary consent forms confirmed by an acceptable witness. With regard to the conduct of human research, the basic elements of information necessary to such voluntary informed consent shall include:

1. A fair explanation to the individual of any procedures to be followed and their purposes, including identification of any procedures which are experimental;

2. A description of any attendant discomforts and risks reasonably to be expected;

3. A description of any benefits reasonably to be expected;

4. A disclosure of any appropriate alternative procedures that might be advantageous for the individual;

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

6. An instruction that the individual is free to withdraw his voluntary informed consent and to discontinue participation in the human research at any time without prejudice to him.

A copy of the Voluntary Informed Consent form is incorporated by reference with this chapter.

6VAC15-26-20. Applicability.

This chapter shall apply to any individual, group, or agency conducting research which that uses human participants within the Virginia Department of Corrections, including any facility, program or organization owned, operated, funded, or licensed by the department.

6VAC15-26-30. Policy.

A. No human research may be conducted without informing the participant or his legally authorized representative in writing of the risks, procedures, and discomforts of the research. The voluntary informed consent of the participant or his legally authorized representative to participate in the research must be documented in writing and supported by signature of a witness not involved in the conduct of the research, except as provided in 6VAC15-26-90 F 6VAC15-26-102. Arrangements shall be made for those who need special assistance in understanding the consequences of participating in the research.

B. Each human research review activity 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. No offender shall be subjected to experimentation or participation in research against his will.

C. Nontherapeutic research using institutionalized participants shall be is prohibited unless it is determined by the research review committee HSRRC that such nontherapeutic research will not present greater than minimal risk.

D. The individuals conducting the research shall be required to notify all participants of research of the risks caused by the research which are discovered after the research has concluded. Research involving known and substantive physical, mental, or emotional risk to the participants, including the withholding of any prescribed program or treatment, is specifically prohibited.

E. Department of Corrections studies, program evaluations, and routine data analyses for management purposes are exempt from this policy. Medical research shall only be conducted in accordance with Department of Corrections Operating Procedure 701.1, Health Services Administration, which is incorporated by reference with this chapter.

F. The burden of proof for review by any committee shall be with the principal researcher. Research shall not interfere with the rights of offenders or Department of Corrections' employees.

G. Proper precautions must be exercised for the protection of the research participants rights and for the overall safety and security of the public, the researcher, and the Department of Corrections.

H. Research shall not interfere significantly with ongoing programs or operations of the Department of Corrections.

I. The research findings shall not identify individual participants. The confidentiality and anonymity of all offenders and other parties engaged in the research will be maintained.

J. Researchers are required to notify all participants of risks caused by the research that are discovered after the research has concluded.

K. Each human research activity shall be reviewed and approved by the HSRRC.

L. No human research activity involving the Department of Corrections shall be initiated without a research proposal reviewed and approved by the HSRRC.

M. Each submitted research proposal must be accompanied by a research agreement signed by the principal researcher, or research project supervisor or advisor.

N. All research proposals, research agreements, and accompanying documentation must be submitted to the HSRRC electronically via email.

O. The burden of proof for review by the HSRRC shall be with the principal researcher.

P. Research shall not commence until all procedural and applicable human research reviews and approvals are completed and the director or applicable deputy director signs an approval memorandum on behalf of the department. This approval memorandum and necessary information describing the project shall be sent to the appropriate Department of Corrections organizational unit head, regional director, and principal researcher.

Q. This chapter does not apply to Department of Corrections studies, program evaluations, and routine data analyses for management purposes.

Part II
Human Research Review Committees

6VAC15-26-40. Certification process. (Repealed.)

A. Organizational units seeking to conduct or sponsor human research are required to submit statements to the department assuring that all human research activities will be reviewed and approved by a human research review committee. Organizational units shall report annually to the director 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 organizational unit affiliation and a copy of the minutes of committee meetings.

B. Prior to the initiation of a human research project, organizational units shall also send to the director a one-page summary containing the following information:

1. Name, address, telephone numbers, and title and affiliation of principal researcher;

2. Name of person who will supervise the project, if different from the principal researcher;

3. Funding source, if any;

4. Date the proposal was submitted to the appropriate human research review committee;

5. Title of project;

6. An objectives statement of the proposed project with anticipated results;

7. Methodology describing in a concise manner the research design, sampling strategy, and analytical techniques to be used and indicating the effects of the research methodology, if any, on existing programs and organizational unit operations;

8. The voluntary informed consent statement;

9. Time frame indicating proposed beginning and ending dates;

10. Department resources required, including personnel, supplies and materials, equipment, workspaces, access to participants and files, and any other resources that the researcher will require from the department or its subsidiaries; and

11. Project endorsement for student research. Letters or other documents must be attached to indicate endorsement of the project by the academic advisor or other appropriate persons.

C. Each person engaged in the conduct of human research or proposing to conduct human research shall associate himself with any organizational unit having a committee, and such human research shall be subject to review and approval by the committee in the manner set forth in this section.

D. The director may inspect the records of the committee.

E. The chairman of the committee shall report as soon as possible to the head of the organizational unit and to the director any violation of the research protocol which led the committee to either suspend or terminate the research.

Part II
Human Subject Research Review Committee (HSRRC)

6VAC15-26-50. Composition of research review committees the HSRCC.

A. Each committee The HSRRC shall have at least five three members, appointed by the organizational unit head director or designee, with varying backgrounds to provide complete and adequate review of activities commonly conducted by the organizational unit researchers. The committee HSRRC shall be sufficiently qualified through the experience and diversity of its members, including consideration of race, gender and cultural background. In addition to possessing the professional competence necessary to review specific activities, the committee must be able to ascertain the acceptability of applications and proposals in terms of organizational unit commitments and regulations, if applicable by law; standards of professional conduct and practice; and community attitudes. If a committee regularly reviews research that has an impact on an institutionalized or other vulnerable category of participants, 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.

1. The HSRRC shall not be comprised entirely of men or of women.

2. The HSRRC shall not be comprised entirely of members from one organizational work unit.

3. The HSRRC shall have at least one member who is not otherwise affiliated with the Department of Corrections and is not an immediate family member of a person who is affiliated with the department.

B. No committee shall consist entirely of men or women, or entirely of members of one profession. At least one member shall be an individual whose primary concerns are in nonscientific areas (e.g., lawyers, ethicists, members of the clergy). At least three members shall be individuals who are not otherwise connected with the department. In addition to possessing the professional competence necessary to review research proposals, the HSRRC must be able to ascertain the acceptability of research proposals in terms of organizational work unit commitments, this chapter, applicable Department of Corrections' operating procedures, any applicable state and federal law or regulation, standards of professional conduct and practice, and community attitudes.

C. Each committee shall include at least one member who is not otherwise affiliated with the organizational unit and who is not part of the immediate family of a person who is affiliated with the organizational unit.

D. C. No member of a committee the HSRRC shall participate in the committee's HSRRC's initial or continuing review of any research project in which the member has a conflict of interest (defined as having direct involvement in or department approval authority over the proposed human research or otherwise having a conflict of interest under applicable Virginia law). The committee HSRRC has responsibility for determining whether a member has a conflicting interest.

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

F. E. A quorum of the committee HSRRC shall consist of a majority of its members including at least one member whose primary concerns are in nonscientific areas. If a quorum cannot be established (or cannot meet within the established time frames) from the existing committee HSRRC, the organizational unit head director or designee may replace temporarily an active committee member with an alternate to the degree needed to establish a quorum.

G. One member of the committee shall be designated as secretary of the committee and shall take and prepare formal minutes of each meeting.

H. The committee and the organizational unit shall establish procedures and rules of operation necessary to fulfill the requirements of this chapter.

6VAC15-26-60. Elements of each committee's review process. (Repealed.)

A. No human research shall be conducted or authorized by an organizational unit or agency unless such committee has reviewed and approved the proposed human research project giving consideration to:

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 are adequate and appropriate, and whether the written consent form is adequate and appropriate in both content and language for both the research and participants of the research;

6. Whether the persons 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 board may establish; and

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

B. Each committee shall review and approve projects to ensure conformity with the approved proposal at least annually.

C. Research shall be approved by the committee which has jurisdiction over the participant. When cooperating organizational units conduct some or all of the research involving some or all of the participants, each cooperating organizational unit is responsible for safeguarding the rights and welfare of human participants and for complying with this chapter, except that in complying with this chapter organizational units may enter into joint review, rely upon the review of another qualified committee, or make similar arrangements aimed at avoiding duplication of effort. Such arrangements may be made by the committee chairperson with the approval of a majority of the members present at a meeting of the committee.

D. The committee shall consider completed research proposals within 60 days after submission to the committee's chairman. 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 shall notify investigators and the organizational unit in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure committee approval.

E. The committee shall develop a written procedure to be followed by a participant who has a complaint 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 who shall refer it to the committee to determine if there has been a violation of the protocol.

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

6VAC15-26-61. Duties and responsibilities.

A. The HSRRC shall establish procedures and rules of operation necessary to fulfill the requirements of this chapter.

B. The HSRRC shall review all submitted research proposals for the following:

1. Completeness, including:

a. Researcher information.

(1) Name of principal researcher

(2) Affiliation

(3) Mailing address

(4) Telephone number

(5) Email address

(6) Names of all other researchers participating in the research project

(7) Name of research project supervisor or advisor, if different from subdivision 1 a (1) of this subsection

(a) Telephone number

(b) Email address

(8) Funding source

(9) Curriculum vitae of principal researcher, all persons named as researchers and research project supervisor or advisor

b. Research proposal information.

(1) Date research proposal submitted to HSRRC

(2) Title of research proposal

(3) Purpose of research proposal

(4) Methodology

(a) Research design

(b) Sampling methods

(c) Methods of analysis

(5) Discussion of the research proposal in the context of relevant literature

(6) Discussion of the benefits to the Department of Corrections as well as the field of study

(7) Copies of any surveys or instruments to be used

(8) Voluntary informed consent forms

(9) Timeline for the research project

(10) Department of Corrections resources required (including personnel, supplies, materials, equipment, workspace, access to participants and files, etc.)

(11) External Institutional Review Board (IRB) approval (including academic IRBs, research group IRBs, and government IRBs); all external IRB approvals must be received before the HSRRC will initiate review of a submitted research proposal

c. Letters of endorsement.

2. Compliance with this chapter and all applicable state and federal laws and regulations. Compliance includes, but is not limited to:

a. The researchers' ability to obtain the appropriate security clearances to enter an organizational work unit.

b. The researchers' adherence to an organizational work unit's standards for appropriate attire, including dress or wardrobe, jewelry, hair, grooming, body piercings and tattoos.

c. The researchers' ability to pass an organizational work unit's security screening process for contraband, including weapons of any kind, alcohol, drugs of any kind, cellular phones, other electronic devices, tobacco products (including lighters and matches), and any other items deemed as potentially adversely impacting the safety and security of the Department of Corrections, organizational work unit, department staff, research participants or other offenders, the researchers, or the general public.

3. Adherence to basic research standards, including:

a. Credentials. The principal researcher shall have academic or professional standing in the pertinent field or job-related experience in the areas of study or be directly supervised by such a person.

b. Ethics. The research shall conform to the appropriate standards of ethics of professional societies such as the American Psychological Association, the American Sociological Association, the National Association of Social Workers, or other equivalent society.

c. Protection of rights. The principal researcher is responsible for the conduct of his staff and assumes responsibility for the protection of the rights of participants involved in the research project.

d. Confidentiality or anonymity. Research project information given by participants to the researcher or researchers shall be confidential or anonymous depending on the study design. This does not preclude the reporting of results in aggregated form that protects the identity of individuals, or the giving of raw data to the Department of Corrections for further analysis. The confidentiality of any such raw data shall be monitored by the department. Persons who breach confidentiality or anonymity shall be subject to sanctions in accordance with applicable laws, policies, and procedures.

e. Participant incentives. The opportunity to participate in research is considered sufficient incentive for participation. The offering of additional incentives is prohibited without specific written approval from the applicable Department of Corrections deputy director. Sentence reduction or pecuniary compensation are always prohibited as incentives.

4. Determination if the research proposal is subject to the human research review requirements of §§ 32.1-162.16 through 32.1-162.20 of the Code of Virginia.

5. Agreement with Department of Corrections research procedures.

a. The principal researcher and research project supervisor or advisor must submit a separate, signed written research agreement when submitting their research proposal indicating that the principal researcher, research project supervisor or advisor, and all other researchers and staff under their supervision who are associated with the research project have read, understand, and agree to abide by Department of Corrections research procedures.

b. The research agreement shall establish a timeline for the research project and the specific date when the principal researcher shall submit the final report to the HSRRC.

c. In the case of student research, the student's academic advisor must sign the research agreement indicating endorsement of the research project.

C. After reviewing each submitted, complete research proposal, research agreement and accompanying documentation, the HSRCC will vote to approve or deny the research proposal.

D. A research proposal shall be approved by the HSRRC when a majority of the quorum of the HSRRC votes to approve the research proposal.

E. In the event a research proposal is denied, the HSRRC shall notify the principal researcher of the reason or reasons for denial and any requested clarifications, edits, updates, or additions that can be made to the research proposal. The principal researcher may resubmit a revised research proposal with these requested clarifications, edits, updates, or additions. The HSRRC will then review the resubmitted revised, complete research proposal in accordance with 6VAC15-26-50 B.

F. Upon approval of a research proposal by the HSRRC, the HSRRC shall prepare a research brief summarizing the research proposal with any comments. The research brief will be provided to the director or the appropriate deputy director for review and approval.

G. Upon approval of the research brief by the director or the appropriate deputy director, the HSRRC shall provide an approval memorandum and necessary information describing the research project to the organizational work unit head, regional director, and principal researcher.

H. The HSRRC shall retain a separate electronic file for each submitted research proposal. Each electronic file shall contain:

1. The original submitted research proposal.

2. The research agreement.

3. Any accompanying documentation.

4. Any resubmitted revised research proposals.

5. The research brief.

6. The approval memorandum.

7. Any progress reports.

8. The final report.

9. All communication between the HSRRC, principal researcher, research project supervisor or advisor, the Department of Corrections Director, and the applicable deputy director, regional director, and organizational unit head pertaining to the research project.

I. At the time the research agreement is signed, the HSRRC shall establish due dates for progress reports to be provided by the principal researcher. These progress reports will inform the HSRRC of the status of the research project and any difficulties encountered that might delay or preclude completion of the research project.

J. The HSRRC shall establish research priorities consistent with the needs of the Department of Corrections.

K. The HSRRC shall regulate the number and timetable of research projects so as to not disrupt the normal functioning of any Department of Corrections operational work unit.

L. Upon receipt of a complaint from an organizational unit head or participant, the HSRRC will investigate to determine if there has been a violation of these regulations, Department of Corrections operating procedures, the research proposal, the research agreement or any applicable state or federal laws or regulations.

M. If the HSRRC determines that a principal researcher, researcher, research project supervisor or advisor, or staff supervised by them has violated any provisions of this chapter, Department of Corrections operating procedures, the research proposal, the research agreement, or any applicable state or federal laws or regulations, the HSRRC may terminate the research project at any time.

N. The HSRRC shall submit to the Governor, the General Assembly, and the director or his designee at least annually a report on the human research projects reviewed and approved by the HSRRC, including any significant deviations from the approved research projects.

6VAC15-26-70. Kinds of research exempt from committee review. (Repealed.)

Research activities in which the only involvement of human participants will be in one or more of the following categories are exempt from this chapter unless the research is covered by other sections of this chapter:

1. Research conducted in established or commonly accepted educational settings, involving commonly used 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.

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:

a. The participants' 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 participants' financial standing, employability, or reputation; 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.

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 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 sexual behavior, drug or alcohol use, illegal conduct, or family planning.

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

6. Research involving solely a combination of any of the activities described in this section.

6VAC15-26-71. Reports.

A. The principal researcher must submit progress reports to the HSRRC by the dates agreed upon in the research agreement. These progress reports must be submitted electronically via email.

B. The principal researcher must submit a final report to the HSRRC. The final report must be submitted electronically via email.

C. The HSRRC reserves the right to reproduce the final report for official Department of Corrections use only.

6VAC15-26-80. Expedited review procedures for certain kinds of research involving no more than minimal risk. (Repealed.)

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. Under an expedited review procedure, the review may be carried out by the committee chairperson or one or more experienced reviewers designated by the chairperson from among members of the committee. In reviewing the research, the reviewers may exercise all of the authorities of the committee except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in 6VAC15-26-60.

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

C. Research activities involving no more than minimal risk and in which the involvement of human participants will only be in one or more of the following categories (carried out through standard methods) may be reviewed by the research review committee through the expedited review procedure.

1. The study of existing data in the form of records on department personnel or inmates, probationers, or parolees, automated or other records.

2. Research on individual or group behavior or characteristics of individuals, such as studies of perception, attitudes or interaction patterns, where the investigator does not manipulate participants' behavior and the research will not involve stress to participants.

6VAC15-26-81. Records maintenance.

A. The principal researcher shall maintain records adequate to enable the Department of Corrections to ascertain the status of the research project at any given time.

B. The principal researcher shall maintain completed voluntary informed consent forms in a secure location for at least three years.

6VAC15-26-90. Informed consent. (Repealed.)

A. No human research may be conducted in the absence of voluntary informed consent subscribed to in writing by the participant or by the participant's legally authorized representative 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 shall be subscribed to by both the minor and his legally authorized representative. An investigator shall seek such consent only under circumstances that (i) provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and (ii) minimize the possibility of coercion or undue influence. The information that is given to the participant or the representative shall be in understandable language.

B. No individual shall participate in research unless subsection A of this section is met for each individual. The 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, 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 research project. Each participant shall be given a copy of the signed consent form required by 6VAC15-26-30 A except as provided for in subsection F of this section.

C. No legally authorized representative may consent to nontherapeutic research unless it is determined by the committee 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 participant.

D. The committee may approve a consent procedure which omits or alters some or all of the elements of informed consent set forth in 6VAC15-26-10, or waives the requirement to obtain informed consent provided the committee finds and documents that:

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

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

3. The research could not practicably be performed without the omission, alteration or waiver; and

4. Whenever appropriate, the 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:

1. A written consent document that embodies the elements of informed consent required by 6VAC15-26-10. 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 6VAC15-26-10 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 participant or the representative in addition to a copy of the short form.

F. The committee may waive the requirement for the 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 that the principal risk would be potentially harmful resulting from a breach of confidentiality. Each participant will be asked whether he wants documentation linking him to 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 explaining the research.

6VAC15-26-91. Publication rights.

A. Researchers are not permitted to publish beyond the approved research proposal without further review and approval from the HSRRC.

B. The researcher shall furnish the HSRRC with an electronic copy of the published research findings.

C. The Department of Corrections shall be permitted to use the data collected in the research project and to reproduce the materials as they are published.

D. Without the explicit written approval of the researcher, the Department of Corrections should not publicly distribute any dissertation or thesis material that the researcher has not published or presented publicly or professionally.

E. Without prior approval from the HSRRC, research conducted by employees or agents (including but not limited to interns, volunteers, contractors, and vendors) of the department is the property of the department and cannot be published without the approval of the director or the appropriate deputy director.

6VAC15-26-100. Committee records. (Repealed.)

A. Documentation of all committee activities shall be prepared and maintained and shall include the following:

1. Copies of all research proposals reviewed, evaluations that may accompany the proposals, approved sample consent documents, progress reports submitted by researchers, reports of injuries to participants, and correspondence related to the research;

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

3. Records of continuing review activities;

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

5. A list of committee members;

6. Written procedures for the committee; and

7. Statements of significant new findings provided to the participants.

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 at reasonable times and in a reasonable manner.

6VAC15-26-101. Research exempt from HSRRC review.

The following are exempt from HSRRC review:

1. Department of Corrections' studies, program evaluations and routine data analyses for management purposes.

2. Research conducted by the Department of Corrections, Division of Education in established or commonly accepted educational settings, involving commonly used educational practices, such as:

a. Research on regular and special education instructional strategies.

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

3. Research involving required agency survey procedures, unless responses are recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants, and either:

a. The participants' responses, if they become known outside the research, could reasonably place a participant at risk of criminal or civil liability or be damaging to a participant's financial standing, employability, or reputation; or

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

4. Research involving solely the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publically available or if the information taken from these sources is recorded in such a manner that participants connot be identified, either directly or through identifiers linked to the participants.

6VAC15-26-102. Waiver of signed voluntary informed consent form.

A. The HSRRC may waive the requirement for the researcher to obtain a signed voluntary informed consent form for some or all participants in a research project if it finds that the only record linking the participant and the research would be the consent form and that the principal risk would be potentially harmful resulting from a breach of confidentiality.

B. Each participant will be asked whether he wants documentation linking him to the research, and the participant's wishes will govern.

C. In cases where the documentation requirement is waived, the HSRRC shall require the researcher to provide participants with a written statement explaining the research.

6VAC15-26-110. Mandatory reporting. (Repealed.)

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

Part III
Role of the Department, Director, and the Board

6VAC15-26-120. Role of the department, director, and the board.

A. The director, or his designee, shall establish and maintain records of organizational unit the HSRRC assurances, annual reports, and summary descriptions of research projects to be reviewed by the board.

B. The director, or his designee, shall review communications from committees the HSRRC 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 rights of human research participants. The board shall be kept informed.

C. The director shall arrange for the printing and dissemination of copies of this chapter.

Part IV
Applicability of State and Federal Policies

6VAC15-26-130. Applicability of state and federal policies.

A. No statement in this chapter shall be construed as limiting in any way the rights of participants in research under regulations promulgated by the board pursuant to §§ 53.1-5 and 53.1-5.1 of the Code of Virginia.

B. Human research that is subject to policies and regulations for the protection of human participants promulgated by any agency of the federal government shall be exempted from this chapter. Annual certification shall be made that exempted projects have complied with the policies and regulations of federal agencies to the director and the board.

6VAC15-26-140. Applicability of federal policies. (Repealed.)

Human research which is subject to policies and regulations for the protection of human participants promulgated by any agency of the federal government shall be exempted from this chapter. Annual certification shall be made to the director and the board that exempted projects have complied with the policies and regulations of federal agencies.

NOTICE: The following forms used in administering the regulation were filed by the agency. The forms are not being published; however, online users of this issue of the Virginia Register of Regulations may click on the name to access a form. The forms are also available from the agency contact or may be viewed at the Office of the Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond, Virginia 23219.

FORMS (6VAC15-26)

Research Proposal - Sample (Operating Procedure 020.1), Attachment 1, effective April 1, 2010 (rev. 1/10).

Research Agreement (Operating Procedure 020.1), Attachment 2, effective April 1, 2010 (rev. 1/10).

Voluntary Informed Consent to Participate in Research (Operating Procedure 020.1), Attachment 3, effective April 1, 2010 (rev. 1/10).

DOCUMENTS INCORPORATED BY REFERENCE (6VAC15-26)

Operating Procedure 701.1 - Health Services Administration, Effective Date January 1, 2012, Amended March 29, 2012, Virginia Department of Corrections.

VA.R. Doc. No. R11-2246; Filed October 2, 2012, 10:03 a.m.