Part III. Explanation of Individual Rights and Provider Duties
12VAC35-115-50. Dignity.
A. Each individual has a right to exercise his legal, civil, and human rights, including constitutional rights, statutory rights, and the rights contained in this chapter, except as specifically limited in this chapter or otherwise by law. Each individual has a right to have services that he receives respond to his needs and preferences and be person-centered. Each individual also has the right to be protected, respected, and supported in exercising these rights. Providers shall not partially or totally take away or limit these rights solely because an individual has a mental health or substance use disorder or an intellectual disability and is receiving services for these conditions or has any physical or sensory condition that may pose a barrier to communication or mobility.
B. In receiving all services, each individual has the right to:
1. Use his preferred or legal name. The use of an individual's preferred name may be limited when a licensed professional makes the determination that the use of the name will result in demonstrable harm or have significant negative impact on the program itself or the individual's treatment, progress, and recovery. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation and the reasons for the restriction shall be documented in the individual's services record. The need for the restriction shall be reviewed by the team every month and documented in the services record.
2. Be protected from harm including abuse, neglect, and exploitation.
3. Have help in learning about, applying for, and fully using any public service or benefit to which he may be entitled. These services and benefits include educational or vocational services, housing assistance, services or benefits under Titles II, XVI, XVIII, and XIX of the Social Security Act, United States Veterans Benefits, and services from legal and advocacy agencies.
4. Have opportunities to communicate in private with lawyers, judges, legislators, clergy, licensed health care practitioners, authorized representatives, advocates, the Office of the State Inspector General (§ 2.2-308 of the Code of Virginia), and employees of the protection and advocacy agency.
5. Be provided with general information about program services, policies, and rules in writing and in the manner, format and language easily understood by the individual.
6. Be afforded the opportunity to have an individual of his choice notified of his general condition, location, and transfer to another facility.
C. In services provided in residential and inpatient settings, each individual has the right to:
1. Have sufficient and suitable clothing for his exclusive use.
2. Receive nutritionally adequate, varied, and appetizing meals that are prepared and served under sanitary conditions, are served at appropriate times and temperatures, and are consistent with any individualized diet program.
3. Live in a humane, safe, sanitary environment that gives each individual, at a minimum:
a. Reasonable privacy and private storage space;
b. An adequate number of private, operating toilets, sinks, showers, and tubs that are designed to accommodate individuals' physical needs;
c. Direct outside air provided by a window that opens or by an air conditioner;
d. Windows or skylights in all major areas used by individuals;
e. Clean air, free of bad odors; and
f. Room temperatures that are comfortable year round and compatible with health requirements.
4. Practice a religion and participate in religious services subject to their availability, provided that such services are not dangerous to the individual or others and do not infringe on the freedom of others.
a. Religious services or practices that present a danger of bodily injury to any individual or interfere with another individual's religious beliefs or practices may be limited. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation. The reasons for the restriction shall be documented in the individual's services record.
b. Participation in religious services or practices may be reasonably limited by the provider in accordance with other general rules limiting privileges or times or places of activities.
5. Have paper, pencil and stamps provided free of charge for at least one letter every day upon request. However, if an individual has funds to buy paper, pencils, and stamps to send a letter every day, the provider does not have to pay for them.
6. Communicate privately with any person by mail and have help in writing or reading mail as needed.
a. An individual's access to mail may be limited only if the provider has reasonable cause to believe that the mail contains illegal material or anything dangerous. If so, the director or his designee may open the mail, but not read it, in the presence of the individual.
b. An individual's ability to communicate by mail may be limited if, in the judgment of a licensed professional, the individual's communication with another person or persons will result in demonstrable harm to the individual's mental health.
c. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation and the reasons for the restriction shall be documented in the individual's services record. The need for the restriction shall be reviewed by the team every month and documented in the services record.
7. Communicate privately with any person by telephone and have help in doing so. Use of the telephone may be limited to certain times and places to make sure that other individuals have equal access to the telephone and that they can eat, sleep, or participate in an activity without being disturbed.
a. An individual's access to the telephone may be limited only if, in the judgment of a licensed professional, communication with another person or persons will result in demonstrable harm to the individual or significantly affect his treatment.
b. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation and the reasons for the restriction shall be documented in the individual's services record. The need for the restriction shall be reviewed by the team every month and documented in the individual's services record.
c. Residential substance abuse services providers that are not inpatient hospital settings or crisis stabilization programs may develop policies and procedures that limit the use of the telephone during the initial phase of treatment when sound therapeutic practice requires restriction, subject to the following conditions:
(1) Prior to implementation and when it proposes any changes or revisions, the provider shall submit policies and procedures, program handbooks, or program rules to the LHRC and the human rights advocate for review and approval.
(2) When an individual applies for admission, the provider shall notify him of these restrictions.
8. Have or refuse visitors.
a. An individual's access to visitors may be limited or supervised only when, in the judgment of a licensed professional, the visits result in demonstrable harm to the individual or significantly affect the individual's treatment or when the visitors are suspected of bringing contraband or threatening harm to the individual in any other way.
b. The director or his designee shall discuss the issue with the individual and inform the human rights advocate of the reasons for any restriction prior to implementation and the restriction shall be documented in the individual's services record. The need for the restriction shall be reviewed by the team every month and documented in the individual's services record.
c. Residential substance abuse service providers that are not inpatient hospital settings or crisis stabilization programs may develop policies and procedures that limit visitors during the initial phase of treatment when sound therapeutic practice requires the restriction, subject to the following conditions:
(1) Prior to implementation and when proposing any changes or revisions, the provider shall submit policies and procedures, program handbooks, or program rules to the LHRC and the human rights advocate for review and approval.
(2) The provider shall notify individuals who apply for admission of these restrictions.
9. Nothing in these provisions shall prohibit a provider from stopping, reporting, or intervening to prevent any criminal act.
D. The provider's duties.
1. Providers shall recognize, respect, support, and protect the dignity rights of each individual at all times. In the case of a minor, providers shall take into consideration the expressed preferences of the minor and the parent or guardian.
2. Providers shall develop, carry out, and regularly monitor policies and procedures that assure the protection of each individual's rights.
3. Providers shall assure the following relative to abuse, neglect, and exploitation:
a. Policies and procedures governing harm, abuse, neglect, and exploitation of individuals receiving their services shall require that, as a condition of employment or volunteering, any employee, volunteer, consultant, or student who knows of or has reason to believe that an individual may have been abused, neglected, or exploited at any location covered by this chapter shall immediately report this information directly to the director.
b. The director shall immediately take necessary steps to protect the individual until an investigation is complete. This may include the following actions:
(1) Direct the employee or employees involved to have no further contact with the individual. In the case of incidents of peer-on-peer aggression, protect the individuals from the aggressor in accordance with sound therapeutic practice and this chapter.
(2) Temporarily reassign or transfer the employee or employees involved to a position that has no direct contact with individuals receiving services.
(3) Temporarily suspend the involved employee or employees pending completion of an investigation.
4. Providers shall afford the individual the opportunity to have an individual of his choice notified of his general condition, location, and transfer to another facility.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 29, Issue 4, eff. November 21, 2012; Volume 31, Issue 1, eff. October 8, 2014; Volume 33, Issue 10, eff. February 9, 2017.
12VAC35-115-60. Services.
A. Each individual receiving services shall receive those services according to law and sound therapeutic practice.
B. The provider's duties.
1. Providers shall develop, carry out, and regularly monitor policies and procedures prohibiting discrimination in the provision of services. Providers shall comply with all state and federal laws, including any applicable provisions of the Americans with Disabilities Act (42 USC § 12101 et seq.), that prohibit discrimination.
2. Providers shall ensure that all services, including medical services and treatment, are at all times delivered in accordance with sound therapeutic practice. Providers may deny or limit an individual's access to services if sound therapeutic practice requires limiting the service to individuals of the same sex or similar age, disability, or legal status.
3. Providers shall develop and implement policies and procedures that address emergencies. These policies and procedures shall:
a. Identify what caregivers may do to respond to an emergency;
b. Identify qualified clinical staff who are accountable for assessing emergency conditions and determining the appropriate intervention;
c. Require that the director immediately notify the individual's authorized representative and the advocate if an emergency results in harm or injury to any individual; and
d. Require documentation in the individual's services record of all facts and circumstances surrounding the emergency.
4. Providers shall assign a specific person or group of persons to carry out each of the following activities:
a. Medical, mental health, and behavioral screenings and assessments, as applicable, upon admission and during the provision of services;
b. Preparation, implementation, and modifications to an ISP based on ongoing review of the medical, mental, and behavioral needs of the individual;
c. Preparation and implementation of an individual's discharge plan; and
d. Review of every use of seclusion or restraint by a qualified professional who is involved in providing services to the individual.
5. Providers shall not deliver any service to an individual without an ISP that is tailored specifically to the needs and expressed preferences of the individual and, in the case of a minor, the minor and the minor's parent or guardian or other person authorized to consent to treatment pursuant to § 54.1-2969 A of the Code of Virginia. Services provided in response to emergencies or crises shall be deemed part of the ISP and thereafter documented in the ISP.
6. Providers shall write the ISP and discharge plan in clear, understandable language.
7. When preparing or changing an ISP or discharge plan, providers shall ensure that all services received by the individual are integrated. With the individual's or the individual's authorized representative's authorization, providers may involve family members in services and discharge planning. When the individual or his authorized representative requests such involvement, the provider shall take all reasonable steps to do so. In the case of services to minors, the parent or guardian or other person authorized to consent to treatment pursuant to § 54.1-2969 A of the Code of Virginia shall be involved in service and discharge planning.
8. Providers shall ensure that the entries in an individual's services record are at all times authentic, accurate, complete, timely, and pertinent.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.
12VAC35-115-70. Participation in decision making and consent.
A. Each individual has a right to participate meaningfully in decisions regarding all aspects of services affecting him. This includes the right to:
1. Consent or not consent to receive or participate in services.
a. The ISP and discharge plan shall incorporate the individual's preferences consistent with his condition and need for service and the provider's ability to address them;
b. The individual's services record shall include evidence that the individual has participated in the development of his ISP and discharge plan, in changes to these plans, and in all other significant aspects of his treatment and services; and
c. The individual's services record shall include the signature or other indication of the individual's or his authorized representative's consent.
2. Give or not give informed consent to receive or participate in treatment or services that pose a risk of harm greater than ordinarily encountered in daily life and to participate in human research except research that is exempt under § 32.1-162.17 of the Code of Virginia. Informed consent is always required for surgical procedures, electroconvulsive treatment, or use of psychotropic medications.
a. To be informed, consent for any treatment or service must be based on disclosure of and understanding by the individual or his authorized representative of the following information:
(1) An explanation of the treatment, service, or research and its purpose;
(2) When proposing human research, the provider shall describe the research and its purpose, explain how the results of the research will be disseminated and how the identity of the individual will be protected, and explain any compensation or medical care that is available if an injury occurs;
(3) A description of any adverse consequences and risks associated with the research, treatment, or service;
(4) A description of any benefits that may be expected from the research, treatment, or service;
(5) A description of any alternative procedures that might be considered, along with their side effects, risks, and benefits;
(6) Notification that the individual is free to refuse or withdraw his consent and to discontinue participation in any treatment, service, or research requiring his consent at any time without fear of reprisal against or prejudice to him; and
(7) A description of the ways in which the individual or his authorized representative can raise concerns and ask questions about the research, treatment, or service to which consent is given.
b. Evidence of informed consent shall be documented in an individual's services record and indicated by the signature of the individual or his authorized representative on a form or the ISP.
c. Informed consent for electroconvulsive treatment requires the following additional components:
(1) Informed consent shall be in writing, documented on a form that shall become part of the individual's services record. This form shall:
(a) Specify the maximum number of treatments to be administered during the series;
(b) Indicate that the individual has been given the opportunity to view an instructional video presentation about the treatment procedures and their potential side effects; and
(c) Be witnessed in writing by a person not involved in the individual's treatment who attests that the individual has been counseled and informed about the treatment procedures and potential side effects of the procedures.
(2) Separate consent, documented on a new consent form, shall be obtained for any treatments exceeding the maximum number of treatments indicated on the initial consent form.
(3) Providers shall inform the individual or his authorized representative that the individual may obtain a second opinion before receiving electroconvulsive treatment and the individual is free to refuse or withdraw his consent and to discontinue participation at any time without fear of reprisal against or prejudice to him. The provider shall document such notification in the individual's services record.
(4) Before initiating electroconvulsive treatment for any individual under age 18 years, two qualified child psychiatrists must concur with the treatment. The psychiatrists must be trained or experienced in treating children or adolescents and not directly involved in treating the individual. Both must examine the individual, consult with the prescribing psychiatrist, and document their concurrence with the treatment in the individual's services record.
3. Have an authorized representative make decisions for him in cases where the individual has been determined to lack the capacity to consent or authorize the disclosure of information.
a. If an individual who has an authorized representative who is not his legal guardian objects to the disclosure of specific information or a specific proposed treatment or service, the director or his designee shall immediately notify the human rights advocate and authorized representative. A petition for LHRC review of the objection may be filed under 12VAC35-115-200.
b. If the authorized representative objects or refuses to consent to a specific proposed treatment or service for which consent is necessary, the provider shall not institute the proposed treatment, except in an emergency in accordance with this section or as otherwise permitted by law.
4. Be accompanied, except during forensic evaluations, by a person or persons whom the individual trusts to support and represent him when he participates in services planning, assessments, evaluations, including discussions and evaluations of the individual's capacity to consent, and discharge planning.
5. Request admission to or discharge from any service at any time.
B. The provider's duties.
1. Providers shall respect, protect, and help develop each individual's ability to participate meaningfully in decisions regarding all aspects of services affecting him. This shall be done by involving the individual, to the extent permitted by his capacity, in decision making regarding all aspects of services.
2. Providers shall ask the individual to express his preferences about decisions regarding all aspects of services that affect him and shall honor these preferences to the extent possible.
3. Providers shall give each individual the opportunity and any help he needs to participate meaningfully in the preparation of his services plan, discharge plan, and changes to these plans, and all other aspects of services he receives. Providers shall document these opportunities in the individual's services record.
4. Providers shall obtain and document in the individual's services record the individual's or his authorized representative's consent for any treatment before it begins. If the individual is a minor in the legal custody of a natural or adoptive parent, the provider shall obtain this consent from at least one parent. The consent of a parent is not needed if a court has ordered or consented to treatment or services pursuant to § 16.1-241 C or D, 16.1-275, or 54.1-2969 A 1 or B of the Code of Virginia, or a local department of social services with custody of the minor has provided consent. Reasonable efforts must be made, however, to notify the parent or legal custodian promptly following the treatment or services. Additionally, a competent minor may independently consent to treatment for sexually transmitted or contagious diseases, family planning or pregnancy, or outpatient services or treatment for mental illness, emotional disturbance, or substance use disorders pursuant to § 54.1-2969 E of the Code of Virginia.
5. Providers may initiate, administer, or undertake a proposed treatment without the consent of the individual or the individual's authorized representative in an emergency. All emergency treatment or services and the facts and circumstances justifying the emergency shall be documented in the individual's services record within 24 hours of the treatment or services.
a. Providers shall immediately notify the authorized representative of the provision of treatment without consent during an emergency.
b. Providers shall continue emergency treatment without consent beyond 24 hours only following a review of the individual's condition and if a new order is issued by a professional who is authorized by law and the provider to order treatment.
c. Providers shall notify the human rights advocate if emergency treatment without consent continues beyond 24 hours.
d. Providers shall develop and integrate treatment strategies into the ISP to address and prevent future emergencies to the extent possible following provision of emergency treatment without consent.
6. Providers shall obtain and document in the individual's services record the consent of the individual or his authorized representative to continue any treatment initiated in an emergency that lasts longer than 24 hours after the emergency began.
7. Providers may provide treatment in accordance with a court order or in accordance with other provisions of law that authorize such treatment or services including § 54.1-2970 of the Code of Virginia and the Health Care Decisions Act (§ 54.1-2981 et seq. of the Code of Virginia). The provisions of these regulations are not intended to be exclusive of other provisions of law but are cumulative.
8. Providers shall respond to an individual's request for discharge set forth in statute and shall make sure that the individual is not subject to punishment, reprisal, or reduction in services because he makes a request. However, if an individual leaves a service against medical advice, any subsequent billing of the individual by his private third party payer shall not constitute punishment or reprisal on the part of the provider.
a. Voluntary admissions.
(1) Individuals admitted under § 37.2-805 of the Code of Virginia to state hospitals operated by the department who notify the director of their intent to leave shall be discharged when appropriate, but no later than eight hours after notification, unless another provision of law authorizes the director to retain the individual for a longer period.
(2) Minors admitted under § 16.1-338 or 16.1-339 of the Code of Virginia shall be released to the parent's or legal guardian's custody within 48 hours of the consenting parent's or legal guardian's notification of withdrawal of consent, unless a petition for continued hospitalization pursuant to § 16.1-340.1 or 16.1-341 of the Code of Virginia is filed.
b. Involuntary admissions.
(1) When a minor involuntarily admitted under § 16.1-345 of the Code of Virginia no longer meets the commitment criteria, the director shall take appropriate steps to arrange the minor's discharge.
(2) When an individual involuntarily admitted under § 37.2-817 of the Code of Virginia has been receiving services for more than 30 days and makes a written request for discharge, the director shall determine whether the individual continues to meet the criteria for involuntary admission. If the director denies the request for discharge, he shall notify the individual in writing of the reasons for denial and of the individual's right to seek relief in the courts. The request and the reasons for denial shall be included in the individual's services record. Anytime the individual meets any of the criteria for discharge set out in § 37.2-837 or 37.2-838 of the Code of Virginia, the director shall take all necessary steps to arrange the individual's discharge.
(3) If at any time it is determined that an individual involuntarily admitted under Chapter 11 (§ 19.2-167 et seq.) or Chapter 11.1 (§ 19.2-182.2 et seq.) of Title 19.2 of the Code of Virginia no longer meets the criteria under which the individual was admitted and retained, the director or commissioner, as appropriate, shall seek judicial authorization to discharge or transfer the individual. Further, pursuant to § 19.2-182.6 of the Code of Virginia, the commissioner shall petition the committing court for conditional or unconditional release at any time he believes the acquittee no longer needs hospitalization.
c. Certified admissions. If an individual certified for admission to a state training center or his authorized representative requests discharge, the director or his designee shall contact the individual's community services board to finalize and implement the discharge plan.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 31, Issue 1, eff. October 8, 2014.
12VAC35-115-80. Confidentiality.
A. Each individual is entitled to have all identifying information that a provider maintains or knows about him remain confidential. Each individual has a right to give his authorization before the provider shares identifying information about him or his care unless another state law or regulation, or these regulations specifically require or permit the provider to disclose certain specific information.
B. The provider's duties.
1. Providers shall maintain the confidentiality of any information that identifies an individual. If an individual's services record pertains in whole or in part to referral, diagnosis or treatment of substance use disorders, providers shall disclose information only according to applicable federal regulations (see 42 CFR Part 2, Confidentiality of Alcohol and Drug Abuse Patient Records).
2. Providers shall obtain and document in the individual's services record the individual's authorization or that of the authorized representative prior to disclosing any identifying information about him. The authorization must contain the following elements:
a. The name of the organization and the name or other specific identification of the person or persons or class of persons to whom disclosure is made;
b. A description of the nature of the information to be disclosed, the purpose of the disclosure, and an indication whether the authorization extends to the information placed in the individual's record after the authorization was given but before it expires;
c. An indication of the effective date of the authorization and the date the authorization will expire, or the event or condition upon which it will expire; and
d. The signature of the individual and the date. If the authorization is signed by an authorized representative, a description of the authorized representative's authority to act.
3. Providers shall tell each individual and his authorized representative about the individual's confidentiality rights. This shall include how information can be disclosed and how others might get information about the individual without his authorization. If a disclosure is not required by law, the provider shall give strong consideration to any objections from the individual or his authorized representative in making the decision to disclose information.
4. Providers shall prevent unauthorized disclosures of information from services records and shall maintain and disclose information in a secure manner.
5. In the case of a minor, the authorization of the custodial parent or other person authorized to consent to the minor's treatment under § 54.1-2969 is required, except as provided below:
a. Section 54.1-2969 E of the Code of Virginia permits a minor to authorize the disclosure of information related to medical or health services for a sexually transmitted or contagious disease, family planning or pregnancy, and outpatient care, treatment or rehabilitation for substance use disorders, mental illness, or emotional disturbance.
b. The concurrent authorization of the minor and custodial parent is required to disclose inpatient substance abuse records.
c. The minor and the custodial parent shall authorize the disclosure of identifying information related to the minor's inpatient psychiatric hospitalization when the minor is 14 years of age or older and has consented to the admission.
6. When providers disclose identifying information, they shall attach a statement that informs the person receiving the information that it must not be disclosed to anyone else unless the individual authorizes the disclosure or unless state law or regulation allows or requires further disclosure without authorization.
7. Providers may encourage individuals to name family members, friends, and others who may be told of their presence in the program and general condition or well-being. Except for information governed by 42 CFR Part 2, providers may disclose to a family member, other relative, a close personal friend, or any other person identified by the individual, information that is directly relevant to that persons involvement with the individual's care or payment for his health care, if (i) the provider obtains the individual's agreement, (ii) the provider provides the individual with the opportunity to object to the disclosure, and (iii) the individual does not object or the provider reasonably infers for the circumstances, based or the exercise of professional judgment, that the individual does not object to the disclosure. If the opportunity to agree or object cannot be provided because of the individual's incapacity or an emergency circumstance, the provider may, in the exercise of professional judgment, determine whether the disclosure is in the best interest of the individual and, if so, disclose only the information that is directly relevant to the person's involvement with the individual's health care.
8. Providers may disclose the following identifying information without authorization or violation of the individual's confidentiality, but only under the conditions specified in the following subdivisions of this subsection. Providers should always consult 42 CFR Part 2, Confidentiality of Alcohol and Drug Abuse Patient Records, if applicable, because these federal regulations may prohibit some of the disclosures addressed in this section.
a. Emergencies: Providers may disclose information in an emergency to any person who needs that particular information for the purpose of preventing injury to or death of an individual or other person. The provider shall not disclose any information that is not needed for this specific purpose.
b. Providers or health plans: Providers may permit any full-time or part-time employee, consultant, agent, or contractor of the provider to use identifying information or disclose to another provider, a health plan, the department, or a CSB, information required to give services to the individual or to get payment for the services.
c. Court proceedings: If the individual or someone acting for him introduces any aspect of his mental condition or services as an issue before a court, administrative agency, or medical malpractice review panel, the provider may disclose any information relevant to that issue. The provider may also disclose any records if they are properly subpoenaed, if a court orders them to be produced, or if involuntary admission or certification for admission is being proposed.
d. Legal counsel: Providers may disclose information to their own legal counsel or to anyone working on behalf of their legal counsel in providing representation to the provider. Providers of state-operated services may disclose information to the Office of the Attorney General or to anyone appointed by or working on behalf of that office in providing representation to the Commonwealth of Virginia.
e. Human rights committees: Providers may disclose to the LHRC and the SHRC any information necessary for the conduct of their responsibilities under these regulations.
f. Others authorized or required by the commissioner, CSB, or private program director: Providers may disclose information to other persons if authorized or required for the following activities:
(1) Licensing, human rights, or certification or accreditation reviews;
(2) Hearings, reviews, appeals, or investigations under these regulations;
(3) Evaluation of provider performance and individual outcomes (see §§ 37.2-508 and 37.2-608 of the Code of Virginia);
(4) Statistical reporting;
(5) Preauthorization, utilization reviews, financial and related administrative services reviews, and audits; or
(6) Similar oversight and review activities.
g. Preadmission screening, services, and discharge planning: Providers may disclose to the department, the CSB, or to other providers information necessary to screen individuals for admission or to prepare and carry out a comprehensive individualized services or discharge plan (see § 37.2-505 of the Code of Virginia).
h. Protection and advocacy agency: Providers may disclose information to the protection and advocacy agency in accordance with that agency's legal authority under federal and state law.
i. Historical research: Providers may disclose information to persons engaging in bona fide historical research if all of the following conditions are met:
(1) The request for historical research shall include, at a minimum, a summary of the scope and purpose of the research, a description of the product to result from the research and its expected date of completion, a rationale explaining the need to access otherwise private information, and the specific identification of the type and location of the records sought;
(2) The commissioner, CSB executive director, or private program director has authorized the research;
(3) The individual or individuals who are the subject of the disclosure are deceased;
(4) There are no known living persons permitted by law to authorize the disclosure; and
(5) The disclosure would in no way reveal the identity of any person who is not the subject of the historical research.
j. Protection of public safety: If an individual receiving services makes a specific threat to cause serious bodily injury or death to an identified or readily identifiable person and the provider reasonably believes that the individual has the intent and the ability to carry out the threat immediately or imminently, the provider may disclose those facts necessary to alleviate the potential threat.
k. Inspector General: Providers may disclose to the Office of the State Inspector General (§ 2.2-308 of the Code of Virginia) any individual services records and other information relevant to the provider's delivery of services.
l. Virginia Patient Level Data System: Providers may disclose financial and services information to Virginia Health Information as required by law (see Chapter 7.2 (§ 32.1-276.2 et seq.) of Title 32.1 of the Code of Virginia).
m. Psychotherapy notes: Providers shall obtain an individual's authorization for any disclosure of psychotherapy notes, except when disclosure is made:
(1) For the provider's own training programs in which students, trainees, or practitioners in mental health are being taught under supervision to practice or improve their skills in group, joint, family or individual counseling;
(2) To defend the provider or its employees or staff against any accusation or wrongful conduct;
(3) In discharge of the provider's duty, in accordance with § 54.1-2400.1 B of the Code of Virginia, to take precautions to protect third parties from violent behavior or other serious harm;
(4) As required in the course of an investigation, audit, review, or proceeding regarding a provider's conduct by a duly authorized law enforcement, licensure, accreditation, or professional review entity; or
(5) When otherwise required by law.
n. A law-enforcement official:
(1) Pursuant to a search warrant or grand jury subpoena;
(2) In response to their request, for the purpose of identifying or locating a suspect, fugitive, an individual required to register pursuant to § 9.1-901 of the Sex Offender and Crimes Against Minors Registry Act, material witness, or missing person, provided that only the following information is disclosed:
(a) Name and address of the individual;
(b) Date and place of birth of the individual;
(c) Social security number of the individual;
(d) Blood type of the individual;
(e) Date and time of treatment received by the individual;
(f) Date and time of death of the individual;
(g) Description of distinguishing physical characteristics of the individual; and
(h) Type of injury sustained by the individual;
(3) Regarding the death of an individual for the purpose of alerting law enforcement of the death if the health care entity has a suspicion that such death may have resulted from criminal conduct; or
(4) If the health care entity believes in good faith that the information disclosed constitutes evidence of a crime that occurred on its premises.
o. Other statutes or regulations: Providers may disclose information to the extent required or permitted by any other state or law or regulation. See also § 32.1-127.1:03 of the Code of Virginia for a list of circumstances in which records may be disclosed without authorization.
9. Upon request, the provider shall tell the individual or his authorized representative the sources of information contained in his services records and provide a written listing of disclosures of information made without authorization, except for disclosures:
a. To employees of the department, CSB, the provider, or other providers;
b. To carry out treatment, payment, or health care operations;
c. That are incidental or unintentional disclosures that occur as a by-product of engaging in health care communications and practices that are already permitted or required;
d. To an individual or his authorized representative;
e. Pursuant to an authorization;
f. For national security or intelligence purposes;
g. To correctional institutions or law-enforcement officials; or
h. That were made more than six years prior to the request.
10. The provider shall include the following information in the listing of disclosures of information provided to the individual or his authorized representative under subdivision 9 of this subsection:
a. The name of the person or organization that received the information and the address if known;
b. A brief description of the information disclosed; and
c. A brief statement of the purpose of the disclosure or, in lieu of such a statement, a copy of the written request for disclosure.
11. If the provider makes multiple disclosures of information to the same person or entity for a single purpose, the provider shall include the following:
a. The information required in subdivision 10 of this subsection for the first disclosure made during the requested period;
b. The frequency, periodicity, or number of disclosures made during the period for which the individual is requesting information; and
c. The date of the last disclosure during the time period.
12. If the provider makes a disclosure to a social service or protective services agency about an individual who the provider reasonably believes to be a victim of abuse or neglect, the provider is not required to inform the individual or his authorized representative of the disclosure if:
a. The provider, in the exercise of professional judgment, believes that informing the individual would place the individual at risk of serious harm; or
b. The provider would be informing the authorized representative, and the provider reasonably believes that the authorized representative is responsible for the abuse or neglect, and that informing such person would not be in the best interests of the individual.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 29, Issue 4, eff. November 21, 2012; Volume 31, Issue 1, eff. October 8, 2014.
12VAC35-115-90. Access to and amendment of services records.
A. With respect to his own services record, each individual and his authorized representative has the right to:
1. See, read, and get a copy of his own services record, except information that is privileged pursuant to § 8.01-581.17 of the Code of Virginia, and information compiled by the provider in reasonable anticipation of or for use in a civil, criminal, or administrative action or proceeding;
2. Let certain other people see, read, or get a copy of his own services record if the individual is restricted by law from seeing, reading, or receiving a copy;
3. Challenge, request to amend, or receive an explanation of anything in his services record; and
4. Let anyone who sees his record, regardless of whether amendments to the record have been made, know that the individual has tried to amend the record or explain his position and what happened as a result.
B. With respect to the services records of minors:
1. A minor must have the permission of a parent, guardian, or other person standing in loco parentis before he can access his services record. He may access his services record without this permission only if the records pertain to treatment for sexually transmitted or reportable contagious diseases, family planning or pregnancy, outpatient care, treatment or rehabilitation for substance use disorders, mental illness or emotional disturbance, or inpatient psychiatric hospitalization when a minor is 14 years of age or older and has consented to the admission.
2. A parent may access his minor child's services record unless prohibited by 42 CFR Part 2, parental rights have been terminated, a court order provides otherwise, or the minor's treating physician or clinical psychologist has determined, in the exercise of professional judgment, that disclosure to the parent would be reasonably likely to cause substantial harm to the minor or another person.
C. The provider's duties.
1. Providers shall tell each individual and his authorized representative how he can access and request amendment of his own services record.
2. Providers shall permit each individual to see his services record when he requests it and to request amendments if necessary.
a. Access to all or a part of an individual's services record may be denied or limited only if a physician or a clinical psychologist involved in providing services to the individual talks to the individual, examines the services record as a result of the individual's request for access, and signs and puts in the services record permanently a written statement that he thinks access to the services record by the individual at this time would be reasonably likely to endanger the life or physical safety of the individual or another person or that the services record makes reference to a person other than a health care provider and the access requested would be reasonably likely to cause substantial harm to the referenced person. The physician or clinical psychologist shall also tell the individual as much about his services record as he can without risking harm to the individual.
b. If access is denied in whole or in part, the provider shall give the individual or his authorized representative a written statement that explains the basis for the denial, the individual's review rights, as set forth in the following subdivisions, how he may exercise them, and how the individual may file a complaint with the provider or the U.S. Department of Health and Human Services, if applicable. If restrictions are placed on access, the individual shall be notified of the restrictions and conditions for their removal. These restrictions and conditions also shall be specified in the services record.
(1) If the individual requests a review of denial of access, the provider shall designate a physician or clinical psychologist who was not directly involved in the denial to review the decision to deny access. The physician or clinical psychologist shall determine within a reasonable period of time whether or not to deny the access requested in accordance with the standard in subdivision 2 a of this subsection. The provider shall promptly provide the individual notice of the physician's or psychologist's determination and provide or deny access in accordance with that determination.
(2) At the individual's option, the individual may designate at his own expense a reviewing physician or clinical psychologist who was not directly involved in the denial to review the decision to deny access in accordance with the standard in subdivision 2 a of this subsection. If the individual chooses this option, the provider is not required to designate a physician or clinical psychologist to review the decision.
c. If the provider limits or refuses to let an individual see his services record, the provider shall also notify the advocate and tell the individual that he can ask to have a lawyer or authorized insurer of his choice see his record. If the individual makes this request, the provider shall disclose the record to that lawyer or authorized insurer (§ 8.01-413 of the Code of Virginia).
3. Providers shall, without charge, give individuals any help they may need to read and understand their services record and request amendments to it.
4. If an individual asks to challenge, amend, or explain any information contained in his services record, the provider shall investigate and file in the services record a written report concerning the individual's request.
a. If the report finds that the services record is incomplete, inaccurate, not pertinent, not timely, or not necessary, the provider shall:
(1) Either mark that part of the services record clearly to say so, or else remove that part of the services record and file it separately with an appropriate cross reference to indicate that the information was removed;
(2) Not disclose the original services record without separate specific authorization or legal authority (e.g., if compelled by subpoena or other court order);
(3) Obtain the individual's identification of and agreement to have the provider notify the relevant persons of the amendment; and
(4) Promptly notify in writing all persons who have received the incorrect information and all persons identified by the individual that the services record has been corrected.
b. If a request to amend the services record is denied, the provider shall give the individual a written statement containing the basis for the denial and notify the individual of his right to submit a statement of disagreement and how to submit such a statement. The provider shall also give the individual (i) a statement that if a statement of disagreement is not submitted that the individual may request the provider to disclose the request for amendment and the denial with future disclosures of information and (ii) a description of how the individual may complain to the provider or the Secretary of Health and Human Services, if applicable. Upon request, the provider shall file in the services record the individual's statement of disagreement. If needed, the provider shall help the individual to write this statement. If a statement is filed, the provider shall:
(1) Give all persons who have copies of the record a copy of the individual's statement.
(2) Clearly note in any later disclosure of the record that it is disputed and include a copy of the statement with the disputed record.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Errata, 24:6 VA.R. 889 November 26, 2007; amended, Virginia Register Volume 33, Issue 10, eff. February 9, 2017.
12VAC35-115-100. Restrictions on freedoms of everyday life.
A. From admission until discharge from a service, each individual is entitled to:
1. Enjoy all the freedoms of everyday life that are consistent with his need for services, his protection, and the protection of others, and that do not interfere with his services or the services of others. These freedoms include:
a. Freedom to move within the service setting, its grounds, and the community;
b. Freedom to communicate, associate, and meet privately with anyone the individual chooses;
c. Freedom to have and spend personal money;
d. Freedom to see, hear, or receive television, radio, books, and newspapers, whether privately owned or in a library or public area of the service setting;
e. Freedom to keep and use personal clothing and other personal items;
f. Freedom to use recreational facilities and enjoy the outdoors; and
g. Freedom to make purchases in canteens, vending machines, or stores selling a basic selection of food and clothing.
2. Receive services in that setting and under those conditions that are least restrictive of his freedom.
B. The provider's duties.
1. Providers shall encourage each individual's participation in normal activities and conditions of everyday living and support each individual's freedoms.
2. Providers shall not limit or restrict any individual's freedom more than is needed to achieve a therapeutic benefit, maintain a safe and orderly environment, or intervene in an emergency.
3. Providers shall not impose any restriction on an individual unless the restriction is justified and carried out according to this chapter or otherwise required by law. If a provider imposes a restriction pursuant to this chapter, except as provided in 12VAC35-115-50, the following conditions shall be met:
a. A qualified professional involved in providing services has, in advance, assessed and documented all possible alternatives to the proposed restriction, taking into account the individual's medical and mental condition, behavior, preferences, nursing and medication needs, and ability to function independently.
b. A qualified professional involved in providing services has, in advance, determined that the proposed restriction is necessary for effective treatment of the individual or to protect him or others from personal harm, injury, or death.
c. A qualified professional involved in providing services has, in advance, documented in the individual's services record the specific reason for the restriction.
d. A qualified professional involved in providing services has explained and provided written notice so that the individual can understand the reason for the restriction, the criteria for removal, and the individual's right to a fair review of whether the restriction is permissible.
e. A qualified professional regularly reviews the restriction and that the restriction is discontinued when the individual has met the criteria for removal.
4. If a court has ordered the provider to impose the restriction or if the provider is otherwise required by law to impose the restriction, the restriction shall be documented in the individual's services record.
5. Providers shall obtain approval of the LHRC of any restriction imposed on an individual's rights under this subsection or 12VAC35-115-50 that lasts longer than seven days or is imposed three or more times during a 30-day time period. If the LHRC finds that the restriction is not being implemented in accordance with this chapter, the director shall be notified, and the LHRC shall provide recommendations.
6. Providers may develop and enforce written program rules, but only if the rules do not conflict with this chapter or any ISP and are needed to maintain a safe and orderly environment.
7. Providers shall, in the development of these program rules:
a. Get as many suggestions as possible from all individuals who are expected to obey the rules;
b. Apply these rules in the same way to each individual;
c. Give the rules to and review them with each individual and his authorized representative in a way that the individual can understand them, including explaining possible consequences for violating them;
d. Post the rules in summary form in all areas to which individuals and their families have regular access;
e. Submit the rules to the LHRC for review and approval upon request of the advocate or LHRC; and
f. Prohibit individuals from disciplining other individuals, except as part of an organized self-government program conducted according to a written policy approved in advance by the LHRC.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.
12VAC35-115-105. Behavioral treatment plans.
A. A behavioral treatment plan is used to assist an individual to improve participation in normal activities and conditions of everyday living, reduce challenging behaviors, alleviate symptoms of psychopathology, and maintain a safe and orderly environment.
B. Providers may use individualized restrictions such as restraint or time out in a behavioral treatment plan to address challenging behaviors that present an immediate danger to the individual or others, but only after a licensed professional or licensed behavior analyst has conducted a detailed and systematic assessment of the behavior and the situations in which the behavior occurs. Providers shall document in the individual's services record that the lack of success or probable success of less restrictive procedures attempted or considered, and the risks associated with not treating the behavior, are greater than any risks associated with the use of the proposed restrictions.
C. Providers shall develop any behavioral treatment plan according to their policies and procedures, which shall ensure that:
1. Behavioral treatment plans are initiated, developed, carried out, and monitored by professionals who are qualified by expertise, training, education, or credentials to do so;
2. Behavioral treatment plans include nonrestrictive procedures and environmental modifications that address the targeted behavior; and
3. Behavioral treatment plans involving the use of restraint or timeout are submitted to an independent review committee, prior to implementation, for review and approval of the technical adequacy of the plan and data collection procedures.
D. In addition to any other requirements of 42 CFR 483.440(f)(3), providers that are intermediate care facilities for individuals with intellectual disabilities shall submit any behavioral treatment plan that involves the use of restraint or time out, and its independent review committee approval, to the SCC under 42 CFR 483.440(f)(3) for the SCC's approval prior to implementation.
E. Providers other than intermediate care facilities for individuals with intellectual disabilities shall submit any behavioral treatment plan that involves the use of restraint or time out, and its independent review committee approval, to the LHRC, which shall determine whether the plan is in accordance with this chapter prior to implementation.
F. If either the LHRC or SCC finds that the behavioral treatment plan violates the rights of the individual or is not being implemented in accordance with this chapter, the LHRC or SCC shall notify the director and provide recommendations regarding the proposed plan.
G. Behavioral treatment plans involving the use of restraint or time out shall be reviewed quarterly by the independent review committee and the LHRC or SCC to determine if the use of restraint has resulted in improvements in functioning of the individual.
H. Providers shall not use seclusion in a behavioral treatment plan.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 33, Issue 10, eff. February 9, 2017; amended, Virginia Register Volume 35, Issue 2, eff. November 1, 2018.
12VAC35-115-110. Use of seclusion, restraint, and time out.
A. Each individual is entitled to be completely free from any unnecessary use of seclusion, restraint, or time out.
B. The voluntary use of mechanical supports to achieve proper body position, balance, or alignment so as to allow greater freedom of movement or to improve normal body functioning in a way that would not be possible without the use of such a mechanical support, and the voluntary use of protective equipment are not considered restraints.
C. The provider's duties.
1. Providers shall meet with the individual or the individual's authorized representative upon admission to the service to discuss and document in the individual's services record his preferred interventions in the event his behaviors or symptoms become a danger to himself or others and under what circumstances, if any, the intervention may include seclusion, restraint, or time out.
2. Providers shall document in the individual's services record all known contraindications to the use of seclusion, time out, or any form of physical or mechanical restraint, including medical contraindications and a history of trauma, and shall flag the record to alert and communicate this information to staff.
3. Seclusion may be used only in an emergency and only in facilities operated by the department; residential facilities for children that are licensed under the Regulations for Children's Residential Facilities (12VAC35-46); inpatient hospitals; and crisis receiving centers or crisis stabilization units that are licensed under Part VIII (12VAC35-105-1830 et seq.) of 12VAC35-105.
4. Providers shall not use seclusion, restraint, or time out as a punishment or reprisal or for the convenience of staff.
5. Providers shall not use seclusion or restraint solely because criminal charges are pending against the individual.
6. Providers shall not use a restraint that places the individual's body in a prone (face down) position.
7. Providers shall not use seclusion or restraint for any behavioral, medical, or protective purpose unless other less restrictive techniques have been considered and documentation is placed in the individual's safety plan, the crisis ISP, or the ISP that these less restrictive techniques did not or would not succeed in reducing or eliminating behaviors that are self-injurious or dangerous to other people or that no less restrictive measure was possible in the event of a sudden emergency.
8. Providers that use seclusion, restraint, or time out shall develop written policies and procedures that comply with applicable federal and state laws and regulations, accreditation and certification standards, third party payer requirements, and sound therapeutic practice. These policies and procedures shall include at least the following requirements:
a. Individuals shall be given the opportunity for motion and exercise, to eat at normal meal times and take fluids, to use the restroom, and to bathe as needed.
b. Trained, qualified staff shall monitor the individual's medical and mental condition continuously while the restriction is being used.
c. Each use of seclusion, restraint, or time out shall end immediately when criteria for removal are met.
d. Incidents of seclusion and restraint, including the rationale for and the type and duration of the restraint, shall be reported to the department as provided in 12VAC35-115-230 C.
9. Providers shall comply with all applicable state and federal laws and regulations, certification and accreditation standards, and third party requirements as they relate to seclusion and restraint.
a. Whenever an inconsistency exists between this chapter and federal laws or regulations, accreditation or certification standards, or the requirements of third party payers, the provider shall comply with the higher standard.
b. Providers shall notify the department whenever a regulatory, accreditation, or certification agency or third party payer identifies problems in the provider's compliance with any applicable seclusion and restraint standard.
10. Providers shall ensure that only staff who have been trained in the proper and safe use of seclusion, restraint, and time out techniques may initiate, monitor, and discontinue their use.
11. Providers shall ensure that a qualified professional who is involved in providing services to the individual reviews every use of physical restraint as soon as possible after it is carried out and documents the results of his review in the individual's services record.
12. Providers shall ensure that review and approval by a qualified professional for the use or continuation of restraint for medical or protective purposes is documented in the individual's services record. Documentation includes:
a. Justification for any restraint;
b. Time-limited approval for the use or continuation of restraint; and
c. Any physical or psychological conditions that would place the individual at greater risk during restraint.
13. Providers may use seclusion or mechanical restraint for behavioral purposes in an emergency only if a qualified professional involved in providing services to the individual has, within one hour of the initiation of the procedure:
a. Conducted a face-to-face assessment of the individual placed in seclusion or mechanical restraint and documented that alternatives to the proposed use of seclusion or mechanical restraint have not been successful in changing the behavior or were not attempted, taking into account the individual's medical and mental condition, behavior, preferences, nursing and medication needs, and ability to function independently;
b. Determined that the proposed seclusion or mechanical restraint is necessary to protect the individual or others from harm, injury, or death;
c. Documented in the individual's services record the specific reason for the seclusion or mechanical restraint;
d. Documented in the individual's services record the behavioral criteria that the individual must meet for release from seclusion or mechanical restraint; and
e. Explained to the individual, in a way that he can understand, the reason for using mechanical restraint or seclusion, the criteria for its removal, and the individual's right to a fair review of whether the mechanical restraint or seclusion was permissible.
14. Providers shall limit each approval for restraint for behavioral purposes or seclusion to four hours for individuals age 18 and older, two hours for children and adolescents ages nine through 17, and one hour for children under age nine.
15. Providers shall not issue standing orders for the use of seclusion or restraint for behavioral purposes.
16. Providers shall ensure that no individual is in time out for more than 30 minutes per episode.
17. Providers shall monitor the use of restraint for behavioral purposes or seclusion through continuous face-to-face observation, rather than by an electronic surveillance device.
D. For purposes of this section, "safety plan," "crisis individualized services plan," or "crisis ISP" shall have the same meaning as those terms are described in 12VAC35-105-1860 and 12VAC35-105-1870.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 31, Issue 1, eff. October 8, 2014; Volume 33, Issue 10, eff. February 9, 2017; Volume 40, Issue 22, eff. July 17, 2024.
12VAC35-115-120. Work.
A. Individuals have a right to engage or not engage in work or work-related activities consistent with their service needs while receiving services. Personal maintenance and personal housekeeping by individuals receiving services in residential settings are not subject to this provision.
B. The provider's duties.
1. Providers shall not require, entice, persuade, or permit any individual or his family member to perform labor for the provider as a condition of receiving services. If an individual voluntarily chooses to perform labor for the provider, the labor must be consistent with his individualized services plan. All policies and procedures, including pay, must be consistent with the Fair Labor Standards Act (29 USC § 201 et seq.).
2. Providers shall consider individuals who are receiving services for employment opportunities on an equal basis with all other job applicants and employees according to the Americans with Disabilities Act (42 USC § 12101 et seq.).
3. Providers shall give individuals and employers information, training, and copies of policies affecting the employment of individuals receiving services upon request.
4. If vocational training, extended employment services, or supported employment services are offered, providers shall establish procedures for documenting the decision on employment and training and the methodology for establishing wages. Providers shall give a copy of the procedures and information about possible consequences for violating the procedures to all individuals and their authorized representatives.
5. Providers who employ individuals receiving services shall not deduct the cost of services from an individual's wages unless ordered to do so by a court.
6. Providers shall not sell to or purchase goods or services from an individual receiving services except through established governing body policy that is consistent with U.S. Department of Labor standards.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007.
12VAC35-115-130. Research.
A. Each individual has a right to choose to participate or not participate in human research.
B. The provider's duties.
1. Providers shall obtain prior, written, informed consent of the individual or his authorized representative before any individual begins to participate in human research unless the research is exempt under § 32.1-162.17 of the Code of Virginia.
2. Providers shall comply with all other applicable state and federal laws and regulations regarding human research, including the provisions under Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 and § 37.2-402 of the Code of Virginia.
3. Providers shall obtain review and approval from an institutional review board or research review committee prior to performing or participating in a human research protocol. Documentation of this review and approval shall be maintained and made available on request by the individual or his authorized representative.
4. Prior to participation by individuals in any human research project, the provider shall inform and provide a copy of the institutional review board or research review committee approval to the LHRC. Once the research has been initiated, the provider shall update the LHRC periodically on the status of the individual's participation.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.
12VAC35-115-140. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; repealed, Virginia Register Volume 33, Issue 10, eff. February 9, 2017.