Maryland Reporting Obligations that May Apply to Investigators or Other Members of the Research Team
May 2006
Maryland law contains a number of statutory reporting obligations that may apply to researchers, whether the researchers are physicians, non-physicians who are licensed health care providers, or, in some circumstances, researchers who are not care providers. (See the attached table for detailed descriptions of the reporting obligations that could potentially apply in the research setting.)
In some cases, the statutory language that requires reporting seems to contemplate the existence of a patient-provider relationship, while in others the reporting requirements apply broadly to ‘any person,’ which would include members of the research team. Helen Bowlus, Assistant Attorney General and advisor to the Maryland Department of Health and Mental Hygiene, has advised us that subjects enrolled in research protocols may in many cases be considered “under care,” and that no categorical exclusion from reporting requirements exists for providers who are conducting research.
Further, we believe that federal “Certificates of Confidentiality” do not shield a researcher from the obligation to report diseases, conditions, or circumstances when such reports are required by state law.
I. Infectious/Communicable Diseases, HIV Testing, AIDs Diagnoses
When the investigator is a physician with a patient “under care,” the investigator must make immediate reports of infectious or contagious diseases, including AIDs, to the health officer in the county where the physician cares for the patient. Any investigator who is a licensed health care provider must make such a report (with the exception of AIDs) within 48 hours.
A “physician in attendance” must report positive syphilis tests for patients, pregnant women, and infants, and must notify the health officer if a patient who tests positive fails to return for medical observation.
The reporting requirements for a positive HIV test or low CD4+ lymphocyte count apply to “facilities and offices” ordering the tests, as well as to medical laboratory directors. Although this reporting requirement might not appear at first glance to require reporting by investigators, Maryland regulations contemplate that research HIV testing is covered: COMAR, the compilation of State regulation, contains a “research exception” for truly anonymous HIV testing performed under an IRB-approved protocol, as well as a detailed procedure for seeking a research exemption to reporting from the Director of AIDs Administration.
II. Child or Elder Abuse or Neglect
As described in the chart below, health care providers must make these reports in specific oral and written forms, however, “any person,” is also required to make either an oral or written report of suspected child abuse. No caregiver-patient relationship is necessary to trigger the reporting obligation. Persons other than licensed health care providers “may” report suspected abuse or neglect of a vulnerable adult.
In short, any member of the research team who is a licensed health care provider will be covered by the obligation to report child abuse or neglect, while any non-provider member is also obligated to report suspected abuse or neglect of a child. Although licensed providers are obligated to report suspected neglect or abuse of a vulnerable adult, non-provider investigators, who are permitted but not obligated to make such reports for adults, may be precluded from doing so if the reporting involves disclosure of protected health information (HIPAA may restrict disclosure of PHI to reports of adult abuse or neglect to those circumstances under which the report is required by law or the circumstances constitute an emergency.)
III. Abuse of Developmentally-Delayed Individuals
Any person who believes that an individual with a developmental disability has been abused shall report the abuse promptly to the executive officer or administrative head of the licensed service provider, who shall in turn make a report to law enforcement authorities.
IV. Threats of Harm
Investigators who are mental health providers licensed under the Health Occupations Article have a statutory duty to warn of a patient’s threats to inflict imminent physical harm upon specific victims. This duty may be discharged by “reasonable and timely” efforts to inform law enforcement and the identified victims. The statutory language implies but does not specifically require a patient-provider relationship, so it is possible that the duty to warn might be found to extend to certain research settings involving investigators who are mental health providers.
V. Injuries
In certain Maryland counties (although not Baltimore County or City), physicians, pharmacists, dentists or nurses who treat individuals with injuries that appear to have been caused by auto accidents or lethal weapons must report this information to local or state police as soon as possible. Physicians, pharmacists, dentists, or nurses who treat injuries that appear to have been caused by gunshots or moving vessels must submit a report containing specific information to the city or county police (or, for vessels, the DNR), “as soon as possible.” Licensed physicians or registered nurses who are primarily responsible for the treatment of certain serious burn injuries must submit a report as soon as practicable to the county fire chief or state fire marshal.
Any member of the research team is covered by the requirement that “any person” report to the health officer any knowledge of an animal bite.
VI. Cancer
Each hospital, freestanding laboratory or ambulatory care center, or physician must submit a cancer report for all patients initially diagnosed , treated, or admitted
Reportable Event, Disease, or Condition | Legal Requirement | Circumstances Under Which Report Required |
Infectious or contagious diseases specified by MD DHMH or regulation | Health-General §18-201 (diseases specified in COMAR 10.06.01) Health-Gen §18-205 (laboratory directors) COMAR 10.06.01 | A “physician with reason to suspect that a patient under the physician’s care has an infectious or contagious disease [except HIV/AIDs] that endangers public health.” Report must be made “immediately” to the health officer in the county where the physician cares for the patient. OR The director of a “medical laboratory” defined at Health-Gen §17-201(b)(1) as “any facility, entity, or site that offers or performs tests or examinations in connection with the diagnosis and control of human diseases or the assessment of human health, nutritional, or medical conditions . . ,“ then PI must report to the health officer when a specimen evidences the diseases/conditions listed in the statute. NOTE 1: 18-202 requires an “administrative head” of an institution (defined to include hospitals) who has reason to believe that an individual on the premises of the institution has an infectious or contagious disease (except for HIV/AIDs), to “immediately” submit a report to the health officer. NOTE 2: COMAR 10.06.01 further requires the following: "A. Sources of Reports. (1) Health Care Providers. A physician, physician's assistant, dentist, chiropractor, nurse practitioner, nurse, podiatrist, any other licensed health care provider, a medical examiner, or an administrator of a hospital, clinic, dispensary, or nursing home who knows of a case of a reportable disease, condition, outbreak, or unusual manifestation shall report it to the health officer within the time limits specified in §B of this regulation.” Reports under this COMAR provision must be made to the health officer within 48 hours, except for certain diseases for which reports must be made immediately by telephone. NOTE 3: COMAR 10.06.01.02 defines “physician” to include “physician’s designee working under the supervision of the physician.” |
HIV Infection | Health-Gen. §18-207 COMAR 10.18.02 COMAR 10.18.02.06 COMAR 10.18.02.01 COMAR 10.18.02.02 | Except for a designated anonymous HIV test site, a facility or office that orders a test for HIV and receives a test result that documents the presence of HIV as defined by the CDC laboratory criteria shall, upon the Secretary's request, make available to the Secretary, or an agent of the Secretary, the information necessary to compile an HIV/AIDS case report. The director of a medical laboratory must submit a report of a positive HIV test or of a CD4+ lymphocyte count less than 200 per cubic millimeter, within 48 hours to the health officer. The director may not disclose, directly or indirectly, the identity of any individual tested. Research Exception: The requirements for reporting HIV+ test results do not apply when the test is conducted as part of research conducted by an institution within Maryland under the following conditions: (a) All personal identifiers are removed from the specimen before testing; Exemptions: Out of state patients; Exemption granted by AIDs Administration. The reporting requirements also do not apply if the specimen is taken from a patient known to reside outside of Maryland, or is tested as part of a research project granted an exemption by the Director of AIDs Administration. The research must be IRB-approved and must either be to test the safety or efficacy of an HIV vaccine, or must not be primarily intended to provide medical treatment to participants. To obtain an exemption, the principal investigator must submit to the AIDS Administration a copy of the approved protocol, a notice of IRB approval, and a letter from the PI stating that the project will provide the Director of AIDs Administration annual reports of the following:
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AIDS | Health-Gen §18.201.1 |
A physician who has diagnosed a patient under the physician's care with acquired immunodeficiency syndrome according to the current definition published in the morbidity and mortality weekly report by the Centers for Disease Control and Prevention of the Department of Health and Human Services shall submit immediately a report to the health officer for the county where the physician cares for that patient. |
Child Abuse or Neglect | Family Law §5-704 and §5-705. | An investigator who is a health practitioner, police officer, educator, or human service worker, acting in a professional capacity in this State, who has reason to believe that a child has been subject to abuse, shall notify the local department or appropriate law enforcement agency. If any covered person has reason to believe that a child has been subject to neglect, the person must notify the local department and, if acting as a staff member of a hospital, notify the head of the institution or the institution’s designee. Both oral and written reports in a specific form are required, with a copy to the local State’s Attorney where abuse is suspected. [Statutory exceptions for certain confidential and privileged communications]. Under §5-705, “any person” other than the persons listed above who has reason to believe that a child has been subject to abuse or neglect shall make either an oral or written report that meets specified requirements “to the extent possible” [with exceptions for certain confidential and privileged communications]. |
Abuse or Neglect of Vulnerable Adults | Family Law §14-302 | A health practitioner, police officer, or human service worker who “contacts, examines, attends, or treats an alleged vulnerable adult, and who has reason to believe that the adult has been subject to abuse, neglect, self-neglect, or exploitation shall notify the local department, and if acting as a staff member of a hospital . . . immediately give the required information to the institution head/designee. Reports shall be in writing or by telephone, and must be made ‘as soon as possible.’” Any individual (other than those listed above) who has reason to suspect elder abuse/neglect may file a report. |
Abuse of Developmentally-Delayed Individual | Health-Gen. §7-1005 | Any person who believes that an individual with a developmental disability has been abused shall report the abuse promptly to the executive officer or administrative head of the licensed service provider, who shall in turn make a report to law enforcement authorities |
Threats of Harm | Courts & Judicial Proceedings §5-609 | A “mental health care provider” licensed under the Health Occupations Article or any institution or facility that provides treatment or services to individuals who have mental disorders has a statutory duty to warn of known threats of imminent physical injury: b) In general.- A cause of action or disciplinary action may not arise against any mental health care provider or administrator for failing to predict, warn of, or take precautions to provide protection from a patient's violent behavior unless the mental health care provider or administrator knew of the patient's propensity for violence and the patient indicated to the mental health care provider or administrator, by speech, conduct, or writing, of the patient's intention to inflict imminent physical injury upon a specified victim or group of victims (1) The duty to take the actions under paragraph (2) of this subsection arises only under the limited circumstances described under subsection (b) of this section. (2) The duty described under this section is deemed to have been discharged if the mental health care provider or administrator makes reasonable and timely efforts t (i) Seek civil commitment of the patient; (ii) Formulate a diagnostic impression and establish and undertake a documented treatment plan calculated to eliminate the possibility that the patient will carry out the threat; or (iii) Inform the appropriate law enforcement agency and, if feasible, the specified victim or victims of: 1. The nature of the threat; |
Injuries Apparently Caused by Auto Accidents ,Lethal Weapons, Gunshots, Burns, or Moving Vessels | Health-Gen §20-701 Health Gen §20-702 (moving vessel injuries) Health Gen §20-703 (Gunshot injuries) COMAR 10.07.04.05 (Burn injuries) | In Allegany, Anne Arundel, Charles, Kent, Montgomery, Prince George’s , Somerset, Talbot, and Wicomico Counties, a physician, pharmacist, dentist or nurse who treats an individual for an injury that shows evidence of having been caused by an auto accident or lethal weapon shall notify the county sheriff, police, or state police “as soon as practicable.” |
Syphilis: Failure to comply with medical observation; contact reporting; positive serological test for mother or infant | COMAR 10.06.01.17 | A physician in attendance shall report to the health officer immediately and in writing the name and address of an individual who is receiving or has received treatment for syphilis; or is under medical observation or treatment for syphilis in an infectious or potentially infectious stage, who fails to return for observation or treatment within one week of the date of a missed appointment and is not known to be under treatment elsewhere. A physician in attendance upon a patient having syphilis shall request the health officer to conduct a contact investigation or report to the health officer any untreated individual identified as having had potentially infectious contact with an individual having syphilis. A physician in attendance upon a pregnant woman diagnosed with syphilis shall report the case to a health officer immediately. A physician in attendance upon an infant born to an untreated woman with a positive serological test for syphilis shall report test results for the mother and infant to the health officer immediately. |
Animal Bites | COMAR 10.06.01.04 | Applies to anyone: “Any individual having knowledge of an animal bite shall report the bite to the health officer.” |
Cancer | Health-Gen §18-204(b) COMAR 10.14.01.02 and 10.14.01.03 | Each hospital, freestanding laboratory or ambulatory care center, or physician must submit a cancer report for all patients initially diagnosed , treated, or admitted |