IRB Manual
      5.4 New York State Reporting Requirements
 

The requirements listed below should be read in conjunction with the information on confidentiality certificates (Section 5.2). In the opinion of OMH Counsel, a Confidentiality Certificate takes precedence over State laws requiring disclosure of the names or identifying characteristics of research subjects.


5.4.1 Child Abuse
   

The consent form must state this reporting requirement if the IRB determines that the nature of the research and/or subject population makes it reasonable to expect that child abuse will be discovered.

The following persons are required to report or cause a report to be made when they have reasonable cause to suspect that a child coming before them in their professional or official capacity is an abused or maltreated child or when they have reasonable cause to suspect that a child is an abused or maltreated child where the parent, guardian, custodian or other person legally responsible for such child comes before them in their professional or official capacity and states from personal knowledge facts, conditions or circumstances which, if correct, would render the child an abused or maltreated child: any physician; surgeon; medical examiner; coroner; dentist; osteopath; optometrist; chiropractor; podiatrist; resident intern; registered nurse; hospital personnel engaged in the admission, examination, care or treatment of persons; a Christian Science practitioner; school official; social services worker; day care center worker; provider of family or group family day care; employee or volunteer in a residential care facility or any other child care or foster care worker; mental health professional; peace officer; police officer; district attorney or assistant district attorney; investigator employed in the office of a district attorney or other law enforcement official.

The report shall be made to the facility director who shall then be responsible for reporting to the statewide child abuse register.

Due to federal confidentiality requirements, relating to alcoholism and substance abuse patients and clients, all OASAS employees prior to making any reports should contact the OASAS Counsel's Office to determine if any other action is required.

(Note: The statewide child abuse register may be called by any person who has a reason to believe that a child is being abused. However, when the report is made in a person's OMH, OPWDD or OASAS professional capacity the report should be made through the appropriate facility director. The telephone number is 1-800-342 3720.)


5.4.2 AIDS
   

Section 24.1 of the New York State Sanitary Code provides the mandate and instructions for reporting known and suspected cases of AIDS. Persons associated with the clinical recognition of a known or suspected case (e.g., physicians, pathologists, infection control practitioners, and others designated by law) have the responsibility of notifying the New York State Health Department.

Reports should be made to the N.Y. City Health Department (212) 566-3630/3624 or to the N.Y. State Health Department in Albany (518) 474-4284.

The consent form for a study must inform potential subjects of the reporting requirement if the IRB determines that the nature of the research is such that a newly diagnosed case of AIDS can reasonably be expected to be identified by the investigators during participation.

Due to federal confidentiality requirements relating to alcoholism and substance abuse patients and clients, all OASAS employees prior to making any reports should contact the OASAS Counsel's Office to determine if any other action is required.


5.4.3 Alzheimer's Disease
   

Effective January 1, 1987 the State Public Health Law was amended to require reporting of all newly diagnosed cases of Alzheimer's Disease, and other Primary Degenerative Dementias, to the Department of Health (DOH) for the purposes of tracking and research. All such reports are kept confidential by DOH as prescribed by law and regulation.

Where the IRB determines that there is a reasonable expectation that participation in a research project will newly diagnose Alzheimer's Disease, or other Primary Degenerative Dementias, the reporting requirements must be disclosed in the consent form.

Due to federal confidentiality requirements relating to alcoholism and substance abuse patients and clients, all OASAS employees prior to making any reports should contact the OASAS Counsel's Office to determine if any other action is required.
     
   


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