Data Encryption and Security Security systems should be adequate to ensure the confidentiality and security of all stored records and demonstrate compliance . Paper files containing confidential or otherwise protected health information about subjects should be stored in locked, fire and water proof enclosures with controlled access. Honest Broker An honest broker is the individual in the organization with the authority to act on behalf of an organization to link research identifiers and clinical identifiers in order to provide data, specimens or images to researchers without revealing the identity of subjects. The honest broker cannot be a member of the clinical or research team. Identify the position/person assigned as the honest broker and outline the policies and procedures that enable the honest broker to perform his/her function. Data Use Agreements Data Use Agreements outline the terms and conditions under which the research [tissue or data] bank will disclose subjects’ protected health information in the form of a limited data set to the data recipient(s), such as sponsors, co‐operating institutions and/or researchers. The terms health information” and data set” shall have the same definitions as found in “protected “limited the HIPAA Privacy Rule 45 CFR 164.501 and 45 CFR 164.514(e)2. Material Transfer Agreements Material Transfer Agreements specify the rights, obligations, and restrictions of both the providing and receiving institutions with respect to issues such as ownership, publication, intellectual property and permitted use liability. Contact the Rowan University Office of Technology Transfer and Business Development for instruction on how to develop Rowan University‐approved Material Transfer Agreements. Certificate of Confidentiality (if applicable) Certificates of Confidentiality, issued by the National Institutes of Health to protect identifiable research information from forced disclosure, may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects, such as damage to their financial standing, employability, insurability, or reputation. Certificates of Confidentiality allow the investigator and others who have access to research records to refuse to disclose identifying information on research subjects in any civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level. They help protect researchers and institutions from being compelled to disclose information that would identify research subjects, and assure confidentiality and privacy to subjects. Indicate
Data Encryption and Security Security systems should be adequate to ensure the confidentiality and security of all stored records and demonstrate compliance . Paper files containing confidential or otherwise protected health information about subjects should be stored in locked, fire and water proof enclosures with controlled access. Honest Broker An honest broker is the individual in the organization with the authority to act on behalf of an organization to link research identifiers and clinical identifiers in order to provide data, specimens or images to researchers without revealing the identity of subjects. The honest broker cannot be a member of the clinical or research team. Identify the position/person assigned as the honest broker and outline the policies and procedures that enable the honest broker to perform his/her function. Data Use Agreements Data Use Agreements outline the terms and conditions under which the research [tissue or data] bank will disclose subjects’ protected health information in the form of a limited data set to the data recipient(s), such as sponsors, co‐operating institutions and/or researchers. The terms “protected health information” and “limited data set” shall have the same definitions as found in the HIPAA Privacy Rule 45 CFR 164.501 and 45 CFR 164.514(e)2. Material Transfer Agreements Material Transfer Agreements specify the rights, obligations, and restrictions of both the providing and receiving institutions with respect to issues such as ownership, publication, intellectual property and permitted use liability. Contact the Rowan University Office of Technology Transfer and Business Development for instruction on how to develop Rowan University‐approved Material Transfer Agreements. Certificate of Confidentiality (if applicable) Certificates of Confidentiality, issued by the National Institutes of Health to protect identifiable research information from forced disclosure, may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects, such as damage to their financial standing, employability, insurability, or reputation. Certificates of Confidentiality allow the investigator and others who have access to research records to refuse to disclose identifying information on research subjects in any civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level. They help protect researchers and institutions from being compelled to disclose information that would identify research subjects, and assure confidentiality and privacy to subjects. Indicate