VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

7.4. Informed Consent Review & Documentation Unless specifically waived by the IRB, informed consent must be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, 45CFR46.116 (see Section 14. Informed Consent ). 7.5. Safety Monitoring When appropriate, the IRB will ensure that the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects 7.6. Privacy and Confidentiality There should be adequate administrative, procedural and technical provisions to protect the privacy of subjects and maintain the confidentiality of data. The assessment of adequacy should include consideration of the sensitivity of data. Although there are some specific state and federal regulations governing privacy of some specific types of records (e.g., HIPAA, FERPA, state health care records privacy laws), privacy and confidentiality protections for human subjects do not derive merely from governmental regulation. They are also integral to the ethical principle of “respect for persons” as enunciated in the Belmont Report. The IRB will ensure adequate provisions to protect the privacy of subjects and maintain the confidentiality of the data (see Section 13. Confidentiality ). HIPAA (for covered entities) If human subjects research creates or uses individually identifiable health information that is “protected health information” as defined by the Health Insurance Portability and Accountability Act (HIPAA), the research use of that protected health information may require additional IRB review and documentation (see Section 15. HIPAA & IRB Review). FERPA The Family Educational Rights and Privacy Act (FERPA) protects information in student education records. The term “education records” includes all information about a student that is recorded and retained by an educational institution, although the federal regulations do contain a number of exceptions. FERPA provides that information from a student’s education records may not be released to others without the student’s or parent’s prior written consent. If the student is over 18 or enrolled in college, the student must give the consent. FERPA only applies to educational records and not to the process of informed consent related to the research itself. In the research context, information from education records may be released, without the student’s or parent’s consent, to organizations conducting studies for, or on behalf of, educational agencies or institutions, but only if the study is: (1) for developing, validating or administering academic predictive tests, (2) to administer student aid programs or (3) to improve instruction. In order to qualify for this exception, the study must be conducted in such a way that parents and students may not be personally identified by anyone other than those working on the study, and the information must be destroyed when it is no longer needed for the study purposes. Certificates of Confidentiality The Public Health Service Act at 301(d), 42USC241(d) authorizes HHS agencies to issue Certificates of Confidentiality in response to an application submitted to the agency by the investigator. Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for participating human subjects. The Certificate of

VCOM Institutional Review Board Policies and Procedures

Page 15 of 40