Standard Operating Procedures - Chapter 14

SOCIAL SCIENCE AND EDUCATION RESEARCH

14.1	Social and Psychological Harm
14.2	Privacy and Confidentiality Concerns

14.1 Social and Psychological Harm

When reviewing behavioral and social sciences research, the IRB ensures that investigators have made every attempt to minimize risks and possible harms to participants, whether social, psychological or physical. Potential risks to participating in behavioral and social science research could be, but are not limited to, breach of confidentiality, invasion of privacy, psychological distress, embarrassment, risk to reputation, employability, and insurability.

14.2 Privacy and Confidentiality Concerns

The IRB follows 45 CFR 46.111(a)(7) and 21 CFR 56.111(a)(7) when determining the adequacy of the plan provided by researchers to protect the privacy of participants and maintain confidentiality of the data. (If a research study will involve protected health information, all privacy and confidentiality mandates outlined in the HIPAA regulations (45 CFR 160/164) are also followed.)

In accordance with 45 CFR 46.116, the IRB takes into account the description of the extent, if any, to which confidentiality of records identifying the participant will be maintained when reviewing the informed consent form. For research that falls under FDA jurisdiction, a statement that the FDA may inspect the research records is added to the consent form.

Investigators are instructed to store and secure their data in a confidential manner as outlined in their application unless a modification has been submitted for review and approval. If possible, the research is conducted without any type of identifiers associated with the data. If data is gathered with personal identifiers, whenever possible, personal identifiers are removed from data and code numbers are used with master code lists. The master code list and signed informed consent forms are stored separately from the data. In accordance with federal regulations, researchers must maintain their signed informed consent forms for a minimum of six years from the close of the study. Study sponsors may have additional requirements regarding retention of data and consent forms.

For research involving the use of audio, video or digital recordings, researchers submitting to the HRPO must adhere to IRB Guideline - “Research Involving Audio, Video or Digital Recordings of Research Participants”, which is available on the HRPO website. Researchers must inform participants in the informed consent form where recordings will be stored, who will have access to them, and the year by which the tapes will be destroyed. Researchers have the option to archive recordings or use recordings in future research, classroom or conference presentations, etc. In order to archive recordings, researchers must provide a justification to the IRB for archiving the recordings and give the participant, in the informed consent form, the option of declining or allowing the recordings to be archived or used for future research, educational or conference presentations.

The IRB may request a researcher to obtain a Certificate of Confidentiality (CoC) from the NIH if the research is of a sensitive nature and protection is warranted.