Policies

Federal regulations and Yale policy require that all institutions that rely on a Yale Institutional Review Board (IRB) as the IRB of record must have and adhere to appropriate policies for the protection of human research subjects. These policies must be submitted with the RA application.

Required Policies

Every RA must have adopted written policies that describe the RA's human subjects protection program. At a minimum, such policies must include policy statements on the following issues:

• Scope and Authority of the Human Subjects Protection Program
• Investigator/Staff Training and Education
• Compliance with Yale IRB Policies
• Reporting Adverse Events
• Reporting Noncompliance
• Investigator Access to Policies
• Document Retention
• Investigator Conflict of Interest
• Research Oversight and Auditing

An organization may 1) create its own original policies or 2) use the Institutional Policy Template (IPT) that Yale has created to assist potential RAs. This template provides examples of policy statements to support a human subjects protection program. This template may be adopted in full or modified, as appropriate, by RAs.

Special Topic Policies

In addition to the required policies identified above, each organization may wish to adopt additional policies or procedures tailored to the unique research environment of that organization. The use of special topic policies should reflect the type of research being conducted currently as well as future anticipated research. Examples of special topic policies include policies for the inclusion of vulnerable populations in research; policies to address certain research practices; or policies for the use of protected health information. Yale has created sample policies for some of the most common research situations, and organizations may adopt them in full or modify them as appropriate. This is not an exclusive list of sample policies. Each organization is responsible for creating a complete and robust set of policies to reflect its research environment.

• Sample Policy for the Participation of Students and Employees in Research
• Sample Policy for the Participation of Decisionally Impaired Individuals in Research
• Sample Policy for the Participation of Children and Minors in Research
• Sample Policy for the Recruitment of Subjects
• Sample Policy for the Use of Deception and Incomplete Disclosure in Research
• Sample Policy on International Research
• Sample Policy on the Participation of Non-English-Speaking Individuals
• Sample Policy for the Participation of Pregnant Women and Fetuses in Research
• Policy on the Use and Disclosure of Protected Health Information for Research Purpose
• Policies and Standard Practices for the Protection of Human Subjects in Research

Required Training

Individuals involved in the design, conduct, and reporting of human subjects research must complete training in human subjects protections, and, if applicable, in HIPAA as it pertains to research.

The organization's Signatory Official (SO) and the Human Protections Administrator (HPA) must complete training in the following areas:

• Human subjects protection training (free, web-based course);
• HIPAA as it pertains to research, if applicable (Researchers' Guide to HIPAA); and
• OHRP FWA training.