1) Commentary

This section provides an explanation of how to interpret the Element.

2) Regulatory and Guidance References

Listed here are regulatory and guidance citations from the U.S. federal agencies that oversee research with human participants. These citations were updated on September 22, 2016. Also, listed here are the guidance citations from the International Committee on Harmonisation - Good Clinical Practice (E6) guideline.

Organizations that must follow a certain set of regulations (e.g., DHHS or FDA) must meet the regulatory requirements. Organizations that are not bound to follow a particular set of regulations are not required to meet them, but they should describe and provide equivalent protections, when applicable.

3) Required Written Materials

This section contains the requirements for written materials an organization must have to meet the Element.

AAHRPP uses the generic term “policies and procedures” to refer to all types of written materials. Policies and procedures include any written materials that the organization uses to define and communicate its practices, such as standard operating procedures, policy statements, procedure descriptions, checklists, guidelines, educational materials, job descriptions, memoranda, forms, templates, strategic plans, Web sites, charters, by-laws, mission statements, or other forms, that are used to administer the Human Research Protection Program. Policies and procedures are not limited to IRB or EC policies and procedures; other organizational procedures are likely to be relevant, such as some policies related to human resources, budgeting, pharmacy, contracting, student orientation, corporate compliance, or corporate ethics.

A policy is generally defined as a strategy, goal, or objective. It defines an expectation regarding a behavior or course of action. A procedure is a method by which a policy can be accomplished. Procedures should describe the operational steps that are followed to meet regulatory requirements. A restatement of the regulations or guidance is generally insufficient to provide the necessary specificity. Procedures should include:

1. An explanation of how key regulatory terms are interpreted,
2. The actions that are taken,
3. The title of the person, office, or entity responsible for taking the action, and 4) The timing of actions.

No single format is required for policies and procedures, and no specific wording is required to be used in policies and procedures. Organizations have used a range of models for writing policies and procedures. Procedures should provide enough detail to be understandable to individuals within the organization who use them. Procedures should reflect actual practice within the organization.

AAHRPP has provided a description of the content for many policies and procedures. U.S. regulatory requirements, such as the criteria for approval of research, elements of disclosure for the consent process, or types of disclosure for financial interests, are not listed. The organization must use the federal regulations to obtain these requirements.

4) Common Types of Materials That May Be Used to Meet the Element

These are examples of the types of materials organizations have provided to meet the Element. Sometimes, materials are listed under this section when there is requirement for written materials to meet the Element. AAHRPP has included this section under the Element to assist organizations in meeting the Element. Organizations that do not have the materials should not create them to meet the Element. The listing is intended only a facilitative tool.

In this section, “procedures” are not listed as an example of a written material that may be used to the meet the Element. In some cases, the combination of an application form and reviewer evaluation tool will be sufficient to meet the Element, and a written procedure in addition to the application form and reviewer evaluation tool is not needed. This must be judged uniquely for each Element and for each organization.

5) Outcomes

These are the practices that an organization should have in place.