Help for Researchers and Study Personnel
Understanding required contract language
Help for researchers: Understanding DOH's required contract language.
Investigators serving as sponsors
Help for Researchers and Study Personnel: Investigators Serving as Sponsors
Scientific or Scholarly Rationale or Purpose
Researcher Help: Describe the Scientific or Scholarly Rationale or Purpose
Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #1)
Help for Researchers: Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #1)
Describe how the Investigator has the resources necessary to protect participants before conducting the research study
Researcher Help: Describe how the Investigator has the resources necessary to protect participants before conducting the research study
Research involving data registries
Researcher Help: Research involving data registries
Basic Elements of Informed Consent
Researcher Help: Basic elements of informed consent required by regulation
Continuing Review Subject Information Questions
Examples of how to answer Continuing Review, Subject Information questions. The IRB needs to know how many participants have been enrolled in total, or during the past review period, and to know how many have withdrawn or been screening failures to conduct substantive and meaningful continuing review.
Procedures used in research
Help for Researchers: Identify procedures used in research, and distinguish from treatments or procedures used in standard practice
Risks and potential benefits
Help for researchers: Risks and potential benefits