New protocol submissions may be reviewed by expedited review, as defined by U.S. and Canadian regulations and published guidance.
Schulman’s Minimal Risk Review service provides expedited review of qualifying new Protocol and Informed Consent (IC) submissions.
In order to qualify for Minimal Risk Review, research may involve no greater than minimal risk to human subjects. “Minimal risk” is the level of risk an average healthy person would be expected to encounter during typical daily experiences.
The research must also involve only activities described by one or more of the following categories:
- Research on a drug for which an IND application is not required
- Research on a medical device for which an IDE is not required
- Research on a device that is cleared/approved for marketing and is used in accordance with its label
- Blood sample collection within certain limits
- Prospective collection of biological specimens (such as urine, sweat, hair, or skin cells) for research purposes by noninvasive means
- Collection of data through noninvasive procedures routinely used in clinical practice not involving x-rays or microwaves (such as ECG, ultrasound, hearing testing, or moderate exercise)
- Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis)
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, or program evaluation
To learn more about the types of research that qualify for Schulman’s Minimal Risk Review services, please contact Business Development or call 513.761.4100.