On January 21, 2019, regulations governing human subjects changed. Major changes include:
- New exemption categories and refinement of existing exemptions, including:
- Research involving benign behavioral interventions that meets certain conditions may be exempt;
- Some research involving use of identifiable secondary information or biospecimens may be exempt when its use is governed by specific confidentiality protections (e.g., HIPAA);
- Surveys and interviews with adults where identifiable sensitive information is collected may be exempt when adequate privacy and confidentiality protections are in place;
- The exemption related to research involving normal educational practices now requires consideration of its effects on students’ education and assessment of educators.
Note: Some exempt research is subject to “limited IRB review”, which is similar to an expedited review process.
- Annual continuing review is no longer required for most minimal-risk research, including research where remaining activities are limited to data analysis.
- Informed consent changes
- New focus on how consent forms are written and how information is presented to participants to facilitate understanding;
- New requirement to inform participants of whether data may be used for purposes other than the current study;
- New requirements to inform participants about potential for biospecimens to be used for commercial profit, whether the research involves whole genome sequencing, and whether clinically relevant results may be returned;
- Obtaining consent prior to screening/assessing eligibility is not required under certain conditions;
- For clinical trials, one IRB-approved informed consent form used to enroll subjects must be posted on a publicly available Federal website within certain timelines.