Provide Feedback on Topics the ORIC is Exploring
The ORIC is considering a number of new initiatives and changes to policies and guidance. Take a look at what we're working on and let us know what you think.
The questions currently available for public comment are listed below. Click on the question to expand the section, and submit your comments to the ORIC. Your comments may remain anonymous if you wish, but we hope you will provide your contact information so we can contact you to follow up in more detail if needed.
- What do you perceive are the benefits to this change?
- What do you perceive are the barriers to this change?
- Are there certain types of studies where it would be easier to make this change?
- Are there certain types of studies where this requirement would be inappropriate?
- Would you, your study team, or your department require or prefer additional training on simplifying consent language?
- Are there any additional resources you would prefer in order to make this change?
- What languages do you anticipate encountering the most?
- What do you perceive are the benefits to this change?
- What do you perceive are the barriers to this change?
- Would you feel confident securing an interpreter to assist with the consent process and all study visits, either through hospital interpreter services, or through the Office of Research Participant Advocacy?
- When should the IRB allow the Short Form to be used as opposed to a Fully Translated Consent?
- For the types of studies you/your department conduct, how important is it to have all participant-facing materials translated (beyond the consent form)?
- Are there certain types of trials where it would be easier to make this change?
- Are there any additional resources you would prefer in order to make this change?
Returning results in plain language allows for investigators and sponsors to honor the essential contributions and voluntarism of study participants in research studies, while improving the transparency of the conduct of the research.
Read more about the return of individual results
Read more about the return of summary/aggregate results to participants
- What do you perceive are the benefits to this change?
- What do you perceive are the barriers to this change?
- Are there certain types of studies where it would be easier to return results?
- Are there certain types of studies where this requirement would be inappropriate?
- What additional resources would you need in order to make this change?