Vague descriptions of researcher roles/responsibilities within the protocol.
Unclear descriptions of participants’ experiences. IRB reviewers need to understand participants’ experience from recruitment through when they have completed their participation.
Inconsistencies between the protocol and information provided in the consent processes. Examples include:
- The protocol states participants will be paid $5 but the consent form states $8.
- Recruitment flyers indicate the study takes 15 minutes but it actually takes 30 minutes.
- A research activity is not described in the consent form but is described in the research description.
Consent form issues:
- Consent language at too high a reading-level.
It is widely accepted that the average American reads at 7-8th grade reading level. Many people do not understand academic jargon. For example “aggregate” or “randomization,” or “negotiating identities.” See our Plain Language guide.
- Using “I understand.”
These statements may discourage participants from asking questions after they have signed the consent form.
- Not addressing the participant directly.
Participants should be addressed as “you.”
- Not fully describing the study procedures.
- Telling participants their data will be kept “confidential” with no details as to how this will occur. See our Confidentiality guide.
- Forgetting to include the new elements of informed consent:
- Include a “Key Information” subheading.
- Inform participants whether their identifiable or de-identified data (may or will not) be made public or used for future research purposes.
- Clarify whether you intend to sequence participants’ genome, if your research includes the collection of biospecimens, such as saliva samples.