Full Board Review
If the proposed research does not qualify for either Exempt or Expedited Review, it will be subject to a Full Review. In addition, if the proposed research involves any of the following, it will be subject to Full Review.
- Children under the age of 18
- Individuals with impaired decision-making capacity
- Economically or educationally disadvantaged persons
- Procedures that might cause physical harm
- Procedures that might cause significant psychological/emotional distress
- Collection of information about highly sensitive topics
- Collection of information about illegal behavior
- Collection of information that could seriously harm the participant legally, socially, financially, etc., if other people could identify them
Issues to Consider
Risks—Carefully consider the risks to participants when designing your study. Outline the risks that you have identified and your plans to address them in your Description of the Research. Make sure to clearly delineate the risks in the Consent (and assent for children). Identify resources with contact information to ameliorate risks (e.g., counselling services for emotional upset).
Coercion or Undue Influence—When using convenience samples consider whether there is undue influence or coercion to participate in research. For example, children may feel obligated to participate in research that their teacher is conducting. Ethical considerations require researchers to think about ways to mitigate this issue. For example, teachers may want to consider collecting data in another teacher’s classroom or have someone else collect the data in their classroom. Students as participants are often appropriate for research, provided elements of coercion and undue influence can be minimized.
Confidentiality—Protocols should be designed to minimize the needs to collect and maintain identifiable information about research participants. Research data must be protected and access to data should be based on a “minimum necessary” standard. Identifiers should be removed and data should be destroyed as soon as possible. Your protocol must address the safeguards used to maintain confidentiality and data security. Please note that the research protocol is confidential (and not anonymous) if the researcher has any awareness of who the participants are, e.g., through in-person data gathering, capture of IP addresses, or collection of names on consent forms.
Procedure for review
Protocols requiring Full Review are examined by the entire IRB and discussed at a convened meeting. Please see our Timelines and Forms web page for submission deadlines and meeting dates for Full Review protocols, as well as required format for your submission. The deadline for submission is one week before the Full Board Review meeting. Once the IRB has met, a member of the board will reach out to you with the outcome.
If you have questions about what type of review may be appropriate, please contact the Chair of the IRB at firstname.lastname@example.org prior to submitting a proposal. The IRB, however, makes all final determinations of what level of review is required.
IRB duties are described in the Federal Regulation for Protection of Human Subjects (45 CFR 46).