Lack of Parental Permission Forms, Child Assent Forms, and Assent Script/Procedure
When children are involved, both parental permission and children's assent forms are usually required. For children under age 12, an oral assent script & procedure (rather than written consent) is most often appropriate.
Requested Information Not Provided
The IRB application consists of questions that solicit specific information needed for the IRB to review the protocol and make a decision. Responses to questions should address the information/document that is being requested for that question.
Inappropriate Referrals to Other Documents
The IRB protocol must be complete and include all requested information in the appropriate sections. It should not include statements such as, "Refer to Research Proposal," or "See NSF proposal."
Contradictory or Inconsistent Information
All information throughout the IRB protocol should be consistent. For instance, the compensation amount listed in the IRB application should match the amount listed in the consent form. Inconsistent information requires the IRB to return an application so it can confirm the correct information.
Complicated or Technical Language
The language in the recruitment materials and consent forms should be understandable to the target population. Do not use technical language or terms specific to a discipline.
Overstatement of Possible Benefits
In most research, expected results are tenuous at best. If no direct benefits to the subjects due to participation are foreseen, it is appropriate to state this. Payments or course credit are not benefits; they are incentives and should be listed separately from benefits and risks.
Misidentifying Data as Anonymous or De-identified
Data cannot be anonymous if a researcher knows who provided it at any time, even if there is nothing recorded with the data that can identify the research participant (e.g., in-person interviews); data are rarely considered anonymous. De-identified data requires that no information that can be reasonably used to identify an individual be recorded with the data. Oftentimes, a combination of information can be used to identify individuals, such as combining demographic information and responses to open-ended questions. Researchers should critically evaluate the types of questions used (e.g., open-ended) and target participant population (e.g., drawn from a specific organization/location) when determining whether identifiable information is recorded with the research data.
Insufficient Explanation of Confidentiality Protections
Methods for maintaining confidentiality of the data (e.g., coding procedures, who has access to the files, how long the data will be kept, mechanisms/platforms for securely storing data, etc) should be described in detail in the IRB protocol.
Failure to Explain Impact of Non-Participation
When treatment or services are involved, an affirmation should be included indicating that a decision not to participate will not affect the availability of services to which the individual is entitled. When students are involved, an affirmation should be included indicating that non-participation will not affect grades or academic standing.
Lack of Recording Statement
When video or audio recording is involved, a participant should be told that they may review the completed tape and ask that any or all parts in which they appear or are heard may be destroyed. Parental permission forms should not offer the parent(s) access to their child's recordings.
Failure to Obtain Permission from Cooperating Institutions/Departments
When cooperating institutions/departments are involved, a letter from an official authorized to give permission should be included. This letter of cooperation demonstrates the institution/department’s understanding of the research procedures and agreement that the research must be voluntary for its constituents; the institution/department cannot coerce or unduly influence individuals to participate in the research. See template here. (Note that letters of support used for funding applications do not usually suffice for IRB applications because they do not address specific human subjects issues; please use the IRB’s letter of cooperation template).