Common pitfalls and mistakes seen on IRB applications

1. The Form A/B/C page is not signed and dated.

You must submit a scanned copy of the complete Form A/B/C with all necessary signatures.

2. The Form A/B/C is not dated, or has dates that have already passed.
The date on which you submit the IRB application must be accurate, or at least within a few days of the actual submission date.

For the proposed date to commence data collection, do not write "as soon as possible" (Everyone wants to begin as soon as possible!) or "upon IRB approval" (Everyone begins upon IRB approval!). Provide a specific date that is realistic and reasonable. It is not reasonable or realistic to expect to begin data collection a week or two after the application has been submitted.

3. The application is incomplete and missing some of the required forms/documentation.
The kinds of information missing most often include:

Recruitment materials, including fliers to be mailed out or posted around campus,and emails or letters to potential participants/ administrators at targeted agencies.

Links to online materials, such as online consent forms and surveys

Downloaded copies of the final versions of the consent form and survey that appear online

A complete application contains the following elements:
 

  • The signed Form A/B/C
  • Research Outline
  • All recruitment materials in their final form, including fliers and/or emails/letters to be sent to potential participants
  • All consent forms in their final forms
  • All surveys in their final forms (or a list of initial questions for semi-structured interviews)
  • A clickable link to online consent forms and surveys (if applicable)
  • Signed administrative consent letters for projects that intend to recruit subjects and/or collect data at a site outside the College (if applicable).

4. The research design is too vague or incomplete so as to allow the IRB to evaluate potential risks to participants in the research design.
All elements of your research design, including recruitment, data collection, and data analysis/presentation, must be well thought out and planned before submitting your IRB application.

You cannot give the IRB just a general idea of what you plan to do and then work out the details later. The IRB needs to know the details of the research plan in order to assess risks.

Providing details on the research plan includes where, when, and how you plan to recruit potential participants. Many researchers fail to address the recruitment portion of their research pan.

5. The researcher fails to acknowledge risks in the research design.

  • All foreseen potential risks must be identified.
  • ALL research involves risk. Your project will not be approved if you state that it does not involve any risk.
  • At a minimum, studies that intend to maintain the confidentiality of the participants and their data always run the risk of a breach of confidentiality, no matter how small. The same is true with respect to anonymity.
  • The risks and safeguards identified in the Research Outline must be the same as those identified on the consent form.

 

6. The consent form does not contain all the information a potential subject needs to make a fully informed decision regarding whether or not they want to participants.
Many times, the IRB requests that more information be included on the consent form so that potential participants can better consider the level of risks involved,especially with regard to the potential for a breach of confidentiality. This includes,for example:  

  • The total number of subjects to be recruited (there are greater risks to confidentiality, for example, if there are 5 participants rather than 50 participants)
  • How the data that is gathered will be used. This includes the possible grouping of answers according to demographic variables or other background information about the participants, as well as the possible use of direct quotes and how participants will be referred to if direct quotes are used
  • Who will receive or see the results of the study (this is especially important if the findings will be shared with participants, colleagues or supervisors)

7. The Research Outline and/or consent form fail to include other required types of information.
Please make sure you follow the instructions for completing the Research Outline and the Instructions for the consent form (available for download on the IRB web site) carefully and thoroughly.

Please read the web site. Note updates to important information, such as the contact phone number for the IRB.

If you plan to conduct an online survey, please consult the Online Surveys tab on the IRB web site, and make sure that you follow the instructions there for procedures and safeguards with online surveys.