Common IRB Errors

  1. Myths about IRB process
  1. Myth: The IRB process is difficult to go through, long and drawn out, etc. The IRB process does not have to be complicated or drawn out. The most common reasons for delays in sending out applications for review or for a student not getting approval in a timely manner are: 1) incomplete applications, 2) poorly written applications. Please make sure you utilize resources that are online, including the Policy and Procedures Manual that provides detailed information about the IRB process. Many students do not appear to read this manual.
  1. Myth: The IRB functions as a dissertation advisor: The IRB’s purpose is to safeguard the rights and welfare of human subjects. When we review a study we are looking at it from this perspective. We can help provide answers to questions investigators may have before they submit about issues dealing with the protection of human subjects, but we are not in a position to be able to address questions regarding the scientific merit of using particular measures, procedures, whether hypotheses can be reasonably answered using the data to be collected, etc. These are methodological issues that need to be addressed by your committee and chairperson.
  1. Myth: The IRB takes responsibility for ethical issues related to the conduct of a study. IRB approval means that the study as it has been described to us is considered to have in place appropriate procedures and safeguards for protecting the rights and welfare of human subjects. However, the researcher (the investigator) is ultimately responsible for ensuring that the study is carried out using the procedures approved (i.e., the investigator does not change study procedures without first consulting the IRB), and that adverse events are quickly reported to the IRB.
  1. Common application errors (general):
  2. Not having application signed by advisor
  3. Not including supervisor review form
  4. Not submitting 2 copies of all documents
  5. Not submitting first three chapters of dissertation (doctoral students)
  6. Not including certificates of completion of on-line education course - student must complete, as well as chairperson; also, if student plans to involve any research assistants in project these individuals must also complete the on-line tutorial. Please visit for the training.

Please consult the application checklist on-line at

  1. Exempt Applications: Common errors:
  1. Item 1: failure to adequately describe research project, goals, objectives, research questions, hypotheses. Someone who is not an expert in your field of study should be able to read this description and have a good idea of the purpose, scope, and goals of the study. Technical terms should be defined; the population to be studied should be clear.
  2. Item 2: Failure to refer to one of the categories of research that allow for an exempt application to be made.
  3. Item 3: Failure to adequately describe the involvement of human subjects. We should know how many people you propose to include in your study, what procedures you will be subjecting them to, how long their participation will take and over what time frame the study will be conducted. In describing procedures you should be as specific as possible. Don’t just say something like, “participants will be given a questionnaire.” What type of questionnaire is it (i.e., what is the nature of the questions to be asked), how long is it, who will administer the questionnaire, how will the questionnaire be administered (e.g., individually, group setting, and where) etc. We need to know how contact with human subjects will occur.
  4. Item 4 (reason for exemption): Failure to adequately explain how the study meets the category indicated in item #2 and why study should be considered to pose less than minimal risk to participants.
  1. Item 5 (records): Failure to provide sufficient information about security of records. Who will have access to records? How will records be secured (e.g., locked file cabinet, password protected computer files). We want to ensure that not just anyone will be able to get a hold of data and figure out who participated in study and what their responses to study questions, etc were.
  1. Item 6 (identification of subjects): Failure to provide enough information about procedures that will be used to ensure that subject data is kept confidential. If there will be a way to link participants’ identities to specific data (i.e., the data is not being collected anonymously), how does the researcher propose to keep data confidential. Security of the data is important here (i.e., keeping in a locked, secure location), but also taking steps like making sure that no names or other personally identifying information appear on data forms (e.g., that subjects don’t write their names, birth dates, etc. on surveys), that a list that links subject numbers to specific participants (i.e., a list that indicates subject #1is Mary Smith, subject #2 is Joe Chang, subject #3 is Maria Alvarez, etc) is kept in a separate secure location from the study data (e.g., completed surveys); data should also be kept separate from signed informed consent forms.
  1. Item #7 (data collection tools): Failure to adequately describe the tools, measures, procedures to which subjects will be exposed. There should be a thorough description of these items and anything that the subjects will see or hear should be included in the application – thus, we need to see actual copies of questionnaires, interview protocols, etc. We also need to see scripts of how the study, measures, or procedures will be introduced/described to subjects.
  1. Item 8 (permission from institutions): Failure to supply written documentation that individuals from organizations/institutions from which subjects will be recruited have approved data collection to take place. In some cases, this permission will require the student to go through an IRB at the institution where the data is to be collected (e.g., if the student is proposing to collect data from students at another university); in other cases, a letter from an appropriate institutional official will suffice if the institution does not have an IRB or determines that the project does not need to go through the IRB to have approval for subject recruitment granted.
  1. Item 9 (HIPAA): For most students this will not apply, but students must familiarize themselves with HIPAA to know whether this item does apply or not. The policy and procedures manual contains information pertaining to HIPAA. HIPAA standards relate to the collection of what is known as Protected Health Information (i.e., defined as any individually identifiable health information collected or created as a consequence of the provision of health care by a covered entity, in any form, including verbal communications). HIPAA standards become an issue when a researcher is planning to collect data from what is known as a covered entity.

A Covered Entity is: a) a health care provider who transmits health information in electronic transactions for which the Secretary has adopted standards/for certain purposes (e.g., a physician who electronically bills for services), b) a health plan, c) a health care clearinghouse. PepperdineUniversity is considered to be a hybrid entity --- some parts of campus are considered covered entities and others are not. For example, if an investigator wished to collect data through the StudentHealthCenter, this is considered a covered entity and HIPAA provisions apply.

  1. Signature lines: Failure to have faculty supervisor sign form.
  1. Expedited/Full Application: Common Errors
  1. Item 1 (summary of project): failure to adequately describe research project, goals, objectives, research questions, hypotheses. Someone who is not an expert in your field of study should be able to read this description and have a good idea of the purpose, scope, and goals of the study. Technical terms should be defined; the population to be studied should be clear.
  1. Item 2 (dates of project): it’s a good idea to ask for approval for a 1 year period even if you think data collection may take less time; IRB can grant approval for expedited/full review projects for 1 year max; if you ask for approval for only 6 months and end up needing longer to collect data you will need to complete an application for continuing review at the time approval expires; if study will continue beyond 1 year this continuation application also has to be completed.
  1. Item 3(cooperating institutions): If other investigators outside of Pepperdine are involved in study or cooperating institutions involved, they must be described/named here.
  1. Item 4(subjects): Common errors in this part of the application include not clearly specifying the number of subjects, where they will be recruited from, how they will be contacted, and inclusionary and exclusionary criteria. With regard to the latter, the investigator should provide appropriate explanations for why certain inclusionary and/or exclusionary criteria are being utilized (e.g., if individuals in the study have to be between the ages of 18-40, why is the upper limit of 40 being selected?) Also, students should remember to include copies of any flyers, recruitment scripts, etc that will be used in the study.
  1. Item 5 (procedures): This is probably one part of the application that students most often do not adequately complete. Even though doctoral students are asked to turn in a copy of their dissertation proposal (which includes Methods section) with the IRB application, the IRB application should provide sufficient information that it is not necessary for reviewers to refer to through the dissertation proposal to understand what procedures participants will be exposed to (the Methods section of the dissertation proposal can be consulted if more detail is needed, but the application itself should provide enough basic detail for any reviewer to understand what the study procedures are).
  1. Items 6 and 7 (risksbenefits):Student investigators often err on the side of not adequately describing risk and overstating benefits. Most research that our students do is relatively low risk so usually there are not a lot of risks associated with the studies we review; however, students should consider things like whether subjects will feel anxious, upset, or uncomfortable by the things they will be asked to do as part of participating – these would constitute risks. Sometime risks are relatively minor like feeling bored or fatigued during study, but they should nonetheless be mentioned.

The most common error regarding study benefits is for students to say that subjects will directly benefit from participation in the research. This is rarely the case. Unless an individual is going to be getting some kind of personalized feedback on how (s)he answered measures, completed tasks, etc that were part of the research, in the vast majority of cases participants receive no direct benefit from participation. Benefits may take the form of societal benefits such as adding to the body of knowledge in a particular area.

  1. Item 8 (Informed Consent, HIPAA, Data Security):many of the items previously discussed under exempt application, common errors regarding data security, and HIPAA apply here as well. The Policy and Procedures manual outlines the required elements for an informed consent document and investigators should make sure their consent docs have these elements. These include things like making it clear that participation is voluntary, clearly describing what study participation involves and how long it will take, identifying the risks and benefits of participation, and so on. Investigators sometimes forget to clearly identify themselves and their advisor in the consent document as the individuals who are conducting the research and the purpose for which the research is being carried out (i.e., dissertation). Other common errors include things like making the reading level or language used in the consent at too high a level for likely participants.

Application for Waiver or Alteration of Consent Procedures. The main points to make here are that there needs to be a compelling reason why an investigator should be allowed to either alter the consent procedure (e.g., not fully disclose all details of research; something like this might be appropriate in, for example, a psychology study where deception will be involved but then subjects will be fully debriefed), or waive documentation of consent (i.e., not collect signed consent forms). The latter is the most commonly requested modification to the consent process that is requested, but there are specific criteria/questions that must be addressed in order for such a waiver to be approved. For example, it would not be appropriate for an investigator to simply say, “It’s too much of a hassle for me to obtain signed consent forms – I want to complete my research as quickly as possible.”).

Even for exempt applications, we expect a consent procedure to be followed. That is, a consent form or (if a waiver of documentation of consent is being sought) an unsigned document that provides subjects with enough info so that they understand the terms of participation.

GPS IRB version 5.19.09