IRB Flowcharts and FAQs

Refer to WU IRB Process Flowchart or Belmont report for definitions of research and human subjects.

If the purpose of your project is a translation of knowledge into practice or implementation/evaluation of a process in a local environment only, you should submit a QI protocol. If the purpose of your project is scientific, systematic investigation with intent to disseminate generalizable information (to more than just your local environment), you should submit some type of research protocol (please refer to category decision tree).

Please refer to category decision tree.

According to 45 Code of Federal Regulations 46.101 the following categories are usually eligible from exempt status of IRB approval/review:

• Normal Educational Practices and Settings - This category is limited to the study of normal educational practices and be conducted in commonly accepted settings such as elementary, secondary, or postsecondary settings.
• Anonymous Educational Tests, Surveys, Interviews, or Observations – If the research data contain any subject identifiers and if disclosure of data to unauthorized persons could harm the subject in any way, the research is not exempt.
• Identifiable Subjects in Special Circumstances – Tests, surveys, interviews or observation of public behavior, if the subjects are elected or appointed public officials or candidates for public office.
• Collection or Study of Existing Data – The data must be publicly available, or the information derived from use of the data, records, or biological specimens must be recorded so that subjects cannot be identified.
• Public Benefit or Service Programs – Research and demonstration projects that are conducted by or subject to the approval of governmental department or agency heads, such as Welfare, Medicaid, and Social Security.
• Taste and Food Evaluation and Consumer Acceptance Studies – Should be limited to taste and food quality evaluation studies that do not involve consumption by the subject of any type or volume of food that has any potential risks.

Research or activities falling into one of these categories and for which there is minimal or no risk (defined below) to human subjects may be considered by the IRB to be exempt from IRB review. Investigators who believe that their project or study is exempt should file an “Application for Determination of Exemption” with the IRB.

Go to the IRB Forms and Template Page here.

NONE! You may not advertise for, contact, or consent human subjects without IRB approval.

Use the WU’s consent form template. Remember to customize it to your specific project without deleting any required elements of consent and maintain first-person language throughout.

Confidentiality
Information is considered to be confidential when only the investigator(s) or individuals on the research/project team can identify which responses came from which individual subjects. Researchers/quality improvement project leaders are responsible for making every effort to protect confidential information to prevent anyone outside of the study/project team from connecting individual subjects to their individual responses.

Anonymity
Information is considered anonymous when even the investigators or individuals on the research/project team cannot match the responses to the individual subjects who provided them. This may be the result of not collecting any identifying information or recording information using only non-identifiable codes. No identifying information should be collected unless it is essential to a well-designed study protocol.

Adapted from: Confidentiality vs. anonymity. Retrieved from http://www.irb.vt.edu/pages/confidentiality.htm retrieved October 19, 2012

Because the predicted grade reading level of lay public is 8th grade, your consent form should target 8th grade reading ability or lower. Some strategies to help reduce grade reading level are: (1) limit the number of words with three or more syllable and (2) use active (rather than passive) voice. You can check the grade reading level of your Word document by following these steps: Search “reading level” in the HELP menu of your version of Word. Following the instructions for turning on reading level statistics. Construct the consent form as a Word document. Highlight the text of your consent form. Select tools. Select Spelling and Grammar. After Word finishes checking spelling and grammar, it will display readability statistics. Look at the Flesch-Kincaid reading level. It should be at or below 8.4.

Please refer to IRB committee meeting schedule for the current academic year. Only complete protocols with attachments and forwarded signature pages will be considered for review.

(1) read and follow Waynesburg University’s IRB guidelines; (2) Complete NIH human subjects education, CITI training for the protection of human subjects or equivalent. (3) attach all appropriate or requested supporting documents and attachments (this includes permission from outside agencies to use their site/employees/students, permission to use survey instruments/questionnaires [from copyright holder] ; (4) promptly forward hard copies of all appropriate or requested signature pages; (5) be sure to include all required elements in consent form/assent form and maintain first-person language; (6) be attentive to grade reading level of consent form/assent form – ensure it is congruent with your target population, (7) be sure to clearly communicate your research procedures on your protocol application. Your procedures must be in sufficient detail to allow the IRB to evaluate all contact points between a member of the research team and your human subjects.

If your project will include another facility or institution that has an IRB, you likely need approval from both (or all) IRBs. If Waynesburg University’s (WUs) IRB is the IRB of record (primary IRB) for your project, we will, upon request, provide a letter of protocol approval for you to forward to the alternate IRB(s). If an alternate IRB is the IRB of record (primary IRB) for your project, you will still need to submit a protocol to WUs IRB as well as a letter of approval from the alternate IRB(s). Please note: Approval from one IRB does not ensure that all IRBs will approve the same protocol details. IRB committee members have the responsibility to question and/or ask for clarification/revision for any protocol, design, or consent details for which they are unsure adequately protect the rights of human subjects.

In cases where reliability and validity of an assessment are not established use the phrase:

The reliability and validity of the (name instrument i.e. Wait Time Survey) has not been established.

In Instruments where the instrument has reliability and validity, use a citation

Ex: The reliability and validity of the Beck’s Depression Inventory was established in Studies by Beck & Smith, 2008.

Assent is permission from children subjects, aged 7 – 17 years. It is believed that children between these ages can comprehend what you are doing to them or asking them to do for your research project and they should have the right to grant you permission to use them in your project. Informed consent from a parent or legal guardian is also required. Assent forms should be written in the first person, at a grade reading level congruent with the expected grade reading level of your pediatric subjects but not generally above 4th grade reading level.

If ANY member of your quality improvement team will be accessing ANY element of protected health information without informed consent of all subjects, YES, you do! (Please review the HIPAA waiver form). Additionally, Principal Investigators and team members with access to protected health data must supply a certificate of completion for a HIPAA training course within 12 months of the application date. An affidavit that the PI has reviewed the National Institutes of Health Privacy Rule Information for Researchers: https://privacyruleandresearch.nih.gov/pr_02.asp or viewed the HIPAA Awareness DVD from the Waynesburg University Eberly Library (call no. 344.730412 H667 2009) will also fulfill this requirement.

Create a document that addresses each requested revision. DO NOT RESEND A NEW PROTOCOL.

• Ethically risks outweigh benefits
• Idea not well-developed
• If every item is not succinctly yet fully described or addressed. Strive for quality over quantity of information

Submit an entirely new protocol application complete with signature page.