This form should be prepared by the Principal Investigator (PI) and attached to any research project proposal involving human subjects.
Describe the problem or issue you hope to address in your research.
Most projects involve an intervention (i.e. a change in practice based on evidence) as well as an assessment of the efficacy of that intervention.
Include specific details concerning all activities that will be part of your project.
The data you collect as part of your project should focus on success of the intervention and should not include private identifiable information. Note: The collection of any private identifiable data constitutes human subject research. Private identifiable data includes: medical and clinical records, results of test intended to measure participant knowledge, attitudes, behaviors, and beliefs, and interview or surveys seeking private information about the individuals participants. Private identifiable data typically does not include surveys or interviews that are intended to evaluate the efficacy of a program or intervention or which focus on organizational practices or social issues.
If your project involves an intervention that will occur organizationally or across the site as a whole explain that in your answer.
In your response, be certain to provide as many details as possible. Such as: • What is the intervention? • What activities will they have completed pre- and post-intervention? • Will all participants receive the intervention? If not, how will participants be assigned to control or test group. • Are special qualifications needed to implement the intervention? Is so, describe your qualifications to implement it?
Answer the questions for the first data set (records) that you will be analyzing. If you have additional data sets (records), you will need to provide the same information for each data set, repeat until you provide information about all the records you’ll be analyzing.
Includes name, title, address, phone number, etc. If the data set is publicly available include information on how the public may access the record.
Include name, title, and phone number. If you are pulling the data from a database or internet site yourself provide details on how you’ll access the data.
Publicly available means that any individual is able to access the data without permission to do so.
De-identified means that all identifying information will be stripped from the records before they are given to you. If the information contained in the records are about an entity rather than individuals, choose ‘yes’ as identifying information refers to individuals not entities.
For example, if you will access the data via a website give details and provide the URL. If you will be provided the data physically or electronically, detail the format and methods that will be used.
E.g., Information about the participants’ psychological or mental health, illegal activities, HIV status, SSN, etc. Sensitive data should only be collected if vital to the data analysis.
Examples of sensitive data include HIPAA protected information, FERPA protected information, information would/ could cause loss of reputation, employment, financial status, etc.
For example, coding or removal of identifiers as soon as possible, limitation of access to data, use of locked file cabinets, and protection of computer-based data systems, etc. Include specific procedures for all forms of data.
Sites must be identified to the IRB. However, in published research the site must be anonymized. You will need to refer at a minimum to the state in which the site resides (if it has a geographical location) and steps taken so that the reader cannot infer the site.
For example, all documents will be coded, you’ll use a pseudonym, you collected anonymous data via survey, etc.
If you are collecting non-public data on an organization, you are required to obtain permission from that site or sites in order to use their site in your research. Complete the information for each site here.
Select the user to approve this request.