When you are creating an eResearch application, these tips may be helpful:
- Standard of Care
- Site Approval Letter
- Is your site engaged?
- International Research
- Vulnerable populations/sensitive topics
- Is your research exempt?
- Final exempt determination
- Adding a non-UM colleague to the eResearch study team
- Why does the IRB ask for so many details?
- How are primary reviewers assigned?
- Do you need more help?
Standard of Care
If you are a researcher from the School of Health Professions and Studies, or the School of Nursing, it is best to add language to your application describing a standard of care for your project (when and if applicable). This will often help guide a primary reviewer’s understanding for which part of your research is “standard of care” and what will be considered a “new” or “different” treatment, (in most cases, the focus of the research project). This language is usually included at the beginning of Section 4 (the abstract section) and may need to be added in other sections of the application.
Site Approval Letter
If you are using a site other than the University of Michigan-Flint for part of your research project (i.e., collecting data from a senior center or surveying students at a junior high school), it is important to add this information to your application (Sec. 3). In many cases, it is customary to obtain a Site Approval Letter from the data collection site. A Site Approval Letter is an indication to the IRB that administrators at the research site (where you will be collecting data) have given their permission for you to recruit their: students, patients, clients, residents, employees, and or use their patient medical records with a HIPAA waiver, etc. Site Approval Letters are uploaded into the eResearch application and should be written on the research site’s stationary (Section 3-1.8) and contain the signature(s) of an authorizing agent such as a school principal or the director of a community center. This correspondence confirms to the IRB that the communication is official and it is okay to be doing research at the organization or facility.
Is your site engaged?
Sometimes persons employed at a data collection site will be answering questions about your research project, helping with informed consent, included in data entry, data analysis, and/or statistical analysis, etc. In other words they may become engaged in the research project. If a site is considered engaged, you must include this information in your application (Sec. 3-1.1).
For more information about who is considered engaged, follow one of these links:
If you will be doing international research it is important to emphasize and list all expertise that you may have (e.g., Peace Corps, native land, family ties, fluent in the language, etc.) in regards to your project. Please remember to submit important documents such as the informed consent form, recruitment, email announcements, letters, etc., in the native language of the country you will be visiting as well as in English. Site approval letters are also important documents to include in your application when applicable.
Vulnerable populations/sensitive topics
If you are doing research that involves vulnerable populations (children, persons with diminished capacities, college students, pregnant women, prisoners, etc.) and/or the research will be collecting data about sensitive topics (i.e., drug use, sexual behaviors, alcohol consumption for minors, etc.) please make sure that you allow ample time for the IRB to consider your project. It is customary to allow the IRB thirty days to consider an application. When vulnerable populations and/or research with sensitive topics are involved, it often takes longer than the standard time frame for an application to move through the approval process. Sometimes these projects are deemed as “full board review”, and can take up to 8 weeks or longer to be considered.
Is your research exempt?
Do you think your research project falls into an exempt category? Please remember that although some research projects do qualify for exemption, this does not necessarily mean that they are exempt from IRB review. The project may be exempt from some of the regulations that are normally applied. Want more information about exempt categories? Please click here.
Final exempt determination
Also remember that a PI may initially make a suggested determination for exemption with their project, but it is up to the IRB to either concur with that assessment or to determine that this is incorrect, and may reassign it to either expeditable or full board review status.
Adding a non-UM colleague to the eResearch study team
In order to add a non-UM colleague to the eResearch study team:
Create a UM Friend account for your non-UM colleague. Visit the following URL for directions: http://www.itd.umich.edu/itcsdocs/s4316/.
Ask your non-UM colleague to log into eResearch using the newly-created Friend account and Kerberos password. Direct your colleague to www.eresearch.umich.edu. This permits the eResearch system to activate the new account.
Go into Section 1.3 of the application to add a new study team member. Type your non-UM colleague’s last name into the search field. You should be able to find his or her name listed in the drop-down box. Select and define his or her role on the study.
If your non-UM colleague’s role is co-investigator or study coordinator, he or she must complete the human subjects module in PEERRS. The link to the modules can be found on the eResearch website. If his or her institution has a similar requirement, submit documentation of completion to OVPR at firstname.lastname@example.org.
If your non-UM colleague’s role is co-investigator, he or she will be prompted by eResearch to “accept” the role. A link is sent via email for your colleague to access in order to do this.
Why does the IRB ask for so many details?
Adding details to an application helps guide an IRB reviewer to accurately access risk levels for each project and to try and understand what the researcher is trying to accomplish with their research project. It is often helpful if researchers add detail in “layman’s” terms. Keep in mind that all IRB personnel are not experts in every field of study and they may not be an expert in your field of study.
How are primary reviewers assigned?
In order to create an atmosphere of non-conflict of interest, the IRB staff assigns protocols to a diverse group of reviewers with a wide range of expertise, background and discipline. Board members (reviewers) are representatives from all of the colleges on the UM-Flint campus and projects are assigned across disciplines to try and alleviate conflicts of interest within any particular department.
Do you need more help?
If you need help with eResearch or for questions about your project, contact the IRB office.