Human Research Protection Program
Institutional Review Board Office
Initial Review Application and Instructions – Expedited / Full Board
REFERENCE FORM ONLY
· This document has been developed to help in preparing and submitting an initial review application for expedited and full board projects; it includes the question as displayed in the MSU IRB online application system along with related help text available through the MSU IRB online system.
· The form questions are bolded
· The form instructions and tips are italicized
· Complete and submit the initial review application through MSU IRB Online System ONLY
Contact Information
· If you have questions about completing this form, please contact us.
· Phone: 517-355-2180 / Email: / Visit hrpp.msu.edu for staff contact or additional information
1A / Responsible project investigator ID#: Click here to enter text.
· The ID# format is as follows:
o MSU Faculty, Academic Staff, Staff: Z-PID
o MSU Students (including graduate students and residents): A-PID
o Non-MSU Affiliates: Contact the IRB for a G-PID
· Enter the ID# of the Responsible Project Investigator (Principal Investigator, PI); with limited exceptions, only MSU regular faculty, emeritus faculty, and fixed term faculty employees with rank of assistant professor or higher may be designated as PI
· See HRPP Manual Section 4-9, Designation as Principal Investigator for requirements and exceptions related to designation as the PI
· To be added to the application, the individual needs to be registered with the MSU IRB Online System
1B / Secondary investigator ID#: Click here to enter text.
· If there is a secondary investigator, enter ID#. The secondary investigator will be included on IRB correspondence. For example, if this is a graduate student research project, typically the graduate student will be listed as the secondary investigator.
· The ID# format is as follows:
o MSU Faculty, Academic Staff, Staff: Z-PID
o MSU Students (including graduate students and residents): A-PID
o Non-MSU Affiliates: Submit a request for a G-PID through the online “Request a Guest ID” form available at http://hrpp.msu.edu/form/request-guest-id
1C / Additional investigator or key personnel ID#: Click here to enter text.
· If there are additional investigators or key personnel, enter ID#s.
· If there are more investigators than the space provided, please submit as an attachment document that lists the additional investigator(s) names and appropriate ID#s.
· The ID# format is as follows:
o MSU Faculty, Academic Staff, Staff: Z-PID
o MSU Students (including graduate students and residents): A-PID
o Non-MSU Affiliates: Submit a request for a G-PID through the online “Request a Guest ID” form available at http://hrpp.msu.edu/form/request-guest-id
1D / Person preparing document ID#: Click here to enter text.
· Enter the ID# of the individual who is preparing the initial application. If the application is being prepared by multiple individuals, identify the person who has prepared the majority of the application. This may be the study coordinator, secondary investigator, or the responsible project investigator.
· The ID# format is as follows:
o MSU Faculty, Academic Staff, Staff: Z-PID
o MSU Students (including graduate students and residents): A-PID
o Non-MSU Affiliates: Contact the IRB for a G-PID
2 / Study coordinator ID#: Click here to enter text.
· If there is a study coordinator for the project that you would like copied on IRB communications such as reviewer comment(s) and approval letter(s), enter ID#.
· The Responsible Project Investigator and the Secondary Investigator (if listed) will receive correspondence for the project, so you do not need to list them as the study coordinator.
· The ID# format is as follows:
o MSU Faculty, Academic Staff, Staff: Z-PID
o MSU Students (including graduate students and residents): A-PID
o Non-MSU Affiliates: Contact the IRB for a G-PID
3 / Title of Project. Click here to enter text.
· List your project title.
· Please note that this will be the project title that will be listed on IRB correspondence (e.g. approval letters); if the project is externally sponsored, it is helpful to use the same title as the related contract or grant if possible. It is preferable for the same title to be used on all study documents, e.g. consent, data collection forms.
4 / Have you ever received a 45 CFR 46.118 designation for this project? / ☐ No ☐ Yes
· A 45 CFR 46.118 designation is a determination that is used for certain types of applications for grants, cooperative agreements, or contracts that may be submitted to federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal.
· If a 45 CFR 46.118 designation has been made by the MSU IRB for this study, answer "yes" and provide the MSU IRB# assigned to the project. If not, answer "no."
· See HRPP Manual Section 8-4, 45 CFR 46.118 Designation for requirements
If you answered yes, complete 4A.
4A / List IRB number: Click here to enter text.
5 / Select category of review (one). ☐ Expedited ☐ Full Board
· There are three types of initial review:
o Exempt
o Expedited
o Full board review (also called convened IRB review)
· For minimal risk research, consult the Exempt Categories and Expedited Categories
o Research that includes any activity that is not in an exempt category cannot be given an exempt determination
o If you select Expedited or if this is an Exempt application, you will be asked to select the appropriate categories
· For research that involves more than minimal risk OR if the research does not fit into an exempt or expedited category, full board review is required. MSU policy requires all research with prisoners to be reviewed by the full board for initial review applications
· It is important for investigators to guide the IRB by categorizing their own research project. However, if the project is not eligible for the category selected, the category will be changed.
· See the “Definitions” webpage of the hrpp.msu.edu website for the definition of minimal risk
· See HRPP Manual Sections 8-1, Exemptions, 8-2, Expedited Review Procedures, or 8-3, Full Board Review Procedure for detailed information about the distinctions in review categories and the relevant review processes
If you answered “Expedited”, complete 5A.
5A / Indicate sub-category(ies). Categories are summary descriptions; please use the blue question mark for the full text of each category.
☐ / 1. Clinical studies of drugs and medical devices when neither an IND or IDE is required.
☐ / 2. Collection of blood samples from healthy, non-pregnant adults or other adults.
☐ / 3. Prospective collection of biological specimens for research purposes by noninvasive means.
☐ / 4. Collection of data through noninvasive procedures routinely employed in clinical practice.
☐ / 5. Research involving materials that have been collected, or will be collected for nonresearch purposes.
☐ / 6. Collection of data from voice, video, digital, or image recordings made for research purposes.
☐ / 7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, or quality assurance methodologies.
5B / Please describe why your project is minimal risk. For a definition of minimal risk, click on the blue help question mark.
6 / Education / Training Requirement. Is this project being conducted to fulfill the requirements of an education/training program? Select (one)
☐ Undergraduate Research ☐ Master’s Thesis
☐ Ph.D. Dissertation ☐ Residency
☐ Other In-Training Research Project ☐ Project is Not Primarily an Education / Training Activity
· If this project is being proposed to fulfill an educational requirement such as a Master's Thesis, Ph.D. Dissertation, Residency, Undergraduate Research, or an Other In-Training Program, select appropriate option.
· If it is "Other," provide a description of the other type of training program.
· If not being proposed to fulfill an educational requirement, select "Project is Not Primarily an Education / Training Activity."
If you answered “Other In-Training Research Project," complete 6A.
6A / Other: please describe. Click here to enter text.
7A / Funding. Are there any funding sources for this project (including received and/or pending grants or contracts)? / ☐ No ☐ Yes
· If the project is sponsored by external sources (e.g. U.S. Federal Government, Industry, etc.) or internal funds (e.g. departmental grant), select yes and complete sub-questions 1 and 2; submit a copy of the draft or executed contract, the grant proposal, etc.
· For sub-question 1, identify the source and provide the OSP/CGA App Number – i.e. the number generated by the etransmittal (app#)
· For sub-question 2, select yes if the funding is pending (e.g. not yet awarded, contract not executed) and describe the current status (e.g. submitted to granting agency, just-in-time)
· If the project is funded, also include a copy of the funding material to the IRB with application submission
If you answered yes, complete 7A1 and 7A2.
7A1 / Select appropriate funding source(s). Multiple funding sources may be selected. If a funding source is selected, list the name(s) of the funding source(s) and the CGA number. / ☐ No ☐ Yes
Funding Source Type / If funding source is selected, list the name(s) of the funding source / OSP/CGA Number
☐ No / ☐ Yes / U.S. Federal Government (e.g. Department, Agency) / Click here to enter text. / Click here to enter text.
☐ No / ☐ Yes / U.S. State Government
(e.g. Department, Agency) / Click here to enter text. / Click here to enter text.
☐ No / ☐ Yes / Foreign Government / Click here to enter text. / Click here to enter text.
☐ No / ☐ Yes / Industry Sponsored / Click here to enter text. / Click here to enter text.
☐ No / ☐ Yes / Foundation or Non-Profit / Click here to enter text. / Click here to enter text.
☐ No / ☐ Yes / Internal Funds
(e.g. MSU department) / Click here to enter text. / Click here to enter text.
7A2 / Are any of the funding sources pending? / ☐ No ☐ Yes
If you answered yes, complete 7A2i and 7A2ii.
7A2i / Describe pending funding source(s). Click here to enter text.
7A2ii / If the project is not funded will you do the research? / ☐ No ☐ Yes
7B / The protection of human subjects often requires resources be dedicated for things such as the consent process (space, personnel), the performance of the research (trained personnel interacting with subjects, time, access to subjects, access to facilities) care of subject issues or injuries (counseling, medical care), confidentiality of data (space, equipment) and other monetary and non-monetary resources. Describe the resources that are available for this project for the protection of human subjects. Click here to enter text.
· This question must be answered, regardless of funding status
· In this question, investigators should describe the resources available to protect human subjects involved in the research. This includes both monetary and nonmonetary resources as needed (e.g., space, equipment, staff, time, expertise, counseling, medical care).
· See HRPP Manual 6-2-B, Minimization of Risks: Adequate Resources for a list of resource considerations
8A / List all site(s) where this research will be conducted. Click here to enter text.
· List all sites where the project will be conducted
· Be as specific as possible
· List the name of the site (e.g. name of the elementary school, hospital, clinic)
· If you are collecting data through the Internet, list the location as the Internet
· See HRPP Manual Section 6-9-F, Special Considerations: Multiple Research Sites for considerations when research is conducted at sites external to MSU
8B / Do any of these sites have their own IRB? / ☐ No ☐ Yes
· Indicate if any of the sites listed in A have their own IRB
8C / Will employees or agents of non-MSU organizations (e.g. schools, companies, hospitals) be involved in the research? / ☐ No ☐ Yes
· Examples of non-MSU organizations include schools, companies, hospitals, private practices, state departments, other universities
· If yes, describe in (1) the individuals' involvement in the research (e.g. will they perform research procedures, will they obtain consent)
· Depending upon the type of activity, the individuals' involvement may engage their organization in the research which could require additional steps depending on the project funding
· See HRPP Manual Section 6-9-F, Special Considerations: Multiple Research Sites for considerations when research is conducted at sites external to MSU
If you answered yes, complete 8C1.
8C1 / Explain how the employees or agents will be involved (e.g. will they perform research procedures, will they obtain informed consent from subjects). Click here to enter text.
8D / Will MSU units (e.g. Department of Radiology, Biomedical Research Informatics Core (BRIC), Department of Psychology) outside the control or supervision of the investigator be involved in the conduct of the research? / ☐ No ☐ Yes
· Indicate if other MSU units outside the control or supervision of the investigator will be involved in the conduct of the research; for example, will your project involve Department of Radiology (e.g. MRI scan), Biomedical Research Informatics Core (e.g. data storage), volunteer subject pool)?
· If yes, identify the MSU units in (1)
If you answered yes, complete 8D1.
8D1 / Identify the units. Click here to enter text.
8E / Are any of these sites international? / ☐ No ☐ Yes
· Indicate if any of the research sites will be outside the U.S.
· If yes, indicate in (1) whether there is a local ethics board and if so, identify the board in (i)
· See HRPP Manual Section 2-5, International Research for considerations when conducting research outside the U.S. and HRPP Manual Section 6-9-F, Multiple Research Sites, for requirements when the research will involve research sites that are external to MSU
If you answered yes, complete 8E1.
8E1 / Is there a local ethics review board? / ☐ No ☐ Yes
If you answered yes, complete 8E1i.
8E1i / Identify the ethics board. Click here to enter text.