|
Directions
Each form has specific directions. Please read them before completing the form. Below
are general instructions for all the IRB forms:
- Submit completed forms to irbforms@memphis.edu.
- E-mail submission is required. Use irbforms@memphis.edu to submit documents. Use irb@memphis.edu for questions and requests.
- Please do not submit forms (or requested revisions) to individual IRB Staff e-mail
addresses (which cannot accommodate the file size of IRB submissions).
- Be sure to submit all required documents in a single WORD document with a table of
contents, page numbers, and continuous line numbers. Applications that are not properly formatted or complete will be return unprocessed. It is permissible to submit documents that cannot be converted to word as labeled
attachments to your application package.
- Student investigators must have their faculty advisors forward their completed applications
to irbforms@memphis.edu. This along with the advisor’s U# on the last page of the application acts as the
advisor’s electronic signature.
- Please allow at least thirty (30) days for processing. For information on the IRB
process and application review cycle, see the IRB Flow Chart.
- Please read the forms carefully! Answer all questions completely and thoroughly. If
you feel a question does not apply to your research state that and explain why. Do
not leave any questions blank. Incomplete applications will not be processed and will be returned to the investigator
for completion.
- Use the Consent Form and Assent form templates on the website. Alter only when necessary.
- The IRB will confirm receipt of your documents via e-mail within one business day.
If you do not receive confirmation, please contact us at irb@memphis.edu.
Determination Form (DET): Are you unsure as whether or not your project qualifies as research or if it involves
human subjects? Fill out this form and submit it to irbforms@memphis.edu for a determination by the IRB on whether or not you are required to apply for approval.
A determination will be made within three business days.
The UM IRB will no longer use separate applications for Exempt and Non-Exempt research.
Review of any research involving human subjects where the data necessary to complete
the research does not already exist will be facilitated by the investigator completing
the Request for Protocol Approval Form(RPA). All RPA's will be screened for exempt
status. If your research falls within one of the six categories listed as EXEMPT
under 45 C.F.R. 46(101)(b) then your approval letter will state that the research
is exempt and under what category it falls.
All Non-exempt research will either sent to the Full Board for review unless it meets
the federal criteria for an Expedited Review and if there is a reviewer available
to conduct the review prior to the next Full Board meeting. See Expedited Review criteria
45 C.F.R.46.110.
Note: Research involving the following subject populations cannot be not granted EXEMPT
Status:
1. Pregnant women when they are the targeted subject population
2. Students participating in the Psychology Subject Pool
3. Students if the investigator is their instructor
4. Employees if the investigator is their supervisor
5. Most research with children
6. Prisoners
Use this form if the following applies:
General characteristics of all exempt research include the following:
• Private identifiable information cannot be recorded by the investigator or members of the research team if the possibility
exists that release of that information could affect the individual’s reputation,
employability, or financial status
• Research participants do not sign a consent form but should be informed about the nature of the study via the
use of an “introductory script”
• Prior scientific review by a School or Departmental review committee is not required
Exemptions cannot be secured for research using the following populations:
1. Pregnant women when they are the targeted subject population 2. Students participating in the Psychology Subject Pool 3. Students if the investigator is their instructor 4. Employees if the investigator is their supervisor 5. Most research with children 6. Prisoners
Request for Protocol Approval (RPA): Use this form for all non-exempt research or if you are unsure about whether or
not your research is non-exempt.
Request to Amend an Approved Protocol (RAAP): Use this form to modify an approved protocol. Any changes to an approved protocol must be reviewed and approved by the IRB prior
to implementation.
Request to Amend an Exemption (RAE): Use this form to make changes to exempt research. Any changes to exempt research must be reviewed and approved by the IRB prior to
implementation.
Request to Renew a Protocol (RRP): This form is used to renew approval annually for any research involving human subjects
ruled non-exempt by the IRB. This form and the appropriate attachments need to be
submitted no less than 30 days prior to the approval expiration date listed on your approval letter. If IRB approval is
allowed to expire, the researcher must STOP research activity on the expired protocol until IRB approval is secured.
Secondary Analysis of Existing Data (SAED): Use this form when conducting research using data that has already been collected by someone else or another entity.
Adverse Events Form (AEF): Investigators are required to inform the IRB of any adverse events experienced by
human subjects in relation to the research project within ten (10) calendar days of
the event.
Human Subjects Research Completion Form (COMP): This form is used by Principal Investigators to notify the IRB that their research
project has been completed. Both exempt and non-exempt research projects require that
this form be submitted once all data collection and data analysis is finished.
Templates
Assent template: use this form when research involves children ages 7 – 17.
Consent template: use this form to gain consent from for adult research participants.
Parental Consent template: use this to gain parental consent when research involves children under the age of
eighteen.
Interview Consent form: use this form when interviewing research participants.
Exemption Request – Reviewer Checklist: This form is used by the IRB Administrator to determine if your protocol qualifies
as exempt research.
Sample Recruitment Flyer: Word Document or PDF
Waivers
Request for Waiver of Written Documentation of the Consent Process: The purpose of this form is to provide support for IRB members when reviewing research
involving the waiver of written documentation of the consent process. This form must
be used to request a waiver of written documentation of consent. Based on federal
regulation 45 CFR 46.117 [C].
|