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Change in Alabama Law Regarding Age of Consent to Participate in Research

In May 2015, Governor Robert Bentley signed into law Act 2015-167, which lowered the age of consent to participate in research (“age of majority”) to 18 years old for IRB-approved research conducted by a federally accredited college or university. Therefore, parental permission is no longer required for 18-year-olds who may now provide their own consent to participate in IRB-approved research conducted at UA.

Accordingly, the UA IRB has updated its relevant policies, guidance, and forms (see table below). The revised IRB documents must be used for all IRB submissions (new, modification, and continuing review/renewal) received within the Office for Research Compliance beginning July 17, 2015.

New Protocols:
Beginning immediately, new protocols submitted to the IRB may reflect this change.

Currently Approved Protocols:
Please note that no changes to currently approved protocols regarding the revised age of majority may be initiated without prior IRB review and approval. The currently approved protocol, including age criteria and consent/assent procedures, must continue to be followed until any changes are approved by the UA IRB.

You may update your currently approved protocol as follows:

  • At any time via a modification request or
  • At the time of continuing review/renewal.

Within your modification or continuing review application, please request one of the following options as applicable to your study:

  • This protocol is currently approved for participants ages 19 and older, and I would like to revise this to include participants ages 18 and older.
  • This protocol is currently approved for participants ages 18 and older. With the change in state law, parental permission (or waiver of parental permission) and the Application for Research involving Children are no longer applicable, and I am retracting these from the protocol.
  • This protocol is currently approved for participants above and below age 18. This protocol will continue to enroll children; therefore, parental permission (or waiver of parental permission) and the Application for Research involving Children are still applicable for minors. However, protocol documents (e.g., consent, assent) are being revised to reflect that 18-year-old participants may consent for themselves per the change in state law.

 

Revised IRB Documents - July 2015
Form Notification to IRB of Emergency Use of a Test Article (Word) (PDF)
Form Request for Waiver/Alteration of Informed Consent (Word) (PDF)
Form Application for Research involving Children (Word) (PDF)
Form Applications for Research involving Pregnant Women, Human Fetuses, and/or Neonates (Word) (PDF)
Form Application for Research involving Children with Cognitively Impaired Persons (Word) (PDF)
Guidance Alabama Law on Children, Minors, Consent, and Other Research-Related Topics (Word) (PDF)
Guidance Informed Consent (Word) (PDF)
Guidance Template - Informed Consent for a Medical or Health-Related Research Study (Word) (PDF)
Guidance Template - Informed Consent for a Non-Medical Study (Word) (PDF)
Guidance Template for Study Presentation for Web Surveys (Word) (PDF)
Policy Conflict of Interest for IRB Members, Chairs, and Consultants (Word) (PDF)
Policy Research involving the Internet (Word) (PDF)
Policy Waivers, Alterations, and Exceptions to Informed Consent or Its Written Documentation (Word) (PDF)
Policy Protection of Children in Research (Word) (PDF)
Policy Student Research Pools (Word) (PDF)

 

 

 

 

 

 
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