Informed Consent Document and Process Policy Updates

IRB Policy 15.1, which provides the required elements for the informed consent document, has been updated.  http://www.uams.edu/irb/15%201%20June%207%202007.pdf

IRB Policy 15.1 previously addressed adding a separate note to file regarding the consent process.  These requirements are now addressed in IRB Policy 15.5.   http://www.uams.edu/irb/Policy%2015%205%20-%20Documentation%20of%20Informed%20Consent_4_5_2007.pdf

Key updates to 15.1 include:

1.  New requirements for standard confidentiality statement regarding institutional offices

 Rationale:  As the IRB of record for institutions listed in its assurance, the IRB recognized that oversight offices at these institutions need limited access to study records for financial, compliance or other legitimate reasons. 

New Clause Elements:  In addition to the UAMS Institutional Review Board and the Office for Human Research Protections, all consent forms must now reference “other institutional oversight offices” in the confidentiality statement.  As before, you must also list any funding source or sponsor who may access the records, and the FDA if the study is subject to FDA oversight.

2. New requirements for standard confidentiality statement regarding mandated reporting

 Rationale:  The IRB was aware that many, if not most, researchers are mandated reporters for child abuse and other harmful behaviors under the law.  

 New Clause required if any member of the study team is a mandated reporter:  “By law, the study team must release certain information to the appropriate authorities if at any time during the study there is concern that:

●       child abuse or elder abuse has possibly occurred or 

●       you disclose a desire to harm yourself or others.”

3.  Revised injury clause

 Rationale:  An attempt has been made to address the differences between institution and sponsor requirements and simplify the language.  There are now three clause options. One is for studies at the VA.  One, what will basically become our standard clause, is for non-VA studies where the sponsor has not offered any compensation for injury.  Then, there is one for non-VA studies where a sponsor has offered some form of compensation for injury. When using this clause, you simply add any sponsor specific language to the end of the standard clause.   

For details see page 3 and 4 of IRB Policy 15.1 at:  http://www.uams.edu/irb/15%201%20June%207%202007.pdf

4.  Revised last paragraph

 Rationale:  During some of training courses, various concerns with the previous language had been expressed. This new paragraph is an attempt to address those concerns.

         Last paragraph must now read:  “The purpose and voluntary nature of this study, as well as the potential benefits and risks that are involved have been explained to me. I have been able to ask questions and express concerns, which have been satisfactorily responded to by the study team. I have been told that I will be given a copy of this consent form.”

 All new studies and any future consent form updates should use the new language provided in IRB Policy 15.1.

IRB policies can be found at:  http://www.uams.edu/irb/IRB_Policies.asp

 

IRB Policy 15.1 was revised effective April 5, 2007.  In this revised policy which can be found on the IRB web site are three options for injury to the participant statements.  Options 1 and 2 are for non-VA studies and Option 3 applies only to VA studies.  The IRB requires that one of these options be used in the consent form that will be used as part of a study.  Link to the IRB web site Policy 15 is as follows:

http://www.uams.edu/irb/15%201%20June%207%202007.pdf

 

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