INFORMED CONSENT CHECKLIST
IC 701-A 1/9/15
Informed Consent Checklist
Investigator:
Study Title:
Federal Regulation Requirements – 50.25; 46.116
Yes No
Introduction (stating this is research) 50.25 (1); 46.116a (1)
Purpose of study 50.25 (1); 46.116a (1)
Description of study procedures (identifying any that are experimental)/Avoid unnecessary detail 50.25 (1); 46.116a (1)
Duration of subject involvement 50.25 (1); 46.116a (1)
Identification of procedures which are experimental 50.25 (1); 46.116a (1)
Potential foreseeable risks or discomforts of participation 50.25 (2); 46.116a (2)
Potential benefits of participation 50.25 (3); 46.116a (3)
Alternatives (medical treatments or other courses of action, if any) 50.25 (4); 46.116a (4)
Confidentiality of records statement / Protection of confidentiality explained “FDA must be mentioned by name for any study involving food, including dietary supplements, that bears a nutrient content claim or health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products”
Compensation for injury statement if greater than minimal risk 50.25 (6); 46.116a (6)
Contact persons (Investigator / IRB patients rights) 50.25 (7); 46.116a (7)
Statement of voluntary participation 50.25 (8); 46.116a (8)
Refusal to participate or subsequent withdrawal does not result in penalty or loss of benefit to which participant is otherwise entitled 50.25 (8); 46.116a (8)
Informed consent is free of Exculpatory language 50.20; 46.116
Copy of consent available to subject 50.27 (a); 46.117a
Questions statement (offer to answer questions now and later) 46.116a (7)
Statement about UND IRB:
If you have questions regarding your rights as a research subject, you may contact The University of North Dakota Institutional Review Board at (701) 777-4279.
· You may also call this number about any problems, complaints, or concerns you have about this research study.
· You may also call this number if you cannot reach research staff, or you wish to talk with someone who is independent of the research team.
· General information about being a research subject can be found by clicking “Information for Research Participants” on the web site: http://und.edu/research/resources/human-subjects/research-participants.cfm 46.116a (8)
If Applicable to Study
Yes No N/A
Unforeseen risks to subject (embryo) (fetus) statement 50.25 (b)(1); 46.116b
-required for medical research
-Add for non-medical research when risks of the intervention are not well known.
Reasons for involuntary termination of participation by investigator 50.25 (b)(2); 46.116b (2)
-required for medical research
Additional costs to participate (if any) 50.25 (b)(3); 46.116b (3)
-required
Consequences for withdrawal and procedures for orderly termination from the research (adverse health/welfare effects if any) 50.25 (b)(4); 46.116b (4)
-required whenever early withdrawal by participants may place them at increased risk of harm.
New findings statement (to be provided if relevant) 50.25 (b)(5); 46.116b (5)
-required for medical research
-Add for non-medical research whenever new information may be discovered during the course of the study that may affect participants’ willingness to continue in the research.
Number of subjects (if it may have an impact on the decision to participate) 50.25(b)(6); 46.116b (6)
-Required
Emergency treatment statement (for greater than minimal risk studies) 50.25 (d) 46.116f
-Required for medical research
Other Requirements
Yes No N/A
Description of who subjects will be / selection criteria
Page numbers on each page (ex: 1 of 8)
Titles match on consent form and application sheet
Clear invitation to participate
Person(s) conducting research (names, titles and affiliations)
Line for subject signature and date
Access to records statement (who will have access to records)
Explanation of methods of risk reduction
Provision made for securing the assent of the child (7-17) and the consent of the parent/guardian if children are included as subjects 46.408a
Payments (incentives and/or expense reimbursements, if any)
Lay Language (understandable) used
Behavioral/Social. Consent addresses additional counseling or support services if necessary
Biologic/Tissue Banking N/A
Yes No Statement asking the participant to “donate” their blood, tissue etc.?
Yes No Statement whether the blood, tissue etc. will be used for future use?
Yes No Statement whether the participant or doctor will be given the research results?
Yes No Statement on who retains ownership of the samples once donated?
Yes No Statement on what studies will be done on the blood or tissue that is donated?
Yes No Statement whether the blood, tissue, etc. will be sold in the future?
Yes No Statement whether the participant will be paid for donating the blood, tissue for future research?
Yes No Statement whether the participant will be penalized for deciding not to donate the blood, tissue, etc?
Yes No Statement whether the participant will donate blood, tissue, etc. for the future?
Yes No Statement about the risks of donating the tissue, blood etc.?