Informed consent assures that prospective human participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate
Are there different ways that I can obtain informed consent?
The long form (STRONGLY RECOMMENDED)
The short form with oral presentation
What information needs to be in the informed consent form?
(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) a description of any reasonably foreseeable risks or discomforts to the participant;
(3) a description of any benefits to the participant or to others which may reasonably be expected from the research;
(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
(5) a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
(6) for research involving more than minimal risk, an explanation as to whether any compensation will be made and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) an explanation of whom to contact for answers to pertinent questions about the research and research participants' rights (Eric Allen , Director of Office of Research Compliance, 256-1482); and
(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Do I have to get the informed consent signed and dated?
In most cases yes the informed consent document has to be signed and dated
The IRB can determine if the research meets the criteria for waiving documentation (signed informed consent)
Is it possible to get a waiver of informed consent or elements of informed consent?
In most cases some form of informed consent is required
The IRB can determine if certain elements of informed consent can be waived or the entire process of obtaining informed consent
Where can I find samples of informed consent forms?
The ORC website under IRB forms
Would you like a sample approved consent form or IRB application?
Contact the IRB representative in your department to obtain a copy of one of their approved studies. If you do not haven IRB representative on the list, please contact the ORC for assistance.
Are there any additional rules for Nursing Research in conjunction with Moses Cone?
Yes, the research should be submitted to the Cone Health Nursing review committee.
PI’s should contact Anita Sherer at 336-832-7372
If I want to do research at Cone Health do I have to submit protocols to both IRB’s?
Research that is approved at UNCG as exempt or expedited does not need to be submitted to the Cone Health IRB
Research that is approved at UNCG by the full board may need to be reviewed Cone Health IRB for review
Are there any special requirements for working with medical records at Moses Cone?
Yes, the PI must contact the IRB chair at Cone Health and provide them with a research summary. The Moses Cone IRB Chair will make the necessary contacts to obtain access for the PI to the appropriate information.
Are there any additional documents required for recruiting participants or conducting research at Cone Health?
Yes, there may be additional documents to be reviewed. Please contact Jacqueline Prevett at 336-832-2330 for further information. There may be other steps you need to take.
If I conduct research in the school system do I need approval from the district or just the school in which I plan to conduct the research?
All school systems don’t follow the same rules regarding conducting research in their school. Some school systems require an independent review of the research by a research review committee similar to an IRB. While others only need the principal to review and approve the research
If both the school system and UNCG IRB need to review the protocol, who do I submit to first?
This decision is up to the investigator, however the ORC’s recommendation is that the PI submit the protocol to either UNCG or the school system for review first, but not simultaneously
If I am leaving the university and I have an open protocol, what should I do?
The PI will need to complete a Closure formand submit it to the IRB. If leaving the university to work or attend another institution, then the PI/Student will need to seek approval for that study at the new institution since UNCG will no longer be responsible for the protocol