w88 slot online Common Rule requirements for informed consent
The federal regulations for the protection of human subjects (Common Rule) were w88 slot online effective January 20, 2019 to reduce administrative burdens for low-risk research while enhancing protections for research participants. These enhanced protections involved changes to the consent process.
The informed consent requirements introduced via the w88 slot online Common Rule are listed below. These requirements apply to the following types of studies reviewed by the UNR IRB:
- Greater than minimal risk w88 slot online
- w88 slot online conducted or supported by a federal agency
- w88 slot online involving prisoners or incomplete disclosure or deception
w88 slot online Common Rule requirements for informed consent (45 CFR 46.116)
General w88 slot online
w88 slot online Standard
The subject or their legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an w88 slot online decision about whether to participate, and opportunity to discuss that information
Key w88 slot online
w88 slot online consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might now want to participate in the research. This part must be organized in a way that facilitates comprehension.
Basic Element of w88 slot online
Include one of the following statements if the w88 slot online involves collection of identifiable private information or identifiable biospecimens:
- The identifiable private information or identifiable biospecimens may be used for future research or distributed to other researchers without further w88 slot online after identifiers have been removed
OR - Information or biospecimens will NOT be used for future w88 slot online even if identifiers are removed
Additional Elements of w88 slot online (required if applicable)
- A statement that the subject’s w88 slot online (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
- A statement regarding whether clinically relevant w88 slot online results, including individual w88 slot online results, will be disclosed to subjects, and if so, under what conditions; and
- For w88 slot online involving biospecimens, whether the w88 slot online will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).