The Task Force sought research ethics approval from the College of Nursing the Ethics Committee and developed informed consent procedures and forms.
To meet U.S. Food and Drug Administration requirements for the use of nonlicensed tests in these laboratories, CDC developed informed-consent documents and informational materials that clinicians used when collecting specimens for SAR-CoV testing from their patients.
A challenge for researchers employing these technologies is to develop appropriate informed consent [ 1, 2], given the enormous amount of information generated for each research participant, and the wide range of medically-relevant genetic results.
These data were used to develop the informed consent process, establish HIV incidence rates in the proposed study sites, and assess HIV risk factors and their desired dosing strategies.
With the Health Insurance Portability and accountability (HIPAA) regulations in the United States, the responsibility somehow lies with the hospital and their legal department to develop an informed consent document for publication in medical journal [ 4].
At the University of Cincinnati in Ohio, neonatologists are developing two informed consent documents—one that meets the legal requirements, the other a much shorter booklet that explains the goals and potential risks of the study in plainer language, with a multiple choice test at the end to make sure trial parents have understood it.
We have developed an informed consent process and document for clinical WES in the pediatric oncology clinic that utilize a dedicated informed consent team with specific genomics training and experience and rely upon active communication with the patient's clinical team regarding the clinical status of the patient and the emotional status of the family.
The commission also offers recommendations for an ongoing revamp of the Common Rule, including: developing simple, standard informed consent forms; allowing multi-site studies to go through a central ethics review; and easing review requirements for studies that pose minimal risk.
An empirical literature has developed around the informed consent process that raises concern about what participants understand or remember about the consent process [ 16].
Investigators have a responsibility to identify additional risks associated with genetic research participation for stigmatized individuals or groups when developing approaches for informed consent, and should also use culturally appropriate strategies to protect marginalized groups [ 43, 44].
