The IRB Office is posting today a new version of its research plan. The two changes are in response to discussions in the IRB meetings. Question 4.b.15 (a) and (b) aim to elicit more information about the accuracy and reliability of diagnostic tests. Question 8.b. seeks more detail about the anticipated frequency and severity of risks of harm to participants or others posed by study procedures.The IRB Office is posting today a new Dari translation of the JHSPH HUMAN SUBJECTS RESEARCH ETHICS FIELD TRAINING GUIDE, provided by Linda Bartlett of International Health and the staff of the RAMOS II project in the JHSPH Kabul office.
Investigators who involve Maryland children in their studies must obtain legally effective informed consent from their parent or legal guardian. “Guardianship” status varies from custodianship (child lives with the adult) to full legal adoption. Children in a guardianship situation short of full legal adoption are in the State foster care system, and the State must approve their inclusion in research studies. The IRB is posting a Guidance explaining how to seek that approval, called “Enrolling Maryland Foster Care Children in Research”, and the State-required application form called, “Department of Human Resources Social Services Administration Child Welfare and Policy: Inclusion of Foster Children in Human Subjects Research or Research-related activities.” Please contact the IRB Director if you have any questions.
The FDA has added a new requirement to informed consent documents for clinical trials. By March 7, 2012, the informed consent document for a clinical trial subject to FDA regulation must contain the new agency-supplied statement about the clinical trial registry databank. The statement reads in part: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. Law.” We have modified the JHSPH IRB instructional consent form template to include this language, and encourage all investigators who conduct studies subject to FDA regulation to modify their consent documents to include this required statement.