Copies of all consent form versions used to collect the samples/data to be shared (or the draft consent form, for a new study).The IRB needs five things as part of a request for Institutional Certification: If the study was NIH funded, did the informed consent align with the NIH policy in place at the time the data or samples were collected?.If consent is waived, does the sharing align with the Belmont Principles and human subjects regulations? This may depend on what identifiers are involved.Ethical: whether subjects would reasonably understand that their data might be shared in this manner, based on the informed consent form/discussion, and whether it is appropriate given the study population's beliefs, attitudes, and laws.The IRB weighs in on whether the data sharing plan is ethical, and if it complies with any applicable policies and regualtions. What and how does the Emory IRB review for my request? The NCI has an excellent web site explaning the policy: Click Here Only large-scale genomic analyses falls under the policy - as defined by the NIH. A specific Institutional Certification is required for these plans. Note: Genomic Data Sharingis a subset of data sharing that falls under a special NIH policy (the 'Genomic Data Sharing' policy). This is a form stating that not enough information is available, but that the ultimate consent form and protocol will comply with the NIH policy. Provisional Certification is an option when the information below is not yet available (e.g.Thus, information must be provided to the IRB for us to review.OSP will want confirmation of compliance from Emory IRB, however, before signing.OSPВ should sign all forms - NIH requires that they be signed by an 'institutional signatory.' IRB does not have that authorization.The NIH requested an 'Institutional certification' to share my study data in a repository, and/or to approve my grant proposal's data sharing plan.

Nih certification