Investigator Action: No action: The study does not involve identifiable private information or identifiable biospecimens No action: The consent form already contains the necessary language Modify consent form to state that de-identified information or biospecimens could be used for future research without additional informed Modify consent form to state that the information or biospecimens will not be used or distributed for future research even if identifiers are removed, ensure consistency with OSIRIS 5.8 or PittPRO Data and Specimens (if this option is chosen, no data or specimens from the study can be shared, even if Commercialization Regulation 46.116 (c)(7): If applicable, include a statement that identified or de-identified biospecimens may be used for commercial profit and whether the subject will share in the profit or not Investigator Action: No action: The study does not involve identifiable or de-identified biospecimens No action: The consent form already contains the necessary language Modify consent form to state whether or not a subject will share in commercial profit Clinically Relevant Research Results Regulation 46.116(c)(8): if applicable, include a statement whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions Investigator Action: No action: The study does not involve clinical procedures No action: The consent form already contains the necessary language Modify consent form to state whether or not the results will be disclosed and under what circumstances, consistent with OSIRIS or PittPRO Whole Genome Sequencing Regulation 46.116(c)(9): if applicable, for research involving biospecimens, include a statement that the research will or might include whole genome sequencing Investigator Action: No action: The study does not involve identifiable or de-identified biospecimens
Investigator Action: No action: The study does not involve identifiable private information or identifiable biospecimens No action: The consent form already contains the necessary language Modify consent form to state that de-identified information or biospecimens could be used for future research without additional informed Modify consent form to state that the information or biospecimens will not be used or distributed for future research even if identifiers are removed, ensure consistency with OSIRIS 5.8 or PittPRO Data and Specimens (if this option is chosen, no data or specimens from the study can be shared, even if Commercialization Regulation 46.116 (c)(7): If applicable, include a statement that identified or de-identified biospecimens may be used for commercial profit and whether the subject will share in the profit or not Investigator Action: No action: The study does not involve identifiable or de-identified biospecimens No action: The consent form already contains the necessary language Modify consent form to state whether or not a subject will share in commercial profit Clinically Relevant Research Results Regulation 46.116(c)(8): if applicable, include a statement whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions Investigator Action: No action: The study does not involve clinical procedures No action: The consent form already contains the necessary language Modify consent form to state whether or not the results will be disclosed and under what circumstances, consistent with OSIRIS or PittPRO Whole Genome Sequencing Regulation 46.116(c)(9): if applicable, for research involving biospecimens, include a statement that the research will or might include whole genome sequencing Investigator Action: No action: The study does not involve identifiable or de-identified biospecimens