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Pregnant Women, Fetuses, & Neonates
...therapy) to the point of independently maintaining heartbeat and respiration. Research Not Funded by DHHS If the IRB finds that the research presents a reasonable opportunity to further the understanding,... -
Prisoners
...prisoners have any real choice in participation in research, or whether incarceration prohibits free choice. The following applies to all research involving prisoners, regardless of funding source. The requirements in... -
SEKESC-IRB Participant Information
...research. During the assent process: Parents or guardians give informed permission for their child to join the clinical research. The research team explains the research to the child in language... -
Children
...IRB determines that the research falls in this category, the research will be sent to the IRB Chair for DHHS review. For non-federally-funded research, IRB will consult with a panel... -
Persons with Mental Disabilities or with Impaired Decision-Making Capacity
...decision-making capacity must not be subjects in research simply because they are readily available. The proposed research entails no significant risks, tangible or intangible, of if the research presents some... -
SEKESC-IRB Informed Consent
...study involves research. Explain the purpose(s) of the research. Describe the procedures to be followed and the duration of participation. Identify whether any procedures are experimental When appropriate, describe any... -
SEKESC-IRB Regulations
...Guidance – The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by HHS.... -
SEKESC-IRB Review Processes
...research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), research equipment form, tests, surveys,... -
Governing Principles
...be fully protected, both during and after the conduct of a research activity within IAW. Requests by any human research subject for withdrawal from a research activity will be honored... -
Activity Preparatory to Research & Decedents
...a research protocol or for similar purposes preparatory to research; No PHI is to be removed from the covered entity by the researcher; and The information being sought is necessary...