Ohsrp.nih.gov

Home [ohsrp.nih.gov]

WebFind your IRB Team's contact information here. Call the IRB Directly: 301-402-3713. Send us an Email: [email protected]. Visit our Getting Started Page and our …

Actived: 2 days ago

URL: https://ohsrp.nih.gov/

Secondary Research

WebSecondary research is considered human subjects research that requires IRB review when the specimens/data are identifiable to the researchers and were collected for another …

Category: Health Go Health

Common Rule Bulletin 4

WebThe revised Common Rule (rCR), referred to as the “2018 requirements” or sometimes as “the Final Rule”, contains several new provisions that take effect for all new research …

Category: Health Go Health

Exemptions from IRB Review and the Revised Common Rule: …

WebIt was published in 1991. “The Common Rule” was recently revised with an effective date of June 19, 2018 and a compliance date of January 21, 2019. It applies to …

Category: Health Go Health

Common Rule Bulletin 1

WebThe revised Common Rule (rCR), referred to as the “2018 requirements” or sometimes as “the Final Rule”, contains several new provisions that take effect for all new protocols …

Category: Health Go Health

AAHRPP Activities

WebIn addition, and they will assist us with the assessment of QAQI activities in the ICs. The remainder of the AAHRPP data collection will start in January 2020 from the …

Category: Health Go Health

IRB Handbook for Investigators, Institutions, Sponsors, and …

WebIRB Handbook for Investigators, Institutions, Sponsors, and Sponsors’ Representatives Handbook Version 5 (September 2021) 6100 Merriweather Dr. | Suite 600 | Columbia, …

Category: Health Go Health

Benefits in research: How should we think about and …

WebBIOETHICS AT THE NIH. Benefits. Objectives for this session: 1. Describe regulatory guidance regarding benefits 2. Distinguish different types of benefits

Category: Health Go Health

Consent Templates and Guidance

WebGetting your Consent Form (ICF) Approved Quickly. To create clear, simple consent documents: Follow the instructions in the NIH IRB's template; Adhere to the …

Category: Health Go Health

Guidance about Natural History Studies

WebNatural history studies are important avenues of investigation that can increase our understanding of disease and lead to important diagnostic and therapeutic advances. …

Category: Health Go Health

IRB Tip Sheet: Inclusion of Pregnant Subjects in Clinical Research

WebPregnant Subjects or Fetuses. Inclusion approved under 45 CFR 46.204: Research involving pregnant women or fetuses. Conditions that must be meet for the approval of …

Category: Health Go Health

Determining Whether Your Project Meets the Definition of …

WebAn activity that is methodologically driven. Involves a prospective plan. Has a hypothesis. Data or information is collected in an organized and consistent way. The …

Category: Health Go Health

IRB Handbook for Investigators, Institutions, Sponsors, and …

Category: Health Go Health

Quality Management in Clinical Research

WebSection 1.46 Quality Assurance (QA) All those planned and systematic actions that are established to ensure that the trial is performed, and the data are …

Category: Health Go Health

Important Changes to Informed Consent: The Regs, the …

Web46.116(h) continued: 3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last …

Category: Health Go Health