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In This Section Texas Health Research & Education Institute
Institutional Review Board

Online Resources


Texas Health Resources Links


Submission Review Tool for PIs and Study Staff
Please note that the Research Compliance Office/IRB Staff has developed a submission review tool.  This tool was created to assist Principal Investigators and Study Staff with assessing and addressing study related information prior to sending submissions to the Texas Health Resources IRB. The primary goal of this tool is to assist with accelerating the time it takes for a Principal Investigator to receive IRB final approval of a submission.

Texas Health Resources
This links you to the Texas Health Resources homepage.

Texas Health Research & Education Institute
This links you to the Texas Health Research & Education Institute website.

Research
This links you to the research homepage within the Texas Health Research & Education Institute website.

Clinical Trials
This links you to the clinical trials homepage within the Texas Health Research & Education Institute website.

Partnering with Texas Health Research & Education
This links you to the research development homepage within the Texas Health Research & Education website.

Texas Health Resources System Compliance
This links you to information on the System Compliance area at Texas Health Resources.

Code of Business Ethics
This links you to the Texas Health "Code of Business Ethics" handbook.

Language Access Services & Disability Support Services Toolkit
A toolkit created by Texas Health Diversity and Inclusion to show services offered, such as, language interpreters, sign language interpreters, and other translation services.


Links Outside Texas Health Resources

Food and Drug Administration
A U.S. government agency within the U.S. Department of Health and Human Service (HHS), the FDA enforces laws on the manufacturing, testing and use of drugs and medical devices.

National Institutes of Health (NIH)
A U.S. Public Health Service (PHS) entity within the DHHS, the NIH serves as the federal government's primary agency for advancing knowledge in biomedical and behavioral sciences in order to understand and treat human diseases.

Department of Health and Human Services
A U.S. government agency, the HHS was established to protect the health of the U.S. population. Its mission specifically includes the protection of all humans participating in clinical research.

Office for Human Research Protections (OHRP)
A U.S. government agency within the HHS, the OHRP helps ensure the protection of humans participating in clinical research.

Online Tutorial for Clinical Researchers
This is the Web-based Clinical Research Training Online Course for Principal Investigators that addresses one of the essential standards (training and education) approved by the NIH for performing clinical research in the Intramural Research Program. All NIH intramural clinical principal investigators are required to take the course and successfully complete a final exam.

National Library of Medicine
The National Library of Medicine is the world's largest medical library. It collects materials and provides information and research services in all areas of biomedicine and health care.

IRB Guidebook
Released by the OHRP, this guidebook provides a basic understanding of the background and purposes of the IRB review system.

Human Subject Protections
This is the OHRP Web site dedicated to issues related to Human Subject Protections. It includes topics such as compliance issues, vulnerable subjects' issues and international issues.

Guidance for IRBs, Clinical Investigators, and Sponsors
This is an FDA Web site dedicated to guiding investigators and sponsors in issues related to subjects such as recruitment, charging for investigational products and informed consent.

Good Clinical Practice
This is an FDA Web site dedicated to helping investigators, sponsors, and contract research organizations that conduct clinical studies on investigational new drugs comply with U.S. law and regulations covering good clinical practice.

Center for Drug Evaluation and Research (CDER) Drug Information
This is an FDA Web site dedicated to the evaluation and research of information related to all FDA-regulated drugs.

MEDWATCH Safety Information and Adverse Event Reporting Program
This is an FDA Web site used to find clinically important safety information and report serious problems with human medical products.

Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention, a division of HHS, provides expertise, information and tools for people and communities to protect their health.

Epidemiology Program Office
This is a program within the CDC that serves to strengthen the public health system by coordinating public health surveillance and providing domestic and international support through scientific communications, statistical and epidemiological consultation, and training of experts in surveillance, epidemiology, applied public health and prevention effectiveness.

Harvard School of Public Health: Global Research Ethics Map 
Links to human subjects laws, guidelines and procedures in foreign countries.

International Compilation of Human Subject Protections (2012 edition)
Prepared by OHRP and lists laws, regulations, and guidelines on human subject protections from 92 countries.

Office of Behavioral and Social Sciences Research
The Office of Behavioral and Social Sciences Research, a part of the National Institutes of Health (NIH), stimulates behavioral and social sciences research throughout NIH. It also integrates these areas of research into other areas of the NIH health research enterprise, thereby improving our understanding, treatment and prevention of behavioral and social science diseases.

The Belmont Report
The Belmont Report was created as a result of the 40-year U.S. Public Health Service Syphilis Study at Tuskegee, in which syphilis subjects were denied treatment for their disease. This legislation, which was passed in 1974, created regulations to protect human subjects and created a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to examine ethical issues related to human subject research.



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