Resources
University Rules & Standard Administrative Procedures
Guidance
ClinicalTrials.gov
ClinicalTrials.gov is the result of a federal law requiring that clinical trials be registered to improve public access to information about clinical research, promote public trust in research, and inform future research. In some cases, registration is also required for journal publication.
REDCap
REDCap is a secure web application for building and managing online surveys and databases for research data collection. It provides a no-cost, flexible and secure method to collect data.
REDCap can be used to collect virtually any type of data, including 21 CFR Part 11, FISMA and HIPAA-compliant environments. It is specifically geared to support online or offline data capture for research studies and operations.
Contact the Health Technology Care Team for further assistance with REDCap.
The login page includes an overview of REDCap’s research-centric surveying features.
to obtain access to REDCap.
to manage administrative users’ access to your REDCap projects.
for REDCap to learn how to build a project, use features and modules, choose a project type and implement special features.
Research Ethics
Information about the ethical codes that serve as the foundation for the conduct of research with human participants may be found here:
Regulatory Agencies
Many federal agencies have specific regulations or requirements with regard to research with human participants.
Food and Drug Administration – (FDA)
- Clinical Trials and Human Subject Protection
- Regulations Relating to Good Clinical Practice and Clinical Trials
Office for Human Research Protections – (OHRP)
- International Compilation of Human Subject Research Protections (OHRP)
- Code of Federal Regulation Title 45 CFR Part 46
- OHRP FAQs related to:
- DHHS Educational Videos
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
National Institutes of Health – (NIH)
- NIH’s Definition of Clinical Trial (Background, Definition, Case Studies, FAQs & Decision Tree)
- New Human Subjects and Clinical Trial Form
- Video: How to View, Edit, and Submit Human Subjects Studies through the Human Subject System
- Video: A Walk-through of the PHS Human Subjects & Clinical Trails Information Form
- NIH policies, regulations, training and resources on Human Subjects Research
- Funding Opportunity Announcement (FOA):
- NIH Policy and related guidance for Data and Safety Monitoring (this link provides general and NIH Institute and Center-specific guidance)
- NIH Certificates of Confidentiality Kiosk
National Science Foundation – (NSF)
Department of Defense (DoD)
International Research
Conducting Research outside of the U.S. (general guidelines on over 100 countries)
Conducting Human Research in QATAR
Human Research conducted in Qatar must be reviewed by a Qatari IRB. For more information please contact Texas A&M HRPP or Texas A&M, Qatar to guide you through the process.
IRB Review Board Process for Texas A&M University-Qatar Investigators
Qatar Supreme Council of Health guidelines, regulations and policies