Human Subject Protection Resources
HPTN Protection of Human Subjects Assurance Identification/Certification/Declaration Form (See attachment)
Must be completed annually
Research Ethics Curriculum
A curriculum developed for international researchers conducting research that includes human participants and want to incorporate fundamental ethical considerations in the design and implementation of their research.
Community Research Resources
Research Literacy: Understanding Clinical Trials & Training
A basic understanding of clinical trial concepts and practices is necessary for meaningful community input into research study design and implementation. The more communities understand about the purpose and limitations of research in their communities, the more they will be able to take ownership of the process. Research literate community members can contribute early and directly to protocol development, informed consent, and other study-specific materials and decisions. User-friendly approaches and methods are essential in order to make the science accessible to community members.
- ClinicalTrials.gov provides valuable information on what clinical trials are and answers too many frequently asked questions about aspects of participating in clinical trials.
- Be the Generation HIV Prevention Research (HPR) Training Module is a collaboration of the Legacy Project, FHI 360, HPTN, HVTN, and MTN, provides recent prevention research findings in a curriculum designed to increase scientific literacy of the communities most disproportionately impacted by HIV.
- Basic Scientific Literacy (BSL) Training Module is designed for participants with little knowledge of basic science and research and can be used as a refresher with more knowledgeable participants.is intended to provide information for community members and service and community based organization staff members funded by the Division of AIDS of the US National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health.
Research ethics involves the application of fundamental ethical principles to a variety of topics involving scientific research. These include the design and implementation of research involving human experimentation, animal experimentation, scientific misconduct (such as fraud, fabrication of data and plagiarism) and regulation of research.
Research ethics training has been identified as a key training needed by community educators, CAB members, and community partners, who act as voices for the communities in which the research is being conducted. Community representatives need information on ethical research practices and guidance on their roles and responsibilities in the research process.
- The Research Ethics Training Curriculum for Community Representatives was developed by FHI 360's Office of International Research Ethics specifically to empower community representatives through training and education to act as competent voices for research participants worldwide. The curriculum helps community representatives to understand the research process and their roles and responsibilities as partners of the research team. It also addresses universal principles of research ethics, informed consent, ethics committees and other important issues.
Stigma and Discrimination
Stigma, the disapproval of personal characteristics or beliefs, remains a significant challenge for community educators working in HIV prevention research, given that HIV prevention study communities are often characterized by multiple vulnerabilities. Merely associating with a research project, including participation on a community advisory board(CAB), can result in stigma and/or discrimination. It is important for community educators and advisory board members to recognize and report research-related stigma and social harms to the research team.
- Understanding and Challenging HIV Stigma: Tooklit for Action was designed for nongovernmental organizations (NGO), community groups and HIV educators to raise awareness and promote actions to challenge HIV stigma and discrimination. Based on research in n Ethiopia, Tanzania and Zambia, the toolkit contains more than 125 exercises.
Community Engagement in HIV/AIDS Research
Community representatives working with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH increasingly believe that this type of guidance was essential and in 2009 sought to develop recommendations as a way to address good community practice. These recommendations are intended as a tool to help research staff and community representatives expand and deepen existing partnerships, and forge new ones, with the ultimate goal of facilitating effective community engagement in all aspects of clinical trials research.
- The recommendations are available in English and Spanish.
Identifying effective strategies for reaching out to men in the community, including male partners of female study participants, is a key activity in building support for HIV prevention research. A larger goal is to encourage men to support women’s health and transform social norms and traditional gender roles that place women at increased risk for HIV infection and other reproductive health problems. By involving male opinion leaders as role models, messages can be diffused through social and community networks. Other popular efforts include reaching men in workplaces, through religious institutions, and other social settings.
- Engender Health’s established its Men As Partners (MAP) program in 1996. This program works with men to play constructive roles in promoting gender equity and health in their families and communities.
DAIDS Learning Poral
- Gain access to DAIDS training resources and materials on everything from quality management to laboratory guidelines, clinical site monitoring to community advisory boards.
NIAID GCP Learning Center
- The NIAID GCP Learning Center is a computer-based classroom where courses on the subject of good clinical practices (GCP) are offered free of charge to NIAID staff, contractors and grantees. These courses cover the scientific and ethical standards of human subjects research including NIH, FDA, HHS, and international clinical trial policies, guidelines, and regulations. GCP training requirements of the NIAID clinical terms of award for grants and cooperative agreements can be fulfilled through completing these courses.
R01 Investigator Resources
- Access the R01 Investigator Resources portal to find resources for R01s, NIH's standard independent research grant.
HANC and Collaborative Institutional Training Initiative
- The HIV/AIDS Network Coordination Office (HANC) offers online Good Clinical Practice (GCP), Human Subjects Protection (HSP) and Responsible Conduct of Research (RCR) Training through the Collaborative Institutional Training Initiative (CITI). This training is available to all staff of DAIDS-sponsored clinical research and clinical trials.
FHI 360 Research Ethics Training Curriculum
- Human research ethics rest on three basic principles: respect, beneficence and justice. These principles are the foundation of all regulations or guidelines governing research ethics and transcend all geographic, cultural, economic, legal and political boundaries. Although these principles are universal, FHI 360 Research Ethics Training Curriculum provides researchers with training on the development and philosophy of ethics and how ethical principals can be applied in a practical way.