Manual of Procedures
This Manual of Procedures (MOP) describes the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network structure; operating policies; roles and responsibilities of entities and individuals within the IMPAACT Network; protocol development and approval processes; site selection; process; standardized study operations procedures; data and specimen collection and processing procedures; and quality management, monitoring and evaluation of trials conducted by IMPAACT. See it here.
NIAID HIV Language Guide (March 2020)
The National Institute of Allergy and Infectious Diseases (NIAID), in collaboration with other reviewers, has developed an HIV language guide to encourage the use of affirming and non-stigmatizing language. Read it here.
Representative Studies Rubric (last update: March 2022)
Building on the work of the HANC Legacy Project, HANC has designed a tool, the Representative Studies Rubric (RSR), to guide and monitor enhanced representation in clinical research. The RSR assesses individual studies for the extent to which they are designed to include or exclude underrepresented populations. the RSR consists of a twelve-item questionnaire that examines the representative of study populations in terms of age, ethnicity, gender, injection drug use, pregnancy, race, and sex assigned at birth.
The RSR is also designed to identify erroneous and inappropriate language used in protocols, as language itself can exclude or otherwise impede the participation of underrepresented populations. See the guidance and rubric here.
Get access to IMPAACT publications from 1986 to the present.
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Regulatory and Human Subject Protection Resources
Specimen Repository Search Tool and Proposal Submission Process
Investigators are encouraged to take advantage of the large inventory of biological specimens in the IMPAACT and ACTG repositories for new investigations. The specimens stored at the repositories were initially collected for specific HIV-related studies that have concluded and are now publicly available for use. To increase investigator access to these specimens, an interactive search tool is available at the following website: http://www.specimenrepository.org/RepositorySite/home.html. Here, investigators can learn about the types and numbers of specimens available, information about the studies for which they were collected, and what research was published for those studies. The search tool will also provide a report that lists your specimens of interest. You can then use this report to help write your research proposal to the network.
Investigations using biological specimens from completed IMPAACT studies should be proposed via a New Works Concept Sheet (NWCS), which is accessible here: New Works Concept Sheet (NWCS). Completed NWCSs should be submitted to the IMPAACT Operations Center for review by the IMPAACT network using this email address: firstname.lastname@example.org.
More information on the NWCS submission and review processes is available in Section 15 of the network Manual of Procedures here.
Media Release Form
Complete the electronic Media Release Form here.