Human Research Protection
We are committed to the protection of the human subjects who participate in our research studies. At minimum, all subjects must be given proper informed consent before they participate in any study, and they must be assured of the confidentiality of the data they provide. Studies that involve vulnerable populations or collect sensitive information must include additional protections.
We hold an assurance with the federal Office for Human Research Protections (OHRP) that allows us to review all research involving human subjects through our own Institutional Review Boards (IRBs). The IRBs review each protocol, before any human subjects are contacted or any information about human subjects is accessed, to ensure that appropriate human subjects protections are incorporated into the study procedures.
We conduct an enormous amount of research in a wide variety of technical areas. We have three in-house IRBs, both to ensure that the committee members have the proper expertise to review each study protocol and to facilitate rapid review of protocols. Having three IRBs that meet at different times during the month allows each project leader ample opportunity to obtain the required review before involving human subjects. The membership of each IRB includes both scientific and nonscientific members, and RTI staff as well as unaffiliated members. Two of the IRBs include members who are MDs. Studies that involve medical procedures, drugs, or devices can be reviewed by either of these two committees.
Our research staff also have experience working with research hospitals and other clinical institutions, supporting their IRB submissions and interacting with their IRBs.
Basic Training for Field Interviewers and Others with Limited Involvement in Human Subjects Research
A basic online training tutorial is available for field interviewers, record abstractors, data entry clerks, laboratory personnel, and other individuals with only limited involvement in Human Subjects Research. The tutorial presents basic topics related to human subjects protection and ethics in research, including the history of research with humans, informed consent, privacy, and confidentiality. Trainees will have the option of printing a certificate of completion at the conclusion of the module. A more comprehensive (CD-based) training is required of RTI researchers who have extensive involvement in Human Subjects Research. [Note: RTI staff should contact Teresa Cote in the Office of Research Protection and Ethics to request this CD.]
Maintaining Records of Basic Training Completions
Maintaining records of completion of the basic training by project or unit staff is the responsibility of the RTI project team leaders or managers and not that of the Office of Research Protection and Ethics. To facilitate your training records maintenance, please instruct interviewers and all other staff that you want to complete the basic training to enter a project-specific training code in the Training Code field at the conclusion of the online module. The training code can be one of the following: RTI project number, RTI-unit abbreviation, or international country work location. [Personal identifiers such as employee ID numbers, birthdates, or social security numbers should not be entered because this information is available to anyone who can access the rti.org web site]. You should also instruct each trainee to print their own completion certificate as a hard copy record. The only opportunity to print a certificate will be at the conclusion of the tutorial.