PSLC Project Guidelines

Requirements for Conducting a PSLC Study
Download: Human Subjects Requirements (33.79 Kb), revised 1/25/05

This document outlines the researcher's responsibilities when conducting a PSLC study. All PSLC studies involving human subjects must be approved by an internal review board (IRB). All members of the research team interacting with human subjects and/or human subject data must complete "human subject protections education" training, and all graduate and undergraduate students and post-doctoral and visiting scientists interacting with human subjects and/or human subject data must have received formal training in scientific ethics.

IRBs are needed for any project involving human subject data (Carnegie Mellon faculty, staff, and students see: http://www.cmu.edu/provost/spon-res/compliance/hs.htm, University of Pittsburgh faculty, staff, and students see: http://www.irb.pitt.edu/, and ones home institution if other than Carnegie Mellon University or the University of Pittsburgh). Human subjects training is required for any person accessing human subject data (http://cme.cancer.gov/c01/intro_01.htm, http://rpf.health.pitt.edu/rpf/index.cfm, or a comparable training from ones home institution). In general, studies are eligible for Exempt status if they are (a) of minimal risk, (2) use only anonymized data, and (3) do not have students doing any work other than their regular classroom work. The University of Pittsburgh also requires that Exempt studies fall within one of the following categories: (1) Educational strategies, curricula, or classroom management methods, (2) Tests, surveys, interviews, or observations of public behavior, (3) Existing data, documents, or records, (3) Secondary data analysis, and (4) Data coordinating and other ancillary centers. Exempt studies do not require informed consent from subjects prior to collecting data, although Pitt requires that researchers distribute an Informational Script, which is a letter to subjects describing the study and giving them an opt-out strategy if they so choose. All PSLC studies which do not qualify for Exempt status should qualify as Expedited studies (which means that they do not need Full-board review) because they should all be of minimal risk to the subjects.

Please note that the IRB review process can take up to two weeks or longer, depending on whether the board requests revisions to submitted protocols prior to approval. If a research project has already been approved by a non-CMU IRB, the CMU IRB will accept for review the already approved protocol and approval letter in place of completing the CMU IRB forms.

Prior to conducting research at the PSLC, copies of the IRB protocol and IRB approval letter from all involved institutions must be submitted to the PSLC. Certificates of completion of human subjects training by all members of the research team (anyone who will access human subjects data for the research project) must also be on file at the PSLC.

All graduate and undergraduate students and post-doctoral and visiting scientists interacting with research participants and/or data must have received formal training in scientific ethics. This training is normally provided as modules in a research methods course. For members of the research team who have not fulfilled this requirement, they may take either an approved research methods course (the relevant courses at the University of Pittsburgh are Psy0035 for undergraduates and Psy2400 for graduate students) or complete two Saturday seminars on scientific ethics that are part of the professional development seminar series conducted by Professors Michael Zigmond and Beth Fischer at the University of Pittsburgh (see http://www.survival.pitt.edu/about/history.asp). PSLC will cover the registration costs for these seminars.

Most researchers will need to seek IRB approval for their projects, however the PSLC has some broad coverage for certain LearnLabs and types of projects. The PSLC currently has IRBs to cover a broad range of studies for the ESL, French, and Chinese LearnLabs. Researchers should contact the Research Manager or Michael Bett to see whether their projects may be covered under these broad IRBs.

Requesting Funds to Pay Human Subjects (CMU)
Download: Paying Human Subjects at CMU, revised 12/6/05
This document outlines the requirements for requesting funds at CMU to pay human subjects. A Subject Payment Record is also available.

More information is available at Carnegie Mellon's IRB Site.
and University of Pittsburgh's IRB Site.
.