Collecting data in classroom situations (DOC)- the possibility of coercion when a teacher 'studies' his/her own students
Policy on Research in International Settings (DOC) - considerations for investigators when conducting research abroad.
Additional resources for international human studies, compiled 28 Nov 2010 from the IRB list-serve:
- OHRP’s "International Compilation of Human Research Protections" ver. 2013, http://www.hhs.gov/ohrp/international/intlcompilation/intlcomp2013.pdf.pdf
- Rozovsky & Adams's “Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance” is useful; not comprehensive; includes listings of US state law differences
State of California memo on personal info in research (PDF) - This PDF comes from the State administrative manual (MM-08-09) and addresses the subject of "requests for and approval to release personal information for research." It applies to academic researchers who use personal information held in governmental databases and therefore must be protected through the state human subjects protection committee.
Adverse Event Form (DOC) - Sometimes things in research just don't go as planned. In some cases, such as when not recruiting enough subjects or having to change an aspect of the methods, a simple protocol amendment will suffice. To address that, see "Renewals and changes to methods” in the “Hints, help, and examples” section of the IRB website.
At other times, researchers may encounter "adverse events" and unanticipated problems. Taken from OHRP, an adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom or disease temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Adverse events encompass both physical and psychological harms.
Unanticipated problems include any incident, experience, or outcome that meets all of the following criteria:
- Unexpected (in terms of nature, severity or frequency) given a) the research procedures that are described in the protocol related documents, such as the IRB-approved research protocol and informed consent document; and b) the characteristics of the subject population being studied;
- Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience or outcome may have been caused by the procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Potential examples that relate to the typical kinds of research conducted at Cal Poly Pomona include (but are not limited to): an accident on the treadmill, a loss of datasheets with personally identifiable information, an emotional breakdown during a psychological interview, sickness following a food taste study, or a parent questioning the assent process of her child in an education project. And neither are all adverse events directed at the subject; for example, a vial of blood that breaks poses a bio-hazard to others. As a PI (principal investigator), one needs to think about the risks (the what-ifs) associated with the proposed research when writing the protocol; however, it is recognized that not everything is predictable.
According to federal regulation, it is the PI's responsibility to report adverse events of any kind to the IRB. Click this link to obtain the adverse event documentation form (DOC). Reporting adverse events promptly will enable the IRB and university research community to respond appropriately, to help the researchers continue their work, and to protect human volunteers in research investigations from avoidable harms. The criteria of how unexpected, how related, and how serious the event was will be evaluated and may necessitate a fresh look at the risk/benefit ratio and possibly a revision to the informed consent process.
Confidentiality and conflict of interest - The IRB established a guideline to address these issues for itself. It was approved in March 2011. A copy can be obtained here (DOC).