What Every Researcher Needs to Know

Before Beginning

Requirements

In order to ensure that adequate protections are in place for human subjects involved in research, the IRB requires that the researcher demonstrate he or she has the necessary resources to conduct a proposed study. This includes but is not limited to the following:

Staff

Research staff must be of sufficient number and appropriate expertise to carry out the proposed study

Research staff must have completed appropriate training in human subjects’ protection.  Information on training options is available on the IRB’s Web site at http://www.research.umn.edu/irb/training

Costs

An explanation of funding support for the proposed study should be provided. In the absence of external funding, the researcher must describe how research costs will be covered.

Resources

For certain types of studies, the proximity or availability of additional resources should be described. For example, the proximity of emergency equipment for cardiac care should be described for a study involving treadmill testing. For studies that may involve the potential for subjects to experience psychological or emotional distress, the availability of psychological support in the form of counseling resources or referrals should be described.

Training

If the research is to be conducted by a student, the student’s academic advisor must demonstrate how the scope of the proposed project is appropriate to student research as well as what experience, training or special preparation the student has had that are relevant to the study being proposed. Research conducted outside the U.S. by University of Minnesota researchers falls under University purview and guidelines.

Researchers must describe their qualifications (in the form of relevant coursework, past experience or training) to justify their ability to conduct international research. They must be able to describe the cultural context of the country in which their research will take place with regard to the concepts of research autonomy, consent and recruitment and what subsequent cultural sensitivities will be required. Researchers must describe their knowledge of local community attitudes towards research as well as their knowledge of the native language of the subject population if different from their own.