require an appropriate monitoring procedure that could include monitoring of the consent process, observation of the research procedures, formulation of a data and safety monitoring plan, and review of research related records.

Reasons for requiring IRB review more frequently than annually may include but are not limited to: securing the confidentiality of sensitive information, monitoring the safety of subjects, and ensuring participants are free from undue influence or coercion.

Surveys, questionnaires, focus group and interview questions, and related materials should be reviewed to ensure that they adequately reflect the purpose and procedures in the study and handle sensitive issues appropriately. If the materials ask for information that, according to local law, would require reporting (e.g., elder, spouse, or child abuse), the consent form should explain this exception to the promise of subject confidentiality. There are, however, a variety of psychological and other measures which are considered “standard” and, while they cannot be modified, reviewers should still indicate if use of a given measure is appropriate for a particular study.

In particular, reviewers should consider if survey answers, if known, would impact a subject's reputation, liability, and insurability, or in other ways pose a risk for the subject.

According to the Protection for Pupil Rights Amendment, there are 8 categories of protected information for surveys involving K-12 students. These are: 1) political affiliations of student or student's parent; 2) mental or psychological problems of student or student's family; 3) sex behavior or attitudes; 4) illegal, anti-social, self-incriminating or demeaning behavior; 5) critical appraisals of others with whom students have close family relationships; 6) legally recognized privileged or analogous relationships, such as with lawyers, doctors or ministers, 7) religious practices, affiliations or beliefs of student or student's parent; and income. 8) income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program). Research involving any of the eight identified categories requires written parental informed consent prior to participation of a child.

Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. For example, a researcher might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.

Undue influence can occur through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. For example, a faculty researcher might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the researcher is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives for