A. Before undertaking the project

 1. Carefully review IRB information, including the definitions of the appropriate levels of review and the instructions on the requirements for informed consent.  Members of the IRB and the IRB chair are available for consultation if necessary.
 
  2. Carefully, thoroughly, and accurately complete the appropriate forms.
 
  3. Submit proposals to the Chair of the IRB before initiating the project.  Any proposals submitted for full review should be submitted ten days before the regularly scheduled meetings of the IRB, which are during the fourth and eleventh week of the semester.  The investigator is responsible for submitting the appropriate number of copies of the proposal to the IRB chair.
 
    Basic Status:    1 copy
    Expedited Status:   2 copies
    Full Review Status  7 copies
 
B. After receiving IRB approval

 1. Strictly adhere to the protocol described in the approved proposal.

 2. Obtain a signed consent form for each individual participant in the study.  These must be retained in the files of the primary investigator (or the faculty supervisor).  Consent forms should be stored separately from the data in order to protect participant confidentiality.

 3. If substantial modifications are to be made in procedures after the research has begun, re-submit a proposal to the IRB for approval prior to instituting any changes.

 4. If extra credit in an academic course is being offered for participation in research, alternative opportunities for obtaining extra credit must be available to students who do not participate in research.  Instructors should be made aware that federal guidelines prohibit research participation serving as the only opportunity for earning extra credit.

 5. Complete and return the Annual Progress Report Request when it is received from the IRB in order to notify IRB Chair of the conclusion of the project or termination of data collection. (Deadline for notification is the end of the semester in which the data collection is completed.)

6. If during the conduct of the research the investigator has any evidence that participants have in any way been harmed as a direct consequence of their participation, or that participation functioned as a contributing factor in producing the harm, or for any other reason, the investigator must undertake the following.
 

  a. Make a serious effort to remedy the harm immediately.

  b. Immediately notify the Chair of the IRB irrespective of success or failure of the investigator's efforts to remedy the harm.  The Chair of the IRB may subsequently solicit assistance from appropriate human servicespersonnel.

  c. Continue to monitor the participants until such time as all concerned have determined that the problem has been resolved.

  d. Immediately terminate data collection from the participants in question and postpone all activities associated with the research project until such time as the IRB and other concerned Saint Mary's personnel are satisfied that appropriate modifications of the protocol can and have been made.  Failing this, the project will be permanently terminated.
 

 7. If, during the course of the research, the investigator encounters information that suggests the existence of factors or conditions warranting concern about a participant, those concerns should be brought to and only to the attention of the principal investigator (or faculty supervisor when the principal investigator is a student) who will contact the appropriate individuals (e.g., human services personnel, IRB chair).

 8. If the investigator is including participants who are recruited as a function of being under the care of a physician or psychologist for a condition that might interact with the research procedures, the investigator must obtain written consent from the health care provider for the inclusion of that participant.

 9. The principal investigator (or the faculty supervisor when the principal investigator is a student) must keep all research records for a minimum of three years.  In the case of research involving minors and/or adolescents, records must be maintained until those participants reach the age of majority plus two inspections by the IRB or by an administrative person evaluating the IRB.

Last Updated: January, 1998

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