Federal-Wide Assurance
Written guidelines and procedures are followed when a research proposal is reviewed and for reporting its findings and actions to the administration of the institution. An authorized institutional official holds the responsibility for the oversight of research and IRB functions. This assurance includes:
- The principles and guidelines (previously listed) which directly govern American College of Education and affiliated researchers when conducting research when human subjects participate;
- The policies and procedures related to conducting initial and continued research and how this research is reported;
- Responsive steps when possible problems arise which place subject and/or researchers in potential harm, or when non-compliance concerns develop which require notification and may result in termination of IRB approval;
- Training opportunities for creating quality proposals and to comply with federal rules and regulations;
- Evidence of internal evaluation or auditing of the system to ensure compliance with regard to research using human subjects.
Protecting Privacy
Confidentiality (see additional information in this handbook) and protecting an individual’s privacy are two issues which require specific guidelines. The research design must address how data will be handled in a confidential manner, including the approach to gathering, analyzing, and storing information. Potential invasion of privacy is also to be addressed in the proposal to clearly define the parameters of how and what type of information will be collected, particularly in relation to a reasonable expectation of privacy.
Informed Consent
Informed consent protects the rights of individuals involved in research. Subjects must be given reasonable and accurate information regarding research procedures, purpose and extent of the research, any potential risks or benefits, and the steps required to withdraw from the study if required. The form (Appendix A) documents an individual’s acknowledgment and awareness of these parameters of the study. Additionally, a copy of the Informed Consent Form and/or Waiver of Documentation of Written Informed Consent for Oral Consent Form must be submitted with each IRB Application for which new data will be collected. An Informed Consent Checklist provides details of all the components within the scope of the study.
An Informed Consent Form along with a letter of explanation is sent to the potential participant. The returned form is kept for three years, defining the dates for the study and other pertinent information along with the signature of the individual.
Risk/Benefit Analysis
The IRB is tasked with determining if the potential risk of a research project outweighs the value of the results, defining a dangerous situation as beyond the scope of risk associated with daily living or routine expectations. These include those levels of risk involved in the performance of routine physical or psychological examinations or tests.
It is the responsibility of the researcher to clearly identify the parameters of the study design and provide any estimation of potential harm in order to inform the IRB. Any identified potential risk must be included on the Informed Consent Form. Potential issues IRB should review might include:
- Specific concerns or risks to any given subject participating in the research,
- The level of risk involved,
- Identified benefits to the subject or to society as a whole determine from the research,
- The reasonable level of risk in relation to benefit,
- The accuracy and completeness of the Informed Consent Form, and
- Review intervals to monitor data collection for identified subjects with higher levels of risk.
The IRB may request periodic reports from the researcher for the purpose of determining if the research remains within approval parameters.
Subject Selection
Subjects who participate in the study are identified by an objective and unbiased approach as determined by the research design. Selection should represent equity as to the target participants and in relation to the research topic.
The IRB will also review the proposal regarding the selection of research subjects from vulnerable populations such as children below 18 years of age, prisoners, cognitively impaired persons, and pregnant women. The IRB will particularly review the method used for identification of these participants.
Participants should not be compensated in an excessive manner which might be construed as enticement or incentive or create potential harm to the individual or those related to the individual.
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