Full Review of Research
Full review by the convened IRB is required for research which includes greater than minimal risk to participants, or for research including any procedures which do not fall into the categories described under expedited or exempt review. The ultimate determination of whether participants are at risk and a study requires full review can be made only by the Institutional Review Board (IRB).
When reviewing research proposals, the IRB is primarily interested in safeguarding the rights and well being of the human participants and in assessing the ethical implications of the proposed procedures. In this context, the IRB may pass judgment on "research design," but only to the extent that such design affects the rights or well-being of human participants. In analyzing the risk/benefit ratio of a research activity, both the stated goals and the scientific merit of the research will be considered.
The research must be described to the IRB in a manner that allows adequate review of all aspects of the research. Researchers must not submit dissertation or thesis chapters. The IRB requires that research descriptions and applications adhere to the following narrative outline, which is included in the application form.
- OVERVIEW: Describe the research planned and the rationale for the project, including: (a) research questions(s) or hypothesis(es), (b) most recent relevant research in the area of inquiry (with citation), and (c) purpose of the study. Be specific with your research question(s) or hypothesis(es).
- PARTICIPANTS: Include characteristics and recruitment, specifying: (a) the expected number of participants, (b) characteristics of the population (e.g. age, minority population, special group whose ability to give consent is compromised, pregnant women, fetuses, prisoners), (c) inclusion and exclusion criteria, (d) where you will recruit participants, (e) how you will advertise the research, submitting any flyers, posters, or email scripts to be used; If using a flyer, state how it will be used, such as posting, distributing via email, naming list-serves to be used, etc. and (f) if an institution or other entity is providing access to data or participants, supply a permission letter on their letterhead, signed by an official representative. (See permission letter template on the Forms & Instructions web page.)
- BENEFITS/RISKS: Address both potential benefits and risks to participants. Risks relate to the possibility of harm as a result of participating and can be physical, psychological, financial, social and legal or may result from breaches of confidentiality. State: (a) what the potential risks are to participants, (b) if risks are minimal; specifically, no greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination/testing, (c) how potential risks will be minimized, (d) if risks are reasonable when compared to benefits available and (e) what the potential benefits are to participants and/or the field of study.
- PROCEDURES: Describe the methods and procedures to be used with the participants in the research, in non-technical language. State: (a) exactly what participants will be asked to do, (b) where research will take place, (c) what standardized tests, tools, or measures will be used, submitting instrumentation or questions, discussing reliability and validity; if tools are older than 10 years, discuss rationale for choice, (d) if research-developed tool is used, provide documentation that tool has been piloted, pre-tested or reviewed by 3 professionals in the field of study (Master's degree or higher). If using professionals, supply names, degrees held and contact information. Professionals must also provide a statement of why they endorse tool. Professionals may be faculty or thesis/dissertation committee members, (e) what data/information will be collected, (f) how data will be analyzed, (g) approximate duration of research, (h) if participants will be compensated. If so, please disclose method and rationale (not considered a benefit).
- INFORMED CONSENT: (See templates on Forms Page) Describe the process of obtaining consent from participants. State: (a) how informed consent will be obtained and (b) how informed consent will be documented (oral or written).
Informed consent should convey purpose of study, how participants were selected, procedures, length of study and time required of participants, risks/benefits of participation, voluntariness of participation, procedure for withdrawal and what happens to data, confidentiality of data, data destruction, investigator and sponsor (if applicable) contact information and contact information concerning research integrity.
- RECORDS MANAGEMENT: Records must be kept for as long as the applicable regulations require (at LEAST 3 years; See Records Retention). Please state: (a) the length of retention, (b) that records will be kept in a locked file, (c) who will have access to the records (i.e. researcher, sponsor, transcriptionist, research assistant) and (d) that records will be destroyed and how. If records will not be destroyed, please state that in this section.
The IRB must approve both the form and the procedure by which consent is to be obtained. Full review consent and assent forms require signature lines for the participant and principal investigator. In cases where the signature is the only thing linking a participant to the study, and the primary risk is a breach of confidentiality, the requirement for documentation of consent (signature) may possibly be waived. Please see the informed consent (waiver) section for further information.
A new application for review is required for each research project that differs significantly in terms of procedures or subject populations from a previously approved application.