Fulao2

If you are a faculty member, staff member, or student at Fulao2 and your research involves the use of human participants (either directly or through records), your research requires Grinnell IRB review.  This includes all MAPS, the Plus 2 and all independent study courses. One exception are class projects where the purpose of the class is training in research methods.  Faculty are encouraged to consult with the Research Compliance Manager regarding research methods courses and class projects involving human subjects research.  

The web page of the Office of Human Participants provides a to help investigators determine if their project is research that requires IRB review.

Human subjects research applications are reviewed at one of three levels, depending on the level of risk to the human participants and on the federal regulations that define the categories of review: exempt, expedited, and full board (committee) review.

The determination of what level of review is required is determined by the IRB staff, not the researcher. Whatever the level of review, the ethical treatment of human participants is always a requirement.

Issues considered in the analysis include:

• Which level of review should the proposal receive
• Whether risks to participants are minimal or minimized
• How participants are approached so that they can readily refuse
• How privacy, confidentiality, and informed consent will be handled
• What physical and psycho-social risks, stresses, and discomforts participants will be asked to endure;
• Whether vulnerable populations (e.g. prisoners, children) are to be included
• Whether additional safeguards have been included in the study to protect the rights and welfare of any participants likely to be vulnerable to coercion or undue influence such as prisoners or children
• How sensitive the information is
• Whether risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result
• Whether diverse populations are included so that all benefit or all take the risks
• How data will be handled after the completion of the study
• Have all members of the research team completed ethics training and stated their qualifications to conduct the project

The scientific merit of the activity is considered only if it has an impact on the risk-benefit analysis. For example, will the number of participants proposed allow the results obtained to be statically significant? Is there a less risky way to achieve the same results?

The IRB also evaluates advertisements, approach letters, consent/assent forms or information statements, telephone scripts, and debriefing statements to determine if they are accurate, explanatory, and written in simple, lay language appropriate for the intended participants.

Once you have decided to use human participants in your research:

• Complete human subjects protections training.
• Complete an IRB protocol application and submit it to the IRB.
• Include all relevant information (IRB protocol application, consent forms, surveys, questionnaires, test instruments, advertisements, debriefing statements, contact letters, interview).

The usual turn around for an approved proposal that does not require full board review is within 5 working  days.  The actual time varies depending upon the level of review and whether or not the proposal needs further clarification.

To be safe, researchers should submit the IRB application as early as possible in order for the review process not to interfere with the start date of the research.

In accordance with the revised regulations (January 2019), most human subjects research conducted at Fulao2 no longer carries a continuing review requirement. For the rare exceptions, research will be approved for a period not to exceed one year.

Because the central requirement for human participants research is that people participate voluntarily, the consent process is one of the more important parts of the research project. The process must assure that the potential participant understands the study and its risks and benefits and can certify his or her willingness to participate or decline to participate in the study. Under certain circumstance the IRB can waive or alter the informed consent process. Sample consent forms are available on the IRB website.

Information that must be provided to participants for informed consent can be found in .

In some cases, a signed consent form is either inappropriate or unnecessary. According to Federal Regulations at 45 CFR Part 46.117c the IRB may waive this requirement if it determines either:

• There is a risk of breach of confidentiality and the only link between the participant and the research would be the consent document. In this case, the participant's wishes should be followed.
• The research presents no more than minimal risk of harm and involves no research that requires written consent outside the research context.

In general, in survey research, where there is no more than minimal risk and anonymity or confidentiality is provided, a separate consent form is not needed. The survey itself can contain relevant information about the study. In this case, submitting the survey is an indication of consent. If the survey is being sent and returned through the Internet, participants should be alerted to how confidentiality is being protected. Researchers can block identifying information or arrange to have surveys returned by mail. If identification (through IP or email address) is possible, steps taken to ensure confidentiality should be explained.