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Common Problem Area and Solutions Dual Relationships: Students, Trainees, Clients, and Employees as Subjects Problems and concerns arise when the researcher's students, clients, or employees are asked to participate in research studies. As described in the Belmont Report, "respect for persons" is a guiding principle and requires that subjects enter into the research voluntarily, without feeling any undue pressure to participate. No explicit or implicit coercion should be used to obtain research subjects. When the researcher has a relationship with the potential subjects there is a danger that the subjects will feel obligated to participate. The researcher should ensure that subjects feel free to not participate. Students, clients, and/or employees of the researcher may be unduly influenced by the expectation that participation or nonparticipation will affect their academic, treatment, or employment status. Students: Generally, it is better if faculty do not ask their own students to be subjects in their research because the students may feel compelled to participate. Students may volunteer to participate out of a belief that doing so will place them in good favor with faculty, or that failure to participate will negatively affect their relationship with the investigator or faculty generally. If faculty want to include their own students as subjects, the IRB should require that a third person recruit the students, gather the data, and the data should not be released to the faculty until after the end of the semester when grades have been submitted. The researcher should explain these details in the consent form so that students will not feel coerced into being subjects in their teacher's research. Faculty that are conducting human subjects research should advertise for subjects generally, through notices posted in the school or department, rather than recruit individual students directly in the classroom. This is another way to protect against coercion. If students will be given extra credit for research participation, the researcher should offer students alternative ways to earn extra credit. The IRB should review these alternatives carefully to ensure that the alternative is no more onerous in time or effort than participation in the research study. Clients and Employees: The problems with using clients or employees are essentially the same as with students. Professionals should inform their clients that declining to participate will not affect their treatment or any services to which they are entitled. Employers should assure employees that declining to participate will not affect their job evaluations. With both groups, confidentiality of subject participation is extremely important. Consent forms should specify how the confidentiality of the data will be ensured.
Use of Internet for Surveys/Recruiting Subjects Internet research raises a number of complex issues for the research community. A few of the problems involved are the risks versus the benefits, obtaining informed consent, ensuring confidentiality of data, protecting minors, and evaluating benefits of the research against the risks involved. Researchers' claims about the benefits of their research depend in large part on their ability to collect useful data. But conducting research on the Internet raises questions about data sampling techniques and the validity and reliability of the data collected. It is easy to mislead the researcher about geographical location, age, race, or gender. Minors may respond to a study involving inappropriate subject matter without the researcher knowing it. Although survey research online is similar to traditional survey research, Internet research increases the subjects' risk of being identified or having their personal information accessed by people other than the researcher. The risk of exposure can surface at different stages, from data gathering, to data processing, to data storage and dissemination. Participants may not know that there is a record of the exchange in a cache somewhere on their system or saved in their Internet service provider's log files. All USF researchers who are using Internet surveys may be required by the IRB to:
School of Education, Room 023
USF Course-Related Research Projects Many undergraduate and graduate classes include research projects using human subjects. If the goal of the project is to provide research training and the results will not be used outside of the classroom, these projects usually do not require IRB review. The Committee assumes that the faculty member directing the projects will review each project carefully and ensure that human subjects are protected from unnecessary risks. The IRB has a few guidelines to help faculty decide whether their students' research requires IRB approval. Conditions under which IRB approval is not required for student course-related research are:
Any project that does not comply with all of the conditions listed above should be approved by the IRB before any subjects are recruited or data are gathered. All classes that teach research methods should include a section on the purpose of Human Subject Committees (or Internal Review Boards) before the students begin their projects. Faculty may want to ask the students to complete the web-based training module for getting informed consent from human subjects, available on the OSP home page under Compliance: http://www.usfca.edu/planning_budget/sponsored_projects/compliance.htm This training can be completed within one hour and includes a multiple-choice test at the end.
Oral history usually involves taped interviews between the researcher and participants about a particular historical event, person, or period, with the intention of keeping the tapes for posterity. These interviews constitute research with humans, and the projects should be submitted to the IRB for review. The American Anthropological Association and the American Sociological Association have guidelines that address ethical issues. Both associations urge researchers to comply with federal and institutional requirements pertaining to research. Oral history projects should:
Research that involves program evaluations or quality assurance may or may not need to be reviewed by the IRB. If the purpose of the project is to develop or contribute to general knowledge, it should be reviewed by the IRB. If the project is for internal purposes only, to improve or understand a program, it does not have to be reviewed by the IRB. For clarification, contact the IRB office.
Use of Existing or Secondary Data If researchers plan to use data that already exist, the IRB should review the research if the data involve humans. If the data involve documents, records, pathological specimens, or diagnostic specimens that are publicly available or if the information is recorded so that subjects cannot be identified directly or indirectly, the research will probably be reviewed at the Exempt level. If the identifiers are recorded, researchers should describe in the IRB application the procedures they will use to protect the confidentiality of the subjects. If possible, the identifiers should be removed by a person who already has access to the data before the researcher gains access to the data.
External Agency Deadlines and IRB Review It is recommended that applications to the IRB be submitted for review before a proposal is sent to an external funding agency; however, the IRB realizes that agency deadlines should be met and the turn-around time is often very short. There is no need to miss an agency's deadline because you are waiting for the IRB to review your project. Researchers should submit their applications to the IRB as soon as possible after the agency deadline so that they can be reviewed as quickly as possible. If the proposal for research that involves human subjects is funded, the University will not set up an account for the project unless the IRB has approved the research.
Because prisoners are incarcerated, they may be under constraints that could affect their ability to make a truly voluntary decision about whether or not to participate as subjects in research. The IRB, therefore, has additional duties mandated by 45 CFR 46:302-306 to fully review all protocols involving prisoners, and to include on the review panel a reviewer who is either a prisoner or who has the background and experience to serve as a prisoner representative. It is suggested that consent forms for research with prisoners include addresses for the researchers and the IRB, but not their telephone numbers. This may prevent unwelcome phone calls, and yet the prisoners' rights to report adverse events are still protected. Only certain types of research involving prisoners may be approved by the IRB. They are the following:
When faculty, staff, or students conduct research with human subjects in a foreign country, there may be cultural differences that should be considered in the IRB review. Some of the differences are listed below.
When subjects do not speak or understand English well, the researcher should prepare documents in the language that subjects can understand. As described above, the researcher should provide the IRB with a copy of the document in English, a copy in the language to be used, and a letter from an unbiased individual with expertise in the language (e.g., a USF faculty member) indicating that the translated version is complete and contains the same information as the English version.
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