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| Human Subjects |
Human Subjects Protection
Date: August 28, 2006 To: USF Faculty From: Internal Review Board for the Protection of Human Subjects Re: Student Advising Dear Professors, Greetings from the IRB! The purpose of this memo is to provide you with a number of reminders and suggestions that will assist you in working with your thesis and dissertation students. This information is particularly relevant for anyone who will be chairing a dissertation or directing a thesis, however all graduate instructors can benefit from a familiarity with IRB procedures as most graduate students in our programs are required to conduct research as a part of their degree completion. Please note the following: All research projects that involve interaction with people must be submitted to and approved by the IRB Committee before research commences. Once a complete application is submitted, students will be informed of needed changes or of their approvals within four weeks. It is important therefore to stress to students who are under time constraints that expedited reviews cannot be conducted due the volume of students sending applications in. The IRB reviews studies year round closing approximately three weeks per year usually right around the end of each semester (fall, spring, summer). It is imperative that all thesis and dissertation advisors read and sign student applications. Your initial review screening for completeness, correct grammar, professionalism, etc. will help students gain approval faster by avoiding additional revisions and added wait time to be advised by a committee member. Students must submit TWO copies to the IRB when applying. A complete project will not be reviewed without one copy for IRB files and one copy to be sent to an IRB committee reviewer. Applications must include a completed initial application form and elaboration of items 1-11 (see IRB initial application). Applications must include copies of any instruments, questionnaires, or interviews that your students will use to collect information from participants. This includes forms to be filled out for research purposes as well as scripts of letters, phone calls, or emails that will be used to solicit participation. Flyers created to advertise the study should be included as well. Applications must include letters of institutional consent from authorized representatives of any site where your students will conduct research. This letter should be on official letterhead, signed, and attached to the IRB application. While it is possible to be awarded a conditional approval without this letter, no final approvals will be given without a letter from the appropriate agency giving permission for your student to research within their institution. If your students have a particular site in mind, encourage them to be proactive about soliciting this letter as turning it in with the application will expedite their approvals. Please familiarize yourself with the IRB website, documents, and procedures. Consider spending 10 minutes making a brief presentation to any graduate courses that you teach where students will be eventually responsible for writing a research oriented dissertation or thesis. Please provide all of your students with the IRB website information, email address, and phone extension. Finally, I am most happy to come to your class or faculty meeting and discuss Human Subjects Protection Issues. Our main focus is not enforcement, but rather awareness of the ethical issues involved in research. In-person discussions can facilitate learning (on our part as well), and also smooth the process of reviewing faculty, staff, and student research. While the primary function of the IRB committee is to ensure that any potential harm to people who participant in our students' research is minimized, we are also interested in assisting students toward their goals of graduation and eventual professional contributions. This document and our diligence with students are efforts toward this end. Best Regards, Dr. Terry Patterson Chair Institutional Review Board for the Protection of Human Subjects | |  | USF's OHRP Approved Assurance Number: FWA00002248
(Expires 3/24/2008)
| | USF's IRB Number: IRB00002083 (Expires 11/18/2008)
| | FWA Approval Date: 4/1/2002
| | Common Problems/Solutions
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| Dual Relationships: Students, Trainees, Clients, and Employees as Subjects Use of Internet for Surveys/Recruiting Subjects USF Course-Related Research Projects Oral History Program Evaluations Use of Existing or Secondary Data External Agency Deadlines and IRB Review Prisoners Research in Foreign Countries Non-English Speaking Subjects
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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. The principles involved here are respect for persons and confidentiality. As described in the Belmont Report, respect for persons demands 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 take care to ensure that subjects feel totally free to refuse to 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 and 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. Another alternative way to protect against coercion is for faculty-investigators to advertise for subjects generally, through notices posted in the school or department, rather than recruit individual students directly in the classroom. 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, consent, confidentiality, and the participation of minors. 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: | Include the IRB e-mail address to the IRB telephone number. | | Include either a statement saying there will be no future mailings or an opt-out message that permits addressees to have their names removed from any future mailings. | | If you plan future mailings, add a statement that says, "If you do not respnd to this survey or return the opt-out message, you wil be contacted again with this request X times during the next X weeks." | | Use a blind copy format so that the list of recipients will not appear in the header. |
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 risk. 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: | Subjects are not identified by name or description, and | | Subjects are not selected from a vulnerable or sensitive group such as alcoholics, domestic abuse victims, prisoners, homosexuals, persons in institutional or residential settings, persons with severe disability, etc., and | | Subjects are not required to reveal anything about sensitive personal experiences or behaviors. |
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. This training can be completed within one hour and includes a multiple-choice test at the end. Oral History 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: | Include information in the consent form about how the tapes will be used in the future and who will have access to them. | | Provide participants an opportunity to have their names removed from the tapes and kept confidential in any publications. | | Provide some way to protect the privacy of any third parties who may be named in the interview. |
Program Evaluations 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 generalizable 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. Prisoners 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: - Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
- Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
- Research on conditions particularly affecting prisoners as a class (for example, hepatitis research that is more prevalent in prisons, alcoholism, drug addiction and sexual assaults). If funded by DHHS, the Secretary of DHHS should consult with experts and then publish the intent to approve the research in the Federal Register;
- Research on practices that have the intent and reasonable probability of improving the health or well being of the subjects.
Research in Foreign Countries 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. - Language: When documents should be translated into a language other than English, the researcher should provide 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., an USF faculty member) indicating that the translated version is complete and contains the same information as the English version.
- Minors: When subjects are younger than 18, researchers are required to get written parental permission. However, if local regulations are such that parental permission for research in a school setting would be inappropriate, the researcher should give the IRB proof that this is inappropriate. For example, proof could be a letter saying that parental permission would be inappropriate from an authorized official in the country, or from an USF faculty member who is familiar with the culture.
- Audio/video taping: When researchers audio/video tape subjects, the IRB requires a signed consent form. But in some cultures, subjects would be reluctant to sign an official form. This should be explained in the application, and the IRB will consider alternative means of documenting consent such as obtaining verbal consent on the tape. Subjects should be informed of their rights, confidentiality, and all other aspects of consent.
Non-English Speaking Subjects 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 to the IRB 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., an USF faculty member) indicating that the translated version is complete and contains the same information as the English version. |
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