Topics: Guidelines to individuals planning to submit protocols for IRB review Guidelines for Obtaining and Documenting Consent Participant Compensation Confidentiality Statements Copy to Participant Student Research Policy Recommended wording for informed consent for venipuncture associated with participation in research studies CHS Contact information (consent / assent related documents) Explanations: Guidelines to individuals planning to submit protocols for IRB review As a PI, we are sure that you share our concern for human subjects. We are also sure that you want your protocol reviewed completely and in a timely fashion. To ensure that both occur, please insure that your submission is complete. That is: All required forms are complete and correctly filled out. Enrollment criteria are clearly and completely described. If applicants are to be screened, the committee must know how. If you are going to use a screening instrument, include it with your submission. If your protocol will involve surveys, the committee must review the actual instrument(s) you are going to use. Current, up-to-date copies must be included with your submission. The process of obtaining informed consent must be fully and clearly described. Generally, a copy of the consent form that participants will be signing is not sufficient. You must insure that the subjects are aware that this is research, the purpose of the research, any and all risk to them, any benefits, any cost, etc. The checklist (pdf|doc) outlines the elements that must be covered in the consent process. If confidentiality is an issue, how confidentiality will be maintained must be completely described. Be sure to acknowledge conditions where confidentiality cannot be guaranteed, e.g., IRB review, a subpoena, etc. If the participant information cannot or will not be kept confidential, so state, both in your protocol and in the informed consent. If your protocol has been reviewed by another IRB, it would help if you shared their comments with us. Many times they will have concerns similar to ours, and by letting us know how these concerns were addressed we can avoid unnecessary duplication. Incomplete applications or applications that do not follow these guidelines will be returned to the investigator without review. Complete and clearly written protocols are reviewed faster. Each time a question is asked or a revision made, the process is delayed. If you have questions, consult with the CHS staff before making your submission. Submissions that clearly and succinctly address these issues are appreciated. The committee does not want to see your application for funds or your thesis or dissertation proposal. Minor changes and / or changes in text: Submit one copy in Ramseour format: deletions struck out and insertions highlighted. Submit a clean copy of the revised version Major changes: Submit the revised version with a cover memo detailing the changes and where they are in the attached documents. top of page Guidelines for Obtaining and Documenting Consent Obtaining consent from potential subjects is an ongoing process . The process of informed consent is fundamental to insuring the continuous and adequate disclosure of research risks and benefits.  Informed consent begins with the initial presentation of a research activity to a prospective human subject by the investigator (or a member of the study team) and continues through the end of the research activity and the closing of the research study.  It involves a thorough oral briefing of each potential subject by the researcher, including all informed consent elements per 45 CFR 46.116 . Especially, a discussion of any potential risks and potential loss of privacy.  Efforts should be made to ensure that each subject has fully understood what has been agreed to and has had all questions answered. Subject signature on a consent form may document that the subject has participated in the process of informed consent and has agreed to participate in the study , but, does not by itself constitute informed consent. Research is an on-going process, which may involve the constant re-evaluation of current information and procedures.  Investigators are ethically obligated to keep subjects apprised of issues related to their participation in the study, as appropriate.  Any new information or changes in procedures that affect the participants should be presented to them in writing. In submitting a research protocol to the IRB for review, therefore, investigators are asked to describe their consent process.  Consent forms, as a major component of this process, must be included, but the focus of the IRB will be evaluating the overall consent procedure.  The consent process must be tailored according to the literacy level, and culture of the intended subject.  The IRB may waive the requirement for a signed consent in environments where such a procedure would not be culturally appropriate, or if the consent itself would become the sole personal identifier in an otherwise anonymous and therefore minimal risk proposal.  In such cases, the investigator must show that consent will be adequately demonstrated despite the absence of a signed form. In reviewing consent forms and procedures, the Committee uses the criteria outlined in 45 CFR 46.116. In composing your consent form or procedures, be sure that these elements are addressed.  When conducting research with children, pay particular attention to the section regarding consent of minor subjects. For help in getting started, the following samples can be used as templates of acceptable consent forms: Informed Consent Checklist (pdf) Social Science informed consent (pdf|doc) Oral History informed consent (pdf|doc) Biomedical informed consent (pdf|doc) top of page Participant Compensation Researchers often offer compensation or incentive to subjects for participating in research. UH policy is that the incentive or compensation for participation must be nominal in nature.  The criteria used by the IRB in determining whether an incentive meets this definition, is whether the incentive could be considered either coercive or unduly influencing to the subject population.  Compensation for participation, may be more than nominal, especially in cases with complex or time consuming procedures, but the same criteria will be applied in determining whether it is appropriate. Compensation and incentives must be described in the consent process. These should not, however, be considered benefits, per the criteria listed in 45 CFR 46.116. Please note: In its review of protocols, the IRB must ensure that all participants will be equally compensated for their participation in a study.  To this end, the Committee on Human Studies will not approve studies which have lotteries, or other types of chance-based drawings as their means of compensating participation in research. By their nature, lotteries and chance-based drawings do not recompense each research subject equally for their participation, and as such are not adequate forms of subject compensation. top of page Confidentiality Statements The recommended consent language to address confidentiality (this statement may be adjusted to be appropriate for the target population age or culture): "All personal information will be kept confidential to the extent allowed by law.  Agencies with research oversight, such as the UH Committee on Human Studies, have the authority to review research records." In addition, in research which may require documentation of sensitive information, IRB policy is that investigators keep research data in a secure location. This should be noted in the consent form as well. Recommended language: "Research records will be kept in a locked file in the investigator's office for the duration of the study.  All personal information will be destroyed upon completion of the research project." Consent for Oral History, and other research which may involve audio or video recording of subjects must include notification of this.  The investigator should also explain how the recordings will be used and disposed of.  IRB policy is that, in the absence of a valid research related reason for maintaning audio or video recordings, these recordings should be erased either upon transcription, or upon completion of the project. top of page Copy to Participant In studies where the IRB approves an oral consent procedure, researchers are still asked to provide subjects with a printed copy of the consent information. In particular, be sure to include contact infomation for both the investigator, and the IRB. In studies where the investigators collect a signed consent form, IRB policy is that researchers ensure the subjects retain a copy of the consent material for their future reference. Committee on Human Studies staff recommend researchers include notice of this on the consent form. (i.e.:   cc. to participant) top of page STUDENT RESEARCH POLICY Students as Researchers The CHS policy is that student applications will be reviewed by standards designed to meet the UH's obligations under Human Subjects regulations. As a rule, all applications (student/nonstudent) to the CHS will be reviewed by the same standards and procedures. Feedback is often provided to students as a means of assistance and encouragement. The purpose of this policy is to provide practical experience to students learning about the research process. UH policy requires that all University-related research activities involving human subjects must, at a minimum, comply with the ethical principles stated in the Belmont Report. Copies of the Belmont Report may be obtained from CHS. Special care should be taken when students will be conducting research activities outside of the classroom. Students should be aware that the principles of the Belmont Report and proper consent procedures must be followed. The CHS will conduct a full review and feedback will be provided to the student and/or faculty advisor. All University-related research activities involving human subjects should be submitted to the Committee for review to ensure compliance with human subject regulations and to assist the student in developing procedures which will safeguard and protect the subjects involved in the research. Students as research subjects Instructional/Educational Purpose Student participation as subjects in classroom activities which are designed for instruction or educational purposes and primarily benefit the students, is encouraged. This allows students to experience research activities from the perspective of the research subject. Course instructors are encouraged to include consent procedures and explain the fundamental rights of human research subjects and obligations of researchers. Non-Instructional/Educational Purposes A. Outside Researcher A course instructor who permits an outside researcher to conduct research involving his/her students has primary responsibility for the welfare of his/her students. The instructor should ensure that: the researcher has obtained all necessary University approvals and will abide by University policy in conducting the research; participation of the students is voluntary; risks to the students are minimized and disclosed; informed consent procedures are followed; and ensure that students' confidentiality is protected, particularly if breach of confidentiality could be potentially embarrassing or harmful to students. B. Instructor as Researcher In those instances when an instructor chooses to involve his/her students in his/her research activities which will primarily benefit that instructor and not the students, the instructor should: recruit subjects from the general student population if possible (e.g., advertise in the student newspaper). If not possible, then recruitment should be from classes or courses with which the instructor is not involved. Recruitment of student subjects from the researcher's classes is discouraged; ensure that student participation is voluntary; inform the students of the instructor's interest in the research; minimize and disclose any risks to the students; and ensure that the students' confidentiality is protected, particularly if breach of confidentiality could be potentially embarrassing or harmful to the students. Incentives to students for participating in research activities, such as extra credit or bonus points, must be carefully considered. The Committee recognizes this practice as a means of encouraging student participation, but recommends that alternative opportunities for extra credit be offered to those students who choose not to participate in non-educational research activities. The intent is to minimize coercion in student participation. Extra credit alternatives should be comparable to the effort involved in participating in the research activity. Please feel free to contact the Committee on Human Studies through the Office of Research Services for further information or assistance. top of page Recommended wording for informed consent for venipuncture associated with participation in research studies printer friendly version (PDF, 4KB) The following has been approved by the UH Committee for Human Studies for use in consent forms used in research studies where venipuncture is proposed. Suggested wording: "We are asking you to give cc of blood (about ___tablespoon/s). The risks are minimal and are only those of having blood drawn. This might include mild pain or a bruise at the place where the blood is taken. Occasionally, a person may faint or feel faint when blood is drawn for a blood test. Risk of infection is slight since only sterile one-time equipment will be used." top of page CHS Contact information (consent / assent related documents) For all consent / assent documents with CHS contact information, the correct address is: Committee on Human Studies 1960 East-West Road Biomedical Building, Rm. B-104 Honolulu, HI 96822 Phone: 808.956.5007 Email: uhirb@hawaii.edu top of page