7#D ~>ZZZZZrrrr ~ ""pGuidelines for Faculty and Students Engaged in Human Subjects Research at Union College Revised October, 2001 (This document and other documents related to the use of human subjects in research are available on-line at XXX.) Preamble The ethical conduct of research involving human subjects requires a balancing of societys interests in protecting the rights of subjects and in developing knowledge than can benefit the subjects or society as a whole. investigators should not have sole responsibility for determining whether research involving human subjects fulfills ethical standards. Others, who are independent of the research, must share this responsibility, because investigators are always in positions of potential conflict by virtue of their concern with the pursuit of knowledge as well as the welfare of the human subjects of their research. Report of the National Commission for the Protection of Human Subjects Introduction The stated policy of Union College with regard to human subjects research conducted by its employees and students is embodied in the Code of Federal Regulations, Title 45, Department of Health and Human Services (DHHS), Part 46, Protection of Human Subjects, as well as Article 24A of the New York State Public Health Law. Anyone contemplating human subjects research is required to familiarize himself/herself with these documents. The procedures for complying with certain aspects of these laws are detailed below. The Vice President of Academic Affairs is legally required to stop all research not in compliance with these procedures. Procedures for Researchers to Follow 1. Any Union College staff or faculty member (full or part-time) or Union College student (full or part-time) who proposes to conduct research on human subjects, or who is currently doing so, under the auspices of Union College, is obliged to review the pertinent sections of the DHHS guidelines and Article 24A of the New York State Public Health Law. 2. All human subjects researchers must complete either the official Statement of Intention or the official Statement of Exemption form for each and every research project. Completed forms should be forwarded to the Office of the Dean of Arts and Sciences. The following categories of research are exempt from committee review, provided that a Statement of Exemption form is submitted. (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. 3. All researchers conducting nonexempt human subjects research must submit a Statement of Intention form. If all the answers to the questions are acceptable, the researcher may expect immediate, routine clearance from the committee. In all other cases, the review committee will give the completed statement careful consideration and will render a prompt judgment as to whether the guidelines have been met. If the committee concludes that any aspect of the proposed research is not in conformity with the guidelines, it will request that necessary modifications be made before extending its approval. Any research on human subjects carried out without the express approval of the Committee is in violation of state and federal law as well as the rules of Union College. 4. Following the recommendations of the Office for Human Research Protections (OHRP), the Chairperson of the Human Subjects Committee or designated reviewers may give expedited review without a meeting of the full committee for the following categories of research procedures provided that they present no more than minimal risk to human subject. The definition of minimal risk is that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. Research Categories (1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. (2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. (3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. (4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects, 45 CFR 46.101(b)(4)). This listing refers only to research that is not exempt.) (6) Collection of data from voice, video, digital, or image recordings made for research purposes. (7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects, 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) (8) Continuing review of research previously approved by the full Human Subjects Committee as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis. (9) Continuing review of research that is not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the Human Subjects Committee has determined and documented that the research involves no greater than minimal risk and no additional risks have been identified. 5. In projects where subjects are judged to be at more than minimal risk, two copies of a voluntary informed consent (sample copy is provided) must be completed by each subject. One copy is to be given to the subject; the other should be retained by the researcher for at least seven years following completion of the research project, in the event that subsequent controversy or legal action develops. The general requirements for informed consent, including the criteria for waiving consent, can be found in the DHHS regulations for the protection of human subjects, 45 CFR 46.116 and 46.117. 6. Any significant changes in the conduct of previously approved research that might result in unanticipated potential injury to human subjects must be approved by the Human Subjects Research Review Committee. 7. Research conducted by Union College students in conjunction with faculty members (including independent studies and senior projects), or funded through the Colleges Internal Education Foundation (IEF), must be approved by the Human Subjects Research Review Committee. 8. Departments that teach students how to do research on human subjects must develop a formal policy on human subjects research. The object of this policy shall be to make students aware of their ethical and legal obligations to protect human subjects against injury, and to obtain informed consent from their subjects. Additional Comments The DHHS Guidelines and N.Y. State regulations are taken to be the minimal standards for safe and ethical human subjects research. If a particular academic discipline has promulgated its own set of standards and principles that exceed the state and federal guidelines in their stringency, and if the researcher so chooses, he/she may of course adhere explicitly to these standards (e.g., the American Psychological Associations Ethical Principles in the Conduct of Research with Human Participants). This in no way, however, relieves the researcher of the responsibility to complete and submit the official Union College Statement of Exemption or Statement of Intention form. Finally, it should be clearly understood that neither the Human Subjects Research Review Committee nor the College intends that the establishment and implementation of these standards and procedures should be seen as an attempt to infringe upon academic freedom. The committee expects that the overwhelming majority of research projects undertaken by Union faculty and students fall outside our purview. In the small number of instances in which human research is involved, it is expected that hardly any will present any challenge or uncertainty. We believe that Union researchers will exhibit a high order of ethical sensitivity. Whatever files the Committee may have occasion to accumulate will be held in close confidence, although in the unlikely event of legal complications the records would necessarily have to be put at the disposal of appropriate college administrators and lawyers. The present system is designed both to meet unavoidable legal obligations and to afford a degree of protection to researchers and human subjects. Statement of Exemption From Human Subjects Review Union College A few categories of research are exempt from review by the Human Subjects Research Review Committee. These categories of research, which appear in The Code of Federal Regulations (Title 45), are listed in the Guidelines for Faculty and Students Engaged in Human Subjects Research at Union College. They are explained in more detail in the Institutional Review Board Guidebook. If you and your faculty advisor deem that your research proposal does not require human subjects review, please complete this form and submit it to the Deans Office in Science and Engineering (S-100). You may begin your research after submitting the exemption form. If your proposal requires human subjects review or if you are uncertain whether your proposal requires review, please submit a Statement of Intention to Engage in Human Subjects Research Form. Title of Project___________________________________________________________ Student Name(s) _________________________________________________________ Local address____________________________________________________________ Email address_______________________________ Phone________________________ Please provide a description of your study, explaining the purpose and the procedures. Do not simply attach a copy of your IEF proposal. If a questionnaire is to be used, a copy must be included with the application. If an interview procedure is to be used, the types of questions that will be asked should be described. If deception is used, you must explain either how the subject will be debriefed or why they will not be debriefed. You may use additional sheets or attach your entire description of the project to this form. This Section to be Completed by Student, Faculty and Staff Researchers I have reviewed the guidelines for determining exemption status and am confident that the proposed research is exempt from human subjects review. The category exemption number(s) is (are) _________________________. I understand that although my research project is exempt from review, this does not relieve me of any responsibilities relating to research subjects. I also understand that it is a violation of New York State Public Health Law to conduct non-exempt research involving human subjects without approval from the Human Subjects Research Review Committee. Student Signature(s) ____________________________________ Date______________ This Section to be Completed by Faculty Research Advisors Only I have read the students research proposal, have reviewed the guidelines for determining exemption status and am confident that the proposed research is exempt from human subjects review. The category exemption number(s) is (are) ______________________. I have explained to the student that although his/her research project is exempt from review, this does not relieve him/her of any responsibilities relating to research subjects. I also understand that it is a violation of New York State Public Health Law to conduct non-exempt research involving human subjects without approval from the Human Subjects Research Review Committee. Faculty Name____________________________________________________________ Faculty Signature______________________________________ Date_______________ Statement of Intention to Engage in Human Subjects Research Union College (Type or Print Neatly) Title of Proposal:__________________________________________________________ Student Signature(s): ______________________________________________________ Faculty Signature: ________________________________________________________ (Do Not Write Below This Line) ------------------------------------------------------------------------------------------------------------ The above proposal (check one): _______ Has been given Expedited Approval by the Chairperson of the Human Subjects Committee. You may proceed with the experiment, subject to any qualifications listed below: _______ Has been given approval by the full Human Subjects Committee. You may proceed with the experiment, subject to any qualifications listed below: ______ Has not been approved by the Human Subjects Committee for the reasons given below. __________________ Initials of Chairperson Qualifications or reasons for rejection. _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Statement of Intention to Engage in Human Subjects Research (Answer Questions 1-18) 1. Name of researcher(s): _________________________________________________________________ Box number and/or address: _____________________________________________________________ Phone and Email address: _______________________________________________________________ 2. Name of faculty sponsor of student research: ________________________________________________ Department: __________________________________________________________________________ Phone and Email address: _______________________________________________________________ 3. Title of research project: ________________________________________________________________ 4. Is this research funded: (check one) ___yes ____ no If yes, by whom? ______________________________________________________________________ 5. Characteristics of the subjects: Approximate number of subjects: ______________________________ Age of subjects: __________________ Sex of subjects: M ____ F ____ Both ________ Other important characteristics (e.g., prisoners, subjects in poor mental or physical health, etc.). _____________________________________________________________________________________ _________________________________________________________________________________ _____________________________________________________________________________________ 6. Location of data collection (e.g., place where interviews, observations, etc., will occur). _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ 7. If data collection is to occur at a location other than Union College (e.g., at another college, at an elementary school, or at a business location), describe how you have secured permission from the appropriate individuals at the other location(s). _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Statement of Intention to Engage in Human Subjects Research 8. How will the subjects be sampled, recruited or otherwise enlisted as participants in this study? _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ 9. Describe the manner in which informed consent will be obtained. If informed consent will not be obtained, please explain why it will not be obtained (e.g., to safeguard the anonymity of participants). In most research projects written informed consent is required (see Title 45, Part 46.116). Attach a copy of your informed consent form to this proposal. _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ 10. How will the anonymity of participants and/or the confidentiality of the data be ensured? _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Statement of Intention to Engage in Human Subjects Research For items 11-16, respond by circling Yes or No. If the answer is No, provide a justification for the action to which the question refers. Yes No 11. To the best of my knowledge, none of the human subjects likely to participate in this research will be placed at risk with regard to physical pain or discomfort, psychological stress or discomfort, or social injury. Social injury is understood here to mean such conditions as diminished reputation, or damaged social and personal relationships. If No, please explain: Yes No 12. Information that might affect subjects willingness to participate will not be withheld from them prior to the securing of their consent to take part in the research. If No, please explain: Yes No 13. No coercion or penalties which might negate a subjects freedom to refuse to participate in the experiment or to withdraw voluntarily from participation will be used, and it will be made clear at the onset to participants that they shall be free to withdraw at any time. If No, please explain: Yes No 14. All promises and commitments made to subjects concerning their participation will be duly honored by the researcher. If No, please explain: Yes No 15. Following their participation, all subjects will be provided with a complete explanation of the nature of the study so as to eliminate possible misconceptions about its purpose and to eliminate any stress or discomfort experienced by participants. If No, please explain: Yes No 16. To the best of my knowledge none of the student researchers who will be conducting the research will be placed at risk with regard to physical pain or discomfort, or psychological stress or discomfort. If No, please explain measures taken to minimize the risk to student researchers. 17. In addition to the specific explanations which may have been provided in conjunction with No answers to questions #11-16, please provide any further comments which might help the Review Committee determine whether the proposed research is likely to produce benefits so significant as to outweigh any questionable or risk-producing research procedures. 18. Please provide a description of your study, explaining the purpose and the procedures. Do not simply attach a copy of your IEF proposal. Rather, the Review Committee would like a detailed description of the procedures of your study, so that we can evaluate potential risks to the human subjects. If a questionnaire is to be used, a copy must be included with the application. If an interview procedure is to be used, the types of questions that will be asked should be described. If deception is used, you must explain either how the subject will be debriefed or why they will not be debriefed. SAMPLE INFORMED CONSENT FORM (You may use this form as a guideline for writing the informed consent form. Your specific consent form should include information pertinent to your specific research project, and may need to be considerably different from this sample. The sections written in bold are to be filled in by you.) My name is (name of person doing project), and I am a (student/professor, etc.) at Union College). I am inviting you to participate in a research study. Involvement in the study is voluntary, so you may choose to participate or not. A description of the study is written below. I am interested in learning more about (your research topic.) You will be asked to (state what the subject will be asked to do.) This will take approximately (state the expected length of time). The risks to you of participating in this study are (state the risks to subjects.) These risks will be minimized by (state the procedures you will use to minimize the risks.) If you no longer wish to continue, you have the right to withdraw from the study, without penalty, at any time. (When appropriate, either or both of the following paragraphs should be included.) All information will be kept (either confidential, in the case where subjects identities need to be retained or can be associated with their responses, or anonymous and confidential, in the case where data collection does not allow responses to be connected with a particular subject). Even though all aspects of the experiment may not be explained to you beforehand (e.g., the entire purpose of the experiment), during the debriefing session you will be given information about the experiment and have the opportunity to ask questions. --------------------------------------------------------------------------------------------------------------------- All of my questions have been answered, and I wish to participate in this research study. _________________________________________ _________________________ Signature of participant Date _________________________________________ Print name of participant _________________________________________ _________________________ Name of investigator Date u~hhhhoIWfq` 01667!7-<,<@=>5BCC2C@CCDDoDDFNFH|HIJ6LMPP! @@@@   @  @@@  @@  2P!P]PkSSU.XGXHXX\\\\\\]]^=bbPbQccf fHkxkkkrruv vvvzwzw{wwxxxyy"y$zzz/z[z|zzz{{R|7|?|K||@@     <|}9=>ABCD @XnohiHIJWX  b c H  L M u=f t(34c&56`KLMNWX01JKv   v !3!f!g!W!!"."""#<##$c$$%% %q%&8&''q'(5(()Y))+q+r+,D,- -w-.>..0000223+3L3M344f4g444595:5;6669999::<,<->Bľ@@@@HBBC2C@CAFFFFG)G*GuGvGGGIIIIIIIIIIIIIIIIIIJ7J8KKLsLtLuLLLLLMMNN OOOOPPP P]PkPPPPQQ1Q}QR:R;R[R\S SSSSSTTTTUUU-U.TU.UUUUV6V7VVVVW@WAWWWWXXXXXY[Y\YYZ!Z"ZZZZ[;[<[{[|[[\E\F\\](])]]]]^>^?Ʊ   `h `hh 1^?^^^^_P_Q__``z``a a abacaabbbQbRbSbbcccqcrccd!d"dydzdde7effJfKffffgRgSgghhhZh[ı      6h[h\hhiiiiijiijjjnjojjkkkvkwkxkklMlNmmmmmmmmmmnnnnnnnnnpppHpIpJpKpLpMpNpOppq qqqqqrr rTrUdz@@    ArUrVrWrXrYrZs:s;sssssssssuuuwzwwxxyy{{||}9}:~5~6~7~~~   P<=>@ABCD % @ HHP HH0@8captionTitle*   ix~DDTDADD=/ hBpWGuidelines for Faculty and Students Engaged in Human Subjects Research at Union CollegeAcademic ComputingTimes New Roman{Times New Roman CE|Times New Roman Cyr~Times New Roman GreekTimes New Roman TurTimes New Roman (Hebrew)Times New Roman (Arabic)Times New Roman Baltic~D~D