Rockhurst University Institutional Review Board Policies and Procedures October 2008 The policies and procedures described in the following pages were established to guide the conduct of research involving human subjects, to protect the rights, well-being, and personal privacy of individuals, to assure a favorable climate for the conduct of scientific inquiry, and to protect the interests of Rockhurst University. They are in complete compliance with federal regulations and also reflect sensitivity to the structure and policies of Rockhurst University. The goal of the Rockhurst University Institutional Review Board (IRB) is to assist, as quickly as possible, the conduct of research involving human subjects while at the same time protecting those subjects and the university. Adherence to the guidelines (described below) is necessary to help promote this goal. It should be noted that the IRB Policies and Procedures, as they reflect the Federal guidelines for the responsible conduct of research, are fluid and may be changed without advanced notice. The Rockhurst University IRB will make every effort to maintain consistency with Federal guidelines while effectively communicating substantive changes to the Rockhurst community. The policies and procedures outlined in this manual were adapted from those used by Seattle University.
TABLE OF CONTENTS Section I: Introduction / General Principles 3 Section II: Institutional Review Board 6 Section III: How to Determine if Your Study Requires Full 7 Board, Expedited, or Exempt Review Section IV: Procedures 10 Section V: Protocol Preparation Guide 12 Section VI: Elements of Informed Consent and Consent 13 Form Requirements Section VII: Annual Review, Adverse Effects, Modifications, 16 and Terminations Appendix A: IRB Submission Instructions 17 Appendix B: Sample Informed Consent Form 33 Appendix C: Adverse Effects / Modification Form 36 Appendix D: Annual Review/Termination of Approved Studies Form 38 Appendix E: Definitions 41 Appendix F: Research Ethics 47 2
SECTION I INTRODUCTION / GENERAL PRINCIPLES INTRODUCTION The Rockhurst University Institutional Review Board (IRB) is charged with approving research proposals for the purpose of ensuring that the rights of human subjects are protected. While many activities conducted by faculty, students or staff might appear to be research and are sometimes labeled as research; such projects are not reviewed by the IRB because the project does not meet the federal definition of research (See Appendix E, page 41). According to the federal definition, there are basically two criteria that must be met for an activity to be defined as research. First, the project must be a systematic investigation. This means that the methods of data collection are the prevailing research methodologies in the discipline. Second, the ultimate aim of the project is to generate generalizable results that are expected to contribute to the development of knowledge in the discipline. The concept of generalizability is usually applied to quantitative research, but in this sense also applies to qualitative research because of the expectation to contribute to knowledge. Examples of types of research reviewed by the IRB are given in Section III, page 7 within the context of exempt, expedited and full review. Examples of non-research activities that might appear to be research but do not meet the federal definition are the following: Example 1: Surveys conducted by university administrators to gather information from personnel or students to improve programs are often called institutional research. In this example, systematic methods are used to develop and analyze survey data, but the results are not intended to be generalizable beyond the scope of the institution. Comment: Evaluation research that is conducted on a program that is expected to be published, as a model program to be used nationally should undergo IRB review. Example 2: Class projects in which students are being trained to use certain research techniques (e.g., how to conduct an interview or how to administer a questionnaire) are usually not research. Although the student learns systematic investigation techniques, the results are not generalizable. Comment: a pilot study for a thesis or dissertation should be considered research. Example 3: Quasi-research projects that would not normally be considered research under the federal definition, but for which there is a prior intent to publish or disseminate results at conferences should be submitted for IRB approval. Even though the project might otherwise not be 3
considered research in terms of "systematic investigation," the intent to publish speaks to "generalizability." (See Appendix E, page 41 for the definition of "research.") Comment: Occasionally in research methods courses, a student's work is at such a level that the faculty member might encourage the student to disseminate the results. Until the work is completed, the faculty member might not realize the work is publishable and, therefore, would not have the student seek IRB approval. In this case, the student could seek IRB approval after the fact for "use of existing data." However, if the student develops the project with the intent to publish, then the student should follow the rules for informed consent and seek IRB approval during the process. Example 3 does not apply to publishing results of clinical interventions or other kinds of projects that are clearly not research. Example 4: Use of techniques usually considered research methods might be applied for another purpose, such as to develop a clinical intervention or training program. For example, focus groups are often used in research as the primary data collection method to interview large numbers of people. However, focus groups are also widely used to understand the nature of a problem so that a training program or intervention can be developed for the target population. The focus group might be conducted systematically, but there is no intent to generalize the results, simply to develop a program relevant to the population of interest. Comment: use of focus groups to collect large-scale data sets across groups to develop model programs that might be used nationally are better classified as research and so should be reviewed by the IRB. These examples are not meant to be exhaustive. Any activity involving human subjects should be reviewed with the person s supervisor and, when in doubt, with the IRB to determine whether formal IRB review is necessary. Furthermore, even though the IRB does not review nonresearch activities, it would be reasonable to expect that individuals performing the activities incorporate the principles of respect, justice and beneficence as described in this document into the design of their activities. Consistent with the social justice mission of the University, considerations such as full disclosure, respect for privacy, fair treatment, risk-benefit ratio and informed consent should apply even when the activity is not classified as research. GENERAL PRINCIPLES The following general principles apply equally to all research (See Appendix E, page 41 for definitions) involving human beings, whether carried out solely with University resources or with the assistance of outside funds. The University assumes responsibility for communicating and explaining these principles to faculty, students and staff and for providing procedural guidelines. A. Rockhurst University faculty, staff, and students recognize their responsibility for protecting the rights and welfare of human subjects. B. Appropriate professional attention and facilities shall be provided to insure the safety and well-being of human subjects. No subject in a research activity shall be exposed to 4
unreasonable risk to health or well-being. C. Research involving children (i.e., persons under 18 years of age), other legal incompetents, and persons unable to give informed consent will be approved only with the permission of a parent or legal guardian or attorney-in-fact. (See Appendix B, page 33 for the sample informed consent form). D. The confidentiality of information received from subjects in experiments or from respondents to questionnaires shall be protected, both during and after the conduct of a research activity, within the limits of the law. E. Before a potential subject participates in research involving risk or substantial stress or discomfort, these considerations shall be carefully explained to the subject. The investigator shall be satisfied that the explanation has been understood by the subject. The written consent of the subject containing the substance of the explanation shall be obtained and kept as a matter of record. F. A request by any subject for withdrawal from a research activity shall be honored promptly without penalty or without loss of benefits to which the subject is otherwise entitled. G. Every attempt will be made to adhere to the Belmont Report principles of respect, beneficence and justice. (See Appendix F, page 47.) H. Acceptance of a research proposal by the Rockhurst University IRB in no way absolves the investigator of duties and responsibilities inherent in the conduct of responsible research. 5
SECTION II INSTITUTIONAL REVIEW BOARD The membership of the Institutional Review Board (IRB) is constituted so as to assure a broad range of competencies and includes at least one non-scientist member and one external member who has no direct relationship to the University. The IRB is accountable to the Vice President of Academic Affairs who appoints the chair and the members. The IRB has eight members who are appointed for three-year terms. Due to the nature of the work and the complexity of federal rules and regulations for human subjects, IRB members can be reappointed to additional three-year terms indefinitely at the discretion of the VP of Academic Affairs. The Institutional Review Board has the following responsibilities: 1. To serve as the final authority for the university regarding the participation of human subjects in research. 2. To serve as the university s authority regarding the participation of human subjects in research. 3. To review concerns from research subjects regarding the violation of their rights. The IRB will meet on a monthly basis during the academic year. A meeting may be cancelled at the discretion of the IRB chair if no full protocols are to be reviewed. Deadlines will be announced on the IRB web site. Researchers should submit their protocols for full-board review to the IRB Administrator no later than eight (8) business days before the scheduled meeting date. Protocols received after the deadline will normally be delayed until the next scheduled meeting. The IRB chair will inform researchers within five (5) business days after the scheduled meeting the results of the IRB review of the protocols. 6
SECTION III HOW TO DETERMINE IF YOUR STUDY REQUIRES FULL BOARD, EXPEDITED, OR EXEMPT REVIEW Reference: Code of Federal Regulations, Title 45, Public Welfare, Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks, Part 46, Protection of Human Subjects. EXEMPT REVIEWS do not have to go through full board reviews (See Appendix A, page 17 for instructions). Exempt protocols will be reviewed within 5 working days of log-in and distribution to reviewer. Feedback regarding approval or additional required information will be provided to investigators within 7 working days of log-in and distribution. Your research is exempt if it is: A. Research conducted in established or commonly accepted educational settings outside of Rockhurst University, involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. B. 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. C. 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. D. 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 7
information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. E. Research and demonstration projects that are conducted by or subject to the approval of Department or Agency heads, and that 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. F. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if 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. EXPEDITED REVIEWS do not have to go through full board reviews (See Appendix A, page 17 for instructions). Expedited protocols will be reviewed within 5 working days of log-in and distribution to reviewer. Feedback regarding approval or additional required information will be provided to investigators within 7 working days of log-in and distribution. Your research is expedited if it is: A. Clinical studies of drugs and medical devices only when the drugs or devices have been approved for marketing and are used as prescribed. B. Collection of blood samples by finger stick or venipuncture from non-pregnant healthy adults in amounts less than 550 ml in an eight-week period and no more than twice per week. C. Prospective collection of biological specimens by non-invasive means (e.g., hair and nail clippings, extracted teeth, excreta and external secretions, uncannulated saliva, placenta removed at delivery, amniotic fluid obtained at rupture of membrane prior to or during delivery, dental plaque and calculus, mucosal and skin cells collected by swab and sputum collected after saline mist nebulization). D. Collection of data through non-invasive procedures routinely employed in clinical settings, excluding x-rays or microwaves (e.g., physical sensors that do not shock or invade the subject s privacy, weighing or testing sensory acuity, magnetic resonance imaging, EEG, EKG, moderate exercise or strength testing with healthy non-pregnant subjects). E. Research involving data, documents, records or specimens collected for non-research purposes, such as medical records. 8
F. Collection of data from audio or visual recordings. G. Research on individual or group characteristics when considering the subject s own behavior (including perception, cognition, motivation, identity, language, communication, sociocultural beliefs, practices or behavior) or research employing survey, interview, oral history, focus group or program evaluation measures for purposes of research. FULL REVIEW is required by federal policy if your research meets the federal definition of research (See Appendix E, page 41 for definition) and involves any of the following conditions (See Appendix A, page 17 for instructions): A. Subjects under the age of 18 B. Pregnant women subjects C. Frail elderly subjects D. Incarcerated subjects or persons under a correctional sentence (parolees) E. Mentally impaired subjects F. False or misleading information to subjects G. Withholding information such that subjects consent is in question H. Biomedical procedures I. Procedures that are novel or not accepted practice (if this category applies, explain in the abstract and consent forms how provisions are made to correct, treat or manage unexpected adverse effects) J. Risky procedures or harmful effects, including discomfort, risk of injury, invasive procedures, vulnerability to harassment, invasion of privacy, controversial information, or information creating legal vulnerability (if this category applies, explain in the abstract and consent forms how harmful effects will be addressed and how benefits outweigh risks) 9
SECTION IV PROCEDURES In addition to the federal policies listed on page seven it is the policy of Rockhurst University to require investigators to bring any proposed research involving the use of human subjects to the attention of the IRB. Review procedures are as follows: Before beginning research that involves human subjects, the investigator shall submit a completed IRB submission form to the IRB. The IRB submission form, together with any appropriate supporting material, must provide an adequate basis for approval by an IRB member (See #1 Exempt and Expedited Reviews below) or for transmittal, if required, to the full Institutional Review Board (See #2 Institutional Review Board below). If such further review is required, the Institutional Review Board will review the submission form in light of the general principles in Section I. The signature of the reviewer on the IRB submission form signifies that the research is appropriate to the school and that the investigator is qualified to carry it out. 1. Exempt and Expedited Reviews (See Section III, page 7, for definitions of exempt and expedited reviews.) An IRB member may review and approve exempt research. Two IRB members review and approve expedited research and forward to the IRB Chair, who issues the letter of approval. The Investigator shall: A. Complete the IRB submission form (Appendix A, page 17) by answering all questions in type, providing your signature at the end. If this is a student research project, also obtain the signature of the faculty advisor before submitting for review. B. Attach a copy of any announcements or instructions relating to subject solicitation, such as announcements publicly posted or instructions to professionals who will be asked to contact potential subjects based on particular criteria. C. Attach a copy of all research instruments (e.g., questionnaire, survey, semi-structured interview guide) and a reference/bibliography. D. Attach a copy of all consent forms and assent forms (See Appendix B, page 33). E. Attach copy documenting completion of CITI training. 10
2. Institutional Review Board (Full IRB Review) Research involving the following must be reviewed by the university IRB: A. The investigator shall include in the IRB submission form a description of the manner in which the rights and welfare of the participants will be assured, (e.g., how their physical well-being and privacy will be protected and how their informed consent will be obtained, or why fully informed consent is deemed unnecessary or impractical in the particular circumstances). B. No research involving human subjects shall be initiated until IRB approval has been given. C. Any modification to an approved study must be submitted using the IRB adverse effects / modification form to the IRB for approval. D. Approval of proposed research, as required by federal guidelines, is granted for a period of up to one year commencing with the IRB chair issuing the approval letter. Requests for continuation must be submitted to the IRB before the one-year expiration date within the established timeline for review. E. The IRB requires that consent be obtained prior to the start of data collection. F. For student research the faculty advisor is responsible for reviewing the proposed procedure and specific instruments prior to submission to the IRB. G. Subjects shall be informed of the process by which they can raise concerns about their rights as research subjects: first, they should contact the Principal Investigator (PI) and ultimately, the chair of the university IRB. 11
SECTION V PROTOCOL PREPARATION GUIDE The IRB will meet on a monthly basis during the academic year. A meeting may be cancelled at the discretion of the IRB chair if no protocols requiring full-board review are received within eight (8) business days of the scheduled meeting date. Meeting dates will be announced on the IRB web site. Researchers should submit their protocols to the IRB Administrator at least eight (8) business days before the scheduled meeting date. Protocols received after the deadline will normally be delayed until the next scheduled meeting. The IRB chair will inform researchers within five (5) business days after the scheduled meeting the results of the IRB review of the protocols. Follow the IRB submission instructions in Appendix A, page 17: A. The IRB submission form must be properly completed. All investigators must sign it. B. If for any reason co-investigators are not able to sign the IRB submission form, letters of support signed by them must appear directly behind the IRB submission form. C. The protocol must follow the format in Appendix A. Protocols that do not conform to the established instructions will be returned to the investigator for revision and resubmission. D. Consent form(s) must follow the format in Appendix B. (See Appendix B, page 33 for consent form example.) E. If research is being conducted through institutions such as schools, nonprofits, businesses, etc., a letter for each institution must be included with the IRB submission form. The letter should indicate support of the project and that the PI has permission to conduct the proposed research at the institution. The letter must be on letterhead with an original signature by an authorized official at the institution. E-mails are not acceptable substitutes for a letter. 12
SECTION VI ELEMENTS OF INFORMED CONSENT AND CONSENT FORM REQUIREMENTS Consent forms document that the research project has been adequately explained to the subject. (See Appendix B, page 33 for sample consent form.) Generally written consent forms are required for all research with two major exceptions: A. When mailed, e-mailed or web based questionnaires are used, it can be assumed that consent is given if the Subject returns the questionnaire. It is recommended that a statement be included at the top of the questionnaire that indicates by submitting the questionnaire, the participant consents to participate in the study. B. When it is not feasible to ask Subjects to sign a consent form, an oral consent may be taken and should be recorded if the data are to be collected in audio or video taped interviews. A witness should sign the consent form indicating that oral consent was given. (e.g., interviews with indigenous people who do not have a written language or interviews with people who state that they do not wish to sign their names to preserve anonymity.) However, neither of these conditions exempts the Investigator from fully explaining the study to the Subjects either in a cover letter (for questionnaires) or on tape (for interviews). In both cases, the information on the sample consent form must be explained to Subjects. Consent forms need to be written in clear, concise, non-technical language, and must follow these guidelines: A. Be duplicated on institutional letterhead. B. Label the consent form: Consent to Participate in Research. C. List all investigators with names, addresses, and telephone numbers. Students must list their faculty sponsor(s). D. List the source of support, if applicable. E. Include the following elements: (See Appendix B, page 33 for sample consent form.) Project Title Investigator Advisor 13
Source of Support Purpose Risks and Benefits Compensation Confidentiality Right to Withdraw Purpose The first two sentences should give a brief, non-technical explanation of the study and identify why a particular subject is asked to be in the study. (Example: The purpose of this research is to determine if people of various ages and with different types of illnesses have different problem-solving skills.) Risks Include all reasonably foreseeable risks and discomforts. Such risks could be physical, psycho-social, or legal. Also mention precautions taken to avoid such hazards. If blood is to be drawn, then, if appropriate, mention in the consent form the possibility of a bruise or soreness at the site of venipuncture, or a spasm with loss of blood flow at the site of arterial puncture. Benefits Include any benefits to the Subject or to scientific knowledge. Include any monetary or tangible benefits to the Subject. Compensation Include any cost or payment to the subject, or reimbursement for related expenses. Mention any conditions affecting payment and time of payment. If appropriate, include a statement such as: All costs not related to the research will be charged to me just as though I were not part of this study. If there is no compensation, the consent form must clearly state that subjects will not be paid for participation in the study. Confidentiality Assurance of protection of confidentiality must be included. Describe your plans, and then include appropriate sections of the following: I understand that any information about me obtained from this research, including answers to questionnaires, history, laboratory data, findings on physical examination, or audio or videotapes will be kept strictly confidential. Information that will carry personal identifying material will be kept in locked files for a minimum of three (3) years. I do understand that my research records, just like hospital records, may be subpoenaed by court order. It has been explained to me that my identity will not be revealed in any description or publication of this research. 14
Therefore, I consent to such publication for scientific purposes. Withdrawal from a Study Subjects must be informed that they have the right to withdraw at any time without penalty. Summary of Results The consent form must include a commitment to supply a summary of the results of the research at no cost to the subjects if they request a summary. Voluntary Consent (See Appendix B, page 33 for sample consent form for wording.) Signatures (See Appendix B, page 33 for sample consent form for signatures.) 15
ANNUAL REVIEW SECTION VII ANNUAL REVIEW, ADVERSE EFFECTS, MODIFICATIONS, AND TERMINATION Annual review of approved protocols is mandatory. Renewals are approved by the IRB Chair who may at his or her discretion consult with members of the IRB (See Appendix D, page 38 for form); submit one signed copy and one electronic copy of the form to the IRB administrator thirty (30) days prior to the one-year anniversary date of the study. TERMINATION When a project has been completed or terminated, the PI must within sixty (60) days send written notification to the IRB (See Appendix D, page 38 for form) and submit a project summary. Submit one signed copy and one electronic copy of the termination form and project summary to the IRB administrator. ADVERSE EFFECTS Any adverse effects must be reported within 24 hours to the chair of the IRB. In addition, the Adverse Effects form (See Appendix C, page 36) must be completed with one electronic copy and one signed copy submitted to the IRB administrator. (See Appendix F, page 41 for the definition of adverse effects). All data collection activities must cease until IRB review is completed. MODIFICATIONS Any significant modifications to the originally approved application, requires submission of the Modifications to Approved Protocols form (See Appendix C, page 36 for form.). The PI must submit one original signed copy and one electronic copy to the IRB Secretary and receive approval for modifications from the IRB Chair prior to the implementation of any modifications. Modifications to protocols can be made at any time during the annual approval period. Some modifications are expeditable. Modifications that changes the risk level or significantly changes the project's goals or methodology are not expeditable. Modifications to a full board review protocol must be reviewed and approved by the IRB board at the next scheduled meeting. The IRB chair, shall decide the appropriate review process. When a modification is made and approved, the actual approval date for the project will not change. The modification will merely be acknowledged. The annual renewal will still be due on the anniversary of the original approval date. 16
APPENDIX A IRB SUBMISSION INSTRUCTIONS 17
ROCKHURST UNIVERSITY INSTITUTIONAL REVIEW BOARD PROTOCOL FOR PROTECTION OF HUMAN SUBJECTS IN RESEARCH IRB SUBMISSION INSTRUCTIONS 1. Why does Rockhurst University have an IRB? This federal requirement is part of the legacy of scientific abuses of vulnerable populations such as occurred in the Tuskegee Syphilis Study and the Nazi Medical War Crimes. 2. Who needs to submit to the IRB? a) If your proposal meets the federal definition of research: Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge ; [From http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102;] AND b) You will be working with human research subjects; AND c) You plan to publish or present your data. 3. Who does NOT need to submit to the IRB? a) If you are conducting an in-class evaluation of students or faculty; OR b) You are conducting normal evaluative processes such as program and departmental reviews. For all categories of review, provide 1 written copy with original signatures as well as an electronic copy to the IRB Secretary in the Graduate Studies office, VA 300, in accordance with the following instructions. 1. Complete this Submission Form by answering all questions in type, and providing your signature at the end. If this is a student research project, also obtain the signature of the faculty advisor before submitting for review. 2. Attach a copy of any announcements or instructions relating to subject solicitation, such as announcements publicly posted or instructions to professionals who will be asked to contact potential subjects based on particular criteria. 3. Attach a copy of all research instruments (e.g., questionnaire, survey, semi-structured interview guide.) 4. Attach a copy of all consent forms and assent forms. 5. If research is being conducted through institutions such as schools, nonprofits, businesses, etc., attach letters of support for each institution indicating the PI has permission to conduct the proposed research at the institution. Letters must be on letterhead with an original signature by an authorized official at the institution. E-mails are not acceptable substitutes for letters. 6. Attach copy of documentation of completed CITI training. 18
Submit application for full board review no later than eight (8) business days before the date of the IRB meeting on which the review is to occur. Do not include this page in the submission packet. SUBMIT COMPLETED CHECKLIST AND PROPOSAL SUBMISSION FORM AND ATTACHMENTS TO: IRB Secretary GRADUATE STUDIES OFFICE, Rm 300, Van Ackeren INCOMPLETE SUBMISSIONS WILL NOT BE ACCEPTED FOR REVIEW. 19
Rockhurst University Institutional Review Board 1100 Rockhurst Rd. Kansas City, Missouri 64110 Application for Review of Research Involving Human Subjects A. GENERAL INFORMATION OFFICE USE ONLY # Exempt Log-in date: Expedited Action: Full-Board Date: 1. Principal Investigator(s): ( Name, degree, title, dept, phone #, e-mail) 2. Faculty Supervisor(s) ( If PI is Student): ( Name, campus address, phone #, e-mail) 3. Title of Project: 4. Level of Project: (check all that apply) Project intended for publication or presentation Faculty Research Student Research: The signature of a faculty advisor is required when an RU student is identified as the principal investigator of a research project. The faculty advisor s signature certifies that the research will be conducted in compliance with Federal and University policies. Thesis/Capstone** Class Project Other (Specify) If thesis or capstone research has this protocol been approved by the student s committee? Yes No Program Chair signature approving Capstone Program Chair printed name 20
SPECIFIC REVIEW REQUEST Please note that any request overlapping various categories will require the more intensive means of review Category of Review Requested: (Check one.) Exempt Expedited Full (studies that do not meet criteria for Exempt or Expedited must be reviewed by the full IRB at one of the regularly scheduled meetings) I. If seeking an Exempt review complete this section by checking all that apply. Research conducted in established or commonly accepted educational settings outside of Rockhurst University (see 2.a., p.1), involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 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. 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. 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. 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. 21
Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if 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. II. If seeking an Expedited review complete this section by checking all that apply. Clinical studies of drugs and medical devices only when the drugs or devices have been approved for marketing and are used as prescribed. Collection of blood samples by finger stick or venipuncture from non-pregnant healthy adults in amounts less than 550 ml in an eight-week period and no more than twice per week. Prospective collection of biological specimens by non-invasive means (e.g., hair and nail clippings, extracted teeth, excreta and external secretions, uncannulated saliva, placenta removed at delivery, amniotic fluid obtained at rupture of membrane prior to or during delivery, dental plaque and calculus, mucosal and skin cells collected by swab and sputum collected after saline mist nebulization). Collection of data through non-invasive procedures routinely employed in clinical settings, excluding x-rays or microwaves (e.g., physical sensors that do not shock or invade the subject s privacy, weighing or testing sensory acuity, magnetic resonance imaging, EEG, EKG, moderate exercise or strength testing with healthy non-pregnant subjects). Research involving data, documents, records or specimens collected for non-research purposes, such as medical records. Collection of data from audio or visual recordings. Research on individual or group characteristics when considering the subject s own behavior (including perception, cognition, motivation, identity, language, communication, sociocultural beliefs, practices or behavior) or research employing survey, interview, oral history, focus group or program evaluation measures for purposes of research. III. If seeking a Full review, check the categories that apply to your subjects or methods. Subjects under the age of 18 Pregnant women subjects Frail elderly subjects Incarcerated subjects or persons under a correctional sentence (parolees) Mentally impaired subjects 22
False or misleading information to subjects Withholding information such that subjects consent is in question Procedures for debriefing subjects (specify): Biomedical procedures (If checked, answer the following) (a) Are provisions for medical care necessary? yes (give details): (b) no Has an MD with relevant experience participated in planning the study? yes (attach letter) no (c) Will the study involve drugs, chemical agents, recombinant DNA, genetic research, ionizing radiation, non-ionizing radiation, microwaves, lasers, high-intensity sound, stem cells? yes (specify and describe): no Procedures that are novel or not accepted practice (if this category applies, explain in the abstract and consent forms how provisions are made to correct, treat or manage unexpected adverse effects) Risky procedures or harmful effects, including discomfort, risk of injury, invasive procedures, vulnerability to harassment, invasion of privacy, controversial information, or information creating legal vulnerability (if this category applies, explain in the abstract and consent forms how harmful effects will be addressed and how benefits outweigh risks) 23
Protocol Template 1. Location of Research a. Is this a multi-center project in which RU will function as the coordinating center or lead institution? ( A multi-center study is one where different PIs at different institutions are conducting the same study or aspects of the same study) No Yes, please list collaborating sites and letters of approval from other IRB site(s). If IRB support from collaborating site is conditional on RU approval, please submit letters of cooperation or support, as appropriate. 2. Has this application been submitted to any other Institutional Review Board not listed above? Yes No If yes, provide name of committee, date, and decision. Attach a copy of the approval. 3. Funding * Is this a funded study? Yes ( ) No ( ) If yes, Please provide the following: a. Type of funding: Contract/Grant Subcontract Gift Student Project Other b. Source of funding: Federal Government Other Gov. (i.e., State, local) Foundation Other Private RU Other c. Name of Funding Agency: d. Period of Funding: e. Funding Status: NA Funded Funding Decision Pending *A copy of the approved scope of work and contractual obligations, if any, are required for all sponsored research projects. ( a sponsored research project refers to projects that are receiving financial support). 24
4. In carrying out this research project will you be collecting, reviewing or receiving Protected Health Information? (Protected Health Information is individually identifiable health information transmitted or maintained in any form or medium, which is held by a Covered Entity or its business associate. A Covered Entity is a health plan, a health care clearinghouse, or a health care provider who transmits any health information in electronic form in connection with a HIPAA transaction, such as billing. Yes No If you answered yes please provide as an attachment, information about the covered entity s policies and procedures regarding HIPAA compliance. Investigator(s) certification of successful completion of the CITI Training module(s) regarding HIPAA must also be on file with the IRB. 5. Expected Project Start Date: 6. Expected Project Completion Date: B. SUMMARY OF PROPOSED RESEARCH 1. Project Summary (Provide a brief summary of the scope of work of this project, using non-technical terms that would be understood by a non-scientific reader. This summary should be no more than 200 words.) 2. Purpose and/or Rationale for Proposed Research a. Purpose and background for the proposed project b. Hypothesis/Research Question for proposed project 3. Methodology/Procedures (Describe sequentially and in detail, all procedures in which the research participants will be involved, e.g., paper and pencil tasks, interviews, observations, surveys, questionnaires, reviewing private records/files, physical assessments, audiotaping and/or videotaping, time requirement including number of sessions, amount of time per session, and duration or period of time over which the research will take place, etc. For school-based research where class time is used, describe in detail the activities planned for nonparticipants and explain where both participants and non participants will be located during the research activities. Include a concise description of procedures, locations, time commitments, and alternate activities on the relevant consent and assent forms. Specifically note how the methodology addresses the hypothesis/research question.) 25
4. Measures (List all questionnaires, surveys, interviews, psychological measures, or other measures, that participants will be asked to complete. Submit labeled copies as an attachment to the application and indicate that the instrument is in the public domain or provide appropriate documentation of permission to use each scale.) 5. Location of Research (List all locations where data collection will take place. Be as specific as possible. If you are collecting data in a location where it would be customary to ask permission to conduct the research project [ e.g., schools, community centers, businesses, etc.], a letter stating the sites willingness to grant the researcher access is required. This letter must be submitted before IRB approval can be given. In addition provide a copy of IRB approval from those sites having Institutional Review Boards or another research review process.) 6. International Research (For International research identify the country where the research will be conducted, and provide information about: whether there is an official or government agency in the country that needs to approve the research, the language of the research participants, the literacy level of the research participants, whether research participants face any special risks due to the political or social condition in the research setting and the qualifications of the researcher that allows them to estimate and minimize risks.) 7. Participants Involved in the Study Participant Population (Check all applicable boxes, if any) Prisoners Institutionalized Residents Legally Incompetent Illiterate Participants Employees/Agency Staff Pregnant Women Economically disadvantaged Minors (Under Age 18) (Indicate Age Range) Physically or Mentally Challenged Elementary School Students Secondary School Students Employees or Subordinates of Investigators Public Officials or Candidates for Public Office None of the above (Describe in detail the sample to be recruited including number of participants, inclusion and exclusion criteria, gender, age range and any special characteristics.) 26
8. Recruitment Process (Specifically describe the step-by-step procedures for finding and recruiting research participants or requesting pre-existing data or materials. Name any specific agencies or institutions that will provide access. Identify who will contact prospective participants. Describe solicitation through the use of advertising posters, flyers, announcements, newspaper, radio television or internet, face to face interactions such as direct mail or phone contact, class rooms, subject pools, health care registries, and institutional gatekeepers as applicable. Attach a copy of any recruitment materials including: poster(s) advertisement(s) or letter(s) or solicitation scripts to be used for recruitment.) 9. Compensation of Participants Will participants receive compensation for participation? Yes No (If yes, please provide details including the form of remuneration including dollar amount, course or extra credit, lottery, gift certificate. Explain the remuneration plan, including whether and how pro-ration will be made for partial participation. For lotteries include the number of prizes, nature and value of each prize. Include information about compensation on the relevant consent and or assent forms. Please refer to The Consent Process guidance for more information.) C. POTENTIAL BENEFITS FROM THE STUDY (Discuss any potential direct benefits to participants from their involvement in the project and/or the potential benefits to society that would justify involvement of participants in this study.) D. POTENTIAL RISKS FROM THE STUDY 1. Discuss the known and anticipated risks, if any, of the proposed research. Specify the particular risks(s) associated with each procedure or test. Consider both physical and psychological/emotional risks. 2. Describe any procedures or safeguards in place to protect the physical and psychological health of the participants. [e.g., referral to psychological counseling resources] 27
E. CONSENT 1. Consent Process: (Describe the circumstances and procedures followed as they pertain to obtaining voluntary informed consent.) 2. Informed Consent: (Describe the format and documentation of the informed consent document and attach a copy of the form you will use. Please see The Consent Process guidance for more information.) 3. Waiver / Alteration of Informed Consent Are you requesting a waiver or alteration of Informed Consent? Yes No (If you are requesting a waiver or alteration, describe: (1) how the proposed research presents no more than minimal risk to participants,(2) why a waiver or alteration of informed consent will not adversely affect the rights and welfare of participants,(3) why it is impracticable to carry out the research without a waiver or alteration of informed consent. Also describe how pertinent information will be provided to participants, if appropriate, at a later date. Describe how you will otherwise fully inform participants, i.e., use of an information script, information letter, etc.) For research involving minors, or others who are not competent to give legally valid consent, explain how the participant s understanding will be assessed and how often, include the questions that will be asked or actions that will be taken to assess understanding. Describe the process to be used to obtain permission of parent or guardian. Attach a copy of an informationpermission letter to be used. F. ASSENT (For persons who are not legally competent to give consent but are reasonably competent to decide whether to participate or not, describe the procedure you would use to gain assent and attach the form. Children must assent (or, voluntarily agree) to participate and a parent/guardian must separately provide permission on behalf of his/her child. Two separate forms are required. Children under age 7 may assent either orally or passively, depending on their level of maturity.) Please provide a numbered list of all consent/assent forms used for the study listing the title and purpose (i.e., Child assent, staff consent, parent/guardian permission) 1. 2. 3. 4. 28
Will you be obtaining consent/assent from non-english speaking participants: Yes No If yes, describe the process that will be used to translate documents, the language and qualifications of the translator. (Please note that the IRB requires a back translation be conducted as part of the translation process). G. CONFIDENTIALITY (Describe the procedures to be used to ensure confidentiality of participation and data obtained Confidentiality is required unless participants give express, written permission to have their identifiable information published, presented, or shared. Explain who will have access to raw data, whether raw data will be made available to anyone other than the Principal Investigator and immediate study personnel (e.g., school officials, medical personnel, federal agencies etc.) If yes, who, how and why? Describe the procedure for sharing data. Describe how the research participant will be informed that the data may be shared. Describe any circumstances under which you might be required to break confidentiality. Explain how you will inform potential participants that confidentiality may be broken.) 1. Data Collection (Explain how the data will be kept confidential. If anonymous data collection is proposed, provide details of how investigators WILL NOT HAVE THE ABILITY TO TRACE RESPONSES TO RESEARCH PARTICIPANTS IDENTITIES. For multiphase data collection or if multiple contacts will be made with research participants, specifically explain the tracking and coding systems that will be used. Address the confidentiality of data collected via e-mail, databases, Web interfaces, computer servers and other networked information, as applicable.) Check if any of the following will be used in Data Collection: Audio tapes Video tapes Still photos Other imaging (If any of these data collection methods are used describe how/where tapes will be stored, who will have access to them, and at what point and how they will be destroyed) 2. Data Storage/Disposition (Indicate where and how you will store the data and how long you plan to retain it. Describe how you will ultimately dispose of data including notes, drafts, lists of subjects, disks, etc.) 29