RESEARCH PROTOCOL FOR REVIEW OF PROTECTION OF HUMAN RIGHTSThis protocol must be approved by the Human Rights in rights of the subjects will be guarded in writtenResearch Committee before data are collected. Read the materials and publications arising out of theHuman Rights in Research policy in the appropriate research.Handbook for your program before completing this form. c) How you will provide for debriefing of subjectsSubmit your original of the completed protocol (including following their responses to or involvement in yourall relevant documentation) to the Academic Doctoral research. Describe information given to subjectsOffice. regarding how any questions they have regarding the research can be addressed. Where applicable, describe what will be done in the event of research- related injury. Your name 3. Read the attached Human Subjects Risk Level Assessment Form carefully and mark all items in each Date risk category that are pertinent to your research. Transfer the totals from the form to the following categories: No Risk Minimum Risk Program Moderate Risk High Risk (Return the completed Human Subjects Risk Assessment Form with this protocol.) Title of Proposed Research 4. If your research involves vulnerable populations, include the following in the description of your research procedure: ! If Your Subjects are Minors. Describe how you will obtain each childs assent as well as that of the Readers or Supervisor childs legal guardian. Note: At any level of risk, informed consent must be obtained from both the parent or guardian and the minor before researchRisk Assessment is begun. If consent is given by the minor, but not by the parent or guardian, research is not to beSelect from your proposal the relevant information under conducted. Describe the means to be taken toeach of the following headings and attach it to this reduce risks and to safeguard the subjects.protocol. Describe why alternative, less-risky methods of research would not be possible.1. Describe the subjects. ! If Your Subjects Are Vulnerable to "Undue2. Provide a summary of your research procedure Influence" For example, anyone over whom you indicating all of the following: have authority, or anyone in your care, is vulnerable to your influence. Describe how thea) Methods of data gathering to be used (interview, subjects right to decline participation without questionnaires, and so on). You must attach copies negative consequences will be preserved. of all research instruments to be used, Describe the means to be taken to reduce risks and to safeguard the subjects. Describe whyb) How "informed consent" will be obtained. You must alternative, less-risky methods of research would attach any letters or forms that will be used to not be possible. secure voluntary informed consent. In this section include: ! Other "Vulnerable Populations" For example, • A description of how you will obtain written those who are institutionalized or are unable to consent; make their own decisions are vulnerable. • Or, if written consent is not possible, how you Describe the vulnerability of the subjects and how will obtain verbal informed consent; the risk caused by this vulnerablility will be • how you will indicate to subjects that their minimized. Describe the means to be taken to participation is voluntary and that they are free reduce risks and to safeguard the subjects. to withdraw at any time; Describe why alternative, less-risky methods of • how you will ensure anonymity and research would not be possible. confidentiality of responses; • and, where applicable, how the anonymity and
Topics or questions raised are politically, emotionally, Human Subjects Risk Level Assessment Form culturally, spiritually, or psychologically sensitive.This checklist is provided to help the researchers, reviewers, and Individual or group presentations, phone calls, orthe Human Rights in Research Committee to consider thoroughly questionnaires will be used to solicit participation in the research.the research proposal in light of the potential risk to human The research objective is not revealed at the outset to thesubjects and does not in itself determine the decision or subject in a direct and straightforward manner as in the case ofrecommendations of the Committee. It is not the intent of the research which requires that the subject be naïve regarding theCommittee to use this risk level assessment tool to comment on research in order to participate objectively.the merits, quality, or design of the research beyond the potential Subjects are required to reflect upon their own behavior,risks to human subjects. values, relationships, or person in such a way that one might be influenced or affected, and/or anxiety or concern might be raisedBased on your research purpose, population, and methods, regarding the subject matter of the inquiry.check all items in each category that apply to your researchand indicate the totals in #3 on other side. It is not uncommon The subject may have regrets, concerns, afterthoughts, orfor items to be checked in more than one category, and it may reactions to the research method after the procedure istake only one risk factor to actually place the entire research completed.procedure in a particular category. You may be able to argue in The subject may become tired, weakened, or be mentallysupporting documentation for the value of a research procedure or physically affected as a result of the research and/or method.which justifies the assessed risk level; or you might describe The research may inconvenience subjects by causing aresearch procedures which reduce the potential impact of an delay or intrusion into their routine or schedule.acknowledged risk factor. The survey, interview, or research methodology will intrude on the persons activities or take more than 5 minutes of theNo Risk Level Criteria subjects time. People will be observed randomly in a public place wherethere is no personal identification of subjects. Total: Subjects are not aware of the observation and do not havedirect contact with researcher. High Risk Level Criteria The subject is queried or led to reveal highly personal Only public information will be utilized such as phone information in areas such as significant relationships, trauma,books, directories or other published lists. sexuality, potentially immoral, unethical or illegal behavior. Data are collected without any identifying information. The content focus or the research methodology itself willThere is no possible or imaginable way to trace responses back raise issues that are highly charged politically, emotionally,to subject. culturally, psychologically, socially or spiritually. Data will be used collectively in a statistical manner and no The research will involve a minor who does not have theone individuals response can or will be tracked. authority and/or ability to give fully informed consent for Total: participation. The research will intentionally, or by design, involveMinimal Risk Level Criteria persons who may be of legal age yet who are dependent on Subjects are interviewed or otherwise contacted to solicit others due to a chronic or crisis health concern, developmentalparticipation. delays, advanced age, a language barrier, and/or incarceration in Inquiries are made regarding basic identifying information an institution, which may impair the subjects ability to give fullysuch as age, gender, ethnicity, and so on. informed consent. Subjects are asked to answer general questions regarding Subjects will be selected to participate based upon anon-personal information. particular disorder or health concern. Subjects are to give opinions or viewpoints on The subject is likely to be affected emotionally, socially, orcommonplace matters such as locality, general trends, or other psychologically through the research over the short and/or longbenign topics. term to such an extent that debriefing or other reparative The research will not in any way influence or affect the interventions are planned into the research design (not solely forsubject socially, psychologically or spiritually. preventative purposes). The collection of required information will not take more The research design calls for deception of the subject atthan 3 to 4 minutes of the subjects time. any level. Total: The research involves physical manipulation, contact or touching either with the researcher or between subjects, physical exercise, and/or any medical procedure.Moderate Risk Level Criteria The subject is asked to reveal personal information The research itself or the information obtained from theregarding individual viewpoints, background, behaviors, attitudes subjects may have immediate and/or long term political, legal,or beliefs. economic and/or social consequences for the subjects. Subjects will be selected to participate based upon a Involvement in the research will require more than 60particularly unique characteristic (e.g., they all hold the same minutes of the individuals time or significantly influence theposition in an organization; they have similar training or, they persons routine and/or activities.come from a similar background). Total: Subjects will be selected to participate based upon anextraordinary life experience.
SAMPLE CONSENT FORMSAdapt the following as appropriate for your research or course practice exercise.Informed Consent Cover LetterDevelop a cover letter that includes an appropriate adaptation of the following elements:The research in which you are about to participate is designed to investigate (identify your research purpose) and is beingconducted by (give your name or name the organization sponsoring the research). In this research you will (tell thesubjects what they will be asked to do). Please be assured that any information that you provide will be held in strictconfidence. At no time will your name be reported along with your responses. Please understand that your participation inthis research is totally voluntary and you are free to withdraw at any time during this study.“I acknowledge that I have been informed of, and understand, the nature and purpose of this study, and I freely consent toparticipate.”NameSigned DateUse of QuestionnaireDevelop a cover letter that you will include with the questionnaire that includes an appropriate adaptation of the followingelements:The research in which you are about to participate is designed to investigate (identify your research purpose) and is beingconducted by (give your name or name the organization sponsoring the research). In this research you will (tell thesubjects what they will be asked to do). Please be assured that any information that you provide will be held in strictconfidence. At no time will your name be reported along with your responses. Please understand that your participation inthis research is totally voluntary and you are free to withdraw at any time during this study. By your completion of thisquestionnaire, you are giving informed consent for the use of your responses in this research project.Permission to Participate in Test Administration PracticeI, (give your name), am currently enrolled in a graduate level course which involves learning the appropriate use of (namethe practice test or procedure). I am requesting your permission to participate in taking a (name the appropriate action) sothat I can practice administering this assessment tool. This test involves (tell them what you will ask them to do) and willrequire about (give approximate time). Since this is an administration for practice purposes, please understand that Icannot discuss any test results. Such results would not be considered valid due to my limited experience with such testsand could provide misleading information. Thank you for your participation and help in this learning experience.Name of participantSignature of participant DateSignature of parent or guardian, if applicablePermission to Participate in a Class ExerciseI, (give your name), am currently enrolled in a graduate level course involving learning the appropriate use of (circle one:interview technique, verbal questionnaire, written survey, role play, simulation, other: ). I am requesting yourpermission to participate in this exercise which involves (tell them what you will ask them to do) and will require about(give approximate time). Thank you for your participation in this learning experience.Name of participantSignature of participant DateSignature of parent or guardian, if applicable