Clarkson College
Applied Research ManualClarkson College
Table of ContentsExecutive Summary . 1Applied Research Overview . 2Applied Research Process – Student Flow . 3Applied Research Process – Faculty, Staff and External Constituents . 4Research Support Services . 5Institutional Review Board . 61. Overview of Institutional Review Board . 62. Definition of Terms for IRB Application . 73. Explanation of IRB Review Levels . 104. Guidance for Types of Research that May Require IRB Approval . 125. Human Subject Regulations Decision Chart . 136. Application Process . 14a. IRB Guidelines for Application . 16b. Submission of Application . 17c. Application Submission Review Flowchart. 18d. IRB Application Review Check Sheet . 19e. IRB Decision Appeals Policy . 24Human Subject Research Guidelines . 251. Participants Protection Education . 252. Recruitment Materials Guidelines . 263. IRB Consent Form Guidelines . 284. Rights of Research Participants . 29REVISED 08.2021i
5. Unanticipated Problem/Adverse Event Reporting Policy and Process . 306. Data Collection with Prior IRB Approval policy . 32Forms . 361. IRB Exempt Application . 362. IRB Non-Exempt Application . 423. Consent Forms . 481. Template for Adult Consent Form . 482. Implied Informed Consent and Template . 523. Request for Waiver of Written Informed Consent Form . 554. Template for Parent/Guardian and Child Permission Form . 565. Template for Adolescent Assent Form for Participants Aged 12 to 18 . 604. Request for IRB Renewal . 635. Application for Change of Protocol . 666. Study Closeout Form . 697. Unanticipated Problem/Adverse Event Reporting Form . 71References . 73Acknowledgements . 73REVISED 08.2021ii
Executive SummaryThis document is intended to clarify and emphasize the expectations and process flow of research atClarkson College for internal and external constituents (including students, faculty, and staff), as wellas provide guidance for Institutional Review Board requirements and processes. The Mission ofClarkson College is to prepare students to professionally provide high quality, ethical andcompassionate healthcare services. Through the Values of the College: Learning, Caring,Commitment, Integrity and Excellence, the College remains student centered and is focused on thedelivery of extraordinary education.Applied research at Clarkson College is defined in this document and reflects the student successskills, which are the student learning outcomes of communication, critical thinking, technology,diversity, and professional behavior. The applied research process includes students in allundergraduate and graduate academic programs, faculty, staff, and external constituents. The processrequires continuous assessment and reporting. The outcomes of this process, coupled with theacademic program assessment, are used to make recommendations for improvements annually.Questions regarding the flow and information in this manual can best be answered through consultationwith your program director or research project advisor. Questions regarding the IRB process or overallresearch compliance should be directed to either the IRB Chair or the Director of Research Compliance.REVISED 08.20211
Applied Research OverviewClarkson College Applied Research Definition:The following definition was chosen by the College which reflects both the Mission and theClarkson College Student Learning Outcomes: Communication, Critical Thinking, Technology,Diversity and Professional Behavior.Clarkson College Applied Research focuses on the practical scholarship of integration andapplication. Professional practice benefits from the translation of original research to theglobal society, bringing life theory and reality to research. Scholarship is demonstratedthrough a research project that reflects the breadth of the student's education and thatsynthesizes the knowledge gained through their course of study. Students will use criticalthinking skills to propose an evidence-based strategy, implement an intervention, and/orevaluate outcomes. The project may take on many forms. However, the common elements aretranslation of evidence to improve practices, processes and/or outcomes related to theresearch question, and to communicate their findings using appropriate technology.Leveling of Research at Clarkson CollegeResearch concepts are introduced to our students in all degree levels:The Undergraduate Level (Associates and Bachelors programs) provides a basic knowledge ofresearch elements and design of the research process. Students are introduced to statistics, literaturereview, and appraisal of published articles. Students are expected to create analytical papers supportedand/or substantiated with scholarly sources. A variety of assignments and projects are used to assess astudent’s learning of research skills throughout the undergraduate programs.The Graduate Level (Master and Doctoral programs)Masters Programs provide the students an in-depth knowledge of the research process. Variousresearch designs are analyzed in addition to exploring the relationship between research, theory, andpractice. The courses will prepare the student to appraise published research studies and apply researchfindings to guide evidence-based practice. Students are expected to integrate and synthesizeknowledge, strategies, theories, and principles learned throughout the course of study, bridging the gapbetween coursework and professional practice.Doctoral Programs provide the students an advanced knowledge of the applied research process. Thecourses will prepare the student to evaluate published research studies and design and implementapplied research. Students are expected to integrate and synthesize knowledge, strategies, theories, andprinciples learned throughout the course of study culminating in a scholarly project or dissertation.REVISED 08.20212
Applied Research Process - StudentsAll students follow the Research Process appropriate to their status at the College. Students conductingresearch must work within the guidelines of their academic program procedures and designated projectadvisor/chair, etc., whose background or interests coincide with the purpose and content of theresearch. It is recommended that students have taken a foundational research, scientific investigations,or evidence-based practice course(s) or can demonstrate they have had the appropriate researchcomponents in their discipline. Students must complete the certification in research ethics education,the Collaborative Institutional Training Initiative (CITI). The research project must be approved by theClarkson College Institutional Review Board (IRB) prior to implementation, as necessary. Theprincipal investigator is encouraged to contact the Office of Research Compliance prior to submissionto the IRB for clarification and guidance in terms of project development and ethical requirements forhuman subjects research. The student constituents are depicted in the following processes.Clarkson College StudentResearch ProcessFoundational Courses* Research Design and Methods (I & II)Research Methods and Data AnalysisApplied ResearchEvidence-Based PracticeResearch Courses* (Project Advisor/Dissertation Chair assigned) CITI Certification(anytime throughoutprocess, requiredbefore IRBsubmission)Senior Project (I, II & III)Doctoral Seminar (I, II, III, & IV)Scholarly Project (I, II & III)Dissertation (I, II & III)IRB ProcessProject Implementation(if applicable)*Examples of past courses only; refer to the Academic Catalog for current available coursesREVISED 08.20213
Applied Research: Faculty, Staff & ExternalConstituentsThe College does not require their faculty to research or publish as part of their contract; however, the AppliedResearch Process appropriate to their status at the College as a faculty or staff member follows the process below.The faculty, staff and external constituents are depicted in the following processes and the details in each step ofthe flow are outlined in detail in the table below.1.2.LevelFaculty/Staff ResearchProjectFaculty/Staff asStudents at ClarksonCollege3. Clarkson CollegeContent1.2. 3.Clarkson CollegeFaculty & Staff who areStudents at an ExternalInstitution usingexternal subjects5. External Constituentsusing Clarkson CollegesubjectsResearch ProjectFaculty and Staff who are Clarkson College students will follow the same Research Process as theClarkson College Students.Clarkson College Faculty, Staff or Students, as subjectsSeek IRB approval from the external institution.Complete IRB application to conduct research at Clarkson College and obtain approval letter fromdirector of that program in which you wish to conduct research. Submit IRB application and approval letter to Clarkson College IRB for approval. Faculty & Staff who areStudents at an ExternalInstitution usingClarkson Collegesubjects4.Research Project Process –Notify Director/Supervisor of intent for research Provide current CITI certification. Work with Director of Research Compliance as needed during the research process and before IRBsubmission. Submit application to IRB to obtain approval. Submit closing form to IRB.4.5.External Employees or Patients, as subjects Comply with the external institution’s research protocol.Clarkson College Faculty, Staff or Student as subjects Request approval from department head who is responsible for the population sample, who willconsult with the Clarkson College IRB chair. REVISED 08.2021Obtain documentation of the department supervisor’s decision.Submit application to the CC IRB for approval (Clarkson College IRB will send letter of final approvalto requestor and department head.)4
Research Support ServicesDepartment/Program Resources: Investigators are encouraged to reach out to the department/programdirector, project advisor, and/or other faculty members with the expertise in the area of research beingconducted. Refer to any Academic and Program specific handbooks and policies as they may also behelpful to investigators throughout the research process.Library Resources:The Library offers all resources to the online students through the Clarkson College Website. TheLibrary’s present trend to utilize technologies to support student access to information resources ispossible through full-text databases, EBSCO’s A to Z tool, electronic books and instructional materialsavailable on the College Online Campus course management system.Writing Lab:The Writing Lab offers all students both on campus and online the ability to review and learnscholarly writing. This includes feedback on content, APA formatting, grammar and punctuation.Applied Research Forum:The Applied Research Forum has been established by the College and is organized by the ResearchCompliance Office. The purpose of the Forum is to address contemporary research issues and to assistfaculty, students, and staff in exploring and expanding their knowledge of scholarly research and how toactively engage in applied research. The Applied Research Forum is considered a resource to help in theearly phases of the research process and will provide educational sessions to the College community.The Forum meets once a month, and sessions will be recorded and archived. Faculty, staff, and studentsare encouraged to attend at any time.Principal Investigator Resources: IRB Chair: leads the IRB committee and is available to any faculty and staff to consult on IRBissues, applications, and process to ensure the protection of human participants in the researchprocess.Director of Institutional Effectiveness: available to assist researchers and constituents of theCollege in the formatting and delivery of surveys and dissemination of survey data followingIRB approval.Director of Research Compliance: available to consult on IRB applications and process,general research compliance, and ethical requirements to ensure the protection of humanparticipants in the research process.REVISED 08.20215
Institutional Review BoardOVERVIEW OF INSTITUTIONAL REVIEW BOARDAT CLARKSON COLLEGE“Investigators must balance their interest in gathering data and answering research questionswith society’s mandate to protect the rights and safeguard the welfare of research participants. Societyhas granted a conditional privilege to perform research on human beings the condition is that it mustbe conducted in a way that puts the rights and welfare of human participants first” (Gottesman, 2004, p.i).Clarkson College created its Institutional Review Board (IRB) during the 2003-2004 academicyears. The IRB is composed of at least five members from a variety of disciplines with experience andpreparation in research as well as community members. The members determine the viability ofproposed research in accordance with institutional standards, professional practice, and applicable law.At least one member’s primary concern is scientific, one is non-scientific, and one is not affiliated withClarkson College. The IRB reserves the right to consult with other experts when a research proposal isbeyond the scope of the expertise of the current board members.IRB Responsibilities“If there is any element of research in an activity, that activity should undergo review for theprotection of human subjects” (Belmont, p.5). In light of that directive, the IRB is responsible for thereview of all research performed at Clarkson College in order to ensure that professional, ethical, andlegal standards concerning the use of human participants are being followed. The Standards are those inTitle 45 Code of Federal Regulations, Part 46: Protection of Human Participants (45 CFR Part 46) andinclude the ethical principles of The Belmont Report. In order to approve research covered by thispolicy, the IRB shall determine that risks to subjects are minimized by using procedures which areconsistent with sound research design, and which do not unnecessarily expose subjects to risk. Inaddition, risks to subjects must be reasonable in relation to anticipated benefits, if any, to subjects, andthe importance of the knowledge that may reasonably be expected to result (46.111). Privacy andconfidentiality must be protected, and data must be monitored to ensure subject safety. Attention mustbe paid to subjects’ vulnerability to coercion or undue influence in making an informed decision.Additional safeguards must be provided for vulnerable populations including children, veterans ofmilitary service, prisoners, and individuals with impaired decision-making ability.Note: The Clarkson College Institutional Review Board will not approve any research involvinganimals.The IRB meets 5 times during the academic year monthly to review full-board applications submitted bythe submission deadline (see IRB application submission deadlines and meeting schedule posted on theClarkson College IRB web page).The IRB reviews the application for completeness, accuracy, and coherence. If the application is notapproved, the IRB may refer it to the Director of Research Compliance to consult with the PrincipalInvestigator (PI), who submits the revised application (with all changes highlighted) to the IRB.REVISED 08.20216
DEFINITION OF TERMS FOR THE IRB APPLICATIONComplete the IRB human subject research determination form on IRB webpage (IRB Determination Form Clarkson College) and read all directions for application before completing the IRB application formlocated on the IRB webpage/Canvas IRB Companion/Student Success Guide.Title of Study: Consult the current APA Manual for proper wording and punctuation.Study Site(s): Describe specifically where the study will be conducted, and describe methods used toseek site approval. Include letters of agreement with agencies or locations in the appendices andmethods used to seek site approvalPrincipal Investigator: Principal Investigator (PI) – A Principal Investigator is the primary individualresponsible for the preparation, conduct, and administration of a research project or grant and isobligated to ensure the project is conducted in compliance with applicable laws and regulations andinstitutional policy governing the conduct of sponsored research. Identify your professional or personalrole at the site, and any relationship with potential participants. For example, doctoral students are thedesignated principal investigator.Co-Investigator (Co-I) – Co-Is are key personnel who have responsibilities similar to that of a PI onresearch projects. While the PI has ultimate responsibility for the conduct of a research project, the Co-Iis also obligated to ensure the project is conducted in compliance with applicable laws and regulationsand institutional policy governing the conduct of sponsored research. Identify their professional orpersonal role at the site, and any relationship with potential participants. For example, a doctoralstudent’s scholarly project advisor or dissertation chair is the co-investigator.Problem Statement (e.g., research question, PICO, or PICOT): In one concise sentence, state theproblem or issue, the current remedy or solution, your proposed remedy or solution, and the outcome(s)you hope to accomplish.Purpose of the Study: In a few sentences, describe the purpose of your study. This section serves as thespringboard for the following section. The Purpose should flow from the Problem.Background and Rationale: Provide a brief background for context and support for the Purpose withclear reasons for the study, including why this research is needed. If applicable, state the researchquestion(s) and hypotheses. Finally, note the following guidelines:a. An exempt review requires a summary in APA style with at least two relevant citations and areference page.b. An expedited review requires a summary in APA style with at least four relevant citations and areference page.c. A full review requires a summary in APA style distilled from the investigator’s review of theliterature. This summary includes five or more citations and a reference page. If a grant applicationor other type of proposal exists, simply summarize the literature and attach the proposal as anappendix to the application.To protect human subjects, Federal regulations require that an IRB consist of diverse members from awide variety of backgrounds, including providers, scientists, non-scientists, and members of theREVISED 08.20217
community. Your goal is to communicate clearly, so spell out acronyms, define medical jargon, and useordinary language. Just as with your subjects, your readers may not be providers or experts in your field.Population and Characteristics: Describe the characteristics of the potential population, giving specialattention to any vulnerable populations (see definition below).Vulnerable Population: The World Medical Association (WMA) states some persons requireprotection because “some groups and individuals are particularly vulnerable and may have an increasedlikelihood of being wronged or of incurring additional harm. All vulnerable groups and individualsshould receive specifically considered protection” (WMA, 2018). Examples of vulnerable populationsinclude prisoners, children, pregnant women, neonates/fetuses, mentally disabled persons, militaryservice veterans, and the economically or educationally disadvantaged.Age Range: Give the age range of potential participants. For adult participants, use the legal age ofconsent in the state(s) of the study site(s). For example, the legal age of consent in Nebraska is 19.Method of Subject Selection: Describe the specific inclusion and exclusion criteria, includingscreening methods used to screen subjects. Provide reasons for participation restrictions such as gender,race, religion, or age. Describe all techniques used to recruit individual participants, and include allrecruitment materials such as phone scripts, emails, and flyers in the appendices. Indicate yourprojected, hoped for, or expected minimum and maximum number of participants. If you are using morethan one site, provide the minimum and maximum number of anticipated participants for each site.Description of Research Design, Methodology, Recruitment Procedures, and Collection of Data:In complete sentences, use bullets or numerals to describe the research design, if you will use aquantitative, qualitative, or mixed methods approach, and note how you will ensure the validity andreliability of your study.Detail each step in your Methodology, outlining study and recruitment procedures; a sequentialdescription of what subjects will be asked to do; assignment of subjects to various arms of the study, ifapplicable; and how and in what form data will be collected. In the active voice, state who will recruitand consent subjects, who will carry out all procedures or measurements, and who will collect the dataand keep them secure. Include the number and duration of contacts with each subject, outcomemeasurements, and follow-up procedures. You must also include any data collection instruments (e.g.,interview or survey questions, pre/post-test tools, or evaluation documents) in your appendices.In the Methodology, describe who will be obtaining consent (or permission) and from whom. Includedescription, as relevant, of any waiting period between the initial consent discussion and obtainingconsent, and steps that will be taken to minimize coercion or undue influence. If children will beenrolled as subjects, describe the provisions for obtaining parental permission and assent of the child ifappropriate. If decisionally impaired adults are to be enrolled, describe the provision for obtainingsurrogate consent from a legally authorized representative (LAR).Applicants must include the Informed Consent Form(s) with the application in the appendices.Note: Flawed or weakly designed studies that are deemed sub-standard will not be approved.REVISED 08.20218
Ultimate Distribution and Disposition of the Data Collected: List the entities (Graduate Symposium,for example) with whom study findings will be shred. Study data must be kept securely for up to 3years. State how you will store and ultimately dispose of all data collected.Risk/Benefit Assessment: This section breaks down into several sections in which you evaluate anddescribe all potential risks and benefits to subjects and society. The evaluation of risks and benefits arecritically important in the fully informed consent process (see Section 7) and must also appear in theinvitation to participate.Compensation for Participation: Your assessment of benefits also includes any tangible compensationfor subjects who consent to take part in your study. Compensation may include cash, gifts, gift cards,coupons, reimbursements, educational materials, and food or drink.Steps to Protect Confidentiality and Privacy: Describe how you will ensure that the confidentialityand privacy of your subjects are protected. If you collect data or identifiers that may link data toindividual participants, justify why collecting these data is necessary. If data collected will be used andreported in the aggregate, state that here and in the consent form (see Section 7).REVISED 08.20219
EXPLANATION OF REVIEW LEVELSData collected for the purpose of institutional administrative use (e.g., accreditation or regulatoryrequirements) or internal programmatic development and/or evaluation does not require IRBreview, unless any of the following apply: The data will be disseminated outside of Clarkson College (e.g., conferences, publications). Data collection, analysis or dissemination involves an external entity or partner. Data collection involves asking participants questions of a sensitive nature or elicitingpersonal information regarding their perceptions, feelings, or beliefs rather than abouta specific institutional policy or program.All research that involves human subjects or data and does not qualify under institutional orprogrammatic use (see section 1.2), must submit a IRB Human Subject Determination Form (IRBDetermination Form Clarkson College) for preliminary IRB review.A project that is considered exempt must still be submitted to the IRB and the IRB will certifyexemption from expedited or full-board review.All student projects must be approved by the IRB prior to any data collection or implementation.If you are unsure if your research involves human subjects and requires IRB review/approval,please contact the Research Compliance Office for assistance.Exempt (45 CFR 46.104) – Research may be considered exempt if it falls within one of the belowcategories:a.b.c.d.e.Surveys, interviews, educational tests, and public observations (that do not involve children)Benign behavioral interventionsSecondary research uses of identifiable private information or identifiable biospecimensFederal research or demonstration projectsTaste and food quality evaluation studiesResearch is not exempt if it:is greater than minimal riskor;involves administration or use of drugs or devicesExpedited (45 CFR 46.110) – Research involves no more than minimal risk, and for minor changes inpreviously approved research. Research may qualify for expedited review if it falls within one of thebelow categories:a. Clinical studies of drugs and medical devices only when certain conditions are metb. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certainpopulations and within certain amountsc. Prospective collection of biological specimens for research purposes by noninvasive meansd. Collection of data through noninvasive procedures (not involving general anesthesia or sedation)routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.e. Research involving materials (data, documents, records, or specimens) that have been collected, orwill be collected solely for non-research purposesf. Collection of data from voice, video, digital, or image recordings made for research purposesg. Research on individual or group characteristics or behavior or research employing survey,REVISED 08.202110
interview, oral history, focus group, program evaluation, human factors evaluation, or qualityassurance methodologiesFull Board (45 CFR 46.110) – The probability and magnitude of harm or discomfort anticipated in theresearch are greater in and of themselves from those ordinarily encountered in daily life or during theperformance of routine physical or psychological examination or tests or are not in a category allowedfor Expedited Research. Research that does not qualify for exempt or expedited (presents more thanminimal risks to subjects) will require review at a fully convened IRB committee meeting.Note: Most scholarly journals require proof of IRB exempt certification or expedited or full-boardapproval for manuscript publication. PIs are encouraged to proceed with exempt certification even ifthey believe their project does not fall under the definition of research that requires IRB review.REVISED 08.202111
GUIDANCE FOR TYPES OF RESEARCH THAT MAY REQUIRE IRB APPROVALWhen a study does not require any IRB review: Uses publicly available data/information Data collected for the purpose of institutional administrative use (e.g., accreditation or regulatoryr
Students at Clarkson College 2. Research Project Faculty and Staff who are Clarkson College students will follow the same Research Process as the Clarkson College Students. 3. Clarkson College Faculty & Staff who are Students at an External Institution using Clarkson College subjects 3. Clarkson College Faculty, Staff or Students, as subjects
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