The Baker College Research Manual is a comprehensive guide designed to support ethical, high-quality research within the academic community. It outlines the principles, policies, and best practices that govern responsible research, including data management, publication practices, and the treatment of research participants. By following these guidelines, researchers at Baker College are encouraged to uphold the highest standards of academic integrity and contribute to an environment of scholarly excellence. This manual serves as a valuable resource for faculty, staff, students, and community members helping them navigate the complexities of the research process while maintaining trust and credibility in academic inquiry.
The Baker College Research Manual adheres to the policies contained in the Baker College Research Policy and Baker College Conduct of Research Policy and expands on the role of the Institutional Review Board (IRB) with regards to oversight of research involving human subjects. The manual provides a detailed explanation of the procedures related to the IRB review of proposed research.
Table of Contents
Introduction
Investigators
Background Information You Need to Know
The Application
The Review Process
Appendix A: Review and Approval Categories
Appendix B: Frequently Asked Questions
Appendix C: Guidelines for Parental Consent
Appendix D: Obtaining and Documenting Assent from Minors
Appendix E: Guidelines for International Research Involving Human Participants
All research at Baker College is governed by the Baker College Research Policy and Conduct of Research Policy. Researchers are required to be familiar with and adhere to these policies with regards to the ethical conduct of research at Baker College.
With respect to research involving human subjects, the intent of these policies and review procedures is to safeguard the rights and welfare of human subjects (by the elimination or minimization of research-related risks and the requirement for informed and voluntary participation by subjects) and to ensure Baker College is in compliance with federal rules. The goal of the Baker College Institutional Review Board (IRB) is to work with investigators to promote research which protects all participants, including the College and its investigators. Failure to follow established policies and procedures, or to disregard ethical standards will result in the cancellation of the research project, and may result in additional consequences.
This manual applies to Baker College faculty, staff, and students as well as community members, researchers, and students (from outside of Baker College) who are or will be involved with research projects that involve human subjects. It is designed to be a user-friendly guide to the Institutional Review Board's (IRB’s) policies governing research the (a) Rights and Welfare of Human Subjects Policy, (b) Research Policy, and (c) Conduct of Research Policy. This manual provides step-by-step procedures for preparing and submitting applications to the IRB for review.
All Baker College faculty, staff, and students must complete the CITI Research Ethics and Compliance Training before submitting an application to the Baker College IRB. External community members must submit documentation of completion of an IRB approved equivalent to the CITI Research Ethics and Compliance Training before submitting an application to the Baker College IRB. Researchers must maintain this certification throughout the duration of the research project. Currently, this training is available online at https://about.citiprogram.org/en/homepage/.
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Students (Baker College)
Note: The following section provides information for Baker College students and faculty members who supervise student research.
Student Research Projects (Baker College)
Undergraduate and Graduate Research
Undergraduate and graduate students completing dissertations, theses, projects, or independent study research involving human subjects follow the same procedures used by faculty submitting research. The faculty sponsor is responsible for informing students of the necessary procedures and ensuring compliance with all applicable policies.
Class Research Projects Involving Human Subjects
Students conducting survey research as part of a course requirement may collect opinion-based data from human subjects, provided that responses do not involve personal behaviors or experiences and that the participants remain anonymous. Findings from any such project is not disseminated beyond the classroom setting. Such research does not require IRB review.
Classroom Assignments for Educational Purposes
Classroom assignments designed to demonstrate research methods, rather than to generate generalizable knowledge or disseminate findings beyond the class, do not require IRB oversight. However:
- Projects classified as demonstration research may proceed without review, provided students have the option not to participate as subjects.
- Faculty should ensure students review appropriate research ethics materials, including this manual, to prepare them for future independent research.
Use of Data from Existing IRB-Approved Research
Students utilizing data from a research project that has already received IRB approval must be added as researchers to the original study. The principal investigator (PI) must submit an amendment to the IRB specifying the student’s role in the project.
Use of Archival Data
Students using archival data sets do not require IRB oversight, as they are not directly interacting with human subjects. However, if the data originates from past research at Baker College, it may only be used in accordance with the original IRB-approved protocol or upon submission of an updated protocol.
Even when IRB review is not required, both student researchers and faculty must uphold ethical standards in research involving human subjects. When appropriate, informed consent should be obtained.
Student Responsibilities (Baker College)
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The student conducting research will comply with all guidelines established by the program and College, as well as any applicable guidelines established by any external organization involved in the project.
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The student is responsible for understanding that participation by any person in a research project is voluntary. In the event that any compensation is to be provided, such compensation will be approved in advance by the Institutional Review Board to ensure that principles of “reasonableness” are maintained, and that participants are not subject to undue influence as a result of the compensation offered. Generally, compensation is limited to reasonable reimbursement for the participant’s actual time.
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The student is responsible for submitting for approval all research assignments, prior to his or her initiation. Submission must be made in accordance with established policies and procedures to either the individual faculty member or the IRB.
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The student is responsible for obtaining approval of all research instruments developed in association with a research assignment, i.e., surveys, questionnaires, etc. Approval from the overseeing faculty member or the IRB must be obtained prior to the start of any data collection.
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The student is responsible for considering the cost of completing an assignment. Projects should not be initiated that have the potential to become a financial burden to the student.
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The student is responsible for all legal costs incurred in the conduct of the research, as well as any unanticipated costs that result because of the research or any individual’s involvement in the research project.
Faculty and Staff (Baker College)
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The faculty or staff member conducting research will comply with all guidelines established by the program and College, as well as any applicable guidelines established by any external organization involved in the project.
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The faculty/staff member is responsible for understanding that participation by any person in a research project is voluntary. In the event that any compensation is to be provided, such compensation will be approved in advance by the Institutional Review Board to ensure that principles of “reasonableness” are maintained, and that participants are not subject to undue influence as a result of the compensation offered. Generally, compensation is limited to reasonable reimbursement for the participant’s actual time.
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The faculty/staff member is responsible for submitting for approval all research assignments, prior to their initiation. Submission must be made in accordance with established policies and procedures to the IRB board.
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The faculty/staff member is responsible for obtaining approval of all research instruments developed in association with a research assignment, i.e., surveys, questionnaires. Approval from the IRB board must be obtained prior to the start of any data collection.
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The faculty/staff member is responsible for considering the cost of completing an assignment. Projects should not be initiated that have the potential to become a financial burden to the member/college.
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The faculty/staff member is responsible for all legal costs incurred in the conduct of the research, as well as any unanticipated costs that result because of the research or any individual’s involvement in the research project.
Faculty, Students and Community Members (from other institutions)
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Any faculty/students/community members conducting research will comply with all guidelines established by the program and College, as well as any applicable guidelines established by any external organization involved in the project.
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The faculty/students/community member is responsible for understanding that participation by any person in a research project is voluntary. In the event that any compensation is to be provided, such compensation will be approved in advance by the Institutional Review Board to ensure that principles of “reasonableness” are maintained, and that participants are not subject to undue influence as a result of the compensation offered. Generally, compensation is limited to reasonable reimbursement for the participant’s actual time.
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The faculty/students/community member is responsible for submitting for approval all research assignments, prior to their initiation. Submission must be made in accordance with established policies and procedures to the IRB board.
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The faculty/students/community member is responsible for obtaining approval of all research instruments developed in association with a research assignment, i.e., surveys, questionnaires. Approval from the IRB board must be obtained prior to the start of any data collection.
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The faculty/students/community member is responsible for considering the cost of completing an assignment. Projects should not be initiated that have the potential to become a financial burden to the member/college.
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The faculty/students/community members are responsible for all legal costs incurred in the conduct of the research, as well as any unanticipated costs that result because of the research or any individual’s involvement in the research project.
External researchers must follow their own institution’s IRB policies and procedures. In addition, they must adhere to Baker College’s IRB policies and procedures outlined in the IRB website and in this document.
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Definitions
Research is a systematic and organized effort undertaken to investigate a specific question, problem, or hypothesis with the goal of generating new knowledge, understanding, or solutions. It involves the application of established methodologies to collect, analyze, and interpret data, and is often guided by a clear set of objectives or research aims.
Human Subject means a living individual from whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
Human Subjects Research is a systematic investigation designed to develop or contribute to general knowledge, which involves the collection of data from or about living human beings.
Activities which meet this definition constitute "research," whether or not they are supported or funded under a program that is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. Human Subject Research does not include research utilizing published or publicly available documents or research on elected or appointed public officials or candidates for public office.
IRB refers to the Institutional Review Board. This board is appointed to review research involving human subjects for compliance with applicable federal, state, and local regulations. The IRB membership includes Baker College faculty and staff from relevant disciplines, as well as member(s) of the local community.
At Risk means to be placed in a position with greater potential for physical, mental, social, or financial harm than would be expected for that individual in his or her normal occupation or daily activities.
Minimal Risk means 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.
Reasonable Risks means the relationship of anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
IRB Scope
All research involving human subjects, including research training, must be reviewed and approved by the College’s Institutional Review Board (IRB) before any human subject research can begin. The IRB has full authority to approve, require modifications, or disapprove all research activities that fall within its jurisdiction.
There are three types of review classifications--Exempt from Further Review, Expedited Review, and Full Board Review. Criteria for qualifying for a particular review category are specified by the Department of Health and Human Services. The Exempt classification does not mean that the research project is exempt from review by the IRB; rather, it is a classification assigned by the IRB after its review of the protocol to indicate that the project is exempt from further IRB review as long as there are no modifications in the procedures. Submission of an application is required even if the PI thinks the project should qualify as Exempt.
A detailed discussion of the criteria for the classifications is found in Appendix A. This information is included for your general knowledge and to help you determine a general time frame for the review process.
Explanation of Application Elements
The IRB plays a critical role in reviewing proposed research by evaluating potential risks to participants, ensuring the proper implementation of informed consent processes, and verifying that studies align with the ethical principles of beneficence, justice, and respect for persons as outlined in the Belmont Report. Its review process emphasizes careful consideration of the following elements:
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Risk. Are the procedures and subject’s participation adequately described? Do the study's procedures place the subject at risk in any form? Are risks fully described? Is the risk minimal or reasonable as defined by the Policy? Are the procedures adequate to minimize any risk?
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Benefit. If there are potential risks, should the knowledge from the research be pursued? Do the benefits outweigh the risks? Have the benefits to the subject and/or society been described?
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Informed Consent. Are the subjects provided with sufficient detail in the consent form to assure voluntary and informed consent? Are participants notified that they can withdraw at any time? Are the participants informed about their recourse in the event of injury? Are the participants provided with a name and phone number of a person to call with any questions or problems? Is there any indication of coercion or undue influence?
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Confidentiality/anonymity. Is the selection of participants/subjects fully explained? If the subjects are anonymous, how is anonymity ensured? Are the procedures sufficient to allow for confidentiality of information about individual subjects in both gathering and dissemination of information? Are security measures adequately described?
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Special or vulnerable populations. Are vulnerable populations involved? If so, have particular and appropriate steps been taken to assure they or their legal guardians understand what is going to happen, their participation is voluntary, legal consent has been obtained, etc.? Is selection of subjects equitable?
A pivotal issue in the review process is deciding whether or not the proposed research might place subjects at more than minimal risk. There is no simple, objective criterion that can be applied in all such judgments. The College’s Rights and Welfare of Human Subjects policy states that “which do not unnecessarily expose subjects to risk.” In practice, minimal risk means 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 tests or examinations. This definition acknowledges that most people’s daily lives include challenges and stresses. In practice, the kinds of experiences that "most people" have on a "typical" day are considered minimal risk, exposing subjects to the kinds of physical or psychological stressors that make some of our days rather painful or disturbing would be judged to involve more than minimal risk, despite the fact that such experiences may not always cause lasting harm.
Two other issues central to the evaluation of virtually all proposals are the issues of confidentiality and informed consent. Your application must provide a thorough description of the steps that will be taken to maintain the confidentiality of data. For instance, if the participants will be completing written questionnaires, will they be asked to include or omit their names from these forms? Even when names are omitted, individuals can sometimes be identified from demographic or other background information that they provide. When identifying information is needed, what other steps will you take to ensure that the data will remain confidential? What steps will you take to ensure the confidentiality of photographs and video or audio recordings? A statement to the effect that “confidentiality will be maintained” is not sufficient.
You must obtain the legally effective informed consent of your participants or of their legally authorized representatives. This will mean obtaining a signed consent in most cases. Informed consent must be written or explained in language that is understood easily by the subject or representative, usually language appropriate for the 7th or 8th grade reading levels. You must seek such consent under circumstances that provide the prospective subject with sufficient opportunity to consider whether or not to participate. These circumstances must also minimize the possibility of coercion or undue influence. Subjects must be informed of any foreseeable risks or discomforts. They must also be given an explicit statement explaining that their participation is voluntary, that refusal to participate will involve no penalty, and that they may discontinue participation at any time without penalty.
In the case of an anonymous questionnaire in which a signed informed consent form would provide the only means of identifying the subject, an explanatory letter (see the sample in the “Sample Informed Consent Forms” under the IRB Website) attached to the questionnaire may substitute for a signed informed consent form. While the sections in these samples are relevant to most research studies, the samples themselves are intended to serve as a guide to developing a consent form aligned with the proposed research project.
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The application process begins with the Baker College Pre-IRB Application form which is completed by the PI. The pre-application collects basic information about the proposed research which allows an IRB committee member to review and make recommendations prior to submission of the official application. Student researchers are required to enter the name of their faculty sponsor and the name of the Program Director / Dean overseeing their program. Each will have to approve the submission prior to review. Faculty and staff researchers are required to enter the name of the Vice President for their Department. The Vice President is required to approve the submission prior to review. External researchers will be required to document the Baker College co-investigator.
The following are additional considerations.
Authorization and Approval at External Data Collection Sites
In many cases, PIs will become involved in research projects that reach out to community partners or into business and industry. In all cases, approval must be obtained in writing from all agencies or organizations involved in the research in a scanned format.
Approval by the Baker College system and/or the Baker College Institutional Review Board authorizes a PI to proceed with a particular project but does not authorize the PI to proceed at a location outside of Baker College.
Prior to collecting data at any off-campus site, the PIs must receive permission in writing to operate at a specific site (Note: Students must return this permission to the faculty member overseeing the research project). In some cases, this may require the PI to submit an application to the Institutional Review Board operating within the desired research setting in addition to an application to the Baker College Institutional Review Board. This is particularly likely to occur in medical or hospital settings where permanent IRBs are generally in place. The only exception to this will be the collection of observational data of public behavior in public settings that does not involve direct contact between the researcher and the research participant and does not involve the collection of any information that would allow the individual research participant to be identified. Such research does, however, still require the approval of the Baker College Institutional Review Board.
Authorization and Approval within Baker College
The Pre-IRB Application screening form requires Baker College students, faculty, or staff to obtain approval from the faculty sponsor, Program Director / Dean, or departmental Vice President.
In addition, if the PI plans to use Baker College students or staff as subjects at any Baker College campus, the research study must be reviewed and approved by the President’s Leadership Cabinet following IRB approval.
The Application Submission
The formal IRB application found on the IRB website is completed by the PI following approval of the Pre-IRB application. If the PI is a student, the application must be approved by the student's faculty sponsor and Program Director / Dean. The responsibility for complying with the Policy and Procedures is shared by the faculty sponsor and the student. If the PI is a faculty or staff member, the application must be approved by the Dean or departmental Vice President.
Links to the Application Forms for IRB submission are located on the IRB Website.
Note: Researchers or IRB Applicants from outside Baker College should contact the IRB Chairperson for further information and direction at IRB@baker.edu.
Any questions about the completion of the application should be directed to the Chair of the IRB.
Please bear in mind that you may NOT initiate any research involving human subjects until you have received written notification of IRB approval.
If you have submitted this project to an external agency for funding, attach one copy of the external proposal to the application. If you intend to submit this project to an external agency for funding, forward a copy of the external support proposal to the Chair of the IRB as soon as feasible.
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Once the IRB Application is signed by the PI, the application is automatically logged into the system.
On a weekly schedule, the IRB chair will conduct a review to determine completeness of the application package and determine the type of review (exempt, expedited, or full board review) appropriate to the project application.
The Chair will notify you of the results of the Review and the type of review required for your application. If your package is missing any required components, your application will be returned to you with instructions on how to complete it. You may correct any deficiencies and return the package for a second review. If your application is ready for an Expedited Review or full board review, you will be invited (but not required) to attend the IRB meeting during which the review will occur.
The committee completing an Expedited Review may request clarifications or changes. A detailed, written explanation of the Committee's concerns and requests will be forwarded to you within two weeks of the Committee's review.
If your application does need modifications, you will submit these as a reply to the ticket generated by the original application. Assurances that the changes have been made is not sufficient. The complete modified application must be on file with the Chair of the IRB.
Written notification of the Committee's approval of your application (or a request for further clarifications, if needed) will be forwarded to you within two weeks of the Committee's review of your modified application.
If your application is to appear before the Full Board for review, you will be invited to attend the review. A Full Board Review may request modifications or clarifications; these will be forwarded to you in writing within two weeks of the Board's review. You will receive written notice of approval or denial of your application.
It is the policy of Baker College that the IRB will utilize Department of Health and Human Services criteria for all projects involving human subjects in research when evaluating proposed research protocols. The chairperson or one or more IRB members designated by the chairperson may determine one of three actions: Exemption from Further Review, Expedited Review, or Full Board Review. Please note that any research project may fall under only one category. The following section elaborates upon the types of IRB reviews.
Research Considered Under the “Exempt From Further Review” Category
In order to establish an individual research project as Exempt from Further Review, the PI must complete the appropriate “Baker College IRB Application” (Student or Faculty / Employee). Final determination as to whether a research project is Exempt from Further Review rests with the Chair of the IRB or his/her designee. If the project is certified Exempt from Further Review by the IRB, the PI need not resubmit the project for continuing IRB review as long as there are no modifications in the exempted procedures. Submission of an application is required even if the PI thinks the project should qualify as Exempt.
The following categories are considered Exempt from Further Review:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices such as research on regular and special educational instructional strategies, or 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, or achievement) if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research involving survey or interview procedures, EXCEPT where all of the following conditions exist:
- responses are recorded in such a manner that the human subject can be identified, directly or through identifiers linked to the subject;
- the subject’s responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability; and
- the research deals with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
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Research involving the observation (including observation by participants) of public behavior EXCEPT where any of the following conditions exists:
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observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subject;
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the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability; and
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the research deals with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
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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.
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All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.
Research Considered Under the “Expedited Review” Category
The PI shall submit the appropriate “Baker College IRB Application”. Research activities involving no more than “minimal risk” to subjects and in which the only involvement of human subjects will be in one or more of the following categories may be reviewed by the IRB Expedited Review Subcommittee:
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Collection (in a nondisfiguring manner) of hair, nail clippings, deciduous teeth, and permanent teeth if patient care indicates a need for extraction.
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Collection for analysis of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
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Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, and thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays and microwaves).
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Collection of blood samples by fingerstick or venipuncture, in amounts not exceeding 450 milliliters in an eight-week period, and no more often than two times per week, from subjects 18 years of age or older who are in good health and not pregnant.
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Voice recordings made for research purposes such as investigations of speech defects.
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Moderate exercise by healthy volunteers.
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The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
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Research on individual or group behavior or characteristics of individuals such as studies of perception, cognition, game theory, or test development, in which the investigation does not manipulate subject’s behavior, and the research will not involve stress to subjects.
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Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth, and the process is accomplished in accordance with accepted prophylactic techniques.
Research Considered Under the “Full Board Review” Category
Any research project involving the use of human subjects which does not fall into the “Exempt from Review” or the “Expedited Review” categories must be submitted to the IRB for a full board evaluation. The PI must complete and submit the “Baker College IRB Application,” Student or Faculty & Employee, as appropriate..
Conditions under Which IRB Approval is not required for Survey Research
Students wanting to collect data from human subjects as part of the requirements for a specific class may conduct opinion research that is not specific to the behaviors and/or experiences of the interviewees, as long as informants are not identifiable by name or description. Information collected from surveys of this type may not be disseminated beyond the classroom.
For example, IRB approval is not required for a student to survey people’s opinions about topics such as the following:
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opinions of political candidates or issues
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opinions regarding American-made vs. foreign-made products
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opinions concerning environmental issues or policies
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opinions regarding the subject’s favorite television show, preferred vacation spot, musical preference, etc.
The key factor shared by these examples is that they do not require subjects to reveal anything about their personal experiences, behaviors, and/or identity. Therefore, the subjects are not considered to be placed at risk by their participation. Thus, in these cases, IRB approval is not required.
Additional information concerning student research, and how it is handled by the IRB, can be found in the Baker College Research Manual.
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How do I determine if a project is considered to be research?
The U.S. Department of Health and Human Services (HHS) defines research as: "A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."
Key Questions to Determine If a Project is Research:
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Is the project a systematic investigation?
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Does it involve a structured approach, such as hypothesis testing, data collection, and analysis?
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Does it follow a research methodology?
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Does the project involve human subjects?
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Does the project contribute to generalizable knowledge?
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Is the goal to publish findings, present at conferences, or apply results beyond a specific setting?
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If the findings are intended to be broadly applicable, it is more likely to be considered research.
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Does the project involve an intervention or interaction with individuals?
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If the project manipulates variables, assigns treatments, or gathers information through interviews, surveys, or observations, it may be classified as research.
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Is the data collection for internal improvement or external application?
Types of Projects That May Not Be Research:
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Internal program evaluations
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Quality improvement or assurance projects
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Case reports (if limited to a small number of cases)
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Classroom exercises meant for educational purposes only
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Journalistic or oral history activities that do not generalize findings
How do I determine if a project involves human subjects?
Based on the definition of Human Subjects Research (45 CFR 46.102(e)), A research project involves human subjects if:
Key Questions to Determine If Human Subjects Are Involved:
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Does the study involve direct interaction or intervention?
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Interaction includes any form of communication with participants (e.g., interviews, surveys, focus groups).
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Intervention includes manipulations of the participant’s environment or behavior (e.g., medical procedures, behavioral tasks, experimental treatments).
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Does the study use identifiable private information?
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Private information refers to data that individuals expect will not be shared (e.g., medical records, financial data, academic records).
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Identifiable means the information can be linked to a specific individual, either directly (e.g., name, address) or indirectly (e.g., unique codes that can be traced back to the participant).
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Does the project involve biospecimens?
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If human-derived biological materials (e.g., blood, saliva, tissue) are collected, stored, or analyzed with identifiers, the study qualifies as human subjects research.
Examples of Human Subjects Research
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Clinical trials involving drug testing on participants
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Surveys or interviews that collect personally identifiable opinions or experiences
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Observational studies where participant behavior is recorded in a way that identifies individuals
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Research using identifiable health records or student records
Examples of Studies That May NOT Be Human Subjects Research:
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Studies using only publicly available datasets (e.g., U.S. Census data)
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Research involving deceased individuals (not covered by human subjects protections)
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Anonymous surveys where responses cannot be linked to individuals
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Observations of public behavior where no identifiers are collected
What types of projects must students, faculty, or staff submit to the IRB?
The human subjects review process applies to all research involving the use of human subjects. This applies to research that is funded or unfunded; research that is undertaken by students, faculty, or staff at Baker College; research done on the property of or using the facilities of Baker College; and/or research using College personnel or students as subjects.
What types of course activities do not require IRB approval, and can I make that decision?
Course activities which use human subjects are exempt from review as long as the purpose is purely pedagogical and the results are intended solely for use within the classroom setting. One way to understand these criteria is to consider the purpose of the project. Classroom activities designed to teach research processes that do not involve collecting data for the purpose of creating knowledge are generally exempt. If the results have the potential for public dissemination, IRB approval must be obtained. Anonymous classroom assessment techniques of students for the purpose of improving classroom instruction would be considered exempt from IRB review. If the activities clearly fall within these criteria, the instructor/investigator could make this determination. If the instructor/investigator is not clear on the status of the project or would prefer that the IRB decide such status of the project, the instructor/investigator can submit the proposal to the IRB for review.
Do students undertaking a project as part of a class assignment require IRB approval?
Certain types of survey research, conducted as a portion of a specific course, do not require IRB approval. This includes research in which the responses of participants are not identifiable by name or description, AND where the survey is seeking opinions about various topics. In cases where the participant is not asked to reveal personal experiences or behaviors, IRB approval is not necessary.
When survey research is conducted as a portion of a class in which a participant is asked to disclose identifying information, IRB approval is required. Further, survey research that seeks to identify participants only within a specialized population—such as minors, individuals with disabilities, prisoners, or other vulnerable groups—or investigates a variety of sensitive areas, including but not limited to mental health, substance use, sexual behavior, or illegal activities, requires approval to ensure ethical considerations and participant protections are met.
For all student research activities conducted as a part of a course, the protocol must be reviewed and approved by the course instructor, program director, and campus administrator.
All other research conducted with human subjects as part of a course will require normal IRB approval.
My project involves a community partner. Do I need Baker College IRB approval?
Partnering with a community member in no way alters the Baker College employee’s responsibility to participate in the IRB review process. All policies regarding the review and safeguards for research participants must be maintained in accordance with standard policy.
In some cases, a community partner may have its own institutional review board. In these cases, the community partner may require adherence to policies that are more protective of a participant’s rights than Baker College policy, and Baker College employees would be expected to comply with those policies. If an outside review board sets policy that is less stringent than Baker College policy, all employees will be required to adhere to the policy of Baker College.
In either case, an application must be filed with the Baker College IRB.
Who determines that a project is exempt?
Final determination as to whether a research project is exempt from IRB review is determined during the IRB Review process following initial submission.
What happens if my IRB application is not approved?
You are not authorized to start your project, but you may reapply with recommended changes.
What happens if I do not agree with the committee?
If you believe that the recommended changes indicate that there is a portion of the research that was not fully understood by the IRB, then you may choose to alter that part of the IRB application that appears to have been misunderstood, and resubmit the entire application for a full board review. It is recommended that in such cases the PI attend the full board review to provide any clarification. If the application is again denied, it will be reviewed only following completion of all recommended changes.
I have a sponsored project for an outside organization that must be done within a tight time constraint. Do I need approval, and if so, how long will it take? Will review force me to reject the funding?
Sponsored projects are treated as any other research projects. How long it takes depends on which level of review is required. Reviews are conducted frequently. The normal review process on a complete application may take three to six weeks; modifications to the application will extend this process.
External funding of a project in no way alters the approval process. If the project is not approved by the IRB, the PI may not begin work on the project. This may result in a loss of funds.
I submitted a protocol for review because it was part of an externally-sponsored project. The external sponsor did not fund my project. What do I do?
Many agencies provide investigators with feedback about grant applications that are not funded. If you incorporate any of the suggested modifications into your research protocol, it will be necessary to obtain IRB approval on the new research protocol.
Obviously, re-approval would be necessary with any change in the subject informed consent form.
If you decide not to conduct the research, you should inform the IRB in writing and the IRB file will be closed.
I intend to use a standardized intelligence test (attitudinal or aptitude tests) in class for research purposes; do I need approval?
A protocol would need to be submitted to the IRB for Review.
My potential subjects do not speak English in the home; how do I ensure they understand informed consent?
To obtain Informed Consent for a non-English speaker to participate in research, the subject should be asked in his or her own language for consent/assent to participate.
Informed Consent form should be written in the subject’s home language. OR Consent of a guardian who speaks the subject’s language and understands the subject’s linguistic culture is needed for any non-English speaker because the subject is not capable of giving fully informed consent. Assent of a non-English speaker who is minor may be obtained verbally; however, if assent of the subject is to be obtained verbally, the submission should include a description of how the investigator will ask for assent from the minor subject.
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Research concerned with sensitive issues and involving the participation of minors is becoming more common. In most municipalities, individuals under the age of 18 are generally considered minors. Such research often presents difficult questions related to the protection of human subjects. The purpose of these guidelines is to help researchers plan procedures and prepare proposals that can be approved by the Behavioral IRB.
Risks
Research on health and social issues often involves requesting sensitive information from subjects, some of whom may be minors. The procedures for collecting and handling such data often do pose risks to the subjects. These risks may include some or all of the following:
Violation of Privacy: Collection of data concerning at-risk or socially questionable behavior (for example, questions about substance use or sexual activity) are viewed by many individuals as violations of privacy.
Legal Risks: Data concerning illegal behaviors may place individuals at risk of legal action, if (a) names can be linked to particular responses or observations and (b) the research has not received specific legal protection (e.g., by Certificate of Confidentiality).
Psychosocial Stress and Related Risks: Procedures that raise sensitive issues may generate stress for participants. For example, questions about at-risk behaviors may cause individuals to feel stress related to their self-images or contribute to perceived peer pressure.
Social Relations: Because relevant questions often request information about the behavior or relations with family members, peers, or authorities, some procedures may pose a risk to those relations if confidentiality is not adequately safeguarded.
In addition to these risks, which may be applicable to either minor or adult subjects, research involving minor subjects may also pose risks to parents or other family members. In particular, research soliciting information about at-risk behaviors of family members may place those individuals at legal risk. Furthermore, some parents may believe that their right to determine the activities of their children is violated if signed parental consent is not obtained.
Protection
In general, protection from these risks may be achieved by (a) ensuring the confidentiality of information obtained about subjects, (b) providing access to or information about resources for coping with psychosocial stress caused by the research procedures, and (c) ensuring that the procedures meet the principles of voluntary participation and informed consent. Guidelines for achieving this protection include:
Confidentiality and Anonymity: Information is considered confidential when only the investigator has access to the identity of the individual about whom information is obtained. Information obtained from individual subjects must be kept confidential from public scrutiny, from parents and peers, and from legal and school authorities. This is most easily accomplished by collecting data in a manner that ensures anonymity. Information is considered anonymous when names or other identifying information about individual subjects can at no point be associated with observations or with responses to a survey or other data collection instruments. However, anonymity is not always compatible with research goals (for example, when data collected from the same individual at different times must be linked for analysis). In these cases, procedures for protecting confidentiality must be fully spelled out. When information that might put subjects at legal risk is to be collected, it is the investigator's responsibility to obtain and document specific legal protection (e.g., by Certificate of Confidentiality obtained from a governmental agency).
Psychosocial Stress: The procedures needed to help subjects cope with psychosocial stress that may arise from participating in research will vary depending on the exact nature of the research. If such procedures are required, it will typically be sufficient to provide subjects with information about resources (e.g., counselors) available to them. In cases in which more severe stress seems likely, it may be necessary to ensure that someone qualified to handle such stress be present during data collection.
Voluntary Participation and Informed Consent: These are basic ethical principles for conducting research with human subjects. Subjects must be informed that participation is voluntary, answers to specific questions may be withheld without penalty, and they may withdraw from the research at any time. Because research of this type is often conducted in an institutional setting where subjects' presence is mandatory (e.g., the school classroom), it is especially important that procedures for meeting this requirement be made explicit in the proposal.
The procedure for obtaining informed consent must be documented; often this requirement can be met by informing subjects that responding to survey items constitutes permission to use the collected data, without identifying individual subjects, in published reports of the research.
Parental Consent
A particular concern with research of this nature is the role of parental consent for the participation of minor subjects. The general requirement is that explicit parental consent be obtained in writing for each subject. However, there are situations in which such a consent procedure is not appropriate. The IRB may approve the research as meeting federal requirements for exemption when all of the following conditions are met:
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Data collection is anonymous; that is, at no point are subjects' names associated with information about them.
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Data are collected as part of a required or elective education program in which subjects are already participating; for example, a school curriculum, school band, school sports, etc.
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Participating in the research does not involve risks greater than those incurred by participating in the relevant educational program.
These conditions are not met, and parental consent is required, when:
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A database linking identifying information with responses is maintained, or subjects' identities can be otherwise linked to information about them; or
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The research instruments elicit information about the behavior of specific individuals, rather than about conceptual knowledge covered by the educational program.
There may be additional exceptions to this requirement in other special circumstances. Such circumstances must meet criteria established by 45 CFR 46 at sections 116.d. and 408.c. Usually such exceptions are based on demonstrating one or more of the following:
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That seeking parental consent increases the risk to subjects;
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That no meaningful parental consent can be obtained; or
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That the research cannot practically be conducted if parental consent is required (please note that "practically" here refers to insurmountable obstacles rather than the researcher's convenience).
Researchers are reminded the reading level of informed consent documents should be appropriate to the typical educational background of the research population, and documents designed for college students may not be suitable for seeking parental consent. Researchers should write these documents using short sentences and everyday language. For example, "voluntary participation" may be paraphrased by "you do not have to do this if you don't want to."
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Parental consent is usually required for research involving minors. However, assent—the agreement of the minor—is also an essential part of the informed consent process.
The method for obtaining assent should be appropriate to the child's age, cognitive development, and literacy level. While federal regulations do not specify an exact age requirement, IRBs typically require assent for children 7 years and older. The recommended procedures are as follows:
Ages 6-7: A simple oral explanation of the study should be provided in language the child can understand, and oral assent should be requested. IRBs may require documentation of assent (e.g., a signature from a witness).
Ages 8-13: A more detailed explanation in layperson’s terms should be given, and either verbal or written assent should be obtained depending on the study's complexity and risk level.
Ages 14-17: Written assent is generally required, and the assent form should be developmentally appropriate. In some cases, IRBs may allow older adolescents to provide independent consent if permitted by state law or if parental permission is waived under federal regulations (e.g., for sensitive health topics).
While these age guidelines are commonly followed, IRBs have discretion in determining assent requirements based on the nature of the study. Factors such as cognitive ability, risk level, and state laws regarding minor consent should also be considered.
Assent should always be an ongoing, voluntary process. Minors should be informed that they can withdraw at any time, even if parental permission has been granted.
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These guidelines are prepared as a brief overview of key considerations when conducting research in international settings. The Institutional Review Board (IRB) recognizes that culturally appropriate procedures are an essential part of protecting human research participants. Because research conducted outside the United States must comply with both U.S. federal regulations and local laws and customs, researchers must account for potential differences in research ethics requirements. These guidelines provide an overview of common issues and necessary procedures when conducting international research.
Translation of Research Documents
If any research documents (e.g., consent forms, recruitment materials, surveys) are translated into a language other than English, the researcher must provide:
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An English version of the document.
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A translated version in the language to be used.
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A certification letter from a qualified individual (e.g., a faculty member or professional translator) attesting that the translation is accurate and does not introduce or omit content.
Parental Permission for Minor Participants
Research involving participants under the age of 18 generally requires written parental consent. However, if local customs or regulations do not require active parental permission, the researcher must provide:
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Documentation (in English) of official regulations stating that parental permission is not required.
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A letter from a ranking official (e.g., government or community leader) confirming that parental consent is culturally inappropriate.
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Justification based on ethical considerations for waiving parental consent under 45 CFR 46.116(d) or 46.408(c).
Additional Safeguards When Parental Permission Is Waived:
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Researchers must describe alternative mechanisms for ensuring voluntary participation, such as community leader approval, neutral third-party oversight, or an independent advocate for minors.
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The IRB may require additional protections depending on the nature of the study and potential risks.
Informing Parents When Parental Permission Is Waived
If a waiver of active parental consent is granted, the researcher must:
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Provide a written notice to parents in a format they can understand (e.g., simplified language, translated version).
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Distribute the notice via the most culturally and logistically appropriate method (e.g., community announcements, letters, radio broadcasts).
Local IRB or Ethics Committee Approvals
If the host country has an established ethics review process, the researcher must:
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Obtain formal approval from the host country’s IRB or ethics committee.
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Provide documentation of this approval to the U.S.-based IRB.
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If no local ethics board exists, alternative approvals (e.g., from government officials or community leaders) must be justified.
Note: Some countries (e.g., EU, Canada, Brazil, China) have strict research regulations, and failure to obtain local approval may lead to legal and ethical violations.
Letters of Agreement from Local Officials
The researcher must submit letters of approval from appropriate local authorities, such as:
These letters must be on official letterhead and include an original signature. The letter should confirm that the research protocol, survey instruments, and data collection procedures comply with local expectations.
Cultural Expertise in Research Design
If the researcher is not an expert in the local culture, it is recommended that:
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A cultural consultant (e.g., a faculty member, local researcher, or cultural liaison) accompany the researcher to IRB meetings.
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The researcher receive training on cultural norms and ethical considerations in the host country.
Data Collection and Confidentiality
If third-party data collectors (e.g., research assistants or survey administrators) will be used, the researcher must:
To ensure confidentiality and anonymity:
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If names or identifying details are collected, researchers must explain how anonymity will be maintained.
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If research involves sensitive or legally risky topics, researchers should consider applying for a Certificate of Confidentiality.
International Data Transfer and Storage
Many countries (e.g., the EU, UK, Canada, Brazil) have strict data protection laws (e.g., GDPR, PIPEDA). If data will be transported internationally, researchers must:
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Justify why international data transfer is necessary.
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Describe security measures (e.g., encryption, de-identification) to protect participant data.
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Verify compliance with local regulations regarding data storage and transfer.
Compensation and Benefits for Participants
Researchers must specify:
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Whether participants will receive compensation, reimbursement, or post-study benefits.
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Whether compensation could unduly influence participation.
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Whether there are long-term benefits (e.g., access to study findings, medical follow-ups) for participants.
Note: Compensation must comply with local customs and ethical guidelines to avoid coercion.
Compliance with U.S. and International Regulations
Researchers must ensure that their study complies with:
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U.S. federal regulations (45 CFR 46) on human subjects research.
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Host country laws and ethical guidelines.
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International research ethics principles, including those from:
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The World Health Organization (WHO)
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The Council for International Organizations of Medical Sciences (CIOMS)
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The United Nations Educational, Scientific and Cultural Organization (UNESCO)
Final Considerations
International research presents unique challenges and ethical considerations. To ensure compliance and respect for local customs, researchers should:
Implement appropriate protections for participant privacy, security, and well-being.
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