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Students in Research

Terms in this set (49)

The IRB is an independent committee comprised of at least five members from relevant academic disciplines or experiences. At least one member must be not affiliated with the institution. The IRB must be diverse and must include at least one member whose primary concern is in a scientific area and one who is not a scientist. The members may include faculty, staff, students, as well as members from the local community. The IRB functions as a type of "human subjects advocate" whose role is to protect subjects participating in research. The IRB committee reviews research projects submitted by researchers (students, faculty, or staff). The committee has the authority to approve, require changes to the study procedures, or disapprove proposed research projects. Officials at an institution may disapprove an IRB approved project but cannot approve a project that has been disapproved, suspended, or terminated by the IRB.

IRB members must have the necessary experience and expertise to evaluate proposed research projects. IRBs must be diverse in terms of race, gender, cultural backgrounds, and include members from the community.

The IRB is charged with reviewing all projects involving human subjects for compliance with institutional policies and state, local, and federal laws, as well as the ethical principles contained in the Belmont Report (that is, respect for persons, beneficence, and justice).

The IRB is part of a bigger system, the Human Research Protection Program (HRPP), in charge of the protection of research subjects. The HRPP may include the Office for the Protection of Research Subjects, the Office of Compliance, the Office of Contracts and Grants, and other Institutional officials and committees (for example, a community outreach program).
Research projects are reviewed at three different levels: exempt, expedited, and full board. Minimal risk projects generally fall under the review categories of exempt or expedited review. For studies that are deemed more than minimal risk, a full/convened board review is required. An explanation of each type of review is found below. Student investigators should consult with the IRB/faculty advisor if they are unsure of which review applies to their study.

Exempt Review - Exempt research is research with human subjects that generally involves no more than minimal risk. However, it is "exempt" from the provisions stated in 45 CFR 46, Subpart A (Common Rule). An exempt research project does not require ongoing review by the IRB, unless the project is amended in such a way that it no longer meets the exemption criteria. However, institutional policy may have different requirements for obtaining consent as well as continuing review of exempted protocols. Student investigators should consult with their IRB regarding these matters. The IRB is required to determine if a research project falls under one of the following six exempt categories listed in the federal regulations (45 CFR 46.101(b)):
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
Research on regular and special education instructional strategies.
Research on the effectiveness or the comparison among instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures (of adults), interview procedures (of adults) or observation of public behavior, unless:
Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects. AND
Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) if:
The human subjects are elected or appointed public officials or candidates for public office.
Or the research is conducted for the Department of Justice under Federal statute 42 U.S.C. 3789g, or for the National Center for Education Statistics under Federal statute 20 U.S.C. 12213-1, which provide certain legal protections and requirements for confidentiality.
Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
Public benefit or service programs.
Procedures for obtaining benefits or services under those programs.
Possible changes in or alternatives to those programs or procedures. OR
Possible changes in methods or levels of payment for benefits or services under those programs.
Taste and food quality evaluation and consumer acceptance studies, if
Wholesome foods without additives are consumed or
A food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Expedited Review - If the research presents no more than minimal risk, the IRB may determine it qualifies for an expedited review. The expedited review covers the same elements as a full/convened committee review but can be conducted by the IRB chair or a designated experienced reviewer rather than the whole convened committee. There are nine expedited categories in the federal regulations (45 CFR 46.110):
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
Research on medical devices for which
An investigational device exemption application (21 CFR 812) is not required.
Or, the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week.
Or from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Prospective collection of biological specimens for research purposes by noninvasive means.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications).
Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
* Note: The following apply to the continuing review of research:

Continuing review of research previously approved by the convened IRB as follows:
Where:
The research is permanently closed to the enrollment of new subjects.
All subjects have completed all research-related interventions.
And the research remains active only for long-term follow-up of subjects.
Or where no subjects have been enrolled and no additional risks have been identified.
Or where the remaining research activities are limited to data analysis.
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Full Board (Convened) Review - Studies that involve more than minimal risk require full board review at a convened meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those members present. While federal regulations do not specifically list categories that would fall under full board review, below are certain criteria that may require a study to have full board review:
Studies using vulnerable populations
Studies taking place internationally (particularly those with little or no provisions for protection of human subjects)
Studies where information may be disclosed that could require mandatory legal reporting (e.g., child/elder abuse, drugs, etc.)
Studies involving deception which raises the risk level of the subjects
Studies that fall under the jurisdiction of the Food and Drug Administration
Student research projects are generally reviewed the same as any other human subjects research conducted by faculty or staff. Student investigators, after consultation with their faculty advisor, who are planning on conducting a research project involving human subjects must obtain approval from their IRB. IRB approval must be given prior to any research activity/study procedures. There is no retroactive approval for data previously collected for the current study. Failure to seek approval for thesis or dissertation research may invalidate the study and/or result in a delayed graduation.
A human subject is defined by federal regulations as "a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." (45 CFR 46.102(f)(1),(2))

Living individual - The specimen(s)/data/information must be collected from live subjects. Cadavers, autopsy specimens or specimens/information from subjects now deceased are not human subjects.

"About whom" - a human subject research project requires that the data received from the living individual is about the person.

Intervention includes physical/psychological procedures, manipulations of the subject, or manipulations of the subject's environment for research purposes.

Interaction includes communication between the investigator and the subject. This includes face-to-face, mail, and phone interaction as well as any other mode of communication.

Identifiable private information "includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place," (such as a public restroom) "and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a health care record)" (45 CFR 46.102(f)(2)). "Identifiable" means the information contains one or more data elements that can be combined with other reasonably available information to identify an individual (ex: Social Security #). Student investigators should consult the IRB if they are unsure about certain issues such as identifiable cadaver materials needing review or certain state laws regarding human subjects.

Observational studies of public behavior (including television and public Internet chat rooms) do not involve human subjects as defined when there is no intervention or interaction with the subjects and the behavior is not private. Also, studies based on data collected for non-research purposes may not constitute human subjects research if individual identities are not available (for example, programmatic data such as service statistics, school attendance data, crime statistics, or election returns).

Studies based on data that are individually identifiable but are also publicly available may not constitute human subjects research. However, the term "publicly available" is intended to refer to record sets that are truly readily available to the broad public, such as census data. An investigator should not assume information qualifies as "publicly available" merely because it has been posted on an electronic website and can be accessed without authorization.

What follows are examples of types of studies that qualify as not human subjects research and those that are human subjects research. Student investigators may use this as guidance on whether a project is submitted as human subjects research or may receive the not human subjects determination. However, it is recommended that the student consult with the IRB and/or the faculty advisor on this matter.
Data collection for internal departmental, school, or other institutional administrative purposes is not human subjects research. Examples: teaching evaluations, customer service surveys
Information-gathering interviews where questions focus on things, products, or policies rather than about people or their thoughts regarding themselves are not human subjects research. Example: canvassing librarians about inter-library loan policies or rising journal costs
Course-related activities designed specifically for educational or teaching purposes, where data is collected from and about human subjects as part of a class exercise or assignment, but are not intended for use outside of the classroom may not be human subjects research. Students are advised to contact their local IRB as certain course-related activities may require IRB review. Example: instruction on research methods and techniques. Note: The IRB is only required to review studies that meet the Federal definitions of engagement*, research, and human subject
Biography or oral history research involving a living individual that is not generalizable beyond that individual may not be considered human subjects research. Researchers are advised to contact their local IRB as these studies may be subject to local interpretation.
Research involving cadavers, autopsy material or bio-specimens from deceased individuals is not human subjects research. Note: Some research in this category, such as genetic studies providing private or medical information about live relatives, may need IRB review. Please contact the IRB for further information
Case histories which are published and/or presented at national or regional meetings are often not considered research if the case is limited to a description of the clinical features and/or outcome of a single patient and do not contribute to generalizable knowledge. However, researchers are advised to contact their local IRB as these studies may be subject to local interpretation.
Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB is they are unsure if their data qualifies as "publicly available."
Coded specimens and/or data sets that were not collected for the currently proposed projects do not need IRB review as long as the investigator receiving the data/specimens cannot link the data/specimens back to individual subjects. If the data/specimen provider can ascertain the identity of the subjects (for example, subjects' names, addresses, etc.), the investigator must enter into an agreement with the data/specimen provider that states under no circumstances will the identity of the subjects be released to the investigator. Note: Investigators are not allowed to make this determination. These projects require verification from the IRB or the IRB liaison/designee.
Non-Engagement* in Research occurs when an institution's employees or agents act as consultants on research but at no time obtain, receive, or possess identifiable private information, perform commercial services for the investigators, or inform prospective subjects about the availability of research. Note: the examples above are not an all inclusive listing. Please see the following website for further information.
* An institution becomes "engaged" in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes.
Studies that involve human subjects to test or develop devices, products, or materials that have been developed through research for human use.
Studies that collect data through intervention or interaction with individuals. Examples of this type of research include the evaluation of teaching methods and programs, Internet surveys about alcohol consumption, studies that involve deception, research involving risky behaviors or attitudes, and open-ended interviews with minors about family values in a foreign country that contribute to generalizable knowledge. Data collection using non-identifiable information may be exempt. (Students are advised to discuss with the applicable IRB the process for determining exemptions.)
Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
Studies that use bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if these were not collected for research purposes. However, such research may be considered exempt or Not Human Subjects Research if the materials/data are coded and the investigator does not have access to the coding systems.
Studies that intend to produce generalizable knowledge about categories or classes of subjects from individually identifiable information.
Studies that involve retrospective analysis of existing individually-identifiable private information.
Studies that use human beings to evaluate environmental alterations, for example, weatherization options or habitat modifications
Research belonging to any of the above categories must comply with the Federal Regulations and the Institution's policies for the protection of human subjects.

*Please visit the Office for Human Research Protections (OHRP) website for the code of federal regulations.
To obtain an IRB approval for a study, most student researchers have certain steps to follow:

Student research preparation:
The IRB application is completed under the guidance of the student's faculty advisor. The student's advisor is responsible for guiding the student investigator in the development of the research plan as well as the conduct of the research project. The faculty advisor/committee will refine the project and once it is approved by the committee, they should indicate the expected level of review (exempt, expedited, or full board review). (Please note that the final determination of review category will be made by the IRB.) The advisor also assists students in a design to maximize the benefits and minimize the risks involved in the research, and assure the ethical conduct of the project. The Institution's IRB staff is also available to aid student applicants.
Departmental/Faculty review and approval:
Depending on the Institution's policy, the department chair/faculty advisor must review and sign off on the application before it is submitted to the IRB for review. This signoff may address issues of scientific merit, availability of resources, institutional policies, or other issues at the department level.
Application submitted to IRB for review:
The IRB staff may conduct the initial screening of an application to assist in the future review either for exemption or for further levels of review. The IRB grants the final approval. In some institutions, a designated reviewer/department or school may conduct a pre-review of the application before it is submitted to the IRB for review. If a study is exempt or does not qualify as human subjects research, a designee may determine this and no further approval is required. (The IRB/designee may provide a letter stating that the study qualified as exempt or as not human subject research.)
IRB review outcomes:
The IRB will notify the researcher with one of the following once the application has been reviewed:
Approval - the application is complete, the risks to subjects are minimal/minimized, and the procedures are appropriate. The IRB gives approval for the research to be conducted.
Approval with Contingencies/Stipulations - the application is complete but there are issues/changes that must be addressed before the project can begin. Once a satisfactory response to these contingencies is received and approved by the IRB, the review is complete.
Deferred - applications that are found to have deficiencies (risk to subjects, unclear procedures, serious omissions, ethical issues, or major contingencies) will be deferred. The researcher is sent a memorandum listing the concerns that must be addressed for approval to proceed. The researcher's response is reviewed by the IRB and will be approved or deferred until all issues are addressed satisfactorily.
Non-Approval - Applications that are found to have risks that outweigh the potential benefits to subjects and/or society will receive a non-approval and the research will not be allowed to be conducted. Institutional administrative officials may not override this decision.
Conduct of research and reporting:
Once the application is approved, the researcher may begin recruiting subjects and conducting study procedures. However, the researcher must let the IRB know if any of the following occurs:
Modifications and Amendments to the approved protocol (changes to the original submitted study must be reviewed and approved by the IRB before they are implemented)
Adverse Events/Effects and Unanticipated Problems involving risks to subjects or others (the IRB must be notified immediately if any undue harms result from the study)
Complaints Regarding Human Subjects Research (the IRB must be notified immediately if any complaints, either from the subjects or the study staff, are made regarding the research study)
Breach of Confidentiality (If any personal/confidential data has been inappropriately disclosed by any member of the study staff, the IRB must be notified immediately)
Status Report (Renewal or Closeout):
Prior to the expiration of a study, the IRB will require submission of a status report to assess the study's progress or a final report when the study is completed. Either the student or the faculty advisor may submit the final report.
Informed consent is the process of informing potential subjects about the key facts of a research study and what their participation will involve. The human subjects in the study must participate willingly, after having been adequately informed about the research. If the subjects are from a vulnerable population, such as prisoners or children, additional protections may be required. (See the Code of Federal Regulations). Students are advised to discuss research that may include such populations, as institution specific requirements may also exist. The IRB office as well as dissertation chairs or advisers may be helpful in providing information.

Consent documents must be clearly written and understandable to subjects. The language must be non-technical (comparable to the language in a newspaper or general circulation magazine). Scientific, technical, and medical terms must be plainly defined. Depending on the study population, it is often recommended that the informed consent be written at the sixth to eighth grade reading level. Assent forms for minors and study recruitment materials must reflect the reading level of the minors. *The informed consent must be translated into the primary language of the subject if he/she is not fluent in English.

What elements should be included in an informed consent?

For human subjects to participate in a research study, they need to have enough information to give a truly voluntary informed consent. Information subjects must be given include:

Purpose of the research
Procedures involved in the research
Alternatives available should a subject decide not to participate in the research
All foreseeable risks and discomforts to the subject. *Note that these include not only physical injury but also possible psychological, social, or economic harm, discomfort, or inconvenience.
Benefits of the research to society and possibly to the individual human subject
Length of time the subject is expected to participate
Payment for participation (if applicable)
Person to contact for answers to questions or in the event of a research-related injury or emergency
Statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive
Subjects' right to confidentiality and right to withdraw from the study at any time without any consequences
There are two types of consent that may be required:

Consent - An adult capable of giving permission to participate in a study can provide consent. In most states, the subject must be 18 years of age and competent to make the decision to participate. Parents/legal guardians of minors can also provide consent to allow their children to participate in a study. Check with your local IRB for your state's requirement.

Assent - In most states if the subject is under 18 years of age, assent must be obtained. Assent is a child's affirmative agreement to participate in research. The assent form must include simple language written at the appropriate reading level of the youngest subject in the youth age range. An assent form may also be used if the subject is cognitively impaired. Researchers are advised to contact their local IRB regarding this matter.
The protection of privacy and confidentiality are important issues in the protection of human research subjects. Protection of human research subjects' privacy and confidentiality are extensions of the principles of autonomy (respect for persons) and beneficence from the Belmont Report.

Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.
The investigator must describe plans to protect the subject's identity as well as the confidentiality of the research records. Care should be taken to explain the mechanisms that have been devised to protect the privacy of the subjects, for example, the use of numbering or code or safely locked files in private offices. Furthermore, the investigator should describe who has access to the data and under what circumstances a code may be broken. Without appropriate safeguards, problems may arise with long-term retention of records. In special circumstances requiring additional safeguards to prevent potential criminal or civil prosecution of the participating human subject, the IRB may require the destruction of all data that can identify the subjects. Subjects should be informed of whether the data collected will be retained, and if so, for what purpose, what period of time, or whether and when data will be de-identified or destroyed.

A special situation arises for video or taped data and photographs since these media provide additional potential means for subject identification. Investigators must secure subject consent explicitly mentioning these practices. They should also explain plans for final disposition or destruction of such records.
Risk

Risk is the probability of harm or injury (physical, psychological, social, or economic) occurring as the result of participation in a research study. Both biomedical and social and behavioral research may entail some level of risk to a person's health, physical, psychological, or socioeconomic well being. Student researchers must consider the following risks when conducting their studies:

Risk Resulting from Study Questions/Surveys

In human subjects research, particularly social and behavioral projects, subjects may feel stress caused by the research questions or procedures. Perhaps questions raise painful memories or unresolved issues. Interviews of survivors of personal or state violence, for example, may be very stressful. Questions about at-risk behaviors may cause embarrassment, feelings of guilt, or legal liability when that behavior is generally illegal or socially unacceptable.

Most psychological risks are minimal and transitory, but investigators must be aware of the potential for serious psychological harm.

Breach of Confidentiality

I am going to tell you a secret, but, you MUST NOT tell any one else!
A breach of confidentiality is often the greatest risk to participants in social and behavioral human subjects research. Reputations or employment may be damaged or jeopardized if confidentiality is not maintained.

Information about subjects' activities may place them at risk of legal action. For example, if a researcher asks parents how they discipline their children, information about child abuse may be obtained and must be reported. Similarly, if subjects divulge information about illegal or stigmatizing activities, any disclosure of that information could place the subjects at risk of significant harm.

The kind and level of risk is determined by context. For example, research regarding political activism in some countries may put subjects in serious jeopardy, while it would not in other countries.

In many cases risk to privacy/confidentiality can be eliminated or reduced by careful procedures for ensuring confidentiality. Psychological support and referrals can be built into studies when emotional distress may be an outcome. Consent forms describing the kinds of questions the researcher will ask allow participants to choose whether they wish to divulge certain types of information or explore certain issues.

Benefits

Potential benefits for individual subjects may be easy to define in studies offering interventions for behavioral, psychological, or physical problems. However, research is often conducted as part of a faculty member or graduate student investigation into a specialized field of study. The research may provide no direct benefit to the subjects.

Furthermore, it may be many years before the results of the research are publicly known and made useful to society or to groups of people. Vague promises to benefit science or society are not adequate descriptions of benefit in a consent form or a research application. When there is no direct benefit to subjects, they must be told what the researcher is trying to learn and why. (The only exception would be a study in which deception is a necessary, and IRB-approved, element of the design.)

Note that compensation to subjects is not considered a benefit in the risk/benefit analysis, nor is the fact that participants may find it rewarding to be helpful.
Procedures normally followed outside the United States for research involving human subjects may differ from those set forth in federal regulations and institutional policies. These may result from differences in language, cultural and social history, and social mores. In addition, national policies such as the availability of national health insurance, philosophically different legal systems, and social policies may make U.S. forms and procedures inappropriate. In federally funded research, research activities in a foreign country may be approved if the ethical protections adhered to by a foreign institution are equivalent or greater to those in the U.S.

If protections are deemed equivalent, requests to review or waive some standard elements of U.S. approvals may be considered. However, protections afforded subjects must approximate those provided to subjects in the United States. The investigator is encouraged to contact the Chair of the appropriate IRB to discuss these issues. Investigators will be required to obtain approval from an independent ethics committee (IEC), the IRB equivalent, for research done internationally for studies that are more than minimal risk. Many institutions outside of the United States have Ethics Committees who can review and approve the research. For studies that are minimal risk, the IRB equivalent to an approval letter or permission letter from the research site may be acceptable; however, it will be reviewed on a case-by-case basis. Students proposing to conduct research outside of the U.S. should also be aware that some countries may have more stringent regulations or policies associated with human subjects research.

International research studies must adhere to recognized ethics codes such as: 45 CFR 46, Nuremberg Code, The Declaration of Helsinki, and The Belmont Report. Consent and recruitment documents must be in the language that is readable and understandable by the subjects or the short form and translator method may be used. Additionally, the following issues should be addressed in the IRB application or be considered in the IRB discussion.

Risks/Benefits to Subjects/Community
Language Sensitivity
Community spokesperson or tribal leaders
Infrastructure development/availability
Cultural sensitivities
Justify Use of Population
Genetics/Homogeneity/Validity of data to Other Populations
Ethics Body Equivalent Approval (Research Ethics Review Board/IRB)
Potential Coercion
Paternalism
"Helicopter" Research (data/sample collection & leaving site with no follow-up or benefit)
Literacy Assessment
In an academic institutional setting, students play an integral role as subjects in certain research situations (for example, research dealing with teaching methods, curricula, and other areas related to the scholarship of teaching and learning). An underlying principle of the regulations governing the involvement of human subjects in research is that the subject's participation is voluntary and based upon full and accurate information.

Consistent with an overall concern that research subjects should not be coerced, student and faculty researchers should take particular care to avoid the unintentional or subliminal coercion that may occur when potential subjects are also students. For this reason, faculty researchers, in particular, must avoid involving their own students as research subjects. Faculty who wish to involve their own students as subjects should be able to provide a good scientific reason, rather than convenience, for selecting those students as research subjects. The research project should be relevant to the topic of the class, and participation should be part of the learning experience for the students.

In instances where investigators can provide a good reason for involving their own students in their research, the IRB generally requires that someone other than the investigator (instructor) obtain informed consent and collect the data. When this is not possible, the IRB will consider other methods for obtaining consent and collecting data that would not reveal to the instructor whether or not a specific student participated in the research project until after final grades have been determined. The students should be informed of what these procedures are in the informed consent form. In addition, it is generally recommended that the investigator/professor provide a recruitment flyer or letter to a student pool, general student population, or both so that the student may be the one who initiates contact with the investigator/researcher.

If a student feels he/she has been coerced to participate in a study, he/she should immediately inform the institution's compliance office and/or the IRB.