Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research (whether or not considered related to the subject’s participation in the research). Adverse events encompass both physical and psychological harms. They occur primarily in the context of biomedical research, although they may occur in the context of social and behavioral research.
Anonymity refers to a situation where investigators do not know the identity of a participant. This is typically achieved when investigators do not collect any identifiers (e.g., name, address, telephone number) that link responses to a specific individual. Anonymity means that even you, the researcher, do not know the identity of the respondent.
If you collect identifying information but record a list of codes associated with identifiers (e.g., names), those data are not anonymous. Rather, the data are considered to be de-identified.
If a combination of indirect identifiers (e.g., gender, race, age, etc.) could identify a specific individual, particularly with small samples, you should not call your study data anonymous.
When data are not anonymous, participants may experience risk if a breach of confidentiality occurs and their identifiable information is released without their permission.
Assent is a term used to express willingness to participate in research by persons who are by definition too young to give informed consent but are old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as subjects. Assent by itself is not sufficient, however. If assent is given, informed consent must still be obtained from the subject’s parents or legal guardian. A study seeking to recruit participants who are not legal adults must therefore document both assent and parental permission.
The Code of Federal Regulations. Section 45, part 46 of these regulations pertain to the regulations set by the Department of Health and Human Services, which concerns the function of Institutional Review Boards.
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 without permission in ways that are inconsistent with the understanding established in the informed consent process.
Confidentiality represents an agreement (via informed consent) between the investigator and potential participants that their individual responses and identities will not be disclosed beyond the research team unless they have agreed otherwise (preferably in writing).
Investigators cannot guarantee absolute confidentiality, however, and must inform participants of this. For example, you cannot control whether members of a focus group share others’ information. Or, in the case of a participant complaint, the IRB may need to review data and possibly consult with appropriate College officials. You also must comply with applicable mandatory reporting laws, such as if a participant expresses the intent to harm self or others.
Finally, if you transmit data via the internet (e.g., online or email surveys, Zoom interviews, etc.), a low risk of a breach of confidentiality exists. You can minimize this risk by encrypting data transmission.
Informed consent is a conversation between the researcher and potential research participants, and the consent form is a record of this conversation. Potential participants should be given an adequate opportunity to read the consent form before signing it. The written consent form should include the following information:
A statement of the nature, purposes, procedures, and expected duration of the research that makes it clear to the participants that they are involved in research;
A description of any reasonably foreseeable risks, discomforts and benefits to the participants;
Disclosure of alternatives to the research (In most cases at Macalester, the alternative will simply be not participating.);
A statement regarding who will have access to the research records, how these records will be stored, and for how long authorized researchers will have access to the records;
An explanation of whether any type of compensation or medical treatment is available in the event that injury or psychological harm to the participant occurs during the course of research that imposes physical or psychological risks;
An explanation of whom to contact regarding concerns about the research and research participants’ rights, including the telephone number or e-mail address of the person conducting the research as well as their research advisor, if applicable, and the name and telephone number or e-mail address of the chair of the IRB; and
A statement that participation is voluntary and that the participant may withdraw consent at any time without prejudice. Whether the participant’s consent is written or verbal, it should not include exculpatory language through which the participant is made to waive any of his or her legal rights or release the researchers, research sponsor, or Macalester College from liability.
Deception in research occurs when an investigator purposely misleads participants by providing them with overt misdirection or false information about some aspect of the research during the consent process in one or more research procedures. The IRB accepts the need for certain types of studies to employ strategies that include deception. Use of such strategies must be justified, however. In general, deception is not acceptable if, in the judgment of the IRB, the participant may have declined to participate had they been informed of the true purpose of the research. Studies involving deception always require full review.
Research involving deception will not be approved unless the following conditions are met: 1. Alternative procedures that do not involve deception are not feasible and would invalidate or confound research results. 2. The deception is justified by the study’s scientific or educational merit. 3. Subjects are not deceived about matters such as physical or psychological risks that would affect their willingness to participate. In particular, deception must not be used to recruit research participants. 4. Subjects are told of the deception as soon as feasible. This should generally be at the end of their participation, but when necessary may be at the completion of the study. 5. The deception involves no more than minimal risk. 6. When feasible the consent form indicates that deception may be used or that in some research protocols full disclosure is not possible.
If the research qualifies for a waiver of written consent, a disclosure statement describing research procedures given to a participant may be used. A disclosure statement is not sufficient for applications that receive a full review.
An organization/institution is considered engaged in human research when its employees or agents, for the purposes of non-exempt research projects obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; or (4) when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor (i.e., employees or agents of another institution).
The IRB will determine whether a project qualifies for exempt review. Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46.104.4. Researchers often misinterpret the word exempt to mean there is no IRB review needed. At Macalester, a study must be reviewed by the IRB in order to be designated as exempt from further review. Researchers may wish to consult these decision charts to determine whether a proposal may qualify for exempt review.
Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the federally designated expedited review categories as defined by federal regulations. Expedited reviews are conducted by a member of the IRB committee. They do not require a convened committee meeting.
Research that does not qualify for expedited or exempt review (presents more than minimal risks to subjects) or that seeks to recruit participation from members of vulnerable groups will receive a review at a fully convened IRB committee meeting. This is also known as a “full board review” or “convened review.”
According to 45 CFR 46, a human subject is “a living individual about whom an investigator (whether professional or student) conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
Informed consent is the voluntary agreement of an individual, or their authorized representative, who has the legal capacity to give consent, and who exercises free power of choice without any form of constraint or coercion to participate in research. Consenting is a process where the researcher clearly communicates the risks and benefits of the study, the voluntary nature of participation in the study, and the expectations from the subject if they agree to participate in the study. Informed consent is not a single event or just a form to be signed – rather, it is an educational process that takes place between the investigator and a potential research participant.
Research studies are considered to have an international component when investigators travel abroad to collect data or investigators use or collect data from participants who are outside of the U.S. This includes situations in which a researcher in the United States conducts an online survey in which subjects who live in other countries may respond. Applications for international research should identify whether there is a local IRB, ethics committee, or government entity that must be consulted or that will perform a review within the host country. A copy of the approval notice or supporting documents for the local review should be included with the IRB application.
The primary researcher or principal investigator (PI) who assumes the responsibility of the protection of human subjects. When a Macalester student will work as the PI on a research project involving human subject participants, such as in an Honors or Capstone project, the student must submit a research proposal to the IRB. All student PIs will work with a faculty or staff research advisor throughout the process. See also the note on Investigator Responsibilities.
In Minnesota, a legal adult is a person at least 18 years of age.
A Limited IRB review is required for certain Exempt human subjects research categories. The purpose is to ensure appropriate privacy and/or confidentiality protections are in place with exempt research that involves the collection of sensitive, identifiable data.
Minimal risk is defined by the federal regulations as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
The Office of Human Research Protections has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects (see 45 CFR Part 46).
Privacy refers to an individual’s control over the extent, timing, and circumstances of sharing personal information (physical, behavioral, or intellectual). You must protect subjects’ privacy during study recruitment and data collection. You also must store data securely to prevent, where possible, the identification of individuals.
Privacy pertains to people whereas confidentiality pertains to data; privacy is a right that can be violated whereas confidentiality is an agreement that can be broken.
You may not collect data (words, behavioral observations) without permission if an individual has an “expectation of privacy” (the reasonable expectation that no observation or recording is taking place). An individual would not have an expectation of privacy if engaging in loud conversations or actions on public transit; however, in a classroom or church setting, for example, a person would not expect someone to record their conversations or actions for research purposes.
According to 45 CFR 46.102.l, research “means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
45 CFR 46 specifically excludes certain types of investigations from the definition of “research”: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. Also excluded are public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
Any student serving as the primary researcher (principal investigator) for a study involving human subjects must have a qualified faculty or staff adviser actively engaged in the research project. To be qualified, a faculty or staff member must have relevant experience and/or training to support the protection of human subjects. Research Advisor responsibilities are described in the Guidance for Research Advisors.
Risk is the probability of harm or injury (physical, psychological, social, or economic) occurring as the result of participation in a research study. It is crucial to recognize that both investigators and participants may experience risk through their involvement in research. Most social behavioral research involves no physical intervention and therefore no physical risk, but the potential risks of social or psychological harm must still be considered. What follows is a list of some of the types of harm that may result from research.
Physical Harm. The most obvious sort of harm that could result from research is physical harm. The potential for physical harm is most clearly present in medical experiments that involve testing new drugs or medical devices. While such studies are not carried on at Macalester, members of the Macalester community who work with medical researchers from major universities may encounter the potential for physical harm. Physical harm may also result from studies conducted on athletes, for example, who are undergoing various sorts of stress tests.
Psychological Harm. Research may also create the potential for serious psychological harm. This can occur in several ways. Surveys and questionnaires, for example, sometimes ask respondents to provide confidential information about private matters such as sexual practices or illegal drug use. If there is a breach of confidentiality, the research participants may find their sudden loss of privacy psychologically traumatic. Psychological harm can also occur when research questions or procedures can cause stress, embarrassment, or raise painful memories or present subjects with unwelcome and disturbing information.
Legal Harm. Surveys, interviews and questionnaires that ask participants whether they have engaged in illegal activities such as possession of illegal drugs may expose the respondents to criminal liability if the study does not provide for anonymity. Participants may also be exposed to civil liability if they are asked to answer questions that seek information about the harm that they have done to others. State reporting laws may also pose a legal risk. If a research participant reveals that they are likely to harm someone, there may be a legal duty to warn the threatened person. There may also be state laws requiring the reporting of certain matters such as child abuse and various diseases. In addition, researchers may at some point be faced with a subpoena for records relating to criminal activity of their research subjects.
Financial Harm and Harm to Reputation. Disclosure of certain facts may harm a person’s financial standing or reputation. Surveys that are not anonymous and that seek information about criminal activity, for example, could serve not only to create legal liability for a person but also harm the person’s reputation and financial standing. Similarly, non-anonymous surveys of employees that seek information regarding job performance, for example, could place an employee in jeopardy.
Investigators must be aware of the potential for harm caused by participating in their research. Investigators must also be aware of situations in which research interventions may introduce risks that create compounding trauma because potential participants are already experiencing trauma in their lives. In all cases, the IRB will want to know how such outcomes will be minimized or addressed and may ask investigators to exclude individuals who would otherwise be at risk of experiencing compounding trauma through participation in research.
A population may be considered vulnerable because their enrollment involves issues of coercion, manipulation, and/or undue influence and may require additional safeguards to protect their rights and welfare or because their enrollment requires special consent processes (e.g. assent from children and parental permission from parents). Federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, including, but not limited to, children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Vulnerability to undue influence can also emerge in situations where there is a power relationship that inhibits the autonomy of individuals and undermines the principle of voluntary participation in research. Teachers recruiting students and supervisors recruiting employees to participate in research are examples of situations where individuals may also be considered vulnerable.