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One of the seminal events in the development of the current regulatory environment was the Public Health Service (PHS) Syphilis Study (1932 - 1972), the so-called "Tuskeegee Syphilis Study". Initiated and funded by the PHS, this study was designed initially to make treatment available to African-American men with syphilis, although at the time the study began there was no known effective treatment. After funding to make drugs available was cut, the study became a natural history study. Hundreds of men with syphilis and hundreds of men without syphilis (serving as controls) were enrolled into the study. The men were recruited without their informed consent. They were deliberately misinformed about the need for some of the procedures. For example, spinal taps were described as necessary and special "free treatment."

Even after penicillin was found to be a safe and effective treatment for syphilis in the 1940's, the men were denied antibiotics. To prevent them from being treated by the military or by local physicians, the investigators arranged with the local draft board to prevent the men from being drafted, arranged with local physicians to withhold treatment, and told the men that if they volunteered for the military, they would no longer receive financial compensation for taking part in the study. The study continued to track these men until 1972 when the first public accounts of the study appeared in the national press. The study resulted in 28 deaths, 100 cases of disability, and 19 cases of congenital syphilis. [Levine]

Ethical problems: lack of informed consent, deception, withholding information, withholding available treatment, putting men and their families at risk, exploitation of a vulnerable group of subjects who would not benefit from participation
n the aftermath of the events through the 1970s, the US Congress held hearings on "Quality of Health Care - Human Experimentation" in 1973. The hearings led to the National Research Act of 1974 which:

Established the "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research"
Required the establishment of IRBs at institutions receiving US Department of Health, Education and Welfare (now the Department of Health and Human Services) support for human subjects research
The charge of the National Commission was to:

Identify the basic ethical principles that underlie the conduct of human research.
Develop guidelines to ensure that human research is conducted in accordance with those principles, which, in turn, led to the current federal regulations.
In 1974 the Department of Health, Education and Welfare issued 45 CFR 46 "Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research". Based on the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978), the Department of Health and Human Services (HHS) revised and expanded its regulations for the protection of human subjects 45 CFR 46 in the late 1970's and early 1980's. In 1991 sixteen other federal agencies and departments agreed to apply the basic requirement in 45 CFR 46 to the research they fund or conduct, and in 2005, the Department of Homeland Security adopted the regulations. The basic regulations are referred to as the "Common Rule."
This principle requires researchers to minimize the risks of harm and maximize the potential benefits of their work. This principle demands that researchers and IRBs conduct a careful assessment of the risks of harm and the potential benefits of the research and ensure that the potential benefits justify the risks of harm. This may include, in some cases, alternative ways of obtaining the benefits sought in the research.

The term "risk" refers to a possibility that harm may occur. However, the assessment of risk requires evaluating both the magnitude of the possible harm and the likelihood that the harm will occur. The types of harms to be assessed include not only physical harms but also psychological, legal, social, and economic harms. The term "benefit" is used in the research context to refer to something of positive value related to health or welfare. Those benefits can accrue to individual subjects or to others, such as a community, or humanity as a whole. In general, the risks and benefits to the individual subjects carry more weight than benefits to others. As The Belmont Report states, "Beneficence thus requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantial benefits that might be gained from research."

The rules derived from the principle of beneficence include:

The requirement to use procedures that present the least risk to subjects consistent with answering the scientific question.
The requirement to gather data from procedures or activities that are already being performed for non-research reasons.
The requirement that risks to subjects be reasonable in relation to both the potential benefits to the subjects and the importance of the knowledge expected to results.
The requirement to maintain promises of confidentiality.
For research that involves more than minimal risk of harm, the requirement to monitor the data to ensure the safety of subjects.
Review by an Institutional Review Board (IRB)Next step...
In addition to providing ethical guidance for the conduct of research involving human subjects, the Belmont Principles form the basis for many of the requirements found in the federal regulations. In fact, the specific criteria for IRB approval spelled out in 45 CFR 46.111 of the regulations are drawn directly from the three basic Belmont Principles. Therefore, the Belmont Principles also serve as a guide to compliance with the federal regulations.

According to Section 111, in order to approve research the IRB must determine that all of the criteria in the section are satisfied. The following summarizes the criteria, along with the relevant principles from the Belmont Report:

Risks to subjects are minimized [Beneficence]

Risks are reasonable in relation to anticipated benefits [Beneficence] .
Selection of subjects is equitable [Justice] .
Informed consent is sought from each subject [Respect for Persons] .
Informed consent is appropriately documented [Respect for Persons] .
And when appropriate:

Data collection is monitored to ensure subject safety [Beneficence].
Privacy and confidentiality of subjects is protected [Respect for Persons & Beneficence].
Additional safeguards are included for vulnerable populations [Respect for Persons].
The ethical principles and federal regulation provide a framework for IRBs to evaluate research involving human subjects. However, each research study is unique and a comprehensive review may be a complicated process.
Since the Belmont Report and the other professional ethics codes provide guidance on the ethical conduct of research, the question arises as to why we need IRB review. Why not just obtain a commitment from the researchers that they will follow the ethical principles in the conduct of their research? The answer is found in some basic principles of human nature.

First, highly motivated people tend to focus on their goals and may unintentionally overlook other implications or aspects of their work. Take, for example, driving on the highway. When one is late for an appointment, one tends to drive faster and may be tempted to break the speed limit. It is not that the person does not care about safety; rather, at that moment they are focusing on the goal of getting to their appointment and not considering the safety implications of what they are doing. What keeps most people from driving at excessive speeds is that there is a system in place that results in consequences for people who drive at unsafe speeds. Researchers are highly motivated people who tend to focus on their scientific goals, just as drivers focus on getting to an appointment on time. As a result, they may overlook the ethical implications of what they are doing. The purpose of IRB review is to provide a system that requires researchers to take ethics into account when designing and conducting their research or there will be consequences.

The second principle of human nature that drives the need for IRB review is that no one can be totally objective about his or her own work. One way that this affects the conduct of research is that people underestimate the risks resulting from projects with which they are very familiar. For example, cars had seat belts for years, but people rarely wore them until there were laws requiring seat belt use. Most people understood that seat belts saved lives and prevented injury, so why didn't they use them? In part, people underestimated the risk of having an accident while driving because they drove on a daily basis. Similarly, researchers tend to underestimate the risks of their research, not because they are callous, but because the procedures are so familiar to them. In addition to underestimating risks, researchers have an inherent conflict of interest when judging their own research. They have a stake in getting the research done as quickly and efficiently as possible. As a result of both of these principles, every research activity needs an independent, objective review. This is one important function of the IRB review process.

Even if researchers were well versed in the ethical principles and committed to the ethical conduct of research, IRB review is necessary to ensure that ethical concerns are not overlooked.
In addition to ethical principles, the regulations also reflect the need to maintain the public trust in research. Researchers do not have the right to conduct research, especially research involving human subjects. Society grants researchers the privilege of conducting research. The granting of that privilege is based on the public's trust that research will be conducted responsibly. Erosion of that trust can result in the withdrawal of this privilege.

The federal regulations that currently govern human subjects research evolved as a response to the erosion of public trust that resulted from the scandals described earlier in the course. Without regulations, these events caused the public to question the ethics of researchers conducting human subjects research. Congress, responding to public concern, directed that federal agencies to adopt regulations for research funded or conducted with federal funds and for research using products regulated by the U.S. Food and Drug Administration (FDA). Should additional events erode the public trust, Congress will order additional restrictions and could even ban some types of research altogether.

Public trust is maintained through accountability - the ability of researchers to demonstrate to others that they are conducting research responsibly. Accountability is accomplished through documentation. It is not sufficient for researchers to conduct ethical research. They need to be able to document that they have done so. Therefore, in addition to setting standards for the ethical conduct of research involving human subjects, the federal regulations include requirements for the necessary documentation of that ethical conduct. The purpose of the documentation requirements in the regulations is not to satisfy the regulators, but to preserve the public trust in research.
To generalize is to derive general conclusions from particulars. Generalizable knowledge is a goal of most basic research. Even research about the most narrowly defined topic, such as an individual case study or the study of an isolated community, may be intended to contribute to a body of knowledge such as the function of culture, the expression of gender, or the political views of marginalized community members.

Some investigators in the social and behavioral sciences and humanities contend that the regulations were designed to govern only biomedical research. They then, reasonably, assume that "generalizable knowledge" is only that which is hypothesis driven, quantitative, and replicable. While it is true that scandals in biomedical research drove the development of the current regulations, the regulations were designed to cover all research with human subjects. The regulations specifically refer to interviews, oral history, focus groups, and other qualitative methods. Therefore, the concept of "generalizable knowledge" has to be broadened. (The development of drugs, biologics, and medical devices is governed by a separate set of regulations developed by the Food and Drug Administration.)

An essential consideration is whether it was the original intent of the investigator to contribute to generalizable knowledge. Some activities that involve interactions with humans and data gathering may not fit the definition of research with human subjects, because they are designed to accomplish something else, such as in-house quality improvement. For example, a survey of college students about university counseling services may be designed strictly to improve service delivery for students on that campus, and thus not meet the definition.

Publication of results in a peer-reviewed journal is sometimes used as a measure of whether research is generalizable, but this is too narrow a measure for two reasons. First, not every study will produce results worthy of publication. Second, there are multiple ways in which results can be made available to others without being published in a peer-reviewed journal. Results may be presented at a conference or made the subject of a seminar. They may be shared with colleagues through the Internet or appear in a dissertation.
A living individual" Research about people who are deceased, such as historical research, does not meet the definition of research with human subjects
About whom" Most research in the social and behavioral sciences involves gathering information about individuals. However, some research that involves interactions with people does not meet the regulatory definition of research with human subjects because the focus of the investigation is not the individual. In other words, the information being elicited is not about the individual ("whom"), but rather is about "what".

For example, if a researcher calls the director of a shelter for battered women and asks her for the average length of stay of the women who use the shelter, that inquiry would not meet the definition of research with human subjects. If the researcher interviewed the director about her training, experience, and how she defines the problem of battering, then the inquiry becomes about her - and thus "about whom

"Interventions" Interventions include physical procedures through which data are gathered, such as measuring brain function to supplement paper and pencil inquiries into the development of language. They also include manipulation of the subject or the subject's environment, for example, studies investigating the impact of environmental factors on memory
"Interactions" Interactions include communication or interpersonal contact between the subject and the investigator. Communication does not have to be face to face, and may even exist entirely on paper or in electronic realms. Participant observation is a variant of interaction, often including both formal and informal interviews in addition to observation.
"Identifiable private information" As defined in the regulations, private information includes:

Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. 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 school record).
The regulations further state that private information must be individually identifiable (i.e. the identity of the subject is or may be readily ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research with human subjects.

The following two sections will expand on the definition of identifiable private information

Observing and Recording Private Behavior-t is important to keep in mind that whether a setting is public is, by federal definition, determined in large part by the potential subjects' expectations of privacy, rather than any absolute distinctions between public and private spaces. For example, one might expect that certain behavior, even if conducted in public spaces, is in fact private, such as a conversation in a public park. It is reasonable to assume that one might expect not to be taped while dining with a date at a restaurant.

If investigators wish to obtain information in a context in which subjects would have a reasonable expectation of privacy, the investigator must use covert observation (concealed recording devices and videotaping or use of a one-way mirror) or assume a role in the setting or group being studied. Such studies raise significant concerns about violation of privacy and require additional protections and safeguards for subjects. Observational studies in quasi-public places, for example, hospital emergency rooms or state psychiatric hospital wards, may also raise such concerns.
Private Information Provided by Individuals for Specific Purposes-Individuals provide personal information with the expectation that it not be made public in a variety of settings, for example, at work, at school or college, when receiving health care, or as a member of an organization.

Some of this information is protected by law. For example, school records are protected by the Family Education Rights and Privacy Act (FERPA). Similarly, private health information is protected by the privacy provisions of the Health Insurance Portability and Accountability Act (HIPAA). Generally, although there are exemptions, school and medical records can only be released with express written permission.

Data files including identifiable private information are compiled and maintained by both public and private institutions. Owners of identifiable data impose restrictions on the use of the data. They may release de-identified data publicly, but only release identifiable data to investigators with IRB-approved data protection plans.
Additional Protections for Vulnerable Subjects-
Three subparts have been added to the basic provisions, Subpart A, of the federal regulations:

Subpart B: Pregnant women, fetuses, and neonates
Subpart C: Prisoners
Subpart D: Children
Note: The additional protections for prisoners and children are covered later in the course, and will not be discussed here. The additional protections for pregnant women, fetuses, and neonates are most relevant in biomedical research.

It should be noted that some federal agencies that adopted the Common Rule have also adopted some or all of the other subparts of the DHHS regulations, but others have not. For example, while the Department of Education has adopted the additional protections for children, the National Science Foundation has not.

Assurances with the Office of Human Research Protections-Every institution conducting research with federal support is required to enter into an agreement called an "assurance." Most assurances are negotiated with the DHHS Office of Human Research Protections (OHRP). An assurance identifies the regulations for protecting research subjects that the institution will follow and the ethical principles it will adopt. In the United States these are the Common Rule and the Belmont Report. The assurance also states how broadly the institution will apply the Common Rule and the additional subparts. Some institutions apply the Rule to all research regardless of the source of funding. This means that the Rule would apply to research funded by foundations, associations, internal award programs, all other sources of research support, and when research is not funded. Some institutions also choose to apply the additional subparts, B, C, and D, to all research regardless of the source of funding. Others choose to apply the subparts only to federally funded research
If research is not eligible for exemption, the remaining options are expedited or full review.

To be eligible for expedited review research must meet two criteria:

Pose no more than minimal risk to subjects.

"No more than 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."
Consist only of one or more research activities specified in the regulations as eligible for expedited review.

Eligible activities are similar to those for exempt research (some surveys, interviews, and data analysis) with the addition of some minor or non-invasive medical procedures, such as blood pressure readings, weight measurements, and blood draws that are used occasionally by researchers in the social and behavioral sciences.
The preamble to the list of specified activities notes that if the primary risk to subjects is a breach of confidentiality and the risk can be managed to no more than minimal, then the research may be reviewed through an expedited process.

Institutional policy, local conditions, and subject vulnerability may require review by a convened Institutional Review Board (IRB) even for a study with no more than minimal risk, such as a study of decisionally-impaired individuals. If research involves more than minimal risk and/or does not fall into one of the categories of research eligible for expedited review, it must be reviewed by a convened IRB. This review involves consideration by a larger, more diverse group, thus bringing more perspectives and more experience to the review.
Who Must Review Research with Human SubjectsNext step...
As prescribed in the regulations and implemented by institutional policy there are three possible sets of reviewers.:

Staff or IRB members identified by the institution to screen research for exempt status. These individuals may be staff or IRB members.
One or more members conducting expedited reviews.
Members of a convened IRB for studies requiring full review.
Click the topics below to learn more.

Description of an Institutional Review Board-An Institutional Review Board is a review committee established to ensure that the rights and welfare of human research subjects are protected. Although federal regulations use the term IRB, institutions may choose a different name for the committee, such as Research Ethics Board.

Membership-The minimum size and required composition of an IRB is spelled out in detail in the regulations. An IRB must have at least five members. Its membership must be diverse including considerations of race, gender, and cultural background. The committee is expected to be sensitive to community attitudes; have knowledge and experience with vulnerable populations; and to be conversant with applicable regulations, state and local laws, and standards of professional conduct.

The most important requirement is that an IRB must have the expertise and professional competence to evaluate research. One or more members must have familiarity with the discipline and methods under consideration. If not, the IRB must seek that expertise through consultation. For example, if an IRB is to review research on sensitive topics using web-based surveys, it must have expertise about security issues in the Internet environment or seek outside consultation
Authority of the Institutional Review Board-Federal regulations stipulate that an IRB can:

Approve research.
Disapprove research.
Require modifications to proposed research.
Conduct continuing reviews.
Observe/verify changes.
Suspend or terminate approval.
Observe the consent process and the research procedures.
The regulations also require that IRBs develop procedures for handling noncompliance.
Other Institutional Reviews-Research approved by an IRB may be subject to further review and approval or disapproval by officials of the institution (for example, department heads, deans, research directors). However, if an IRB has disapproved the research, the institution cannot override that determination.
Exempt Research-When research is exempt from the provisions of the Common Rule, it follows that the review criteria provided for expedited and full review would not apply. However, all research should abide by the three basic ethical principles elucidated in the Belmont Report: respect for persons, beneficence, and justice. Thus, for example, the principle of respect for persons would entail securing informed consent from research subjects. Therefore, many institutions have developed forms designed to gather sufficient information to determine not only that a project is exempt, but that it is being conducted in accordance with basic ethical principles.

review Criteria for Expedited and Full ReviewIRB members who are conducting an expedited review, or the convened IRB conducting a full review, must ask the following questions:

1. Have the risks to subjects been minimized using procedures that are consistent with sound research design?
Are the risks reasonable in relation to anticipated benefits?
Is the selection of subjects equitable?
Are adequate procedures in place to ensure privacy and confidentiality?
Is there a plan to monitor the data and safety of the subjects, if necessary?
Will informed consent be sought and appropriately documented? Do proposed alterations or waivers of informed consent meet the criteria for approval?
Are safeguards in place to protect vulnerable populations?

Comparison of Expedited and Full Review-Review procedures for expedited review and full review are similar in several ways:

The review criteria are the same.
Both types of review are documented communication processes between investigators and reviewers.
Expediting reviewers and the full IRB can request modifications to submissions and can approve protocols, continuing reviews, and amendments to approved protocols.
Expediting reviewers and the IRB will specify when a protocol must be reviewed again. By regulation it must be within twelve months, but shorter review periods may be required.
A key difference between the two processes is that expedited reviewers cannot disapprove a protocol. They must refer protocols they cannot approve to the full IRB. All IRB members must be advised about protocols, continuing reviews, and amendments approved through expedited review procedures. Any member of the IRB may request that such approvals be reconsidered by the full IRB.

Publication of results in a peer-reviewed journal is sometimes used as a measure of whether research is generalizable, but this is too narrow a measure for two reasons. First, not every study will produce results worthy of publication. Second, there are multiple ways in which results can be made available to others without being published in a peer-reviewed journal. Results may be presented at a conference or made the subject of a seminar. They may be shared with colleagues through the Internet or appear in a dissertation.
Next step...
Once a protocol has received initial approval through expedited or full review procedures, it must be reviewed, according to procedures described in the Common Rule, within twelve months of its approval date. In addition, changes to approved protocols must be approved prior to implementation, and reports of unanticipated problems must be reviewed

Click the topics below to learn more.

Continuing Review: Expedited or Full?-Federal regulations permit expedited review to be used for continuing review if the initial review was expedited and no new risks were identified. It may also be used when the initial review was conducted by a full IRB under some circumstances, such as 1) when no additional risks have been identified and during the initial review the IRB determined and documented that the research involves no greater than minimal risk, or 2) the remaining activities are limited to data analysis.

The IRB or the expediting reviewer(s) must determine that all the requirements for initial review continue to be satisfied. The Common Rule also requires that continuing review cover specific information, including the number of subjects accrued, a summary of relevant literature, a description of any unanticipated problems and a copy of the current consent form.

Amending Approved Protocols-Changes to approved protocols must be approved prior to their implementation. The regulations state that expedited review procedures may be used to approve "minor changes in previously approved research during the period (of one year or less) for which approval is authorized." Consult with your IRB about your institution's policies and procedures regarding these reviews and about what constitutes a "minor" change.

Proposed changes to exempt research must be reviewed in some manner to ensure that the revised research still meets the criteria for exemption.

Reports of Unanticipated Risks or Harms-Changes to approved protocols must be approved prior to their implementation. The regulations state that expedited review procedures may be used to approve "minor changes in previously approved research during the period (of one year or less) for which approval is authorized." Consult with your IRB about your institution's policies and procedures regarding these reviews and about what constitutes a "minor" change.

Proposed changes to exempt research must be reviewed in some manner to ensure that the revised research still meets the criteria for exemption.
Risks Associated with Participation in Social & Behavioral Sciences ResearchNext step...
Risk in social and behavioral sciences generally fall into the three categories below. Click on the categories to learn more.

Invasion of Privacy-Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. Invasions of privacy can occur if a subject's participation in a study is revealed without the subject's knowledge. For example, if an investigator communicates via email with subjects in a study about recovering from childhood sexual assault, family members with access to email may learn about the assault.

Breach of Confidentiality-Perhaps the primary source of risk in the social and behavioral sciences is that information obtained by researchers could harm subjects if disclosed outside the research setting. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. For example:

An unintended disclosure of subject's HIV status could result in the subject's loss of employment or health insurance coverage.
Public revelations of data collected about sexual preference could result in a loss of social status or discrimination in housing or employment.
Workers asked to reveal their attitudes about the effectiveness of their managers could lose their jobs or be denied promotions if the information is not adequately protected.
Information about illegal activities or status (drug use or immigrant status) can have serious legal consequences for subjects.

Study Procedures-In some cases, simply participating in research can put subjects at risk. For example, responding to questions about a sensitive topic or traumatic event may be distressing to a subject, even if the information divulged is kept in strict confidence.

Another situation in which merely participating in research might pose some risk to subjects is when there is a potential for a breach of confidentiality, not because of inadequate confidentiality procedures on the part of the research team, but from subjects themselves when data is collected in a group setting such as a focus group. Even though participants are typically cautioned not to share information outside the data collection setting, subjects should be made aware that the researcher cannot guarantee confidentiality.
Assessing RiskNext step...Click the topics below to learn more.
Probability and Magnitude of Harm-When assessing risk associated with participation in a research study, there are two distinct elements of risk that need to be considered. One is the probability of harm - the likelihood that a specific harm might occur. Not all possible harms are equally probable, and this fact should be taken into consideration when assessing risk. The second element of risk is the magnitude of such harm.

Sometimes there is great disparity between the probability and the magnitude of harm in a study. For example, a researcher wants to do a web-based survey of college students to elicit information about their sexual behavior and drug use. Identifiers will not be collected; however, the data are vulnerable in transit from an individual's PC to the web server hosting the survey, much in the same way credit card information is vulnerable during transit. Although the probability that the data could be "snatched" in transit and identified is low, it could be done. The magnitude of the possible harm is very high given the sensitivity of the information.

Situation and Time-Risks in research participation are specific to time, situation, and culture. Thus, what may be a socially sensitive issue or topic at one time or place may not be so at another time or place. For example, asking women if they have had abortions would carry very different risks in a country where abortion is a routine medical practice, a country where it is illegal, and a country in which it is legal but the issue is fraught with religious and political controversy
Subject Population-Risks will differ according to the subject population, too. Consider this case: A study on the efficacy of a behavioral intervention for smoking cessation involves both adults and teenagers. Purchasing tobacco products is generally illegal for persons under 18 years of age. For adults, however, it is a health hazard, but not an illegal activity. Thus, any assessment of the risk for teenagers will have to consider that the research focuses on an illegal activity.

Similarly, a survey about sexually transmitted diseases would carry different risks for middle class suburban men, Catholic clergy, and gang members.
Assessing Risk Objectively-Investigators
People, including researchers, tend to underestimate risks involved in activities with which they are familiar and to overestimate the benefit of things that are important to them. Thus, an independent assessment of risk is critical. One function of Institutional Review Boards is to provide this independent assessment.

Potential Subjects
Regardless of the true probability of harm, research indicates that when potential harms are severe, people tend to overestimate the probability. And when potential harms are less severe, such as embarrassment, people tend to underestimate the probability. A good consent process will address these tendencies.
Information that Must Be Provided to SubjectsNext step...
The federal regulations about informed consent list specific elements of information that must be provided to subjects. The elements are divided into two categories. One category includes basic elements to be provided to subjects. The second category lists elements that are included if appropriate. The two lists are provided with comments on the following pages .
Basic ElementsNext step...
A statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental.

A description of any foreseeable risks or discomforts to the subject.
A description of the benefits to the subject or to others.

Note: If there are no direct benefits, the investigator may tell subjects what he or she hopes to learn, how that knowledge will contribute to the field of study or may benefit others if, indeed, such a case can be made.

A disclosure of any alternative procedures or treatments that may be advantageous to the subject.

Note: This requirement is primarily relevant for biomedical research. However, it might be applicable to social and behavioral research if behavioral interventions are proposed.

An explanation of how the institution/investigator will maintain confidentiality of records.

Note: The description must include a full disclosure of any state mandated reporting requirements, such as suspicion of child abuse and/or neglect or harm to others, when warranted by the topic under investigation. State requirements vary, so IRBs and investigators need to be aware of state-specific information.
or research involving more than minimal risk, an explanation regarding whether medical treatment is available if injury occurs.

Note: This element applies primarily to biomedical research. However, there may be circumstances in which it applies to social and behavioral research such as in studies that collect psycho-physiological measures.
Contacts for further information about the research study and about the rights of research subjects. If research-related injury is possible, subjects must be told whom to contact should injury occur.

Note: In field research, particularly in developing countries, there may not be any way for subjects to call or e-mail anyone. Alternative means of communication must be established, such as a local contact on the research team.
A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits, and that the subject may discontinue at any time.

Note: Most researchers in the social and behavioral sciences are not in a position to impose penalties. However, specific study related assurances that there will be not negative consequences associated with choosing not to participate may be appropriate. For example, parents may need to be assured that if they choose not to participate in school-based, school-approved study, it will not affect their children's grades in any way.
All consent forms must state explicitly that subjects may withdraw at any time and may choose not to answer questions or complete specific tasks. In keeping with this requirement, Web-based surveys must be designed so that subjects are not forced to respond to a question before moving to the next one.
Additional ElementsNext step...
Depending upon the nature of the research and the risks involved, IRBs may invoke additional regulatory requirements, such as:

A description of costs a subject might incur. For example, transportation to the research site or childcare costs.
A statement that any significant new findings that might affect a subject's willingness to participate will be provided to the subject.
Consequences of a subject's decision to withdraw from a study, including how compensation will be affected. Subjects need to know, for example, how their compensation will be affected if they choose not to complete an interview. If an institution uses a subject pool of students, the subjects will need to know how many credits they will receive for their participation and under what circumstances they will receive partial credit. Discussion of what happens to data already collected to date if they withdraw part way through the study may also be addressed in this section.
A statement that there may be unforeseeable risks. This requirement applies primarily to biomedical research involving new treatments and procedures.

Exculpatory LanguageNext step...
Recruitment
Recruitment is part of the consent process, because it begins the disclosure process. Thus all recruitment strategies-such as fliers, e-mail messages, newspaper ads, phone calls, and so on-must be reviewed by an IRB before they are implemented.

Exculpatory Language
Subjects may not be asked to waive or even appear to waive any of their legal rights. They may not be asked to release an investigator, sponsor, or institution from liability for negligence. Institutions may provide information about how liabilities are covered.
Waivers of the Elements of ConsentNext step...4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. This process is often referred to as "debriefing."
Federal regulations allow for the waiver or alteration of any or all of the elements of consent provided if, and only if, four criteria are met. These waivers allow researchers to modify the consent process by omitting one or more elements of information or to provide no information at all. When the regulations were written, it was deemed important to include a waiver provision for research on behavior that could not be accomplished if subjects were fully informed about why the research was being conducted.

Criteria for Waiver
The four criteria for a waiver of any of the required elements of informed consent are: (Click on the criteria to learn more.)

1. The research involves no more than minimal risk to the subjects-Minimal risk" means that "the probability and magnitude of harm or discomfort are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests.".2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.-In the absence of specific legal rights, this criterion is often difficult to apply because "rights and welfare" are not defined in the regulations. Also, the parties involved in the research process (researchers, IRBs, and the community of subjects) may not always agree on how to define subjects' rights and welfare. When a waiver is required because the research involves deception, this requirement is usually interpreted to mean that subjects are not "tricked" into participation that they would find objectionable. 3. The research could not practicably be carried out without the waiver or alteration.-mpracticable does not mean time consuming, expensive, or inconvenient. Researchers will have to provide acceptable evidence to their IRBs that securing consent is not feasible, regardless of cost and time. 4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. This process is often referred to as "debriefing."The debriefing process is an opportunity to provide subjects with information not disclosed during the initial consent process. It also provides an opportunity for subjects to withdraw and not have their data included in the research.
Note: Debriefing is not required in situations in which debriefing would cause more harm than good, for example, if subject selection was based on an undesirable or unflattering characteristic.
Common Uses of Waivers in Social and Behavioral SciencesNext step...
Waivers are often needed when research involves incomplete disclosure, deception, or covert observation.

Incomplete Disclosure: The regulations do not require that researchers disclose the hypotheses of their research. To do so might create the phenomenon called the "demand effect" when subjects, knowing what the researcher is looking for, may be inclined to provide it, or alternatively, not to provide it. If even a general description of the purpose of the research might create the demand effect, or in some other way, jeopardize the science, an IRB may waive the requirement to fully explain the purpose of the research. If the waiver is granted, IRBs usually require that the debriefing provide the explanation of the purpose of the research.

Deception: Outright deception can sometimes be justified as essential for investigating a particular phenomenon. For example, subjects may be told that a study is about perception of visual phenomenon, when in fact it is about susceptibility to peer pressure (from the researcher's confederates).

Observation: If people know that they are being observed, they may alter their behavior in such a way that obtaining meaningful results is not possible. Covert observation requires a waiver of all of the elements of consent unless the research has been determined to be exempt from the regulations because 1) the observation concerns public behavior of individuals who either cannot be identified in the data, or 2) that if they could be identified, there is no risk involved in such identifiability.

Waivers of Parental Permission and Child Assent
Waivers of the requirement to secure parental permission for children to participate in research may be waived by an IRB in accordance with the same criteria for waiving consent.

The regulations do not include a list of elements that must be included in a child assent process. It is up to an IRB to determine whether child assent is required, what elements must be included in the assent process, and whether or not the assent must be documented.
Ensuring Free ChoiceNext step...
The principle of respect for persons requires that participation in research be truly voluntary, free from coercion or undue influence. Even when a study is innocuous, subjects must be informed that they do not have to participate, they may choose not to answer particular questions or complete specific tasks, and they may choose to stop participating at any time. Click on the topics below to learn more.

Setting and Time Investigators should consider ways in which the setting of the consent process might include elements of coercion. Potential subjects in the following situations might not feel entirely free to choose whether to participate in a research study if they are:

Adolescents whose parents are in the room.
Adolescents in a group of other adolescents being recruited for the same study.
Parents who receive a letter from the school principal asking them for permission to enroll their children in a study.
Athletes recruited by their coach.
Employees asked to participate by their employer.
Subjects must be given adequate time to consider whether or not they wish to participate in a study. This is particularly true if the study has procedures involve more than minimal risk or will require subjects to disclose sensitive information.


Incentives-Incentives are payments or gifts offered to subjects as reimbursement for their participation. Payment may become coercive if it is so high that it overrides other considerations for potential subjects. Determining whether incentives are coercive depends on the research context and the financial and emotional resources of the subjects. Another potential problem is that if incentives are too attractive, subjects might misrepresent themselves in order to participate in the study.
Safeguards for Vulnerable Subjects-The federal regulations state that IRBs must ensure that appropriate safeguards are in place to protect the rights and welfare of subjects likely to be vulnerable to coercion or undue influence. Potentially vulnerable subjects include children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Additional safeguards for three of these groups are provided in subparts of the federal regulations for protecting research subjects: Subpart B for research on pregnant women, human fetuses, and neonates, Subpart C for prisoners, and Subpart D for children. Discussions of the additional protections for children and prisoners can be found in this course. Research on pregnant women, fetuses, and neonates is discussed in CITI's biomedical course.

Safeguards employed for vulnerable subjects include, among many other strategies, assessing the decision-making capacity of potential participants, requiring parental permission from both parents rather than just one parent for some studies with children, and ensuring that incentives are not coercive.
Privacy and Research MethodsNext step...
While not an exhaustive list, the following material highlights some concerns about privacy in the context of research. Click on each one to learn more.

Observational -Most research involves asking subjects to provide or release information voluntarily following an informed consent process.

Privacy issues arise in regard to information obtained for research purposes without the consent of the subjects.

Such studies may raise ethical concerns when they access identifiable information about subjects without the subjects knowledge. For example, a researcher may videotape subjects when the subjects presume they are on a break between study tasks. An ethical concern is whether an invasion of privacy - a violation of the principle of respect for persons - could be justified by the benefits of the study. Is the knowledge to be gained important enough to involve the subjects without their consent? What, if anything, will the subject be told later?
Studies
Privacy and Study Questions-Privacy and Research MethodsNext step...
While not an exhaustive list, the following material highlights some concerns about privacy in the context of research. Click on each one to learn more.

Observational StudiesPrivacy and Study QuestionsCommunicating with SubjectsFocus GroupsSnowball Sampling



Invasions of privacy can occur if subjects are asked questions that they find intrusive. If a survey instrument or an interview script contain questions that individuals are likely to find intrusive, they must be informed about the nature of the questions in advance. Studies about sexual behavior, childhood abuse, use of psychotropic medications, and other personal topics should include a disclosure in the consent form about the sensitive nature of the questions. The survey instrument or interview process must be designed so that a subject can choose not to answer any question that makes him or her uncomfortable, or that he or she wants to skip for any reason.

Although there is considerable variation in how people define the right to privacy, there are nonetheless community and cultural standards that should be taken into account when designing research. Topics that are considered appropriate in one setting may be offensive and off-limits in another.
Communicating with Subjects-If a study is obviously about stigmatizing conditions, illegal activities, or life experiences that subjects may not want others to know about, communications with the subjects should not reveal their participation in the study to others because to do so would violate the subjects' right to privacy. Study titles should be carefully considered; it is often best if the title alone is not sufficient to reveal sensitive information about participants. A method of communication that is of particular concern is e-mail. Employee e-mail is not secure and some home accounts may be accessed by anyone in the family. Telephone calls to subjects at home may also be of concern. It may be appropriate to script calls carefully so that no information is revealed about the caller or the subject to anyone other than the subject. In some cases it may be appropriate to educate subjects about how to prevent possible violations of their privacy in their homes. For example, researchers may counsel subjects to make sure their home computers are secure or to close their browsers after completing an on-line survey on a sensitive topic.
Focus Groups-Protecting privacy within research using focus groups often requires researchers to modify the kinds of promises of confidentiality that they give in one-to-one interviews. Even though researchers can emphasize to all participants that the comments made during the focus group session should be kept confidential (when the topic warrants), researchers need to inform participants that it is impossible for the researcher to promise that participants will not repeat comments outside the group at some time in the future. Because maintaining confidentiality is not entirely under the control of the researcher, participants need to be encouraged to be as honest and open as they can, but remain mindful of the limits on the researcher's ability to protect confidentiality. In recruiting for focus groups, it is important to inform prospective participants how fellow participants are being selected. Privacy may or may not be an issue in the course of the group discussion, depending on whether individuals already know each other, and the topic. Participants need to know that information to help them decide about their comfort in being part of that group and dealing with the specific topics of the study.
Snowball Sampling-Privacy and Research MethodsNext step...
While not an exhaustive list, the following material highlights some concerns about privacy in the context of research. Click on each one to learn more.

Observational StudiesPrivacy and Study QuestionsCommunicating with SubjectsFocus GroupsSnowball Sampling







Snowball sampling is recruitment technique in which research participants are asked to assist researchers in identifying other potential subjects. If the topic of the research is not sensitive or personal, it may be appropriate for subjects to provide researchers with names of people who might be interested in participation. If the topic is sensitive or personal, such as the fact that someone was adopted, care should be taken so that potential subjects' privacy is not violated. In this case, subjects assisting with recruiting could provide information about the research to potential subjects, rather than giving the researcher names of potential subjects.
ConfidentialityNext step...
The ways in which data will be used and made available to others is part of the agreement researchers make with study participants and must be described during the informed consent process. The following questions are some of those that may be used to guide the design of study-specific confidentiality procedures.

Are identifiers really needed or could data be collected anonymously?
Can identifiers be destroyed, thus anonymizing data?
If identifiers are needed, can coded IDs be created to use for data collection, merging, and analysis, with identifiers kept entirely separate and secure?
If subjects were chosen for the study due to a sensitive or stigmatizing condition or participation in illegal activities, are procedures in place from the very beginning to protect identities, such as a waiver of the requirement to document consent?
Once identifiers are used to create codes to identify various data, can actual identifiers and the list linking them with the code be destroyed, thus anonymizing the data?
How will the data be protected from inadvertent disclosure or unauthorized access during collection, storage, and analysis? Would password protection be sufficiently protective, or would data encryption be necessary in addition? Would the use of stand-alone computers, without network access help prevent access by unauthorized users?
Are de-identified data sufficiently protected from re-identification?
Continued on the next page...Should data be manipulated in specific ways to reduce specificity, by collapsing data into categories with small numbers of individuals, reducing age or geographic specificity, etc.
Does sensitive data need to be protected from subpoena by third parties? Should a Certificate of Confidentiality be obtained?
In studies where it is an issue, are there limits to the promises of confidentiality that the researcher can make to subjects due to state laws requiring researchers to report suspected child abuse or neglect?
How will data be reported? In aggregate? Using pseudonyms? Using real names? Answers to these questions should be shared with participants so they can decide if they are comfortable with the plan.
Does permission need to be obtained to attribute quotations to subjects in a way that reveals their identity?
Who else, besides the researchers, will have access to the data in the present AND in the future?
If audiotapes or videotapes are made, what will be done with them during and after the research? Will they be shown at scholarly conferences? If so, will all subjects be asked if they are willing for the tapes to shown? Will audiotapes or videotapes be archived? Do releases need to be obtained for archiving material? Will the tapes be saved in case they have an as-yet-unknown, research use?
Privacy and Reporting LawsNext step...
Federal Privacy Law
Federal laws protect the disclosure of educational records (FERPA) and of private health information (HIPAA).

Generally, the disclosure of these records to researchers involves securing written authorizations from the potential subjects, although in certain clearly defined circumstances the requirement to secure authorizations may be waived. The module Research in the Schools provides more information about the use of educational records. Researchers in the social and behavioral sciences and the humanities usually do not generate private health information covered by HIPAA, rather they ask for it to be disclosed to them, usually by asking subjects to sign authorizations permitting the disclosure. Most institutions covered by HIPAA have models of authorization forms that they expect researchers to use.

State Reporting Requirements
State reporting laws may limit the promises of confidentiality that researchers can offer subjects. Most state laws identify individuals who must report suspected child abuse and neglect. This requirement should be described when child abuse and neglect might be revealed in a research study. Such studies could involve at-risk youth, school-based interventions, or parenting practices, among others.

On the other hand, there are many studies in which it is extremely unlikely that the topic would arise or that the researcher would be in a position to observe neglect or abuse. For example, a study of decision-making strategies using computer-based activities would not generate information about child abuse and there would be no need to discuss reporting requirements during the consent process.

State reporting laws may cover such matters as specific communicable diseases, the intent to harm oneself or others, and elder abuse. Consult with your IRB about the laws in your state.

International Privacy Laws
Researchers conducting research abroad should identify privacy laws at the research site that may be relevant for the conduct of research with human subjects.