PEERRS

This principle requires researchers to treat individuals as autonomous human beings, capable of making their own decision/choices, and not to use people as a means to an end. The principle also provides extra protection to those with limited autonomy. Elements of autonomy include: Mental capacity (the ability to understand and process information) Voluntariness (freedom from the control or influence of others) Subjects have full autonomy when they have the capacity to understand and process information, and the freedom to volunteer for or withdraw from research without coercion or undue influence from others. Rules derived from the principle of respect for persons include: The requirement to obtain and document informed consent. The requirement to respect the privacy interests of research subjects. The requirement to consider additional protections when conducting research on individuals with limited autonomy

Ethical Principles of the Belmont Report

Pilot studies, feasibility studies, and other preliminary studies clearly fall under the definition of research. Both of the following preliminary components of a study constitute research with human subjects: A focus group of Latino immigrants helping investigators develop a questionnaire with regard to the transfer of sexually transmitted disease between the United States and Central America. Community pilot testing of the questionnaire prior to the administration of the questionnaire and analysis of the results.

"Including research development, testing, and evaluation

A great deal of research in the social and behavioral sciences uses what is commonly thought of as the scientific method. However, the interpretation of the term "systematic investigation" depends largely upon discipline-specific methods. It is possible for research to be systematic without conforming in every respect to the elements of the conventional scientific method. For example, when ethnographers study communities, they may not have a priori hypotheses, but many aspects of their research may be systematic including the selection of subjects, decisions about what observations to record, and their interview process

"Systematic investigation"

Defining "Human Subject"Next step... According to the regulations, A human subject is a "living individual about whom an investigator (whether professional or student) conducting research obtains: Data through intervention or interaction with the individual, or Identifiable private information Click the elements of the definition below to learn more. "A living individual""About whom""Interventions""Interactions""Identifiable private information"Observing and Recording Private Behavior Private Information Provided by Individuals for Specific Purposes

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.

The need for protecting human subjects through research ethics and regulations is as relevant now as ever. Applying the Belmont principles to our studies is an important start: From the principle of respect for persons we need to conduct initial and continuing informed consent. We need to evaluate whether the research allows subjects to withdraw from the research and maintains the welfare of each subject. From the principle of beneficence we need to evaluate the social and scientific value of the research, the scientific validity of the research, and determine whether the research has a favorable risk benefit ratio. From the principle of justice we need to evaluate whether there is fair subject selection. We also need to evaluate the inclusion and exclusion criteria and the methods of recruitment.

Applying the Principles

One of the most important and challenging tasks that investigators face is identifying and evaluating risks associated with participation in research. Unlike biomedical research studies or clinical trials, in which the sources of risk may be more readily identifiable and quantifiable, risks associated with participation in social and behavioral science research are often more elusive and less predictable. However, this does not mean that these risks are any less serious or less real. For example, discrimination due to an inadvertent disclosure of sensitive personal information, such as sexual orientation or a diagnosis of mental illness, could have serious consequences. In rare circumstances, the risks associated with social and behavioral sciences may be physical in nature and not trivial. For example, physical harassment or arrest was identified as a risk in a study of the black market economy in Cuba. Similarly, those who study victims of domestic violence need to consider that their subjects may become the victims of retaliatory violence. It is also possible that when groups or communities rather than individuals are the focus of a study, the group as a whole may be at risk of harm. For example, studies comparing the average IQ of "racial" groups or the prevalence of HIV infected individuals in communities may stigmatize the community being studied.

Assessing Risk in Social & Behavioral Sciences

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.

Beneficence

The principle of justice requires us to treat people fairly and to design research so that its burdens and benefits are shared equitably. Those who benefit from the research should share in the burden of being subjects in the research. Those who serve as subjects in the research should share in the potential benefits from the research. Individuals or groups should not be selected for research participation solely because they are available, cannot say "no" or do not know that they can say "no". In order to avoid exploitation the selection of subjects should solely based on scientific justification. The rules derived from justice include: The requirement to select subjects equitably. The requirement to avoid exploitation of vulnerable populations or populations of convenience.

Balancing the Principles

Content of the Federal RegulationsNext step... The federal regulations for protecting research subjects describe: What research must be reviewed, Who must review it, What questions should be addressed during a review, and What kinds of review need to take place during the life of a project. It is important to note that the federal regulations are intended to provide minimum standards and may be supplemented by institutional policy

Content of the Federal Regulations

On March 31, 1996, a 19-year-old Asian -American student at the University of Rochester responded to an advertisement for study subjects to undergo bronchoscopy for the harvest of alveolar macrophages. The bronchoscopy was difficult and required numerous doses of topical lidocaine. The investigators repeatedly asked the subject if she wanted to continue and the subject nodded her head "yes." The study was completed, but the subject returned to the hospital in cardiac arrest from an overdose of lidocaine and died April 2, 1996. An investigation into this death revealed that the protocol did not limit lidocaine doses, that the doses were not documented, that the subject was not observed after the bronchoscopy, and that the concentrations of lidocaine were increased without IRB approval

Death of a Normal Volunteer

Federal regulations for protecting research subjects provide basic definitions of "research" and of "human subjects." In this topic we will interpret words and phrases used in the definitions from the perspective of research in the social and behavioral sciences and the humanities. It should be noted that reasonable people can and do disagree about how to interpret and apply the definitions and that institutional policies about how to define research with human subjects may vary. Defining "research" "Systematic investigation" "Including research development, testing, and evaluation" "Designed to develop or contribute to generalizable knowledge" Defining "human subject" "A living individual about whom" "Interventions" "Interactions" "Identifiable private information"

Defining Research with Human Subjects

n the fall of 1999, eighteen-year-old Jesse Gelsinger died as a result of his participation in a gene transfer trial. Jesse had a rare metabolic disorder, ornithine transcarbamylase deficiency syndrome (OTC) that was being controlled by medication and diet. Researchers were testing an innovative technique using adenovirus gene transfer. Shortly after treatment Jesse Gelsinger experienced multiple organ failure and subsequently died. This case catapulted research with human subjects into the national media. Serious concerns related to conflict of interest, data safety monitoring, and informed consent have made the Gelsinger case a contemporary illustration of continued doubts about the ethical integrity of research with human subjects. This case has instigated deliberations on all these controversial topics at the national level. The outcome of the discussions has yet to be determined.

Death of Gene Therapy Trial

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.

Expedited or Full Review

he study planned first to obtain information about homosexual practices in public restrooms and then to conduct further investigation on the men who took part in the acts. The researcher went undercover and gained the confidence of the men by acting as a "look out." The researcher identified 100 active subjects by tracing their car license numbers. A year after he completed the initial study of direct observation of homosexual acts the researcher distributed a "social health survey" throughout the communities where he knew the subjects lived and collected data about their sexual orientation, and marital and family status. Ethical problems: invasion of privacy, use of a vulnerable population, lack of informed consent. [Warwick]

Humphrey "Tea Room Trade Study" (1970)

It was the Commission's intention that each of the three principles should have equal moral force. This means that in some situations, the three principles might be in conflict with one another. For example, we might derive from the principle of respect for persons that we should limit the involvement of children in research because children are unable to choose for themselves. But, we might derive from the principle of justice that we must involve children in studies so that children will have the opportunity to benefit from the research. The Belmont Report states that one principle does not always outweigh another. Rather, we are required to consider each case separately and on its own merits in light of all three principles

Justice

The purpose of this study was to learn more about how humans respond to instructions from people in positions of authority. The researchers informed volunteers that the purpose of the research was to study learning and memory. Each subject was told to teach a "student" and to punish the students' errors by administering increasing levels of electric shock. The "students" were confederates of the researcher and were never actually harmed. The "students" pretended to be poor learners. They mimicked pain and even unconsciousness as the subjects increased the levels of electric shock. Sixty-three percent of the subjects administered what they thought were lethal shocks; some even after the "student" claimed to have heart disease. Some of the subjects, after being "debriefed" from the study experienced serious emotional crises. Ethical Problems: deception, unanticipated psychological harms.

Milgram "Obedience to Authority Study" (1963)

In summary, the Nuremberg Code includes the following guidance for researchers: Informed consent is essential. Research should be based on prior animal work. The risks should be justified by the anticipated benefits. Only qualified scientists must conduct research. Physical and mental suffering must be avoided. Research in which death or disabling injury is expected should not be conducted.

Nuremberg

In addition to explicitly identifying these methods, the regulations include provisions that allow for appropriate review of social science, humanities, and behavioral research. For example, the regulations: Identify research activities that are low risk, for example, a survey in which no identifiers are collected, and that are thus exempt from the remaining provisions of the regulations, such as the requirement for continuing review. Identify research activities with no more than minimal risk that can be reviewed by one or more Institutional Review Board (IRB) members, rather than at a convened IRB meeting. Allow for waivers of the requirement to obtain written consent, for example, in a study of undocumented workers. Include provisions that permit researchers to withhold information in the consent process. This provision is important when some degree of deception is required in order to obtain valid results. Allow for the amendment of approved protocols. This process can be used effectively when it is not possible to know at the outset how a study will evolve, for example when the study employs community-based participatory research methods. Require that IRBs have the necessary competence to review specific research activities. This topic will provide an overview of the federal regulations so that researchers can become conversant with their basic provisions.

Provisions for Social Science, Humanities and Behavioral Research

dentify research activities that are low risk, for example, a survey in which no identifiers are collected, and that are thus exempt from the remaining provisions of the regulations, such as the requirement for continuing review. Identify research activities with no more than minimal risk that can be reviewed by one or more Institutional Review Board (IRB) members, rather than at a convened IRB meeting. Allow for waivers of the requirement to obtain written consent, for example, in a study of undocumented workers. Include provisions that permit researchers to withhold information in the consent process. This provision is important when some degree of deception is required in order to obtain valid results. Allow for the amendment of approved protocols. This process can be used effectively when it is not possible to know at the outset how a study will evolve, for example when the study employs community-based participatory research methods. Require that IRBs have the necessary competence to review specific research activities. This topic will provide an overview of the federal regulations so that researchers can become conversant with their basic provisions.

Provisions for Social Science, Humanities and Behavioral Research

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.

Public Trust

Researchers in the social and behavioral sciences and the humanities often assert that the regulations for the protection of human research subjects don't really apply to the kind of research that they do, believing that the rules were written exclusively for biomedical research. There is a kernel of truth in this because revelations in the early 1970s about egregious medical experiments provided the impetus for developing federal standards for protecting human research. However, a close reading of the regulations will find mention of research methods and topics of inquiry relevant for researchers in the social and behavioral sciences and the humanities. Methods include surveys, interviews, focus groups, oral history, participant observation, observations of public behavior, and the analysis of existing data. Topics include research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior.

Regulatory Overview

This principle requires researchers to treat individuals as autonomous human beings, capable of making their own decision/choices, and not to use people as a means to an end. The principle also provides extra protection to those with limited autonomy. Elements of autonomy include: Mental capacity (the ability to understand and process information) Voluntariness (freedom from the control or influence of others) Subjects have full autonomy when they have the capacity to understand and process information, and the freedom to volunteer for or withdraw from research without coercion or undue influence from others. Rules derived from the principle of respect for persons include: The requirement to obtain and document informed consent. The requirement to respect the privacy interests of research subjects. The requirement to consider additional protections when conducting research on individuals with limited autonomy

Respect for Persons

Not all the events that raise concerns about research ethics occurred in the past. Recently, a faculty member from the Business School of a major university designed and implemented a study to elicit responses from restaurants to complaints from putative customers. As part of the project, the researcher sent letters to restaurants falsely claiming that he and/or his wife had suffered food poisoning that ruined their anniversary celebration. The letters disclaimed any intention of contacting regulatory agencies and stated that the only intent was to convey to the owner what had occurred "in anticipation that you will respond accordingly." Restaurant owners and employees suffered severe emotional distress before learning that it was a hoax. The researcher later admitted the falsehood in a letter of apology. He explained that "the letter was fabricated to help collect data for a research study that I designed concerning vendor response to customer complaints." This study had not been submitted to an IRB for review. An investigation by the Federal Office for Human Research Protections (OHRP) followed. In addition, the restaurants filed a lawsuit against the University. Ethical problems: Deception, lack of informed consent, infliction of emotional distress.

Restaurant Letter Study (2001)

To quote from the publication "Preserving the Public Trust" prepared by the Institute of Medicine, "The complex system that sustains research is ultimately premised on trust - trust in the people and organizations that conduct research. In the wake of revelations about lapses in research ethics, such trust must be earned." The evolution of the currently regulatory process governing human subjects research is based on preservation of the public trust by establishing standards for the ethical conduct of human subjects research and requirements to ensure the accountability of researchers engaged in such research. The IRB review system is designed to provide an independent, objective review of research involving human subjects so that the privilege of conducting human subjects research may be maintained.

Summary

In 1979, after a several years of deliberations, the National Commission published the Belmont Report. The Report is a summary of the basic ethical principles identified by the National Commission in the course of its deliberations in February 1976 supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of the basic ethical principles and guidelines that should be used to resolve the ethical problems that surround the conduct of research with human subjects. The Belmont Report identifies three basic ethical principles that underlie all human subject research. These principles are commonly called the Belmont Principles. The Belmont Principles are respect for persons, beneficence, and justice. All individuals involved in the conduct of human research should read the Belmont Report. The conduct of ethical research is not intuitive - being a good person is no more sufficient for the conduct of ethical research than being brilliant is sufficient for the conduct of good science. One must know and understand the basic principles science and know how to apply them to the design and conduct of research in order to do good science. So, too, must one know and understand the basic ethical principles in the Belmont Report and know how to apply them in order to conduct ethical research

The Belmont Report

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.

The Need for Independent, Objective Review of Research

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.

The Public Health Service Syphilis Study (1932-1971)

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

Title 45 Code of Federal Regulation Part 46 (45 CFR 46) Protection of Human Subjects

The Department of Health and Human Services (DHHS) regulations are sometimes referred to as 45 CFR 46, a label that identifies their location in the Code of Federal Regulations. You will probably see 45 CFR 46 quoted in your institution's policies and resource materials. Subpart A of 45 CFR 46 is often referred to as the "Common Rule." Although these regulations were first drafted and adopted by DHHS, most departments that fund research in the social and behavioral sciences, including the National Science Foundation and the Department of Education, subsequently adopted the regulations, thus the designation "Common Rule.

Title 45 Code of Federal Regulation Part 46 (45 CFR 46) Protection of Human Subjects

The first step in deciding whether a project needs review is to determine whether it meets the definition of research with human subjects. If it doesn't meet the definition, it doesn't require review by an IRB, although there may be ethical issues that must be addressed by the researcher's institution. Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge Human subject: a living individual about whom an investigator (whether professional or student) conducting research obtains Data through intervention or interaction with the individual, or Identifiable private information. Once it has been determined that a project meets the definition of research with human subjects, the next step is to determine the type of review it needs. The type of review determines who will conduct the review.

What Must Be Reviewed

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.

What Questions Must Be Addressed During a Review

In this study researchers tape recorded jurors' deliberations in six courtroom trials to measure the influence of attorney comments on decision making. The judge and attorneys knew the research was being conducted, but the jurors did not. The tapes were played at a law conference. The resulting concern that future taping could have a repressive effect on juror deliberations resulted in federal law banning all recording of jury proceedings in 1956. Ethical problems: compromising the integrity of important social institutions, lack of informed consent, invasion of privacy.

Witchita Jury Case (1953)

This landmark psychological study of the human response to captivity and, in particular, prison life, involved assigning roles to male student volunteers as "prisoners" and "guards". The research became so intense, as physical and psychological abuse of "prisoners" by "guards" escalated, that several of the subjects experienced distress less than 36 hours after the study began. Dr. Philip Zimbardo, the researcher, failed to stop the experiment/simulation until six days had passed. Ethical problems: harm to subjects, neutrality of researcher

Zimbardo "Simulated Prison" (1973)