Belmont Report -ME

What is an IRB?

IRBs are committees that consist of 5 or more members with varying expertise and diversity that are responsible for reviewing and approving human subjects research activities on behalf of institutions

What are undue inducements?

Undue inducements are troublesome because: 1. offers that are too attractive may blind prospective subjects to the risks or impair their ability to exercise proper judgment; and 2. they may prompt subjects to lie or conceal information that, if known, would disqualify them from enrolling — or continuing — as participants in a research project.

What are 2 basic convictions related to respect of persons?

1. Individuals should be treated as autonomous agents 2. Persons with diminished autonomy are entitled to protection. Two separate moral requirements: 1. Requirement to acknowledge autonomy 2. Requirement to protect those with diminished autonomy.

What are the two basic ideas in principle of respect for persons?

1. Individuals should be treated as autonomous agents. 2. Persons with diminished autonomy are entitled to additional protections.

What are 3 examples to show lack of respect?

1. Respect for persons demands that subjects enter into the research voluntarily and with adequate information. 2. Not every human being is capable of self-determination. 3.Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them

What is the principle of justice?

It requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research. The principle of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigators to question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability — rather than for reasons directly related to the problem being studied.

What 3 criteria needs to be met when incomplete disclosure is used?

Justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research (2) there are no undisclosed risks to subjects that are more than minimal (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.

What is Subpart A, also called?

"The Common Rule", describes the required protections for all human subjects.

What are 5 formulations of the principle of justice?

(1) to each person an equal share (2) to each person according to individual need (3) to each person according to individual effort (4) to each person according to societal contribution (5) to each person according to merit.

What do you do for informed consent with children subjects?

* Children are considered a vulnerable population, and * Children are unable to provide "legally effective informed consent" A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study. Because children cannot provide informed consent, children provide assent to participate in research, to the extent that they are able, and parents/guardians give permission for a child to participate in research.

What are the information requirements for informed consent?

1. Voluntariness 2. Comprehension 3. Disclosure

What are 3 examples to show lack of respect?

1. to repudiate that person's considered judgments, 2. to deny an individual the freedom to act on those considered judgments, 3. to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

What is a human subject?

45 CFR 102(f) defines a human subject as an individual about whom an investigator conducting research obtains data through intervention or interaction with individual or identifiable private information.

What are the categories of risk and explain each one.

A. Physical B. Psychological Anxiety, sadness, regret and emotional distress, among others. C. Social Participating in research or the revelation of data collected by investigators in the course of the research, if disclosed to individuals or entities outside of the research, could negatively impact others' perceptions of the participant. Social risks can range from jeopardizing the individual's reputation and social standing, to placing the individual at-risk of political or social reprisals. D. Legal Legal risks include the exposure of activities of a research subject "that could reasonably place the subjects at risk of criminal or civil liability." E. Economic Economic risks may exist if knowledge of one's participation in research, for example, could make it difficult for a research participant to retain a job or to find a job, or if insurance premiums increase or loss of insurance is a result of the disclosure of research data.

What is an adverse event?

An adverse event is any undesirable experience associated with the use of a medical product in a patient. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.

What is voluntariness?

An agreement to participate in research constitutes a valid consent only if voluntarily given.

Why is it important to have NIH Inclusion Policies: Women and Minorities?

Because knowledge gained from clinical research may define health policy and shape standards of care for all patients, it is important to consider whether the intervention or therapy under scrutiny "affects women or men or members of minority groups and their subpopulations differently."

What are data and safety monitoring plans?

Data and Safety Monitoring Plans describe protections for research participants and data integrity, and oversight for clinical trials at a level that is commensurate with the risks of participating in the clinical trial. That is, the method and frequency of monitoring is directly related to the possible harms to research participants in the clinical trial.

What should each institution have to engage in NIH funded human subject research?

Each institution that is engaged in NIH-funded human subjects research must: * Obtain or hold a current Federalwide Assurance (FWA), assuring that an institution will comply with HHS regulatory requirements for the protection of human subjects (this is obtained from the HHS Office for Human Subjects Protections (OHRP)); and * Certify to NIH that grant applications and contract proposals describing research involving human subjects has been reviewed and approved by an Institutional Review Board (IRB) designated in the FWA, and will be subject to continuing review by an IRB.

What is equipose?

Equipoise is essential for obtaining generalizable knowledge. If a clear and agreed-upon answer exists, asking research participants to assume the risks of research that will provide the same information is not acceptable; no new knowledge will be gained from the study.

How does a researcher justify the use of placebos?

Examples of justifications for the use of placebos include: An inactive intervention designed to resemble, as much as possible, its active counterpart in clinical research. 1. When there are no approved, effective treatments for the condition, or 2. If there is disagreement about whether standard treatment is better than placebo, or 3. When the additional risk posed by the use of placebo is minor and withholding the current standard therapy would not lead to serious or permanent harm, or 4. If the study is anticipated to result in widespread or major benefits and the receipt of placebo by individuals poses minimal risk.

What is meant by non-engagement in research?

Institutions would be considered not engaged in an HHS-conducted or -supported non-exempt human subjects research project (and, therefore, would not need to hold an OHRP-approved FWA or certify IRB review and approval to HHS) if the involvement of their employees or agents in that project is limited to one or more of the following. The following are scenarios describing the types of institutional involvement that would make an institution not engaged in human subjects research; there may be additional such scenarios:

What does "practice" refer to?

Interventions that enhance the well-being of an individual client and the expectation of success.

What is the importance of the knowledge to be gained?

Investigators reasonably anticipate that the research will contribute to generalizable knowledge. This generalizable knowledge is considered a benefit to others, and risks to research participants must be reasonable in relation to the importance of the knowledge that reasonably may be expected to result

What is meant by benefits?

Positive value related to health or welfare.

What is risk?

Risk is the "probability that a certain harm will occur."

What are the requirements to be exempt?

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies or (b) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods. 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: a. information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects and b. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation. 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph # 2 (above) if: a. the human subjects are elected or appointed public officials or candidates for public office, or b. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. 4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects. 5. Research and demonstration projects which are conducted by or subject to the approval of (federal) department or agency heads and which are designed to study, evaluate or otherwise examine: (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures or (d) possible changes in methods or levels of payment for benefits or services under those programs. 6. Taste and food quality evaluation and consumer acceptance studies, if: a. wholesome foods without additives are consumed or b. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U. S. D. A.

How can IRB waive or alter some or all of the required elements of an informed consent?

The HHS regulations (45 CFR 46.116(c)) allow institutional review boards (IRBs) to waive or alter some or all of the required elements of informed consent A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study. if all of the following conditions are met: 1. "The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; (iv) possible changes in methods or levels of payments for benefits or services under those programs, and 2. The research could not practicably be carried out without the waiver or alteration."

What are the criteria to evaluate application for research in supporting human subjects?

The HHS regulations (45 CFR 46.120) require that Federal Departments and Agencies that conduct or support human subjects research must evaluate all applications for research using the following criteria: * Risks to the subjects * Adequacy of protection against these risks * Potential benefits of the research to the subjects and others * Importance of the knowledge gained or to be gained

What are the additional protections for prisoners involved in research and why do they need them?

The HHS regulations require additional protections for prisoners who are involved as participants in research because they may "be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research."

What are requirements for IRB composition?

The composition of an IRB for the FDA's (a)1 The IRB must have at least five members.[3] (a)2 The members must have enough experience, expertise, and diversity to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place. (a)3 If the IRB works with studies that include vulnerable populations, the IRB should have members who are familiar with these groups. It is common for an IRB to include an advocate for prisoners when considering research that involves them. (b)1 The IRB should include both men and women, as long as they aren't chosen specifically for their gender. (b)2 The members of the IRB must not be all of the same profession. (c) The IRB must include at least one scientist and at least one non-scientist. These terms are not defined in the regulations. (d) The IRB must include at least one person who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. These are commonly called "Community Members." (e) IRB members may not vote on their own projects. (f) The IRB may include consultants in their discussions to meet requirements for expertise or diversity, but only actual IRB members may vote.

What is justice?

The definition of justice has two parts: * Fair procedures and outcomes are used to select research participants, and * There is a fair distribution of benefits and burdens to populations who participate in research.

WHat is confidentiality?

The obligations of individuals and institutions to use information under their control appropriately once it has been disclosed to them.

What is therapeutic misconception?

Therapeutic misconception is the tendency for research participants to: "... downplay or ignore the risks posed to their own well-being by participation ... [due to] the participants' deeply held and nearly unshakeable conviction that every aspect of their participation in research has been designed for their own individual benefit."

Whats meant by systematic assess of risks and benefits?

This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure renders the assessment of research more rigorous and precise, while making communication between review board members and investigators less subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigator's estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.

When do you recruit subjects?

after an approved protocol

Whats the definition of vulnerable subject?

certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted.

How does the principle of bene apply to risk of harm?

interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects' rights have been protected. 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.

What criteria used to select third party for informed consent?

Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm. The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to act in that person's best interest. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject's best interest.

What does practice refer to?

...the term "practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.

What does research refer to?

...the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

What does "research" refer to?

Designates an activity designed to test a hypothesis to be drawn, and to develop or contribute to generalizable examples in theories, principles, and statements in the relationships described in a formal protocol that has objectives and a plan to reach that objective.

What question remains regarding informed consent?

It does not answer the question of what the standard should be for judging how much and what sort of information should be provided.

What is the challenge inherent in applying the Belmont principle of beneficence?

It is how to determine when potential benefits outweigh considerations of risks and vice versa.

What is privacy?

Privacy also refers to the capacity to control when, how and to what degree information about oneself is communicated to others.

What is PHI?

Private Health Information

What is the protection of economic risk?

Protecting confidentiality of data is one method for protecting against economic risks, such as those to employability and insurability. Investigators may elect to keep research data separate from medical records in order to prevent employers and insurance companies from obtaining information that could put the participants at risk.

under what conditions do you need to adapt presentation of informed consent?

Special provision may need to be made when comprehension is severely limited -- for example, by conditions of immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms.

How does subpart A define research?

Subpart A defines research as "a systematic investigation...designed to develop or contribute to generalizable knowledge." This definition includes: * Research development * Testing * Evaluation

What are 5 considerations of justify of research?

(i) Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures. (iii) When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation). (iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits. (v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

What are the challenges in applying the Belmont principle of respect for persons?

* Making sure that potential participants comprehend the risks and potential benefits of participating in research * Avoiding influencing potential participants' decisions either through explicit or implied threats (coercion) or through excessive compensation (undue influence)

What is the general criteria IRB needs from researchers?

* Risks to human subjects are minimized *Risks to human subjects are reasonable in relation to anticipated benefits, if any, to human subjects and the importance of the knowledge that may reasonably be expected to result from the research *Selection of human subjects is equitable *Informed consent will be sought from each prospective research participant or the prospective research participant's legally authorized representative *Informed consent will be appropriately documented *When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the human subjects, and when appropriate there are adequate provisions to protect the privacy of human subjects and to maintain the confidentiality of data

What is meant by risk?

1. Chance (probability) of experiencing harm 2. Severity (magnitude) of the envisioned harm

What are two general rules of beneficence?

1. Do no harm 2. Maximize possible benefits and minimize possible harms

What was the charge of the commission?

1. Identifying the ethical principles to guide all research involving human subjects 2. Developing guidelines for the conduct of ethical research involving human subjects

What the three basic ethical principles?

1. Respect of persons 2. Beneficence 3. Justice

WHats the Nuremborg code?

1. Should have legal capacity to give consent 2. Should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. Should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. The experiment should be conducted only by scientifically qualified persons. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

What contributions of the Declaration of Helsinki?

1. The World Medical Association (WMA) Declaration of Helsinki a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. 2. Although the Declaration is addressed primarily to physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles. 3. It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty. 4. The Declaration of Geneva of the WMA binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act in the patient's best interest when providing medical care." 5. Medical progress is based on research that ultimately must include studies involving human subjects. Populations that are underrepresented in medical research should be provided appropriate access to participation in research. 6. In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests. 7. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality. 8. In medical practice and in medical research, most interventions involve risks and burdens. 9. Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence. 10. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

What are the 4 IRB outcomes?

An IRB review may result in the following outcomes: 1. The research project is considered exempt from further review and the IRB chair informs the PI that research may begin immediately. 2. The research project qualifies for an expedited review and is assigned by the IRB chair to a member of the IRB committee who reviews the application and judges the research project: Approved. The proposal is within acceptable guidelines and the IRB chair informs the PI that research may begin immediately; or Not Approved. The proposal requires a full IRB review. 3. The research project requires a full IRB review and is considered in a regularly convened IRB meeting where it may be judged: Approved as written and the IRB chair informs the PI that research may begin immediately; or Not Approved as written. The IRB chair informs the PI of the parts of the proposal that were not acceptable. The PI may rewrite and resubmit the proposal; or Disapproval. The IRB chair informs the PI that the research project may not be done under the auspices of Trinity College.

What is an expedited reveiw? What are the requirements and who conducts an expedited review?

An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in Expedited Research Categories Research categories that may be reviewed using expedited review procedures by the University of Tennessee at Martin Institutional Review Board (IRB) match federal guidelines and include: ● ● Category G: Clinical studies of drugs and medical devices only when condition Category H: Collection of blood samples by finger stick, heel stick, ear stick, or venipucture as follows: Category I: Prospective collection of biological specimens for research purposes by noninvasive means. Category J: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwave. ● Category K: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45CFR 46.101 (b)(4). This listing refers only to research that is not exempt. ● Category L: Collection of data from voice, video, digital, or image recordings made for research purposes. ● Category M: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identify, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. ● Category N: Continuing review of research previously approved by the convened IRB ● Category O: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption

How should an individual's consent be assessed?

An individual's capacity to consent to a particular study should be assessed based on: "An individual capable of deliberation about personal goals and of acting under the direction of such deliberation." 1. The individual's level of capacity, and 2. The complexity and risks of the study, i.e., the capacity needed for an individual to be able to understand the study well enough to consent to participate

Why does the selection of research subjects need to be scrutinized?

Are some classes are being systematically selected because of easy availability, their compromised position, or manipulation rather than for reasons directly related to the problem being studied. Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

What is consent vs. assent

Assent is an active affirmation of a desire to participate and differs from consent which is recognized as being granted from an individual with the legal authority to do so. Even very young children or those with limited cognitive ability can assent and they can certainly indicate a desire not to participate, which must be honored. Assent should be administered in a manner that is easily understood by the potential participant (either written or verbal) and should be limited to a one-page format. Illustrations might be helpful and larger type makes it easier for some individuals to read.

Whats the common rule?

For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.

What are the 2 components of voluntary consent?

Free of coercion and undue influence. 1. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. 2. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.

What is an exempt review?

Generally, research involving surveys or interviews, the use of existing data, and educational research in the classroom falls within the exempt category. This does not mean, however, that the research is exempt from the requirement to submit an application or follow federal guidelines. It means that the application involves less than minimal risk to subjects and that it is exempt from full review, but the IRB must still review the application to determine that this is the appropriate level of review. One difference between an exempt review and other forms is that exempt research will not be monitored by the IRB on an ongoing basis.

What are the 3 criteria to be met when incomplete disclosure is used?

In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.

What is equitable distribution?

In order to achieve an equitable distribution of the risks and potential benefits of the research, investigators must determine the distribution of different groups (men and women, racial or ethnic groups, adults and children, age, etc.) in the populations that: 1. May be affected by the disease or condition under study, and 2. That are anticipated to benefit from the knowledge gained through the research

What is individual justice?

Individual justice requires that investigators "should not offer potentially beneficial research only to some patients who are in their favor or select only 'undesirable' persons for risky research.

What is informed consent?

Informed consent is designed to inform research subjects about the purpose, risks, potential benefits and alternatives to the research This exchange of such information should occur at enrollment and throughout the study. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.

How does the principle of justice impact the selection of subjects?

Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons.

What is minimal risk?

Minimal risk is defined in the Common Rule to be "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."

What is the protection of social risk?

Often, minimizing social risks to participants involves protecting confidential data, including not only the data collected, but the fact of participation in the research project itself.

What is the protection of physical risk?

Physical risks in research can be minimized by: 1. Carefully and skillfully following protocols 2. Having trained individuals conduct research procedures, through careful monitoring of research participants' health status 3. Recruiting appropriate populations 4. Providing clinical care when needed.

What is the protection of psychological risk?

Possible ways to protect against psychological risks include reminding participants of their right to withdraw from research or limit their participation if they become uncomfortable, providing counseling or psychological support for participants who experience distress, or thoroughly debriefing research participants after research sessions are completed.

What is the proctection with legal risk?

Protections against legal risks often involve protecting the confidentiality of research data. For studies conducted in the United States, investigators can apply for Certificates of Confidentiality, which are intended to prevent investigators from being forced to disclose data that can be linked to identifiable research participants in legal proceedings.

What types of harm should be considered?

Psychological harm, physical harm, legal harm, social harm and economic harm

What are the responsibilities of the IRB?

Safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension. The primary ethical principles in human subjects review are outlined in the Belmont Report, and include "respect for persons", "beneficence," and "justice." The IRB may only approve research for which there is a bona fide informed consent process for participants, for which the risks to subjects are balanced by potential benefits to society, and for which the selection of subjects presents a fair or just distribution of risks and benefits to eligible participants.

What is social justice?

Social justice "requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons."

How does subpart A define human subject?

Subpart A defines a human subject as "a living individual about whom an investigator...conducting research obtains: "OHRP considers the term investigator to include anyone involved in conducting the research." Examples of such additional activities include, but are not limited to: (1) the study, interpretation, or analysis of the data resulting from the coded information or specimens; and (2) authorship of presentations or manuscripts related to the research." 1. Data through intervention or interaction with the individual, or 2. Identifiable private information."

What are considered vulnerable populations?

Subparts B, C and D define the specific categories of research in which pregnant women, human fetuses and neonates, prisoners, or children respectively may be involved. The subparts describe additional requirements for informed consent, and may specify additional responsibilities for the Institutional Review Board (IRB) when reviewing research involving these populations, and list the requirements for research that need additional levels of review and approval.

What does HHS require with studies involving pregnant women?

The HHS regulations require: * Preclinical studies be completed prior to the involvement of pregnant women * A consideration of risks and potential benefits for the fetus and pregnant woman

What is community consultation?

The appropriate way to attain community consent may vary widely, but is often achieved through meetings with large groups of community representatives or community leaders. It is also appropriate to consult a community before conducting research when the research involves risk to discrete, identifiable populations. For example, members of a community may feel stigmatized if a number of members of that community participate in research that may reveal unpopular or dangerous traits.

How does comprehension impact informed consent?

The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.

What are the principle of beneficence factors that investigators consider?

The principle of beneficence requires that investigators consider a number of factors including: * Equipoise Substantial scientific uncertainty about which treatments will benefit subjects most, or a lack of consensus in the field that one intervention is superior to another. * Protecting the privacy of research participants and the confidentiality of research data * Establishing oversight mechanisms to protect the rights and welfare of research participants and to determine the significance of the data

What are the principles of respect?

The principle of respect for persons can be broken down into two basic ideas: 1. Individuals should be treated as autonomous agents "An individual capable of deliberation about personal goals and of acting under the direction of such deliberation." 2. Persons with diminished autonomy are entitled to additional protections

What are the regulated potential benefits to individual participants?

The proposed research has a favorable ratio of potential benefit to risk. This balancing act is often called a risk-benefit analysis.

What is meant by the nature and scope of risks and benefits?

The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons.

What are the requirements for consent with prisoners?

The requirements specific to informed consent for prisoners are: A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study. 1. "Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired" 2. "Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole"

What are the rules with beneficient in research?

Two general rules have been articulated as complementary expressions of beneficent actions: 1. Do no harm 2. Maximize possible benefits and minimize possible harms

What are the 3 basic principles in the Belmont Report?

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

What are the three basic ethical principles?

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

What sources of injustice are there?

Thus injustice arises from social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they can consider distributive justice in selecting research subjects.

What does it mean with Equity vs. Equality in Human Subjects Research?

To treat "equitably" means to treat fairly; To treat "equally" means to treat in exactly the same way. Research should strive for equitable distribution of the risks and potential benefits of the research. This means that investigators are treating the groups involved in the research fairly and justly. It does not necessarily mean that all groups are equally represented, but that their representation is fair and just based on the risks and potential benefits associated with the research.

What are specific guidelines for writing an informed consent?

Unless otherwise authorized by an IRB, research investigators must provide the following information to each subject in writing: Strongly urged to use a format in the body of the consent form that presents information in sections, introduced by headings, and that clearly and simply identifies and describes each of the elements to be discussed, even if the sections repeat information that appears on the printed form. A statement that the study involves research;* An explanation of the purpose of the research and 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, an estimate of their likelihood, and a description of what steps will be taken to prevent or minimize them; A description of any benefits to the subject or to others that may reasonably be expected from the research. Monetary compensation is not a benefit. If compensation is to be provided to research subjects or healthy volunteers, the amount should be stated in the consent document; A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the subject; A statement describing to what extent records will be kept confidential, including a description of who may have access to research records;* For research involving more than minimal risk, an explanation and description of any compensation and any medical treatments that are available if research subjects are injured; where further information may be obtained, and whom to contact in the event of a research-related injury;* An explanation of whom to contact for answers to pertinent questions about the research and the research subject's rights (include the Clinical Center's Patient Representative and telephone number);* and A statement that participation is voluntary and that refusal to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled.*

What is the question that remains regarding informed consent?

What the standard should be for judging how much and what sort of information should be provided.

How is experimental and research different?

When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research.

How is experiental and research different?

When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective.

What are the regulated Protections against risks?

Where appropriate, investigators must describe procedures for minimizing potential risks, including risks to confidentiality, plans for ensuring any necessary medical or professional intervention, plans for data and safety monitoring for clinical trials, etc.

What is research?

the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.