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Regulatory Background

 

Investigators should understand the concept of minimizing risk when designing research and conduct a risk-benefit assessment to determine the level of IRB review of the research. In the protocol application the Investigator should:

  • Assess potential risks and discomforts associated with each intervention or research procedure;
  • Estimate the probability that a given harm may occur and its severity;
  • Explain measures that will be taken to prevent and minimize potential risks and discomforts;
  • Describe the benefits that may accrue directly to subjects; and
  • Discuss and the potential societal benefits that may be expected from the research.

Risks to subjects who participate in research should be justified by the anticipated benefits to the subject or society. This requirement is found in all codes of research ethics, and is a central requirement in the Federal regulations (45 CFR 46.111 and 21 CFR 56.111). Two of the required criteria for granting IRB approval of the research are:

  • Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB Committee will consider only those risks and benefits that may result from the research, as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research.

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Definitions

 

Benefit: A helpful or good effect, something intended to help, promote or enhance well-being; an advantage.

 

Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

 

Minimal Risk: A risk is minimal when “the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater in and of themselves than those ordinarily encountered in daily life of the general population or during the performance of routine physical or psychological examinations or tests.” Examples of procedures that typically are considered no more than minimal risk include: collection of blood or saliva, moderate exercise, medical record chart reviews, quality of life questionnaires and focus groups. See Expedited review categories for a complete listing.

 

Minimal Risk for Research involving Prisoners: The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. A risk is minimal when, "the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental or psychological examinations of healthy persons."

 

Privacy: Privacy is about people and their sense of being in control of others access to them or to information about themselves.

 

Confidentiality: Confidentiality is about how identifiable, private information that has been disclosed to others is used and stored. People share private information in the context of research with the expectation that it be kept confidential and will not be divulged except in ways that have been agreed upon.

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Types of Risks to Research Subjects

 

Physical Harms: Medical research often involves exposure to pain, discomfort, or injury from invasive medical procedures, or harm from possible side effects of drugs, devices or new procedures. All of these should be considered "risks" for purposes of IRB review. 

  • Some medical research is designed only to measure the effects of therapeutic or diagnostic procedures applied in the course of caring for an illness. Such research may not entail any significant risks beyond those presented by medically indicated interventions.
  • Research designed to evaluate new drugs, devices or procedures typically present more than minimal risk and involve risks that are unforeseeable that could cause serious or disabling injuries.

 

Psychological Harms: Participation in research may result in undesired changes in thought processes and emotion (e.g., episodes of depression, confusion, feelings of stress, guilt, and loss of self-esteem). Most psychological risks are minimal or transitory, but some research has the potential for causing serious psychological harm.

  • Stress and feelings of guilt or embarrassment may arise from thinking or talking about one's own behavior or attitudes on sensitive topics such as drug use, sexual preferences, selfishness, and violence.
  • Stress may be induced when the researchers manipulate the subjects' environment to observe their behaviors and reactions. The possibility of psychological harm is heightened when behavioral research involves an element of deception.

 

Social and Economic Harms: Some losses of privacy and breaches of confidentiality may result in embarrassment within one's business or social group, loss of employment, or criminal prosecution.

  • Areas of particular sensitivity involve information regarding alcohol or drug abuse, mental illness, illegal activities, and sexual behavior.
  • Some social and behavioral research may yield information about individuals that could be considered stigmatizing to individual subjects or groups of subjects. (e.g., as actual or potential carriers of a gene; individuals prone to alcoholism). Confidentiality safeguards must be strong in these instances.
  • Participation in research may result in additional actual costs to individuals. Any anticipated costs to research participants should be described to prospective subjects during the consent process.

 

Privacy Risks: Loss of privacy in the research context usually involves either covert observation or participant observation of behavior that the subjects consider private. It can also involve access and use of private information about the subjects. The IRB must make two determinations:

  • Is the loss of privacy involved acceptable in light of the subjects' reasonable expectations of privacy in the situation under study; and 
  • Is the research question of sufficient importance to justify the intrusion?

 

Breach of Confidentiality Risks: Absolutely confidentiality cannot be guaranteed and is always a potential risk of participation in research. A breach of confidentiality is sometimes confused with loss of privacy, but it is a different risk. Loss of privacy concerns access to private information about a person or to a person's body or behavior without consent; confidentiality of data concerns safeguarding information that has been given voluntarily by one person to another. It is important to recognize that a breach of confidentiality may result in psychological harm to individuals (embarrassment, guilt, stress, etc.) or in social harm.

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Conducting Risk-Benefit Assessments

 

Role of the Investigator: When designing research studies, investigators are responsible for conducting an initial risk-benefit assessment using the steps outlined in the diagram below.

 

Role of the IRB: The IRB ultimately is responsible for evaluating the potential risks and weighing the probability of the risk occurring and the magnitude of harm that may result. It must then judge whether the anticipated benefit, either of new knowledge or of improved health for the research subjects, justifies asking any person to undertake the risks. The IRB cannot approve research in which the risks are judged unreasonable in relation to the anticipated benefits. The IRB must: 

  • Identify the risks associated with the research, as distinguished from the risks of therapies the subjects would receive even if not participating in research; 
  • Determine that the risks will be minimized to the extent possible; 
  • Identify the probable benefits to be derived from the research; 
  • Determine that the risks are reasonable in relation to be benefits to subjects, if any, and the importance of the knowledge to be gained; and 
  • Assure that potential subjects will be provided with an accurate and fair description (during consent) of the risks or discomforts and the anticipated benefits.

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Diagram 1: Steps for Conducting a Risk-Benefit Assessment

 

 

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Ways to Minimize Risk

 

  • Provide complete information in the protocol regarding the experimental design and the scientific rationale underlying the proposed research, including the results of previous animal and human studies. 
  • Assemble a research team with sufficient expertise and experience to conduct the research. 
  • Ensure that the projected sample size is sufficient to yield useful results. 
  • Collect data from conventional (standard) procedures to avoid unnecessary risk, particularly for invasive or risky procedures (e.g., spinal taps, cardiac catheterization). 
  • Incorporate adequate safeguards into the research design such as an appropriate data safety monitoring plan, the presence of trained personnel who can respond to emergencies. 
  • Store data in such a way that it is impossible to connect research data directly to the individuals from whom or about the data pertain; limit access to key codes and store separately from the data. 
  • Incorporate procedures to protect the confidentiality of the data (e.g., encryption, codes, and passwords) and follow UCLA IRB guidelines on Data Security in Research.

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Levels of IRB Review

 

Exempt Research

Although the category is called "exempt," this type of research does require IRB review and registration. The exempt registration process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into six (6) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. For additional information see OHRPP Exempt Guidance.

Examples: 

  • Anonymous surveys or interviews 
  • Passive observation of public behavior without collection of identifiers 
  • Retrospective chart reviews with no recording of identifiers 
  • Analyses of discarded pathological specimens without identifiers

 

Expedited Research

To qualify for an expedited review, research must be no more than minimal risk and fall into nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. For additional information see OHRPP Expedited Guidance.

Examples: 

  • Surveys and interviews with collection of identifiers 
  • Collection of biological specimens (e.g., hair, saliva) for research by noninvasive means 
  • Collection of blood samples from healthy volunteers 
  • Studies of existing pathological specimens with identifiers

 

Full Board Research

Proposed human subject research that does not fall into either the exempt or expedited review categories must be submitted for full committee review. This is the most rigorous level of review and, accordingly, is used for research projects that present greater than minimal risk to subjects. The majority of biomedical protocols submitted to the IRB require full Committee review. For additional information see OHRPP Full Board Guidance.

Examples: 

  • Clinical investigations of drugs and devices 
  • Studies involving invasive medical procedures or diagnostics 
  • Longitudinal interviews about illegal behavior or drug abuse 
  • Treatment interventions for suicidal ideation and behavior

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Regulations and References

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Page Last Updated: June 28, 2011