Below are the criteria by which your protocol will be reviewed, as required by the federal regulations.
Be sure to familiarize yourself with these principles so that you can design your research project to maximally protect the human subjects who will be participating in your research and write your Initial Protocol accordingly.
Note that these criteria apply to all human subjects research, regardless of review level (i.e., exempt, expedited, full committee).
Any time a researcher engages human subjects in research, some risk exists. It is never the case that no risk exists to participants in research. If you cannot foresee any risks in your research, please state that the risks to participants are "minimal."
The Institutional Review Board reviews each protocol to determine if the risks to subjects are minimized. The IRB carefully reviews the research proposal to ensure procedures that are consistent with sound research design are used and that they do not expose subjects to unnecessary risks.
Though the Brandeis IRB encourages freedom in research design, it does consider the research plan, including the research design and methodology, to determine that there are no flaws that would place subjects at unnecessary risk.
It is important to note that research can and will contain risks, but the risks should be fully detailed in the research protocol with a description of how these risks will be managed.
Since most of the research submitted to the Brandeis IRB is social and behavioral in nature, the following considerations will be especially helpful when writing a protocol and describing the risks involved. As always, investigators should think carefully about their research, as other risks may also be applicable to it. Some common risks are:The potential for participants to experience stress, anxiety, guilt or trauma that can result in genuine psychological harm.
The risk of criminal or civil liability or other risks that can result in serious social harms, such as damage to financial standing, employability, insurability or reputation; stigmatization; and damage to social relationships.
The risk of individually identifiable private information that you have collected being leaked, resulting in a breach of confidentiality that could harm subjects.
The IRB also considers the qualifications and experience of the research team. Investigators should possess the professional and academic qualifications and experience, along with the resources to conduct the research and to protect the rights and welfare of subjects.
Potential for harm must be warranted based on the possibility and probability of the benefits. The Institutional Review Board will consider such benefits as those that may be gained directly from the research; possible benefits for the future, however (e.g., possible effects of the research on public policy), will not be considered.
Subject criteria and recruitment procedures involved in the research must be equitable. The Institutional Review Board seeks to determine that the burdens and benefits of the research are being distributed equally across gender, race, age, etc.
Such things as the inclusion/exclusion criteria; appropriateness of potential subjects; distribution of potential benefits; recruitment methods; and possibility for coercion, including compensation offered, are considered.
Legally effective informed consent/assent must be sought from each prospective participant (and/or permission from their legally authorized representative) and effectively documented. The Institutional Review Board will review the procedures for informed consent to ensure that all elements of informed consent are provided for.
The IRB will also assess the protocol for any situations that could lend themselves to the perception of coercing subjects to participate in the study.
Waivers for documented informed consent may be requested.
A plan for monitoring collected data for the safety of the subjects, especially where risks to the subjects are substantial, must be included.
The IRB will review the data safety plan to ensure it is appropriate for the risk level of the project.
Provisions must be given in each protocol for the protection of the privacy and confidentiality of subjects and their information.
The Institutional Review Board will consider the nature, probability and magnitude of harms that would be likely to result from a disclosure of collected information outside the research. It will evaluate the effectiveness of proposed de-identification techniques, coding systems, encryption methods, storage facilities, access limitations and other relevant factors in determining the adequacy of confidentiality protections.
Definitions
In discussing anonymity, confidentiality and privacy, keep the following definitions in mind:
Anonymity refers to data that include no unique identifiers such as name or Social Security number.
Confidentiality refers to the agreement between investigator and subject about access by others to the data.
Privacy refers to the interest that persons have in controlling others' access to themselves.
If your research includes vulnerable subjects such as children, prisoners, persons with impaired decision-making capacity or those who are economically or educationally disadvantaged, the IRB will review your protocol to determine that appropriate additional safeguards have been included to protect the rights and welfare of these subjects.
Recognizing the personal dignity and autonomy of individuals and the protection of persons with diminished autonomy.
This means that research participants voluntarily consent to participate in research, that informed consent is obtained, that their privacy and confidentiality are protected, and that they have the right to withdraw from research participation without penalty.
Protecting persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
This means that the risks of research are justified by the potential benefits to the individual or society, the study is designed so that risks to participants are minimized and conflicts of interest are managed adequately.
Distributing the risks and potential benefits of research equally among those who may benefit from the research.
This means that vulnerable populations are not targeted for convenience and people who are likely to benefit from research participation are not systematically excluded.