Criteria for Review

Below are the criteria by which your application 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 IRB application accordingly.

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Minimization of risks

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 IRB 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, they do 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.

While some risks are unavoidable, their effects on the subjects can at times be mitigated through a debriefing. The debriefing is conducted at the end of the subject's participation and may be a simple discussion regarding the subject's participation in the research or may involve the subject being provided with services s/he may utilize in future if the subject experiences delayed effects, such as psychological trauma due to the research directly or as a result of a breech of confidentiality in the future. 

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.

Reasonableness of risks relative to anticipated benefits
Potential for harm must be warranted based on the possibility and probability of the benefits. The IRB 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.
Equitable selection of subjects

Subject criteria and recruitment procedures involved in the research must be equitable. The IRB 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; possibility for coercion, including compensation offered are considered.

Informed consent procedures and documentation

Legally effective informed consent must be sought from each prospective participant (or their legally authorized representative) and effectively documented. The IRB 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.

For more information regarding informed consent, see the IRB's Informed Consent page.

Data safety and confidentiality

A plan for monitoring of 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. Consideration will be given to where it will be stored, how it will be stored, and for how long it will be stored.

The data safety plan should also include procedures for reporting adverse events.

Privacy of subjects and confidentiality of data

Provisions must be given in each protocol for the protection of the privacy and confidentiality of subjects and their information.

The IRB 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 anonymizing techniques, coding systems, encryption methods, storage facilities, access limitations, and other relevant factors in determining the adequacy of confidentiality protections.

In discussing privacy, anonymity, and confidentiality, please keep the following definitions in mind:

  • Privacy refers to the interest that persons have in controlling others' access to themselves.

  • Confidentiality refers to the agreement between investigator and subject about access by others to the data.

  • Anonymity refers to data that include no unique identifiers such as name or Social Security number.

Additional safeguards for vulnerable subjects

If your research includes vulnerable subjects such as children, prisoners, pregnant women, persons with mental or cognitive disabilities, or those who are economically or educationally disadvantaged, the IRB will review your application to determine that appropriate additional safeguards have been included to protect the rights and welfare of these subjects.

For more information regarding vulnerable subjects, see the IRB's Vulnerable Subjects page.