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Human Subjects Research 101

The following pages contain a brief introduction to human subjects research, the Federal Regulations regarding human subjects research, and the review process at Brandeis University for research involving human subjects.

Brief History of the IRB

The modern history of human subjects protections began with the discovery after World War II of numerous atrocities committed by Nazi doctors in war-related research experiments. The Nuremburg Military Tribunal developed ten principles, known as The Nuremburg Code, to judge the Nazi doctors. The significance of the Code is that it addressed the necessity to require the voluntary consent of the human subject and that any individual "who initiates, directs, or engages in the experiment" must bear personal responsibility for the quality of consent.

Similar principles have been articulated and expanded in later codes, such as the World Medical Association's Declaration of Helsinki, which calls for prior approval and ongoing monitoring of research by independent ethical review committees.

Revelations about the 40-year-long United States Public Health Service Syphilis Study at Tuskegee and other ethically questionable research resulted in legislation calling for regulations to protect human subjects and for a National Commission of the Protection of Human Subjects of Biomedical and Behavioral Research to examine ethical issues related to human subject research. The Commission's final and most influential report, The Belmont Report, elucidates three basic ethical principles that investigators must balance when conducting research with human subjects: respect for persons, beneficence, and justice, as discussed on the home page of our IRB website.

The National Research Act of 1974 established the modern IRB system for regulating research involving human subjects. In 1991, 16 federal agencies formally adopted the core of these regulations in a common Federal Policy for the Protection of Human Subjects (also known as the "Common Rule"). The IRB at Brandeis ensures that all research conducted at Brandeis or by a member of the Brandeis community, regardless of funding source, be reviewed according to these policies before research activities may begin.

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Defining Human Subjects Research

Many projects that involve humans may not necessarily be "human subjects research", as defined by the federal regulations. Sometimes questions arise as to whether research should be reviewed by the IRB. The following definitions should provide assistance as researchers plan their research. If researchers have questions about determining if their research is human subjects research, please send a paragraph describing the project to the IRB Office at irb@brandeis.edu or call at 781 736 8133.

The federal regulations in 45 CFR 46.102, give the following definitions:

Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

(Generalizable knowledge generally refers to published papers, public oral presentations, posters at a conference, a dissertation or thesis, etc. If a project is only to be conducted for a class project, it is not considered generalizable research. But please keep in mind that if you are planning to use your class project as the basis for further research later on (that you would like to publish), and it meets the definition of "human subjects research", you will need IRB approval.)

A Human Subject is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

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 medical record).

Identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

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Kinds of Human Subjects Research

To help give an idea of types of projects that are human subject research, some examples of research categories commonly reviewed by the Brandeis IRB are given below. Please keep in mind that this list is not exhaustive.

  1. Social and Behavioral Research - focuses on individual and group behavior, mental processes, or social constructs and usually generates data by means of surveys, interviews, observations, studies of existing records, and experimental designs involving exposure to some type of stimulus or environmental intervention. The vast majority of research reviewed by the Brandeis IRB is social and behavioral research.
  2. Biomedical Research - seeks to increase scientific understanding about normal or abnormal physiology, disease states, or development; and to evaluate the safety, effectiveness, or usefulness of a medical product, procedures, or intervention.
  3. Clinical Research - involves the evaluation of biomedical or behavioral interventions related to disease processes or normal physiological functioning.
  4. Quality Assurance Activities - attempt to measure the effectiveness of programs of services. Such activities may constitute human subject research, and require IRB review, if they are designed or intended to contribute to generalizable knowledge. Quality assurance activities that are designed solely for internal program evaluation purposes with no external application or generalization may not necessarily require IRB review. In all cases, however, the IRB, not the individual investigator, will determine when IRB review of such activities is required.
  5. Pilot Studies - those that involved human subjects are considered human subject research and require IRB review.

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Research Review Process

To initiate the IRB process, researchers need to submit an application detailing the proposed research they would like to perform. Keep in mind that the IRB application, which includes the protocol, is a planning tool to help you design your research. It documents an official account of the intended research methods and procedures you would like to perform. The best protocols demonstrate to the IRB that the proposed research is respectful to the needs of the subjects, that the researcher has carefully and thoughtfully delineated the potential risks to the participants and that those risks have been reduced to a minimum, and clearly shows that the benefits of the research more than justify any risk, inconvenience, or other cost to the subject it might create. Remember, the key to effectively developing an ethically responsible IRB protocol is to plan your research project early and begin writing your protocol along with your research proposal.

All forms and application instructions can be found on the IRB Forms and Application Instructions page of this website.

Once an application has been received by the IRB Office - both the electronic pdf and the original, signed hard copy - the IRB Administrator will confirm receipt of the application and review it. She may send you some suggestions for improving your application before it is sent to the Committee for review.

If you do receive suggestions, please make the appropriate changes to your application, and send the corrected pdf back to the IRB Administrator at irb@brandeis.edu.

If the application qualifies for exempt status or expedited review, the IRB administrator will then send it to the Committee for review on a rolling basis. If the application requires Full Committee Review, the IRB Administrator will save your protocol for review at the monthly IRB Meeting. If the Committee requires any revisions to the protocol, the IRB Administrator will communicate the requested revisions to the researcher. The researcher should then make the requested changes and return the corrected pdf to the IRB Administrator. The IRB Administrator will then send the application back to the Committee for final review, and usually, the protocol will be approved.

The researcher will receive an e-mail containing the IRB determination from the IRB Administrator. Researchers should print out and keep their determination notification with their IRB application for their own records. Please contact the IRB Administrator if you need an official copy of your IRB determination from the IRB Office.

Researchers should carefully note the following requirements in their IRB determination:

Start date The date upon which researchers may begin their project, not before (please remember, there is no "retroactive" IRB approval for projects).
End date The final date upon which the researcher may collect or analyze data. If the research is Exempt, there is not an end date.
Responsibilities If the research project will continue beyond the end date, researchers must complete a Progress Report and Continuing Review Request 30 days prior to the end date. (Suggestion: Mark the 30-day-prior date on your calendar and set a reminder 1 week in advance so that you don't forget!)

If a project is complete - even for exempt research - the researcher must complete a Final Report and Termination Notice.
Additional requests Sometimes the IRB will approve a protocol but require additional information from the researcher. Please submit this information as soon as possible so that your file will be complete.

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Criteria for Review of Research

Below are some of the regulatory criteria by which your research will be reviewed. 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.
  1. Risks are minimized
    Any time a researcher engages human subjects in research, some risk exists. It is never the case that "no" risk exists to participants in a research project. If you cannot foresee any risks in your research project, please state that the risks to participants are "minimal".

    The IRB reviews each protocol to determine if the risks to subjects are minimized. The members carefully review 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 projects can and will contain risks, but the risks should be fully recognized with a description of how these risks will be managed in the research protocol.

    Since most of the research submitted to the Brandeis IRB is social and behavioral research, the following considerations will be especially helpful when writing a protocol and describing the risks involved. As always, researchers 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 qualification and experience of the research team. Researchers should possess the professional and academic qualifications and experience, along with the resources to conduct the research project and to protect the rights and welfare of subjects.

  2. Risks are reasonable relative to anticipated benefits
    The IRB reviews the protocol to determine that the risks of the research are reasonable in relation to the anticipated benefits (if any) to the subjects or to society through the knowledge that may reasonably be expected to result.

  3. Equitable selection of subjects
    Each protocol is carefully reviewed by the Committee for the subject criteria and recruitment procedures involved in the research project. The Committee seeks to determine that the burdens and benefits of the research are being distributed equitably - that is, across genders, races, etc. If you seek to exclude certain populations, please justify your decision.

  4. Informed consent procedures and documentation
    The IRB will review each protocol to determine that legally effective informed consent will be sought from each prospective participant (or their legally authorized representative) and effectively documented. They will also assess the protocol for any situations that could lend themselves to the perception of coercing subjects to participate in the study. If you feel that your research qualifies for a waiver of informed consent, give a detailed explanation for your request to waive it.

  5. Data safety and confidentiality
    Each protocol must provide for monitoring of the collected data for the safety of the subjects, especially where risks to the subjects are substantial. The data safety plan should also include procedures for reporting adverse events, if any.

  6. 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 information about them. 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 researcher 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.

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

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Review Categories
Researchers conducting human subject research are subject to the regulations at 45 CFR 46. These regulations provide for three categories under which human subject research is to be reviewed: Exempt, Expedited, and Full Committee Review. A list identifying and defining the research review categories can be found here.

Exempt Research: The regulations identify specific categories of research activities that are exempt from the regulations on the protection of human subjects in research. While a project may be exempt from the regulations, the ethical principles of conducting research with humans still apply (minimizing risk, maximizing benefit, and ensuring privacy) and all of the rights and protection afforded to human subjects in research are required in Exempt status cases.

At Brandeis, researchers engaged in human subject research that qualifies for Exempt status must still complete a full application form, prepare an informed consent statement, and at the conclusion of the project, complete a Final Report and Termination Form. Investigators may not make the determination that their own research is exempt: Only the IRB can make the determination that research is exempt from IRB review.
Expedited Review: Research projects that qualify for Expedited review may be reviewed and approved without convening a meeting of the entire IRB. The term "expedited" can be misleading: reviews of this type are not "quicker" or conducted with less rigor, rather fewer reviewers are required. Expedited review can be considered when research activities present no more than minimal risk to human subjects and involve only procedures listed in one or more of the nine categories identified in the regulations or for minor changes to previously approved research. Researchers are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) also apply to expedited review.
Full Committee Review: Projects involving greater than minimal risk require approval by the fully convened IRB. Such projects will be reviewed at the monthly IRB meeting, the date and submission deadline of which is posted here. Some examples of Full Committee Review research includes research with children and other vulnerable populations; invasive procedures; any research involving deception; surveys involving sensitive questions, information about sexual practice or illegal behavior, or questions likely to be stressful to the subject.

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Informed Consent

The federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representative) before subjects can be included in research. Keep in mind that obtaining informed consent is a continuous process throughout the research, not just a one-time event when a subject signs a form. Researchers should work to communicate clearly and effectively with their participants and to build trust and cooperation with their participants. Researchers should openly and willingly explain their research and answer questions from subjects and be sensitive to the needs and concerns of their research participants.

Informed Consent
Document		 Obtaining informed consent is most often accomplished through an informed consent form that each researcher creates for the research project. Please refer to the Informed Consent Guidelines for details, directions, and examples of informed consent forms. Be sure to follow these guidelines carefully so that review of your research is not delayed: The majority of required revisions to applications concern the informed consent form.
Waiver or Alteration of Informed Consent Federal Regulations allow an IRB to waive the requirement to obtain written documentation informed consent under certain circumstances. It is the responsibility of each research to request waivers or alterations in the protocol (under Section P: Plans for Obtaining and Documenting Informed Consent), and to ensure that the rights and welfare of participants are adequately protected. Researchers should indicate what conditions are being met that will allow for a waiver or alteration and indicate which elements are being waived or altered.

Part A -- 45 CFR 46.116(c) and (d) The Common Rule permits an IRB to approve the conduct of research without meeting all of the required elements of informed consent. Requests to waive or alter the consent process may be granted under the following conditions:

Government Program Evaluations
  1. The study is an evaluation of a public program of services, is subject to governmental approval, and is evaluating procedures for obtaining benefits, changes in the program, or methods or levels of payment to be made under the program, AND
  2. The research cannot practicably be carried out without the waiver or alteration.
Other Research
  1. The research involves no more than minimal risk,
  2. The waiver or alteration will not adversely affect the rights and welfare of the subject,
  3. The research cannot practicably be carried out without the waiver or alteration; AND
  4. The subjects will be provided with additional pertinent information, if appropriate, after participation.

NOTE: In interpreting the meaning of "practicability" the standard to be met goes beyond inconvenience of the researcher. There must be reasons that make it inadvisable or infeasible to obtain waived or altered elements of informed consent for the IRB to approve the request.
Part B -- 45 CFR 46.117: Waiving Documentation of Informed Consent Informed consent pertains to a process. It is possible to obtain informed consent without documenting the process, and is advisable in some settings. Waiver of documentation is not the same as waiver of informed consent requirements.

Requests to waive the requirement to obtain a signed consent form may be granted when:

The consent form is the only record linking the subject and the research, and the principal risk to the participant would be potential harm resulting fro a breach of confidentiality. Participants will be asked if they want documentation linking them to the research, and the subject's wishes shall govern.

OR

The research presents no more than minimal risk and involves no procedures for which written consent would be required outside of the research context. When submitting a request for waiver of documentation of consent, the request must be accompanied by a script that the researcher will use to present the information that will be presented orally to participants.

Information Sheets In cases where documentation of consent is waived, the IRB may require investigators to provide subjects with a written statement regarding the research called an Information Sheet. Most often, the information sheet is tailored very similarly to the Informed Consent Form without asking subjects to sign to document their consent. Therefore, if you would like to use an information sheet, please use the Informed Consent Guidelines to write this document.
Children If children (>18) will be involved in research, the provisions for informed consent listed in Subpart D of the regulations must be followed. In general terms, these regulations require documented parental consent and child assent.

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Vulnerable Subjects

Federal regulations identify specific populations as being especially vulnerable. These populations have additional protections as outlined in Subparts B, C and D of the regulations. Investigators must give special consideration to protecting the welfare of these vulnerable subjects, including:
  • children
  • prisoners
  • pregnant women, fetuses, and neonates
  • mentally disabled persons
  • economically or educationally disadvantaged persons.

When working with a vulnerable population, researchers should outline how they plan to create additional protections for the rights of these subjects. Some factors to consider are:
  • inclusion and exclusion criteria for selecting and recruiting participants
  • informed consent and voluntarism
  • coercion and undue influence
  • confidentiality of data
  • group characteristics such as economic, social, physical, and environmental conditions, so that the research incorporates additional safeguards for vulnerable subjects.
  • not over-selecting or excluding certain groups based on perceived limitations or complexities associated with those groups. For example, it is not appropriate to target prisoners as research subjects merely because they are a readily available "captive" population.
  • knowledge about applicable laws that bear on the decision-making abilities of potentially vulnerable populations.
  • Having adequate procedures in place for assessing subjects' capacity, understanding, and informed consent or assent. When weighing the decision whether to approve or disapprove research involving vulnerable subjects, the IRB will look to see that such procedures are a part of the research plan.

If you are planning research involving any of the above mentioned vulnerable populations, please consult the Regulations and contact the IRB Office at irb@brandeis.edu or 781 736 8133 to discuss your protocol.

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This page was last modified on March 07, 2012