Human Research Protection Program

The Institutional Review Board (IRB) is part of a comprehensive system, the Human Research Protection Program (HRPP), responsible for the protection of human subjects. Such board were established by the federal government to protect the rights and welfare of human subjects participating in research activities.

The IRB is a committee that ensures that investigators conducting research with human subjects adhere to the ethical principles laid out in the Belmont Report, the Code of Federal Regulations as well as Brandeis university policies and procedures governing human subjects research.

The IRB is responsible for reviewing and approving proposed human subjects research. The IRB review process is designed to protect the rights and welfare of human subjects by ensuring equitable subject selection, obtaining fully informed consent, minimizing risks, maximizing possible benefits and assuring the maintenance of privacy and confidentiality of persons and data. Human subjects research projects cannot be conducted without the approval of the IRB. 

The committee has the authority to approve, require changes to study procedures or disapprove proposed research projects. 

Published in 1978, the Belmont Report serves as the ethical framework for the protection of human subjects and discusses three fundamental principals by which human subjects research has since been guided:

• Respect for persons, or treating individuals as autonomous agents ("capable of deliberation about personal goals and of acting under the direction of such deliberation") and protecting persons with diminished autonomy.

• Beneficence, or protecting individuals from harm by maximizing potential benefits and minimizing potential for harm (risk).

• Justice, or distributing the risks and potential benefits of research equally among those who may benefit from the research.

Respect for Persons Operationalized

Of the Belmont Report’s three ethical principals operationalized by the regulations, "respect for persons" gets the most attention. The cornerstone of this principal is the informed consent process; for to treat a subject as an autonomous agent, one must give that subject the opportunity to make a choice to act based on the facts of the research and his/her own beliefs and values. 

Beneficence Operationalized

The principal of "beneficence" is concerned with weighing the potential for harm to the subjects participating in the research against the benefits the research may produce, or the conducting of a risk-benefit analysis of the proposed research. In many ways, beneficence is the most difficult of the three principals to operationalize.

Justice Operationalized

The concept of equality in the distribution of burdens and benefits forms the backdrop of the Belmont Report’s discussion of the principal of "justice." In the realm of human subjects research, justice is concerned with ensuring that the potential benefits of the research apply to the population from which the subjects were recruited, and that potential harms be distributed fairly. In other words, subjects should not be recruited simply because they are easily available (a "convenient" population), but be a random sampling of subjects representative of the population that stands to benefit from the research. 

The Human Research Protection Program (HRPP) oversees all aspects of human subjects research, including all administrative duties, education and review of human subjects research protocols. The HRPP encompasses the Institutional Review Board, the institutional official, the research integrity team of the Office of Research Administration, the vice provost for research and the associate vice provost for research administration, as well as the investigators.

For a project to require Institutional Review Board review, it must 1) constitute research, and 2) involve human subjects, as defined by the Code of Federal Regulations (see list of detailed definitions). 

Projects conducted by students for educational purposes within a course alone do not fall within the purview of the IRB, as they do not fit the federal regulations definition of research. Such projects occur in a course designed, at least in part, to provide training in research methodology. These projects are commonly conducted as part of a research methods course or research practicum, which involve the supervised practical application of previously studied theories of research methods. 

To the extent that students will be interacting with human subjects, regardless of whether their project meets the Office of Human Research Protection's definition of human subjects research, care must be taken to ensure that those subjects are treated with respect and courtesy, do not have their privacy invaded and are not subjected to unnecessary discomfort (physical or emotional). 

It is important that the instructors fully understand the classroom projects that are proposed and conducted by their students, and that they provide clear and unambiguous guidelines to those students with respect to their interactions with their subjects.  

If, however, a student plans to use the data collected from a course-related project for future human subjects research activities (as a pilot study, for example), the project will require IRB review before being undertaken for the class, as IRB approval is not retroactive. 

Independent projects conducted by students that include systematic data collection from human subjects and that are intended to produce generalizable results are considered research as defined by the federal regulations and so do fall within the purview of the IRB. Such projects include honors theses, graduate theses and doctoral dissertations. 

The principal investigator is the scientist or scholar with primary responsibility for the design and conduct of the research project. Only qualified Brandeis University faculty and staff members may serve as principal investigators on Institutional Review Board protocols.

All undergraduate and graduate students, as well as all postdoctoral scholars, are required to have a faculty or staff member to serve as principal investigator on their research, with the student/scholar serving as supervised researcher. 

Students and postdoctoral scholars planning to conduct a research project involving human subjects must submit a protocol through their faculty or staff adviser, who is then responsible for ensuring the protocol is complete and accurate. All interactions, from original submission through the termination and final report, will take place between the HRPP staff and the principal investigator. 

A student/scholar's adviser or professor generally acts as the principal investigator for their research. Note that principal investigators must understand that they are fully responsible for the research, so must be willing to closely oversee the research. 

Faculty or staff serving as the principal investigator on student/scholar-initiated research must agree to be responsible for the following:

1. Ensuring the supervised researcher is familiar with the ethical practices, regulations and policies that pertain to human subjects research.

2. Ensuring that the supervised researcher has sufficient training and academic preparation to conduct the proposed research.

3. Reviewing the initial protocol and all subsequent modification and continuation requests, ensuring these are complete and accurate.

4. Meeting with the supervised investigator on a regular basis to monitor the progress of the research.

5. Monitoring the research to ensure that no deviations from the approved protocol are made.

6. Remaining available, personally, to supervise the supervised researcher in solving problems should they arise during the course of the research.

7. Arranging for an alternate faculty or staff adviser to assume responsibility during periods of absence (sabbatical leave or vacation), and advising the Institutional Review Board administrator by letter of such arrangements.

8. Being the primary contact for all HRPP office correspondence and interactions, from original submission through the termination and final report. 

Brandeis University policy requires all students and postdoctoral scholars involved in human subjects research to complete the online CITI training in human subjects research prior to initiating or participating in human subjects research (and before submitting your Institutional Review Board protocol).

Yes! The protocol checklist (pdf) can be found on the Forms and Instructions page.

IRB Protocol Submissions

• Protocol review process

• Categories under which your protocols will be reviewed

• Criteria by which protocols will be reviewed to ensure it complies with the Code of Federal Regulations and Brandeis policies and procedures.

• Instructions for compiling protocols

• Ten most common mistakes in IRB protocols

Data Management

• Data management and protection

• Guide to Data Management and Protection (pdf)

Informed Consent

• Informed consent

• Elements of informed consent

• Informed consent template (pdf)

General Information

• Deception in research

• Difference between anonymous and confidential

• International research

• Research with vulnerable subjects

After you have reviewed the HRPP website and you are ready to complete your protocol, keep this in mind: Read the questions carefully and answer them fully!

Finally, the HRPP office is always available and happy to help with questions regarding your IRB protocol and the review process.