Contact us

Lara Kuhn
Assistant Director of Research Integrity and Compliance

Marissa Hamilton
Senior Research Integrity Administrator

Human Research Protection Program
ORA, Mailstop 116
Brandeis University
415 South Street
Waltham, MA 02453

Bernstein-Marcus 121

irb@brandeis.edu

(781) 736-8133 phone
(781) 736-2123 fax

Student Researchers

To help student researchers compile there IRB applications, we’ve prepared this webpage to be used – in conjunction with the rest of the HRPP website – as a guide. 

Student researchers are defined by Brandeis University as undergraduate and graduate students, as well as postdoctoral scholars, conducting human subjects research under the auspices of Brandeis University. 

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What is an IRB?

The Institutional Review Board (IRB) is part of a comprehensive system, the Human Research Protection Program (HRPP), responsible for the protection of human subjects, and was 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, as well as the federal regulations and 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. 

What is the Belmont Report?

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 the potential benefits of the research apply to the population from which the subjects were recruited, and the 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 which stands to benefit from the research. 

What is the HRPP?

The Human Research Protection Program (HRPP) oversees all aspects of human subjects research including all administrative duties, education, and review of human subjects research applications. The HRPP encompasses the IRB, the Institutional Official (IO), 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.

When does my project require IRB approval?

For a project to require IRB review, it must 1) constitute research, and 2) involve human subjects, as defined by the federal regulations (for detailed definitions, see the IRBs Defining Human Subjects Research webpage). 

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. 

Note that, to the extent that students will be interacting with human subjects, regardless of whether their project meets the OHRP 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 instructor fully understand the classroom projects that are proposed and conducted by his/her students, and that s/he provides 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. 

Who may serve as the Principal Investigator on student-initiated research?

The principal investigator (PI) 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 IRB applications.

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 student researcher. 

Students and postdoctoral scholars planning to conduct a research project involving human subjects must submit a protocol through their faculty or staff advisor, who is then responsible for ensuring the application 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. 

How do I choose a Principal Investigator for my research project?

A student/scholar’s advisor or professor generally acts as the Principal Investigator for their research. Note that the Principal Investigator must understand that s/he is 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 student researcher is familiar with the ethical practices, regulations, and policies that pertain to human subjects research.

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

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

  4. Meeting with the student 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 student researcher in solving problems should they arise during the course of the research.

  7. Arranging for an alternate faculty or staff advisor to assume responsibility during periods of absence (sabbatical leave or vacation), and advising the IRB 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. 

What kind of training is required?

It is Brandeis University’s policy that all students and postdoctoral scholars involved in human subjects research must complete the online CITI training in human subjects research prior to initiating or participating in human subjects research. For more information, see the HRPP Training webpage. 

Note that CITI training must be completed before submitting your IRB application.

Is there a checklist for completing an application?

Yes! See the Application Checklist on the HRPP Forms and Instructions webpage.

Where can I go for help?

Instructions for compiling applications can also be found on the HRPP Forms and Instructions webpage and an outline of the review process can be found on the HRPP Application Review Process webpage.

In addition, the HRPP Criteria for Review webpage outlines the criteria by which your application will be reviewed to ensure it complies with the federal regulations and Brandeis University policies and procedures governing human subjects research. The HRPP Review Categories webpage will tell you the category of review – exempt, expedited, or full-committee – under which your application will be reviewed. 

Note that you should familiarize yourself with the entire HRPP website, paying special attention to the Guide to Data Management and Protection (and the HRPP Data Management and Protection webpage), as well as the HRPP Informed Consent webpage (and, in particular, the Elements of Informed Consent and the Consent Form Template).  

General information (such as the difference between Anonymous and Confidential), as well as specific information for such topics as Research with Vulnerable SubjectsDeception in Research, and International Research can also be found on the HRPP website. 

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

In addition, the HRPP office has put together a list of the ten most common mistakes it encounters when reviewing an IRB appication. Use the Ten Common IRB Application Mistakes sheet when putting together and reviewing your application. 

Finally, the HRPP office is always available and happy to help with questions regarding your IRB application and the review process. You can find our contact information to the right.