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Human Subjects Committee

Participant

Have a question, concern, or complaint about your involvement in a research study or your rights as a research participant? If so, please feel free to contact the Human Subjects Committee at 617-384-5487 or Toll Free at 1-866-606-0573. You may also email us at hsc@hsph.harvard.edu.

Participant Rights

As a research participant, you have the right to...

  • know why the research is being done
  • know what will happen to you
  • know the risks, side effects, or pain that may occur
  • know what good may come of the study
  • know what other treatments exist if you do not take part in the research
  • know how your private information will be kept safe
  • know what will happen if you are hurt
  • know whom to contact with questions or concerns
  • ask questions at any time
  • decide whether to participate without being pressured
  • drop out at any time without penalty
  • keep a copy of the consent form

Important Definitions

Research is learning about something in an organized way. Testing an idea or an invention is also research. Research is not the same as treatment.

Human Subject

A living person about whom a researcher gets:

1. information through contact with her/him or
2. private information like school or medical records

Researcher

Someone who carries out a research study. Often researchers are called investigators.

Risk

The chance of a bad outcome. A minimal risk is one in which there is about the same as what you experience in everyday life or during routine medical or psychological tests.

Benefit

Something good that happens to you or someone else. New knowledge is a benefit; better health is, too.

Sponsor

A person or group that gives resources (like money, tools, or medicines) for a study.

Informed Consent

A process of communication between you and the researchers. Informed Consent should help you understand everything you need to know to make a decision. This takes place before you decide whether to take part in the study. If researchers learn about new risks, they should talk about consent with you again. If you have questions, you can ask the researchers and you can change your mind about giving consent and can withdraw if you choose.

IRB (Institutional Review Board)

A committee that reviews research plans before they are begun to help ensure safety and dignity for participants. Federal rules require IRB approval for research with humans if it is supported by the federal government. The Harvard School of Public Health applies the same high standards to all of its human research. Although "IRB" is the common name, some institutions may use different names. The IRB at Harvard School of Public Health is called the Human Subjects Committee.

Belmont Report

Ethical guidance for human subject research; written by members of a National Commission in 1978. The Belmont Report says that three key ideas must guide researchers. These are 1) Respect for persons (free choice); 2) Beneficence (do good, or at least do no harm); and 3) Justice (fairness).

Respect for persons
Researchers should show respect for you, because you can and should be allowed to make your own decisions about things that affect your life. This rule is the basis for Informed Consent.

Beneficence
Researchers should do the least harm to you and the most good for you as they can in conducting a study. This rule requires that researchers put your safety above all else. The benefits outweigh the risks of their research.

Justice
Researchers should recruit subjects fairly. They should avoid recruiting people merely because they are convenient or easy to manage. Ideally, the people recruited will share in the benefits of the study.

Useful Links

OHRP (Office for Human Research Protections) an agency of U.S. Dept. of Health & Human Services.
http://www.hhs.gov/ohrp/

 

OHRP's Becoming a Research Volunteer Brochure
http://www.hhs.gov/ohrp/outreach/documents/3panelfinal.pdf (English version)
http://www.hhs.gov/ohrp/espanol/OHRP3PanelSpanish.pdf (Spanish version)

 

FDA (Food and Drug Administration)
http://www.fda.gov/

 

FDA's Q&A for Clinical Trials Participation
http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html

 

ORI(Office of Research Integrity)
http://ori.dhhs.gov/

 

PRIM&R (Public Responsibility in Medicine and Research)
http://www.primr.org/

 

AAHRPP (Association for the Accreditation of Human Research Protection Programs, Inc. ®
http://www.aahrpp.org/www.aspx?PageID=0

 

ENACCT (Education Network for Advancing Cancer Clinical Trils)
http://www.enacct.org/

 

Harvard's Policy for Processing Human Subjects Payments

http://vpf-web.harvard.edu/documents/pdf/actts_humansubjects_11_2.pdf

This page is maintained by HUMAN SUBJECTS COMMITTEE. To contact us with suggestions, comments, and questions, please e-mail: hsc@hsph.harvard.edu.

Human Subjects Committee
1552 Tremont Street, Boston, MA 02120
Phone: (617) 384-5480
Fax: (617) 384-5484