Human Subjects for Non-funded Research Information

Among the notions central to research with humans are the following three:

1. Participation in research is voluntary;
2. Voluntary participation is based on being informed; and
3. The researcher must guard against making participants vulnerable.

Federal guidelines and University of Massachusetts policy indicate that in order to act consistently with the above notions, in most cases when researchers wish to do research using human participants, the researcher must seek the informed written consent of the participants.

Unless you sign indicating that you are not working with human participants, in most cases you must develop an informed consent form which meets the following guidelines.  The Human Subjects Review Committee will review your consent form with these guidelines in mind.

The Written Consent Form:

1. Indicates:
   1. Who the researcher is;
   2. What the researcher proposes to do; and
   3. For what purpose.
2. Informs the participants of any risks they may be taking by participating. 
3. Informs the participants of their rights:
   1. Their right to withdraw from part or all of the study at any time; and
   2. Indicates position on the right to review material.
4. Informs the participants about how names will be used:
   1. Clear on whether the researcher will seek to protect the participants’ identity or not; and
   2. Clear on pseudonyms or other steps taken to protect identity.
5. Informs participants on:
   1. How results will be disseminated; and
   2. Is it reasonable on projected benefits.
6. Indicates that participants are free to participate or not without prejudice.
7. Provides for consent to appropriate adults in the case of children.
8. Deals with other issues of concern specific to the research project.

These guidelines should assist you in developing a written consent form.  To further assist you, an example of a written consent form and a memorandum concerning what might be appropriate for questionnaire and survey studies are included.  Use the above guidelines and the examples to guide you in developing a written consent form appropriate to your research project.

If you wish further guidance, you may consult with the Human Subjects Review Committee.