Human Subject Protocol
Frequently Asked Questions
What is the Committee for the Protection of Human Subjects and why does a committee need to review projects that involve human participants?
The Committee for the Protection of Human Subjects is charged by Mills College to oversee the health and welfare of human participants involved in research or projects that involve systematic contact (see below). The committee follows the guidelines established by federal and state regulations. It is important to understand also that, although the federal guidelines are primarily established to protect the human participant, the process of review and informed consent also serves to protect the researcher and the College.
What constitutes “research” that needs to be reviewed by the Committee for the Protection of Human Subjects?
Everyone working with human participants should ask themselves this question. Here are some guidelines to help you decide if your work needs human subjects review.
Research is defined as systematic investigation, interaction (communication and interpersonal contact), intervention (data gathering and manipulations of the individual’s environment), examination (testing, evaluation), or the gathering of identifiable personal information (information about behavior or opinions in the absence of formal observation or data recording that potentially identifies a particular individual) that is designed to contribute to generalized knowledge. Demonstration, service projects, and creative or artistic projects that involve systematic contact with human participants with the goal of contributing to generalizable knowledge are considered “research.” These projects often include the use of video or interview material. All “research” projects that are being funded by external or internal sources (e.g., Barrett undergraduate research grant) must be submitted for review.
As a rule of thumb, research projects that require review typically result in some form of systematic or formal presentation, including senior thesis or senior project, conference presentation (including the Mills Undergraduate Research Conference), publication, community video presentation, etc. Interaction or observation of human participants that is supervised within the context of a single class assignment is under faculty supervision and not subject to human subjects review. Faculty who utilize this forms of “research” as a consistent pedagogical technique in their courses may wish to submit for review a generic proposal that covers these instructional “research” activities.
It can be difficult to determine if a demonstration, service project, or creative/artistic project is subject to review. Here are two key elements to consider in determining if your project needs to be reviewed. One element is how you select the human participants. If you are selecting a group of participants by approaching them (by letter, announcement, internet, or in person) and asking them if they wish to participate in your work (random selection, or based on a set of participation requirements, e.g., females between 18 and 24 years of age), then you may indeed be doing “research.” The other element to consider is whether or not the goal of your project is to contribute to generalized knowledge. If your goal is to contribute to the understanding of a phenomenon (e.g., why do individuals wear clothing with sports logos) then you are contributing to generalized knowledge. Creative projects traditionally in the arts and journalism are not considered research. Note though that video arts projects are often artistic research projects and may be subject to review.
As of October 2003, oral history projects are exempt from human subjects review. Oral history is defined as interviews that are designed to explain a particular past. The individuals who are interviewed are selected because of their unique relationship to and perspective on the topic under pursuit.
Above all, if you are uncertain about whether or not your project needs to be reviewed, get more information. Students should contact their advisors. The committee Chair can also answer questions.
May I get started on my research before I have received approval from the human subjects committee?
No. Review is the first step in “research” projects; recruiting and interaction with human participants may not begin until the project has been approved. The researcher is notified in writing when the approval process has been completed. Be sure to keep this letter on file, as you may be asked to provide evidence of approval (e.g., when applying for funding, when approaching other institutions for permission to recruit participants).
What is a consent form and are some projects exempt using written consent forms?
Informed consent is key to the process of protecting human participants. Informed consent is typically documented through the use of a written signed consent form that describes the nature of the project and what the participant should expect to experience. It also establishes in writing that the participant has the discretion to withdraw from the project at any time without ill consequence. The consent form should be written in a language that is understood by the participant. If reading is a problem, the consent form should be read to the participant. The participant should be allowed to ask questions about the project prior to signing the consent form. The consent form must be signed by both the researcher and the participant, or his/her legal representative (e.g., a child’s parent or guardian). A copy of the signed consent form must be provided to person signing the form.
Some projects do not require written signed consent. These projects include interaction with adult participants where failure to provide consent is clearly interpreted from the individual’s nonparticipation (e.g., failure to return an anonymous survey; internet surveys), where the researcher is a “participant observer” (a technique that is popular, for example, in anthropological studies), or some naturalistic observation projects that involve no intervention or interaction with human participants.
How long does it take to complete the review process?
The initial review process takes about two weeks. For the purpose of planning it is important to remember that if the committee requests modifications or responses from you regarding your proposal, review will continue beyond the initial period until it is complete. You should plan for a review that may take 2-4 weeks.
If I am a student, can the review process begin before my faculty advisor has read the proposal and signed the title page?
No. Student projects must be reviewed first by faculty advisors prior to submitting the protocol to the committee. Overview by your faculty advisor is advantageous as faculty can help you submit a thorough protocol and, thus, decrease the amount of time your proposal is under committee review. The committee will not initiate the review process if title page is incomplete. Be sure to get your faculty advisor’s signature prior to submitting your proposal.
How do I recruit participants from agencies or institutions off campus?
Mills approval does not extend to other institutions. If you plan to recruit participants from locations off campus, you first must complete the Mills College human subjects review process. Upon approval of your project, you may then contact other institutions for permission to recruit participants. If the institution has its own human subjects review board, you will need to submit your protocol to this board. If you are recruiting participants using class announcements at other educational institutions (including elementary and high schools), be sure to check with the school principal or dean to find out more about that institution’s specific recruitment rules. Classroom teachers often do not know these rules, so be prepared to speak with the institution’s administrators.
What do I do if my proposal has already been approved but I want to change my study or project?
Let the committee know the status of your project. There are occasions when a project has already been approved but you wish to change or add to the data collection procedures or the manner by which you contact, interview, or interact with your participants. Simple additions or changes do not required full submission of another research protocol. Rather, submit in writing to the committee chair information about the revisions you propose. These revisions will be reviewed; once approved, they are added to your original proposal. As with the original proposal, (1) documents submitted for project changes are not reviewed during academic breaks and (2) revisions cannot be implemented until you have received written approval of the changes.
Some individuals find that their original research or project ideas do not work out and that they must develop new projects. New projects are treated in the same way as first time submissions. This means that a new proposal must be submitted to the committee for review. Approval of a different project under your name or the names of others in your group does not constitute approval for new projects that have different goals and methods of interacting with human participants.