Human Subject Protocol
Instructions for Protocol Format
Human Subjects protocols must include a description of the information provided below. Submission of a research summary or pages of one's proposal and a consent form alone are not sufficient.
Title Page – Basic Information
Please fill out the proposal information sheet provided with this document and use it as your cover sheet for submission to the Committee. The faculty advisor must sign student proposals. Please be sure that all written information is legible (especially name and contact information).
Description of Research
The purpose of the scholarly background section is to provide evidence to the committee that your project is worthy and makes a contribution to your field. Be sure to include reference citations and a bibliography. Remember that it is unlikely that the committee members who review your protocol are familiar with your area of interest, so this section must be sufficiently complete to establish the importance of your project. It is not sufficient to prepare a few paragraphs stating your ideas are important as evidenced by a list of references.
Benefits of the Research to Human Subjects
Specify the benefits of this research to the subjects, and to scientific and human knowledge. The researcher must not assume that actual participation in your project is indeed a benefit, nor is providing a format or context for discussing or engaging in dialogue regarding certain issues necessarily a benefit (unless your project is a form of psychotherapy intervention). The researcher must also take care here not to assume that he or she will be providing feedback about his or her own experience as a benefit to the participant (unless this is specifically a form of your intervention study and design).
Description of the Participants
Specify exactly who the participants in this research will be and approximately how many participants will be included in your project. Be sure to include information about age, sex, and physical, psychological, experiential, social, or any other demographic characteristics that are being used to determine who will be considered a potential participant in this research.
Procedures and Methods
Describe the procedures for recruitment and the data collection settings and measures/methods that will be used with the participants in this study. Be sure to specify what, if any, data will be video or audiotaped. Copies of all measures, including interview protocols, must be submitted in an appendix. Procedures also include the steps you will take to contact agencies or authorities that need to be informed or approve your project beyond the Mills community. Be sure also to include, where applicable, (1) the statement, advertisement, or recruitment flyer that will be used to recruit participants and (2) copies of letters you will use to introduce your project to other institutions (e.g., letters to school principals, child care agencies, jail administrators, battered women’s shelters, etc.). If you are contacting participants through other institutions (e.g., schools, shelters, jails), the names of these institutions should be specified in this section of your proposal.
Potential Risks and Discomforts to Subjects
Identify and discuss all the potential risks and discomforts to participants in data collection procedures identified above. This discussion should be thorough and careful. The researcher should not assume that there are no potential risks or discomforts to participants, even if the project appears to the researcher to be benign or potentially beneficial to participants. It is particularly important to discuss 1) issues of confidentiality and 2) special characteristics of the population being studied.
Means Taken to Minimize Risk and Discomfort
Describe thoroughly the steps the researcher will take to minimize the potential risks and discomforts to the participants identified above. Be sure also to describe how written, video, and audio data will be stored and exactly who will have access to data that have not been made confidential (e.g., by eliminating personal identifying information).
Informed Consent (See link on main page for sample consent form)
Provide the Committee with a copy of the consent form to be used with this research. Be sure the consent form includes:
1) All projects need to have a title.
2) A brief but honest description of what the research participant will experience or should expect during the course of the study, including setting where participation will occur and length of time and/or number of contacts.
3) Explanation that participation is voluntary and that the participant may withdraw from the study at any time without penalty.
4) A description of who will see the participant’s data and how the data will be stored.
5) In some studies, the researcher may wish to use an individual participant’s data in a venue beyond this project. For example, the researcher may wish to show videotape in a class or at a professional conference, or to describe a participant in a media interview. If this form of use is anticipated, the consent form should list potential venues and the participant should initial the venues for which he or she provides consent. The researcher should think this through carefully for without this consent, data that might identify the individual participant can never be used in these other settings.
6) Signature of the participant. If the participant is a minor, state the minor’s name and the signature must be obtained from the parent or legal guardian.
8) Signature of the researcher.
Researchers must provide a copy of the consent form to the participant and keep a copy for one's own records.