If you are plan to conduct human subjects research, you must complete a Human Subjects Protocol form or Exemption Request form, which are available on the forms page.

Contents of a Human Subjects Protocol

The human subjects protocol form should be written in nontechnical language and provide the information listed below. In addition, each protocol should be accompanied by:

• a consent form (with a written consent narrative if using a short consent form),
• a copy of all surveys, interviews or test to be given to the subjects,
• a copy of all materials that will be used to recruit subjects
• a copy of all grant proposals covered by the protocol

Filling out the protocol form

The protocol form should be filled out fully and completely. If a question does not apply, please write ‘NONE’ or explain why it does not apply.

1. Project Start and End Date.
2. Title: A brief, descriptive title of the research project. If the protocol is for a sponsored project, please use the same title as used for the sponsored project proposal.
3. Investigator: The name and contact information for the Principal Investigator who is responsible for the project. Except in rare cases, this must be a UCSC faculty, staff, or student. If the Principal Investigator does not meet the requirements for a Principal Investigator from the UC Contract and Grant Manual 1-500 (members of the Academic Senate or some other academic appointees), then a Faculty Sponsor is needed that does meet the requirements.
4. Faculty Sponsor: Must be a member of the Academic Senate, and should be an individual with experience and training in the area of Human Subjects research. The Sponsor is responsible for reviewing the protocol and overseeing the project.
5. Other Investigators: Please provide a listing of all investigators that will be interacting with human subjects or their data on the project.
6. Monitary Support: Please state the monitary support for the project. Please provide the names of the sponsoring agencies, and include a copy of all sponsored project proposals. If a sponsored projects proposal has been submitted but not yet funded, please include that information as well.
7. Related Projects: If the research is related to a project or other program that has already been reviewed by the UCSC IRB, the title and UCSC IRB identifying number of the related project should be included.
8. Nature and Purpose: A brief summary of the nature and purpose of the proposed research.
9. Subjects: Describe the proposed human subjects, including the number of people to be recruited and their characteristics. State whether any proposed subjects are minors (younger than 18 years old), prisoners, or otherwise vulnerable to coercion or undue influence. See Part V of the Guidelines for a discussion of vulnerable subjects. Also state whether any proposed subjects are members of racial or ethnic minority groups in the country in which the research will take place.
10. Recruitment: Attach any materials to be used for recruiting subjects. Describe how human subjects will be contacted in the first instance and by whom, what they will be told, and how they will be selected for participation. For purposes of recruitment, researchers should not have access to any confidential or private information about a prospective subject without the subject's prior con sent; this includes school children and their parents, clients of private or public assistance programs, patients. Under certain circumstances, researchers may be required to obtain the permission of agencies responsible for the care of the prospective subjects before recruiting them.
11. Questions pertaining to subject pool: If you plan to use minors, pregnant women, fetuses, fetal tissue, or prisoners in your research, please refer to the applicable section of this manual for further requirements.
12. Human Subjects Experience: Please state your Human Subjects experience and training. For those whose projects will be funded by the National Insitutes of Health, all key personnel are required to complete the online NIH training and to return a copy of the completion certificate to your OSP proposal coordinator. For those who are not supported by NIH, we suggest this online training to give you a better idea of the responsibilities and risks related to Human Subjects research: the course is located online at: http://69.5.4.33/c01/.
13. Screening Procedures: If prospective subjects will be screened prior to entry into the research, a "Screening Consent Form," addressing the criteria for exclusion and inclusion in the research, must be prepared for review by the UCSC IRB along with the protocol and participant consent form(s). In addition to the general information given in a form such as this, add a statement regarding what will happen to the information collected about the individual should they not enter into the study.
14. Procedures: Describe how human subjects will be involved. If there is to be intervention or interaction with the subjects, describe fully what researcher and subjects will do, who will conduct the procedures, where and when the procedures will take place, how frequently, and for how long. If identifiable private information about the subjects will be sought, such as personal records, describe them and how they will be obtained. Be sure to describe any photographing or video or audio tape recording of subjects and others.
15. Benefits: Describe the benefits, if any, to the subjects or to society from the proposed re search.
16. Risks: Describe the risks or discomforts, if any, to the subjects, whether physical, psychological, or social, and the means proposed to minimize them. If subjects may become upset or require medical or psychological attention as a result of the research procedures, a means of supplying this attention must be addressed in this section.
A subject is at risk in research if he or she may be exposed to a possibility of harm that is greater than that ordinarily encountered in daily life or during routine examinations or tests. Each investigator should make a conscientious assessment of possible harms and disclose them to the UCSC IRB. It is the UCSC IRB responsibility, as well, to examine each human subject protocol and make its own determination of the research risks and benefits.
If, in the course of the study, the researcher discovers that a subject has an unanticipated disorder requiring treatment, the researcher should disclose this to the subject and offer to help communicate the matter to the subject's physician or otherwise help the subject to obtain appropriate treatment.
17. Confidentiality: Describe the means by which the confidentiality of private data identifying participating subjects will be maintained. Subjects may agree to the release of identifiable data. If so, how this agreement will be obtained should be spelled out explicitly in the protocol. Otherwise, describe where and how the data will be stored, who will have access to it, and how it will be disposed of. If there will be a key to coded information, describe the means of protecting the key. Special precautions should be taken to protect the confidentiality of photographs and audio or video recordings.
The UCSC IRB does not require or recommend that researchers destroy their human subjects data at the completion of their research. Indeed, researchers are encouraged, when appropriate, to make provision in their protocols and consent forms for the future use of their data for other research purposes. However, they should continue to protect the confidentiality of the data and should not make them available to other researchers except in accord with terms spelled out explicitly in the protocol.
In the case of "biomedical, behavioral, clinical, or other research," researchers may seek a certificate of confidentiality from the Federal government. The certificate protects researchers against being compelled to disclose the identity of their subjects in any legal proceeding. Researchers are invited to consult the UCSC IRB for further information.
18. Informed Consent: A description of the informed consent procedures belongs at this point in the protocol, and the consent form(s) and consent documentation should be attached to the protocol. All elements of informed consent must be present in the consent form and consent documentation. If a waiver of informed or documented consent is requested, a thorough justification must be included that addresses the requirements for a waiver. For more information, click on the Informed Consent Link at left.
19. Financial Aspects: Any remuneration or costs to subjects that may result from participation in the research should be described. If remuneration is offered, UCSC IRB will review both the amount and the proposed method of payment to assure that they do not entail coercion or undue influence. Objections might arise, for example, if the entire payment was contingent upon completion of a lengthy study or if the amount was unduly large.
20. Written Materials: If questionnaires, surveys, or interview schedules will be used in the project, please include them with the protocol. If they are not available at the time the protocol is submitted to the UCSC IRB, a detailed description of their contents and manner of administration should be included at this point in the protocol, along with an assurance that copies, when in final form, will be sent to the UCSC IRB.
21. Signatures: The researcher must sign the original protocol. If the researcher is a student, the faculty supervisor of the research must also sign the protocol.
Faculty members who assign or supervise student research involving human subjects are responsible for educating their students to safeguard the well being of the subjects.
22. Telephone numbers: Numbers where the researcher may be reached by the UCSC IRB staff for further information should be included. This may include telephone, FAX, and/or e-mail number(s).
23. HIPAA: If you answer “YES” to any of the questions, you are subject to HIPAA and must address recruitment in the Description of Research AND include the HIPAA worksheet.
24. DISCLOSURE OF INVESTIGATORS’ FINANCIAL INTERESTS This topic is treated in Part VIII of the Guidelines.