Tips for Writing a Protocol Statement

The major responsibility of the Committee for the Protection of Human Subjects is to review research protocols and informed consent documents to ensure that risks to human subjects are minimized and that the procedures and risks are clearly presented to the subjects. These requirements are based on the Code of Federal Regulations on human subjects research, 45 CFR part 46.

All documents should be rigorously edited and proofread before submission, since documents with many spelling, typographical, or grammar errors will be returned to the advisor. Follow the protocol template under Forms and Templates. The following information supplements instructions in that form.

Every protocol statement needs the following elements:

I. Study aim, background, and design
Student research generally requires only 2 to 4 paragraphs here. Clarify and condense the research aim, purpose and design. Make it understandable to the layperson; do not use discipline-specific jargon, acronyms or technical terms without defining them. Include a brief literature review with information on previous research done on this topic, or in this field. Do not copy the Proposal for Culminating Experience description or the entire literature review here, but do cite sources from the bibliography to support a hypothesis or research purpose. Explain the methodology. Describe how you will analyze the data . Will your data fulfill the research purpose or answer the research question?

II. Subject Population
How many subjects will there be? How old? (If under 18, parental consent for a minor to participate in research will be necessary, and a minor assent if the child is between 8 and 17.) Why is this particular set of subjects being recruited? How will you recruit them?

If the researcher will recruit participants in person or over the telephone, we need to see a recruiting "script" to ensure that the researcher is not being inadvertently coercive. The recruitment should be strictly an invitation to participate in a research study. Do not ask for a favor, or for help in finishing a graduate program, or anything else that might be coercive or induce guilt in the potential subject.

If the researcher is using flyers or ad to recruit subjects, the IRB needs to approve them before they are posted or submitted for publication. If subjects are recruited through a class, we need the instructor's permission. Some departments have granted a blanket permission to recruit and conduct research in classes in that department. If subjects will be recruited through an agency or school, the committee needs a letter of permission (on letterhead) from the agency or institution to use their clients or students as subjects. What inclusion/exclusion criteria are there? Will the researcher use personal contacts to recruit?

III. Procedures
These need to be detailed, but as clear, concise and brief as possible. List only those procedures that have to do with the research itself. Do not include things like "Go to the library" or "Buy refreshments for group meeting" or “Obtain signed consent.” Start with a bullet format to clear out unnecessary words. If the researcher will audiotape the interviews, he/she should include that information in this section. Photographing or videotaping subjects require a separate, additional form (under Forms and Templates.)
Once the procedures are listed, state how long they will take. Give both a total time commitment for the subject, and also break down the time for each step of the procedure. Where will the research occur? What time of day? It is possible to say that the time and location of the research will be arranged to be mutually convenient for researcher and subjects, or completely at the subject's convenience.

The committee needs a copy of any questionnaire, survey or interview questions to be used. If the researcher is conducting ethnographic interviews, pleas submit a list of questions you will use to get the conversation started. If the research activity will take place during class time, how will the regular work be made up? If done for extra credit, the researcher must present alternatives for earning extra credit for those students who do not wish to participate in the study.

IV. Risks
Almost all research has the possibility of risk to the subjects as participant. If not physical, the risk can be psychological (anxiety, depression), emotional (anger, sadness, fear), stress, discomfort, or inconvenience. In most cases, the main risk could be loss of the subjects’ privacy, if the subjects can be identified in any way.

When the researcher raises the possibility of a risk in this section, he/she must then state how that same risk will be mitigated or minimized. For instance, state that loss of privacy is a possible risk, then immediately state how the subjects' privacy will be protected, i.e., by never using the subjects' names, by using code names and keeping them separate from the data, or by conducting a survey without names.

Once the data has been collected, how will the researcher protect the confidentiality of the data? Let the subject know that the research material will be locked in a secure room or cabinet, that information is coded and only the researcher will have the code, or that only the researcher or research team will have access to the data. Also, state the ultimate fate of the raw data. See Guidelines for Retention of Data.

If inconvenience is the issue, state that the activity will be arranged to occur at a time and place convenient to the subjects, or that research will be conducted after work or school, or transportation will be arranged.

Discomfort can occur when a subject is asked to relive an uncomfortable time in his/her life, or is asked embarrassing questions. Being observed can make individuals uncomfortable. Being singled out in a class can be uncomfortable. More seriously, letting a superior have access to an evaluation of your job performance can be risky. Admitting in an interview that you are not doing your job, or that you use drugs, or that you think your boss is incompetent, could be very risky to your employment status, if there is a chance your employer could find out. Letting a researcher have access to school records may embarrass a child if damaging information is revealed. Other risks may be far more obvious. The mitigation for the risk of participant discomfort is that the participant does not have to answer all questions, and can stop the entire process at any time.

For instance, if there is a possibility that a subject might become upset by one or more sensitive questions, tell the participants that they can stop answering at any time, answer only those questions they want to, or stop the research at any point without penalty to themselves. If there are sensitive or upsetting questions in the survey that might bring psychological discomfort, a brief list of professional referrals should be included in the protocol for subjects to consult if necessary. (This list should be included as a related document, and it should be mentioned in the protocol and consent.)

Group discussions, or focus groups, contain an added risk of loss of privacy, because the nature of the discussion process is such that the researcher cannot guarantee that participants will not talk about what took place in the group once the group has dispersed. The "extra privacy protection for focus groups" is that the researcher will discuss the need for keeping the proceedings confidential with the group at the beginning, throughout the process and again at the end. A paragraph stating this should be included in protocols and consents for focus group subjects. Some researchers ask the participants to sign a brief statement that they will not discuss what happened in the group outside of the group.
Possible loss of privacy is almost always a concern in the kinds of research done at SFSU. Consider the ways in which this might happen: poor test results are revealed, survey answers can be identified if the participants' names are written on the survey, private information revealed in group discussions can become a source of gossip. All of these could be at the very least embarrassing for a participant. The researcher's responsibility is to take steps to protect the participants' privacy, and to state how that will be done in the protocol and the consent documents.

The researcher should also state how the confidentiality of the data will be maintained, for instance, a survey will be posted online through a third party like Survey Monkey, so that email addresses or web URLs will not be noted by the researcher. Or, the data will be kept in a locked cabinet or office, and the original material will be kept for the duration of the study then destroyed, or all identifiers will be removed and the data will be kept for a number of years in a safe place, or archived in a safe place (describe).

Include the ultimate fate of the data, especially audio and videotapes. (A common procedure with tapes is to keep them locked in a secure place for one year after the study, and then destroy them or erase them. This must be included in the risks section.) Transcripts of the tapes may be kept with identifiers removed.

If the researcher intends to use the data later in conjunction with another study, the consent form must reflect this. The usual wording is: The data will be retained by the researcher without identifiers for possible use in a future project, which will be consistent with the original research purpose.

Use of the subjects' real names or titles or any other identifying marker will require an additional, separate consent. This can be as simple as adding, under Risks in the consent document, a signature line next to or below the following statement:

"I give permission to use my real name in the published research study"_________(subject initials on line.)

V. Benefits
Research does not need to have direct or guaranteed benefits to the subjects to be approved. "Benefits" are very specific, such as a particular drug treatment or therapy for the research subject, or that their medical costs will be paid. Remote possibilities or potential altruistic value should not be stated as benefits. There is a standard line that should be used here: There will be no direct benefits to subjects for participating in this research.

If you want to mention anticipated benefits, use the conditional tense, because you cannot guarantee that these benefits will happen until the research has been completed and the data analyzed. For instance, say that "Anticipated benefits might include a participant’s greater understanding of this subject."

VI. Remuneration
This includes cash payments, gift certificates or anything else a researcher might give subjects in exchange for their participation in a research study.

If there will be remuneration, state what it is: Subjects will be paid $20 cash for their participation in this research study.

If there will be none, state that: There will be no payment for participation in this research study.

VII. Academic or Extra Credit
If subjects will receive academic credit or extra credit for participating in the research study, state that here. In addition, state that alternative methods of earning extra credit will be made available to those who do not want to participate in the research study. If this is not applicable to your project, write "NA” or do not include this section.

VIII. Costs
If there are costs, state them: Subject will be required to pay for transportation to the research location, and parking.

If there will be no costs to the participant, state that: There will be no costs to the subject for participating in this research study.

IX. Alternatives
If the researcher is proposing a treatment or therapy, a disclosure of appropriate alternative courses or treatment that might be advantageous to the subject, if any, is required here.

If you are conducting research during class time, those students who do not want to participate in the research need to be given an alternate activity to do during the scheduled research. This can be as simple as reading ahead in the textbook, or starting homework assignments.

Generally, the alternative is that the subjects do not have to participate in the research.

X. Consent process and documentation
Research needs some form of informed consent to the procedures from the human subjects. See the Belmont Report for a rationale.

Obtaining informed consent is a process, not just a document. The consent process begins with the recruitment of participants, and continues with a full description of the research purpose and personnel, procedures, risks and benefits, and the reiteration that research is voluntary. If the risks change during the course of the project, it is necessary to re-consent the participants to ensure they are fully informed and still agree to participate.

Consent to participate in a research project is generally documented by a signed consent form. The IRB must approve the final consent form that will be presented to the participants. Do not have anyone sign the consent until you have received an official letter of approval from the IRB office. We do not need to see the signed copies, but the researcher is obligated to keep them for at least three years, or more as determined by their discipline. If a researcher is conducting a telephone survey, verbal consent may be obtained, and the IRB must approve the telephone script.

“Implied consent” is a brief consent paragraph appended to the beginning of a survey that states the completion and return of the survey will be taken as consent to participate in the research. This may be used even if demographic data are collected from subjects, as long as the demographics are kept separate from the surveys and the data will be aggregated. A sample of implied consent is included under Forms and Templates.

Written consent is waived under very specific circumstances, as when the existence of a written consent document itself is the only thing linking the subject to information that may cause loss of employment, life, or reputation. Written consent was also waived by the IRB when the subjects were adults participating in a literacy program who could not yet read or write, the subjects, however, did go through a consent process in that a witness read the consent to them and signed that they understood and agreed to the research conditions.

XI. Qualifications of the investigators:
Student qualifications should include any relevant work, volunteer or research experience. Any life qualifications are also useful to know, such as:

• the researcher is a member of the group he/she wishes to study and has insight into the question being investigated, or
• the researcher has had experience with sensitive interviews as a social worker, or
• the researcher is certified in a particular field, or
• the researcher has volunteered with the organization being studied, etc.

Sometimes the addition of investigator qualifications makes the difference in getting approval for participant contact that may otherwise be too risky, for either the subjects or the student investigator.

Also mention the supervising instructor's qualifications, i.e., a full/associate/assistant professor at SFSU; PhD in ___, x years of experience as a researcher in the field.

Faculty and staff qualifications should be stated concisely and clearly.

XII. Bibliography
Some ongoing faculty research protocols may require lengthy bibliographies, but most student research requires no more than 10 bibliographical references. Be sure that any sources cited in the Study Aim, Background and Design section are included in your bibliography. Conversely, make sure that you have included references in this section that support your hypothesis or research purpose.

Formatting Tips:

Page Numbering:
The protocol statement and all consent forms are separate documents, and should be numbered separately. So, number all pages "1 of ___". Include the research title and researcher's name as a header on all documents.

Headings:
Bold the section headings; it makes it easier to check your protocol for all required elements. Include a header with the Research Title and the Researcher's Name on all pages after the first. Remove all Appendix designations before submission.