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Human Subjects Research Applications: Guidance

Below are suggestions about what information to provide when completing the research description required for human subjects research application review, you must provide sufficient information regarding each issue for the IRB to evaluate your application. These suggestions are not all inclusive of everything you might need to address nor are they indicative that everything below must be addressed. The nature of your research should dictate the extent of the information provided to the IRB or compliance office.

1. Purpose of the Research
2. Subject Population Description
3. Research Methods

A. Subject Recruitment
B. Research Location
C. Consent Process
D. Research Activities
E. Confidentiality
F. Deception and Debriefing
G. Potential Modifications

4. Potential Risks and Discomforts
5. Potential Benefits

1. Purpose of the Research (return to top)

• Describe the nature, purpose, and significance of the study.
• Describe the specific objectives or aims of the research and what outcomes are expected, both general and specific.
• What do expect to learn from this research that is not already known in your field?
• How and where will the data be disseminated?

2. Subject Population Description (return to top)

• Describe the anticipated number of subjects, age ranges, and where appropriate, gender, ethnic background, and health status.
• Identify the use of vulnerable populations such as children (under age 18), prisoners, mentally disabled persons, or economically or educationally disadvantaged persons.

3. Research Procedures and Methods (return to top)

A. Recruitment and Selection of Subjects (return to top)

• Describe how participants will be recruited. Attach a copy of any recruitment materials
• Attach, describe, and refer to advertisements and letters.
• Describe the subject inclusion and exclusion criteria
• Describe the nature of the relationship between the researcher(s) and the subjects.

One of the biggest concerns of the IRB is that potential subjects freely volunteer to participate in research projects. Examples of past abuses include prisoners who ‘volunteered’ to participate in medical studies, or students whose perception is that they had to volunteer if they desired a passing grade in a course. These are readily recognized as problems with the ‘volunteer’ requirement. However, researchers might not be sensitive enough to forms of implied pressure. For example, having a teacher diestribute a survey for her own research in her class and then having the students who do not want to volunteer hand back the survey in front of her and all the other students is an example of implicit compulsion that is not allowed. A procedure in which a researcher asks friends to do him a favor by volunteering could be another example of pressure that is not allowed.

A class may have a requirement for research experience, but participation as a subject in a particular project cannot be required. Students must be given a choice of alternative ways to satisfy the requirement. And these alternatives must be reasonable and non-exploitive. For example, providing a student the choice between participating in an hour long project or writing a 10 page research paper is not reasonable.

Researchers may compensate subjects for participating, but payments must be described in the proposal to the IRB. Payments should be appropriate to the risks associated with the research and not of an amount that would alone convince a person to volunteer. Subjects must receive partial payment if they withdraw from the study.

In some projects, once potential subjects are attracted to the project, some type of screening or selection of appropriate subjects is performed. Sometimes potential subjects must be excluded from the study, for example, people with liver damage may be excluded from a nutrition study, or people who are depressed may be excluded from a memory study. The inclusion and exclusion criteria must be described.

For the IRB to be able to determine whether the recruitment process is reasonable and without coercion, a proposal should include a description of the procedure for attracting potential subjects to the projects, including copies of fliers, letters, pamphlets, etc.

B. Research Location (return to top)

• List all sites where the research will be conducted.
• When appropriate, provide letters granting permission to recruit participants and conduct research at these locations.

It is Miami policy that all MU researchers have permission to conduct research granted by the owner of the property or leadership of an organization. This is not only courteous, but it is a matter of maintaining research integrity and human subjects protection. If the owner of a property or the leadership of an organization discovers an unapproved research project being conducted, they may stop the project midway through, thereby placing the research at risk and rendering the subjects already contacted to have been put at risk for no benefit. Researchers are expected to obtain permission to conduct research and maintain documentation from the appropriate authority. Letters of permission must be provided to the IRB whenever research projects involve vulnerable populations.

C. Consent Process (return to top)

• Describe the process of informing the subjects/legal representatives, obtaining consent, and documenting consent.
• Include provisions for gaining assent from subjects under age 18.
• Describe the process for ensuring subjects are voluntarily participating in the research activities throughout the study (provisions for self-withdrawal)

Informed consent refers to a person's freely made decision to participate in a research project based on knowledge of relevant aspects of the project and its implications for the participant's welfare. It is an ongoing process in which participants are given an explanation of the research project in language that they can understand.

In most cases, subjects are informed about proposed research and the risks associated with the project via a written consent form; in fact Federal regulations require written consent. The consent form describes the project and its risks; it also provides sources of additional information if the subject has questions about the project or his or her rights. The investigator must give the subject or the representative adequate opportunity to read the consent form, or it may be read to them, and to have any questions about the study answered before it is signed. A copy of the form needs to be given to the person signing the form. It is important that investigators include a copy of this form with their IRB application so that the IRB can determine if the form is adequate given the risk level and subject population.

I. Basic Elements of Consent. The written consent document shall include information on the following basic elements written in language readily understandable by the subjects.

a. Description of the Research: The nature, purpose, and significance of the research.

b. Research Procedures: The procedures to be followed.

c. Time Required for Participation: The expected frequency and duration of each procedure and total amount of time required for participation.

d. Risks: Any reasonably foreseeable risks or discomforts to the subjects.

e. Benefits: Any benefits to the subject or others which may reasonably be expected from the research.

f. Alternatives: If the potential subject or legal representative declines to participate, how might this effect the opportunities of the subject.

g. Confidentiality: The extent to which confidentiality of records identifying the subject will be maintained. Note: Data should not be described as anonymous if there are any identifying names, or numbers, or information about the individual through which individual subjects could be linked by the researcher or anyone else to his or her responses.

h. Voluntary Participation: A statement that:

• participation is voluntary,
• refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled,
• the subject may discontinue participation at any time or refuse to answer specific questions without penalty or loss of benefits to which the subject is otherwise entitled.

i. Questions About the Study: An offer to answer any questions about the procedures and an explanation of who to contact (the name, phone number and email address of the investigator and, in the case of student investigators, the faculty advisor) for answers to pertinent questions about the research. Where applicable, provide the name of a contact in the event of a research-related injury to the subject.

j. Questions About Rights of Subjects: A statement that subjects may contact the Office for the Advancement of Research and Scholarship (513-529-3600) or <> for questions or concerns about their rights as subjects.

k. Compensation for Injury: For research involving more than minimal risk, an explanation as to whether any compensation or medical treatment is available if injury occurs, and, if so, what they consist of, or where additional information may be obtained.

l. Recording: Plans to audiotape or videotape any sessions or photograph participants need to be described and explicitly agreed to on the consent form.

A short-form written consent document, stating that the elements of informed consent have been presented orally to the subject or the subject’s legally authorized representative may be used. When this method is used, there must be a witness to the oral presentation. The IRB must review a written summary of what is to be said to the subject or representative. A copy of the written statement about the research study and the short-form consent document must be given to the subject or representative.

Consent Form Example

II. Consent/Assent of Special Populations (return to top)

a. Subjects Under Age 18. When the subjects are younger than 18 years of age, including college students, a parent or legal guardian must sign a written consent form. In addition, the child should be asked to ‘assent’ to participate. For older children, e.g. older than 14, this assent should be written. For younger children, this assent should be verbal. Researchers need to provide a script of what will be said to children to seek their agreement to participate.

b. Vulnerable Adults. When subjects include individuals who are not legally or physically capable of giving documented informed consent because of mental incapacity, or inability to communicate, consent must be sought from a legal guardian as well as assent from the subjects themselves. The subjects should also be given an explanation of the procedures at a level appropriate to their condition and asked for their assent to participate in the research project. A written form to document assent may also be appropriate for mildly impaired adults.

III. Waiver of Some Elements of the Consent Process (return to top)

Although the use of a written informed consent form is highly encouraged by the IRB, it is understood that there are situations in which the use of such a form creates problems and therefore the investigator may request a waiver to the requirement to document informed consent in writing. In these cases, the researcher should state in Section 6 of the application “I request a waiver to the requirement to document informed consent in writing” and provide the information the IRB needs to justify waiving the requirement. Examples of situations that the IRB will normally waive the written consent form requirement include:

1. Protecting the identity of participants. The requirement for a signed consent form may be waived when the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.

2. Cross cultural research. If the project involves people in a culture where signed consent forms are not appropriate, the researcher should propose alternative ways to assure that participants fully understand and willingly participate in the research. Usually, verbal consent is required by the IRB. A script describing the procedure should be included in the application.

D. Research Activities (return to top)

Include, as necessary, the following when relating your step-by-step research procedures.

• If appropriate, clearly distinguish between the normal activities subjects will engage in (would occur in the absence of the research) and the research activities. First describe the normal activity in general terms and then describe the activities that will be used for the research aspects of the project.
• Address the frequency and length of time involved in activities added to the curriculum for the purpose of the research and the overall length of research participation;
• Describe the training and experience of persons administering the treatment, collecting data, or accessing the data and relevance of this to human subjects protections.
• Describe the compensation, if any, to subjects for their participation. Payment should be reasonable and prorated with partial payment to those who withdraw before the completion of the research.
• Attach data gathering instruments, copies of questionnaires or interview questions.

E. Confidentiality of the Information (return to top)

• Indicate whether the data will be treated as confidential or anonymous;
• How will participants’ privacy be protected and confidentiality of data maintained;
• How long will confidential documents and information be retained after the end of the study;
• Where and how will data be stored;
• Who will have access to data for which subject identity is known or could be inferred?

There is a difference between confidentiality and anonymity. Confidential treatment of data is required when a dataset and/or research materials include personal identifiers, such as a name, photograph, sound recording, or personal references such as an address, phone number or identification number that may be used to connect a particular subject with his or her data. Even without collecting names along with responses, demographic information such as (male/female, age, occupation, income category, education level) can be used to identify individuals within a group where the composition of the group members is known.

Although the researcher is allowed access to confidential information, it is the responsibility of the researcher to develop procedures that assure that no unauthorized/unapproved person has access. At a minimum, the information should be kept in an inaccessible place, e.g. a locked file cabinet. If the data is maintained in a computer system, then the system should be protected from outsiders. Researchers should be aware that there are legal means (e.g.subpoena) by which confidential information can be made public.

Anonymity refers to the situation in which the dataset and/or research materials contain no personal identifiers through which anyone, including the investigator, could connect individual responses with a specific subject. Data collected through face-to-face interviews, and video, audio or photographic records are not anonymous.

Usually, for as long as personal identifiers are present in a dataset, the researcher is responsible for maintaining the confidentiality of the dataset, and therefore, the research project will receive periodic review (at least annually) to insure that the procedures used to guarantee confidentiality are adequate.

The IRB recognizes that in some research projects, the identity of the subjects is integral to the study and therefore the research material will contain the identity of the person; research oral histories and qualitative clinical studies are examples of this type of research. In these cases, the researcher may petition the IRB to close the project without making the dataset anonymous. The IRB will only consider petitions for projects in which the procedure for obtaining informed consent included explicit documentation that the subject consents to maintaining identity in the dataset.

F. Deception and Debriefing (return to top)

• Provide a rationale and justification for deceiving subjects regarding the research activities
• Describe debriefing procedures.

A special problem of consent arises where informing subjects of some aspects of the research is likely to impair the validity of the research. Deception in research is justified only if it is clear that (1) incomplete disclosure is necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing the subjects. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects and truthful answers should always be given to direct questions about the research.

In preparing material for IRB review, researchers must clearly identify any deception in the research. The rationale for deception, and plans for after-the-fact debriefing of subjects must be provided for review by the committee.

G. Potential Modifications (return to top)

Often in research it is difficult or impossible to design all aspects of the research at the outset. For example, a project may start with a pre-activity survey, the research activity, perhaps using a variety of assignments in a class that would provide research data, and interaction with subjects ends with a post-activity survey. The nature and questions on the post-activity survey may depend greatly on the response of the subjects to the previous research activities. Another example would be when a study takes place over many years and the researchers will need to respond to changes over time. When these types of circumstances exit, rather than attempt to anticipate or limit activities, in Section 3G justify the deferment in planning and likely timing of the submission of a protocol modification form.

4. Potential Risks and Discomforts (return to top)

• In the process of writing the previous materials (Methods), you should note the potential risks and discomforts associated with each research procedure. This includes physical, psychological, social, legal, economic, or other risk. Describe these risks in this section.
• Evaluate the likelihood of occurrence and the degree of seriousness of adverse events.
• Describe procedures for minimizing risks.
• Describe provisions for insuring necessary medical or professional intervention in the event of adverse effects on the subjects.

Risks to human subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society. The central charge of the IRB is to assess the anticipated benefits to be gained from the research in relation to the risks. The IRB needs to determine whether or not the investigator has properly assessed the level and magnitude of risk present in his or her project; minimized risks to the extent possible; and communicated the nature of the risks and anticipated benefits to the subject prior to seeking agreement to participate in the project.

Participation in any research project carries with it a level of risk of distress or harm that ranges from low to significant. Low or minimal risk means that the probability and magnitude of harm or discomfort is no more than engaging in everyday activities or during the performance of routine physical or psychological examinations or tests (e.g., drawing a small amount of blood from a healthy person, or sitting through an hour of tests). Some studies may involve a middle level of risk in which there is expectation of some temporary distress on the part of the subject (e.g. being asked to justify immoral decisions). High or significant risk means that the subjects may experience serious or lasting harm, (e.g. suffer a heart attack while participating in an exercise training program or be exposed to legal, financial or personal repercussions if their responses become known outside the research). A high level of risk is not a sufficient reason to disapprove a proposal; if the anticipated benefits of performing the research are high, and subjects are fully informed of the risks, then a proposal with a high level of risk can be approved.

5. Potential Benefits (return to top)

• Describe the potential benefits to subjects as a result of their participation in this research.
• Describe any potential benefits to society that may be expected from this research.

Benefits of research fall into two major categories: benefits to the subjects and benefits to society. Subjects who are experiencing a new teaching method or examination may benefit directly from research involving evaluation of a procedure or understanding of a learning disorder. Frequently, however, research projects have no immediate therapeutic intent for the subject. However, there may be benefits to society as a whole from the increased knowledge, improved safety, better technology, or improved practice in a field. Direct payments to subjects as an incentive or reward for participation should not be considered a “benefit” to be gained from research.

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