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Informed consent is one of the primary ethical considerations underlying research with human subjects. “Informed” means that the subjects know what they are being asked to do and why, and that they are aware of the potential consequences of their participation in the research. For this to occur, potential subjects need to be provided information about the purpose of the study, what will happen during the study, and any possible risks, benefits, or outcomes they may experience as a result of participation. Investigators are responsible for presenting this information in a way that potential subjects can understand, with no technical jargon or significant omissions. Merely reading the consent form to potential subjects is not a substitute for ensuring that they understand the information in it. Potential subjects should be given the opportunity to ask questions to clear up any confusion or uncertainty before providing consent.

In most cases, federal regulations require that informed consent be documented on paper. It should be reiterated, however, that the consent document does not substitute for discussion and clarification. Ideally, the specifics of the research study will be explained to the potential subject verbally with the paper forms as a guide. Verbal or nonverbal agreement to participate in a study (also known as assent) is insufficient; the informed consent form should be signed by all subjects.

There are some exceptions to the above guidelines:

  • Research involving children or other people for whom cognitive or mental health status may prevent an informed consent process (e.g., people with dementia or intellectual disability) requires consent from a parent, guardian, or other authorized representative. Assent should be provided by the potential subject and noted on the consent form; however, assent is not equivalent to or an appropriate substitute for informed consent.
  • In some cases, the research goals are such that some deception is necessary to answer the primary research question(s). For example, researchers wanting to study conformity may present the study as an examination of perceptual processes such as color vision, because telling the subjects the study is about conformity may influence behavior. For studies of this nature, deception or lack of detail may be allowable in the consent forms. However, subjects in these types of studies should receive a debriefing after their participation explaining the true purpose of the study and the reasons for the deception or lack of detail.
  • Research conducted remotely, such as through telephone calls or surveys administered via internet or sent through the mail, may not be able to use the informed consent process in the same way as in-person research. However, the researcher is still responsible for providing potential subjects with the necessary information they need to make an informed decision about their participation. If in-person discussion of the research study goals and procedures is impossible, then it is crucial that the written description of the study be sufficiently detailed and understandable.

Confidentiality Limitations

The term “confidentiality” in a research context means that participants cannot and will not be individually identified through their responses, either directly or indirectly, without their permission. The most pertinent example of direct linkage is publishing the names of individual subjects. Indirect linkage could include, for example, publishing the name of a group whose members could be identified (e.g., “Dr. Smith’s ENGL 1101 class”, “the members of the International Student Association”) or providing demographic information that is so specific as to apply to a very limited group of people. Researchers should ensure that their data collection, particularly related to demographic data, does not inadvertently create situations that violate the confidentiality of their subjects. If identification of a group (such as a class or members of a particular organization) is considered a relevant part of the research aims and the group will be identified in any resulting publications or presentations, then the consent form should state this.

A related issue is that confidentiality cannot be maintained under certain conditions. For example, researchers who find evidence of child abuse or neglect are required to report that information to the authorities. Similarly, information about potential Title IX violations cannot be guaranteed confidentiality. Researchers whose data collection methods or research goals could reasonably be anticipated to yield information of this nature should include this information in the “Confidentiality” section of their consent form. If questions arise, the appropriate parties (e.g., Title IX Coordinator, Department of Family and Children Services) should be contacted.

Elements of a Consent Form

At a minimum, an appropriate consent form should include the following information, in lay language at the 8th-grade reading level or below:

  • The study title (if not in lay language, then any technical terminology should be explained)
  • A description of the purpose of the study, to include:
    • What question the research is intended to answer
    • Why answering this question is important (i.e., how the research will contribute to knowledge or practices to improve the lives of others)
  • A description of what participation in the study will involve, including:
    • Duration and location of the participation
    • Procedures that will be followed, and what the subject will be asked to do
    • Potential risks to the subject and what will be done to address them
    • Potential benefits to the subject, including any compensation or services
  • A description of how confidentiality will be maintained and the circumstances under which confidentiality cannot be guaranteed (e.g., Title IX violations)
  • A description of the subject’s legal rights, including:
    • The right to refuse and/or withdraw participation at any time with no penalty
    • Acknowledgement that participation is voluntary and involves no loss of legal rights to which the subject would otherwise be entitled
  • What compensation, if any, will be provided in case of study-related injury
  • Contact information for the primary investigator and IRB chair

Other information may be required depending on the nature and purpose of the study. The Department of Health and Human Services Informed Consent FAQ and 45 CFR 46.116(b) web pages provide further clarification on this issue. Investigators are strongly encouraged to review the information on these web pages before submitting their consent forms for IRB review. Inadequate consent forms that require significant revision and clarification can interfere with timely review and approval of the research.

Consent forms should include space for signatures of both the subject and either the researcher or a member of the project staff. If the potential subject cannot provide a signature due to issues such as age or cognitive ability, then their parent, guardian, or authorized representative should sign the form, and this person’s relationship to the subject should be noted (see “Consent for Special Populations” section). Additionally, there should be a space at the bottom of each page for potential subjects to provide their initials to document that they understand the information on that page.

Subjects should have the opportunity to keep a copy of the consent form. Consent forms for online studies should be in a format that allows the consent form to be printed. For telephone-based research, investigators should offer to send the subject a copy of the consent form.

When IRB approval is granted, the investigator will receive a copy of the consent form stamped with the approval date. Copies of this stamped consent form must be used with study participants. If this is not feasible due to the method of data collection and/or consent form administration, then the date of IRB approval must be noted elsewhere on the consent form.

Coercion and Consent for Special Populations

Coercion can occur when potential subjects feel compelled to participate because they do not understand the study or their rights or because they fear negative repercussions if they refuse. Coercion can also occur if there is a power differential between the investigator and subject or if the potential benefits of participating are so great that they would be difficult to refuse. Whether the investigator intends to produce this coercion is irrelevant. If potential subjects do not feel that they have the ability to refuse participation or enough knowledge to understand the study, then coercion is occurring.

Certain groups of people are considered to be particularly vulnerable to coercion due to age, cognitive status, or group membership. These groups include but are not limited to:

  • Children under 18 years of age
  • Pregnant women
  • Fetuses
  • People with cognitive impairments (e.g., dementia, intellectual disability, mental illness)
  • Prisoners
  • Hospital patients or nursing home residents
  • Students

Children and people with cognitive impairment may have difficulty understanding the nature and purpose of the study. Relatedly, individuals under the age of 18 or who have been declared incompetent in a court of law cannot legally provide informed consent. In the case of research involving children, fetuses, or pregnant women, consent from both parents must be obtained if possible. In the case of research involving people with cognitive impairment, consent must be provided by a guardian or other authorized representative, such as a family caregiver. A special subsection of the federal code specifically addresses issues related to the use of children as research subjects.

Prisoners, hospital patients, or nursing home residents may need extra reassurance that their decision about participating and the data they provide will not affect aspects of their life such as the quality of the care they receive, their potential release/discharge date, or their ability to accept or refuse other treatment. A special subsection of the federal code specifically addresses issues related to the use of prisoners as research subjects.

Students may also feel that they cannot refuse to participate in research, especially if the investigator is a faculty member. If participation is tied to any type of course credit, whether extra credit or a required part of the course grade, an alternative assignment should be provided to allow students to earn this credit without being forced to participate in research.

Sample Consent Forms

The following forms represent samples of appropriate consent forms. The specific details in the forms should be changed to reflect the study at hand as well as current contact information for the researcher and IRB chair. Investigators are encouraged to review each example to determine the appropriate format and amount and type of information to include.

Please note that these samples are not exhaustive. Certain types of studies may require more or different details than are provided in these samples. Investigators are responsible for providing their potential subjects with relevant and understandable information to obtain informed consent.

A. Standard Consent Form: This is a prototype of the consent form layout and content appropriate for much human subjects research. The “initials” blank should appear at the bottom of each page except for the page with the subject’s signature. *Complete Word form and mail it along with other forms to irb@gsw.edu 

B. Abbreviated Consent Form for Group Administration or Telephone Use: Here, the consent information is placed at the beginning of a survey or other instrument for use in settings where in-person discussion of the amount of detail found in a standard consent form is impractical. The researcher should still explain the study and information on the consent form to the potential subjects, and potential subjects should still receive the opportunity to ask questions about the study prior to starting their participation. The “opt-out” box is intended to reduce social pressure in group settings. Potential subjects may not want to participate, but may also not want to stand out from the rest of the group by refusing. By checking the “opt-out” box, these subjects can maintain the appearance of conformity but not actually participate in the research. Investigators should discard any surveys on which this “opt-out” box is checked. *Complete Word form and mail it along with other forms to irb@gsw.edu 

C. Research Conducted Online or Through the Mail: This consent form is intended for use in research studies that involve collecting data online or through the mail. The main feature of this consent form is the “Yes” box on the last page, which is used in lieu of a signature in online settings. Consent may be inferred through subject behavior such as checking the box and completing the survey. Additionally, there are no “initials” blanks at the bottom of each page. If this form were being used with a mailed survey, an actual signature should be obtained, and lines for the subject’s initials should appear at the bottom of each page. *Complete Word form and mail it along with other forms to irb@gsw.edu 

D. Research Involving Children or Other Persons Unable to Provide Informed Consent: This consent form is intended to be completed by the parent, guardian, or authorized representative of a person who is unable to provide informed consent due to age or cognitive ability. Although the potential subject in this case cannot legally provide consent, his/her assent should be obtained. The form should include a section indicating either that the subject assents to participate or that assent was waived due to the subject’s age, maturity, or psychological state. If assent cannot be obtained, it should be noted on the form. The subject’s parent, guardian, or authorized representative can choose to deny or withdraw participation if the subject’s assent is not provided or is withdrawn during the course of the research. Investigators studying vulnerable populations should include a passage in the consent form stating that any abuse or maltreatment witnessed by or described to the research staff will be reported to the proper authorities. *Complete Word form and mail it along with other forms to irb@gsw.edu 

Data Collection at Other Institutions

If data will be collected at institutions other than GSW (hospitals, schools, businesses, etc.), it is necessary to provide written documentation that the other institution approves of the research to be conducted. The other institution’s own IRB or research review panel must approve the study, and a copy of this approval must be attached to the GSW IRB application. If the other institution does not have its own IRB or review panel, then written approval should be obtained from an authorized official of that institution and submitted along with the GSW IRB application. If it is not possible to obtain the other institution’s written approval prior to submission of materials to the GSW IRB, then a statement of preliminary contacts with the appropriate officials should be attached to materials submitted for GSW IRB review. Approval from the other institution does not guarantee GSW IRB approval and vice versa. Furthermore, a project that receives GSW IRB approval but does not receive approval from the other institution cannot be conducted at that institution and vice versa.

Researchers from Multiple Institutions

If a project involves researchers from more than one institution, but data will only be collected at one institution, then a single review by one institution’s IRB may be sufficient to avoid redundancy of effort. However, this single review must be approved by the IRB chairs at all institutions involved. If the project will involve data collection at multiple institutions, then each institution must review and approve the proposed projects as described in the “Data Collection at Other Institutions” section.

Children as Research Subjects

Federal guidelines state that the definition of “child” depends on the specific statutes of the state where the research is to be conducted. For research conducted in Georgia, children are defined as individuals under 18 years of age. However, if the research involves subjects in other states or countries, the investigator must adhere to the laws of majority for those states or countries. The age of 18 cannot be assumed to be a universal age of majority.

Investigators are responsible for determining that potential subjects are old enough to participate in research without parental consent. College students and people in a workplace environment cannot be assumed to be adults simply on the basis of their status or position.

Research involving children as subjects requires not only assent (verbal or nonverbal agreement to participate) from the child, but also informed consent from parents or guardians. Under certain circumstances, the child’s assent can be waived. The sample consent forms and federal statutes contain more information about these situations and requirements.

The purpose of any IRB application is to provide sufficient information about the study’s purpose and methodology to allow the committee to effectively evaluate its ethicality. It cannot be assumed that reviewers will be experts in any particular research area. Investigators must therefore prepare their applications with the goal of providing as much relevant information as possible with as little jargon and as few omissions as possible. Neglecting to provide sufficient or clear information regarding the research goals and procedures may delay the approval and research process.

All IRB materials and correspondence should be submitted to the IRB Chair (irb@gsw.edu). Investigators who require more detailed contact information for the IRB Chair should request that information from the Office of Academic Affairs, Room 205, Administration Building, 229-928-1361.

Investigator and Committee Member Training

All investigators are required to complete National Institutes of Health (NIH) training or Collaborative Institutional Training Initiative (CITI) training. NIH and CITI certification for investigators is valid for three years. A copy of the NIH or CITI certificate must be submitted every time investigators submit an IRB application. Georgia Southwestern State University (GSW) does not offer CITI training; however, GSW accepts CITI training certificates obtained at other institutions.

IRB committee members are required to complete and submit proof of NIH or CITI certification to the IRB Chair at irb@gsw.edu. IRB committee member certification is good for two years.

Application Types and Projected Review Timelines

Brief descriptions of the different application requirements and their typical estimated review timelines appear below. Merely submitting the required materials for review does not guarantee approval of the proposed research. Applications that lack clarity or detail, or that come at certain times of the academic year such as during the final exam period or winter break, may take longer to review.

It should also be noted that because GSW’s IRB may not contain any members on 12-month employment contracts with the university, the availability of any type of IRB review during the summer months cannot be assured. Potential investigators are strongly encouraged to submit any proposals before the end of the spring semester.

Exemption: Exemption applications are typically evaluated by the IRB chairperson, although the chairperson may solicit review from other IRB committee members in cases of potential conflicts of interest and/or lack of research expertise. To apply for Exemption from IRB review, the investigator must complete and submit the following materials:

  • The Exemption Application
  • Any questionnaires, consent forms, and other relevant material such as advertisements
  • Any external funding agency’s protocol or application materials
  • Any special approvals, such as release forms from agencies providing specimens

There are no deadlines for submission of Exemption applications; however, investigators should allow at least one month for the application to be processed and approved.

Expedited Review: Expedited Review applications are typically evaluated by the IRB chairperson and two IRB committee members. To apply for Expedited Review, the investigator must complete and submit the following materials:

  • The Expedited Review application
  • The consent form that will be used
  • Any questionnaires and other relevant materials, including advertisements
  • Any external funding agency’s protocol or application materials
  • Any special approvals, such as release forms from agencies providing specimens

There are no deadlines for submission of Expedited Review applications; however, investigators should allow at least one month for the application to be processed.

Full Review: Full Review applications are evaluated by the entire IRB committee. Therefore, all materials must be submitted to the IRB chairperson at least two weeks prior to the regularly scheduled IRB meeting. Investigators are encouraged to attend these meetings to answer any questions about their application, but are not required to do so. To apply for Full Review, the investigator must complete and submit the following materials:

  • The Full Review application
  • The consent form that will be used
  • Any questionnaires and other relevant materials, including advertisements
  • Any external funding agency’s protocol or application materials
  • Any special approvals, such as release forms from agencies providing specimens

Advertisements

Advertisements that incorporate the GSW name or logo must be approved by the Office of University Relations as well as the IRB. Investigators should contact University Relations at 229-931 2028 for more information about these guidelines. Advertisements should be limited to the following information:

  • The name and address of the investigator
  • The purpose of the research and a summary of the eligibility criteria
  • A description of the benefits
  • The location of the research
  • The person to contact for further information

Duration of IRB Approval

A project’s IRB approval lasts for one year, unless otherwise specified, commencing with the approval date. High-risk projects may receive a shorter approval period. Research activities should not continue past the one-year anniversary of the IRB approval date unless the IRB has approved a renewal.

Renewal Instructions

Projects lasting longer than one year require annual renewal. This is true for projects that are still recruiting subjects as well as projects that are still treating or monitoring subjects. For IRB approval renewal, the principal investigator must submit to the IRB Chairperson the following materials:

  • The completed Investigator's Progress Report
  • The most recently approved consent form, minus the IRB approval stamp
  • The complete protocol, including any modifications previously approved
  • Any progress reports sent to the sponsoring/funding agency, if applicable

The IRB Chairperson should issue renewal notices to investigators of active studies prior to the protocol approval expiration date. However, the investigator is responsible for monitoring approval and expiration dates and ensuring that necessary renewal forms are submitted on time.

Amendments or Changes to the Protocol and/or the Consent Form

The investigator must report to the IRB, in writing, any modifications in the consent form, study methodology, and/or protocol. The proposed changes and their effects must be reported before they are implemented. IRB approval may be rescinded if the modifications to the protocol or consent form are considered to render the study unethical.

Adverse Effects or Unanticipated Problems

The investigator must report promptly to the IRB, in writing, any research-related injuries to human subjects or any unanticipated risks to subjects or others at participating sites. Any research project that results in unexpected serious physical, psychological, or emotional harm to the subjects must be terminated immediately. If the research involves an Investigational New Drug or Device, the investigator must also report such incidents to the sponsoring agency and/or the Food and Drug Administration.

Final Report Instructions

When the project is completed, researchers should submit the Final Progress Report to the IRB.

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