Some research falls outside the scope of IRB review. Federal regulations require that IRBs review only certain types of research involving human subjects. The Federal Regulations define research that falls under their purview as research in which both Criteria A and B are met:

1. The research involves human subjects (i.e., living human beings).

   Information on Criterion A

   The federal regulations defines a “human subject” as a living individual about whom a research conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information.

   Definition of Terms

   “Intervention” includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

   “Interaction” includes communication or interpersonal contact between research and subject.

   “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

   “Identifiable private information” is private information for which the identity of the subject is or may readily be ascertained by the researcher or associated with the information.

   “Identifiable biospecimen” is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

2. The activity must be research (i.e., meets the definition of research that is subject to regulation).

   Information on Criterion B

   Research in this context refers to a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

   This is a grey area. Not all data collection is intended to produce generalizable knowledge. For instance, many activities that use the methods of scientific research are designed to evaluate the effectiveness of a practice in a particular setting, referred to as "quality assurance" or "institutional research." These activities typically do not fall under IRB purview, even if the researcher uses scientific research methods and uses private identifiable information on human subjects.

   In addition, the 2018 Revised Common Rule regulations also note that that certain scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) do not fall under IRB purview because they are not designed to contribute to generalizable knowledge. These scholarly and journalistic activities focus directly on the specific individuals about whom information is collected and used, without extending that information to draw generalizations about other individuals or groups. These fields of research are governed by their own codes of ethics and do not fall under IRB purview because the objective of the activities in this category is to provide an accurate and evidence-based portrayal of the individuals involved, and not to develop generalizable knowledge.

   For more information, see the guidance document from Health and Human Services entitled “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements”.

If the project meets both Criteria A and B, proceed to Step 2. If it does not meet both criteria, submission and review is not required. However, because of the ambiguities in determining what falls within the scope of the IRB, it is best to submit a short description of the study to the IRB Chair via email and let the IRB make a determination.

The Office for Human Research Protections (OHRP) provides graphic aids and guides for researchers to determine if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.

Use the HHS Determination Charts: Chart 1 for reference. Note: The HHS Charts may not be updated to reflect all of the 2018 changes. Please contact the IRB Chair with any questions.

Research must be submitted to the IRB requesting review in one of the following designations: (a) Exempt, (b) Expedited Review, (c) Full Board Review, (d) Quality Improvement, or (e) Request Delegation to an External IRB.

1. Exempt Research
   Many of the research studies conducted by Fairfield University researchers qualify for Exempt status. The Fairfield University Journal of Record notes that the IRB "shall be the sole interpreter of when research falls outside its purview and what research is exempt per the federal regulations". Research that you believe qualifies for Exempt status should be submitted to the IRB so that it can determine if it does indeed qualify.

   Information about the types of research that qualify for Exempt status:

   Exemption Category 1: Educational Research in Established or commonly accepted education settings and normal education practices.

   Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

   Read the Guidance for Researchers Seeking to Complete Research on Educational Activities (PDF) for more information.

   Exemption Category 2: Tests, surveys, interviews, or observation of public behavior.

   Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required.

   Note that Exemption Category 2 does not apply to research with children under the age of 18. Also note that Exemption Category 2 applies to surveys, interviews, and observations that measure existing conditions, and it does not apply when there are interventions designed to change subjects' behaviors or responses. See Exemption Category 3 for research involving benign behavioral interventions.

   Exemption Category 3: Benign Behavioral Interventions

   Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required.

   For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

   If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

   Note that research with children under the age of 18 is not eligible for review under Exemption Category 3.

   For more information, see HHS Recommendations on Benign Behavioral Intervention

   Exemption Category 4: Secondary research for which consent is not required (e.g. retrospective chart review)

   Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

   1. The identifiable private information or identifiable biospecimens are publicly available;
   2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under Subchapter C— Administrative Data Standards and Related Requirements, subparts A and E, for the purposes of 'health care operations' or 'research' as those terms are defined under HIPAA or for 'public health activities and purposes' as described under HIPAA; or
   4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

   Exemption Category 5: Research and demonstration projects that are conducted or supported by a Federal department or agency

   Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

   1. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

   Exemption Category 6: Taste and food quality evaluation and consumer acceptance studies

   Taste and food quality evaluation and consumer acceptance studies if:

   1. wholesome foods without additives are consumed, or
   2. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

   Exemption Category 7: Storage or maintenance for secondary research for which broad consent is required

   Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).

   Exemption Category 8: Secondary research for which broad consent is required

   Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

   1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
   2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
   3. An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
   4. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

   Read the Code of Regulations: Subpart A - Basic HHS Policy for Protection of Human Research Subjects for detailed information about these and other categories.

   Use the HHS Determination Charts: Chart 2 for determining what category of exemption the project is. Note: The HHS Charts may not be updated to reflect all of the 2018 changes. Please contact the IRB Chair with any questions.

2. Expedited Review
   Many research projects conducted by Fairfield University researchers qualify to be reviewed under Expedited Review, for example, studies that involve minimal risk to participants. Expedited review is done by the IRB Chairperson or by one or more experienced reviewers designated by the Chairperson from among members of the IRB.
   For research that is approved through expedited review procedures after January 21, 2019, as per the 2018 Revised Common Rule, the approval does not expire. However, in order for the IRB to monitor what studies remain open, an annual Status Report will need to be filed by the researcher after each year, until the research is completed. This is done through a sub-form entitled “Status Report (2018 on) in which they inform the IRB if the project is still ongoing.
   Research that was approved through expedited review procedures before January 21, 2019 will continue to follow the regulations that existed when the study was initially reviewed (the pre-2018 regulations), and therefore approval will expire after one year. Prior to the expiration date each year, the researcher must file an annual report and request to extend the approval period for another year. This is done by submitting a sub-form entitled “Pre-2018 Annual Report.” Continuing Review is required for studies approved through expedited review prior to January 21, 2019 until the researcher has completed all research-related interactions and interventions with participants or when the collection and analysis of identifiable private information, as described in the IRB-approved research protocol, has been completed. This review was required by the existing federal regulations when the research was initially approved and this will continue until the project is terminated. It allows the IRB to monitor the progress of the study and ensures that the study continues to meet the requirements for approval.

   Information about the types of research eligible for Expedited Review:

   Note: the researcher can also use the Human Subject Regulations Decision Charts for determining which expedited review category the protocol falls under. Note: The HHS Charts may not be updated to reflect all of the 2018 changes. Please contact the IRB Chair with any questions.

   To Be Eligible for Expedited Review:

   1. The research must present no more than minimal risk to human subjects, and must qualify for one of the specified categories. However, just because an activity is listed does not mean it is minimal risk.
   2. The categories in this list apply regardless of the age of subjects, except as noted.
   3. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

   Note: Some research of this sort may be eligible to be reviewed under one of the Exempt review categories described above. This listing refers only to research that does not qualify for review under one of the Exempt categories.

   Expedited Category 1: Clinical studies of drugs and medical devices

   Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

   1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
   2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

   Expedited Category 2: Collection of blood samples

   Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

   1. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
   2. from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

   Expedited Category 3: Prospective collection of biological specimens by noninvasive means

   Prospective collection of biological specimens for research purposes by noninvasive means.

   Examples:

   • hair and nail clippings in a nondisfiguring manner;
   • deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
   • permanent teeth if routine patient care indicates a need for extraction;
   • excreta and external secretions (including sweat);
   • un-cannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
   • placenta removed at delivery;
   • amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
   • supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
   • mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
   • sputum collected after saline mist nebulization.

   Note: On October 4, 2010, OHRP clarified that it agrees with the FDA’s position that the following procedures are considered noninvasive:

   • Vaginal swabs that do not go beyond the cervical os;
   • Rectal swabs that do not go beyond the rectum; and
   • Nasal swabs that do not go beyond the nares.

   Expedited Category 4: Collection of data through noninvasive clinical tests

   Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. When medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

   Examples:

   • physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy;
   • weighing or testing sensory acuity;
   • magnetic resonance imaging;
   • electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
   • moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

   Expedited Category 5: Research on data previously collected for nonresearch purposes

   Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

   • Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4).
   • This category includes materials that were previously collected for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed research.
   • The phrase "…or will be collected solely for non-research purposes" pertains to the origin of the materials. For example, blood samples that were collected for a clinical test or the results of a course driven exam given in a history class.

   Expedited Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes

   Expedited Review does not apply if identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

   Expedited Category 7: Research on individual or group characteristics or behavior

   Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

   Note: Some research of this sort may be eligible to be reviewed under one of the Exempt review categories described above. This listing refers only to research that does not qualify for review under one of the Exempt categories.

   Expedited Category 8: Continuing review of certain non-exempt research

   Continuing review of research previously approved by the convened IRB as follows:

   1. where (a) the research is permanently closed to the enrollment of new subjects; (b) all subjects have completed all research-related interventions; and (c) the research remains active only for long-term follow-up of subjects; or
   2. where no subjects have been enrolled and no additional risks have been identified; or
   3. where the remaining research activities are limited to data analysis.

   ---

   Clarifiers regarding category (i):

   • Closure of enrollment only has to apply to the local site, not to all sites,
   • Long-term follow-up may include research interactions (as opposed to intervention) that involve no more than minimal risk to subjects (e.g., quality of life surveys);
   • Long-term follow-up may include collection of follow-up data from procedures or interventions that would have been done as part of routine clinical practice to monitor a subject for disease progression or recurrence, regardless of whether the procedures or interventions are described in the research protocol.

   Clarifiers regarding category (ii):

   • "no subjects have been enrolled" means no subjects enrolled at the local site
   • "no additional risks have been identified" means no additional risks identified at the local site or any other institution engaged in the research project or from any other relevant source since the IRB’s most recent prior review.

   Clarifiers regarding category (iii):

   • The only remaining human subjects research activity is the analysis of data that includes identifiable private information and the IRB reviewer has determined that this activity involves no more than minimal risk.
   • Simply maintaining individually identifiable private information without using, studying, or analyzing such information is not human subjects research and thus does not require continuing review.

   Expedited Category 9: Continuing review of other certain non-exempt research

   Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

3. Full Board Review
   Some projects require what is known as Full Board review, for instance studies that involve more than minimal risk to participants or some studies with vulnerable populations (e.g., subjects who may be vulnerable to coercion or undue influence such as pregnant women, children, prisoners, or individuals with impaired decision-making capacity). If the research does not qualify for any of the other designations (Exempt, Expedited Review, Quality Improvement for Health projects), it likely requires Full Board Review. In Full Board review, all members of the IRB participate in evaluating the research protocol, and voting to approve the protocol can only take place at a convened meeting of the IRB.
4. Quality Improvement Projects in Health
   Quality Improvement (QI) projects in healthcare settings involve systematic, data-guided initiatives or processes designed to enhance health care delivery in a particular setting. QI projects identify effective methods, implement the methods broadly, and evaluate the impact or effect of the implemented changes.
   Read the FAQ about Clinical Quality Improvement (QI) Projects (PDF) for detailed information.
5. Request Delegation to External IRB
   Sometimes Fairfield University researchers conduct research at other institutions such as hospitals or clinical sites that have their own IRBs. We use different review procedures depending on the nature of the research, but in all cases, the Fairfield University researcher should begin by submitting their research protocol to the external IRB and obtaining their approval.

For studies that were reviewed through Expedited or Full Board review at the external IRB, the following steps should be completed:

1. The Fairfield researcher should first submit his or her protocol to the external IRB and obtain their approval.
2. The Fairfield researcher should login to Fairfield University's online IRB system and begin a new project. Fill in the exact same project title as used for the external IRB, and under "Type of Review Requested", select "Delegate to External IRB".
3. Upload the approval letter as well as the full protocol itself and supporting documents (e.g., consent form) that had been submitted to the external IRB.
4. Await notification from the Fairfield University IRB Chair that the protocol has been accepted and the delegation of review authority to the external IRB has been approved. Only then should the researcher begin recruiting and testing participants.

The intention here is to more efficiently have PIs have their research reviewed by the IRB with the most relevant expertise and without having to go through a second IRB in a redundant fashion.

For studies that were designated as Quality Improvement projects or as Exempt Research by the external IRB, the following steps should be completed:

1. The Fairfield researcher should first submit his or her protocol to the external IRB and obtain their approval.
2. The Fairfield researcher should login to Fairfield University's online IRB system and begin a new project. Fill in the exact same project title as used for the external IRB, and under “Type of Review Requested”, select the same category of review (QI or Exempt) that the external IRB designated the research.
3. Fill in the requested information and state explicitly that the protocol has already been approved by the external IRB. Upload the approval letter as well as the full protocol itself and supporting documents (e.g., consent form) that had been submitted to the external IRB.
4. Await notification from the Fairfield University IRB Chair that the protocol has been verified as QI or Exempt research. Only then should the researcher begin recruiting and testing participants.

Some external IRBs will state that the Fairfield IRB must review the protocol first. In that case, the following steps should be followed:

1. The Fairfield researcher should submit his or her protocol to Fairfield University's online IRB system, noting explicitly that the external IRB requires the protocol first be reviewed by the Fairfield University IRB.
2. Await notification by the Fairfield University IRB that the protocol has been reviewed and approved. The approval letter will note that approval is contingent on obtaining approval from the external IRB.
3. The Fairfield researcher should then submit his or her protocol to the external IRB. When their approval is obtained, it should be uploaded to the Fairfield online IRB system using the “submit subform” tab and selecting the “post approval documentation.” The IRB Chair will send a formal letter acknowledging that the external IRB's approval has been received, and only once that is received should the researcher begin recruiting and testing participants.

Consult the links below for detailed information for all types of research in which subjects may be vulnerable to coercion or undue influence:

• Sub-part B, “Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research”
• Sub-part C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects”
• Sub-part D, “Additional Protections for Children Involved as Subjects in Research”

Although all research applications must be submitted online through this website, the researcher may use the Sample Forms below for reference when planning the submission. The researcher can write the protocol in a word processing document and copy and paste into the online system when they are ready or type responses directly into the online system.

• Exempt Research Application Form (PDF)
• Expedited and Full Board Review Application Form (PDF)
• Quality Improvement Projects in Health Application Form (PDF)

Note: These applications may not reflect the latest version of the application due to the recent changes in federal regulations. Please check back soon and contact the IRB Chair with any questions.

The purpose of having an informed consent process is to allow potential subjects to decide whether or not to participate in research. So, participants need to be informed before they consent. The information you provide must have enough detail to ensure that a potential subject fully understands (a) what will happen if they agree to participate, (b) whether there are any potential benefits or risks, and (c) that they can refuse or quit any time. The consent form should not be so detailed that it leads to confusion.

Many different things can be included in statement of informed consent depending on the specificities of the research; there is no single way to ask for informed consent. However, Federal ethics guidelines specify that “key information” be presented in a concise format at the beginning of any consent form, and that this information be presented in language comprehensible to the potential research subjects. Potential subjects deserve sufficient time to read about the research process, and researchers (or their representatives) should be available and prepared to answer questions about the process. Potential subjects must feel free to decline. They should NOT feel coerced or pressured, and you must minimize the possibility that people feel pressured. If necessary, additional information or appendices can be added to the consent form after the “key information.” The goal should be clarity about the project, the requirements, the drawbacks and benefits of participation, and the voluntary nature of agreeing to become involved.

Your paragraph with “key information” should include statements like:

• You are being asked to be part of a research project conducted by…
• Your participation is voluntary. You can refuse now or quit any time later.
• The purpose of the research is to determine…
• You will be asked to…
• It should take [this much time or effort, these specific tasks].
• Compensation for agreeing to participate is limited to…
• The potential risks of participation [if any] might include…
• The benefits of the project to you [if any] might include…
• If you have any questions or concerns about this research, either now or later, you may contact the IRB Adminstrative Liaison.

Other things to consider

Research ideally relies on non-identified information. In other words, data should be collected in such a way that the human subject is not linked to it or identified by it. If this is impossible because of logistical reasons, or research design, one of two statements must be included:

• Your data will not be used in future studies.
• Your data might be used in future studies after identifying elements are removed.

If potential subjects are children, parents and children should each give consent. There is a separate template for that. In all cases special care must be taken with vulnerable populations (the cognitively impaired, prisoners, economically disadvantaged people, and so forth.) Remember that vulnerability may be situational rather than a characteristic of the person herself or himself.

The IRB may waive the requirement for informed consent if it determines that:

• The research involves no more than minimal risk to subjects;
• The research could not be carried out practicably without the waiver or alteration;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,
• Where appropriate, the subjects will be provided with additional information about their participation. (Note: The intent of this final waiver criterion is to require debriefing for participants in research that involves deception.)

Consent Process for Expedited and Full Board Review Projects

Typically informed consent is documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. However, for research eligible for review under Expedited of Full Board review, under special circumstances, the IRB may permit the researcher to use a consent process in which participants do not physically or electronically sign their name on a written consent form. This is called a waiver to the documentation of informed consent. Under other circumstances, the researcher may request that required elements of informed consent be altered or that participants not be asked to provide their consent at all (called a waiver of informed consent).

To understand the difference between waiver of consent and waiver of documentation of consent, consider the experience of the participant: Is the participant aware that he or she is participating in a research study? If not, then consent has been waived. If the participant is given all the relevant information and has been asked for consent verbally, but a written consent document is not used, then documentation has been waived.

The Federal criteria for alteration or waiver can be found in Section 117: Documentation of Informed Consent and should be reviewed by the researcher.

The IRB offers the following templates as guides to writing consent forms for research that qualifies for Expedited Review or Full Board Review. These templates may be edited to suit the needs of the research. Researchers may choose to create their own consent forms, but we strongly recommend using the below templates, as they have been designed to meet the federally mandated required elements of consent Section 116: General Requirements for Informed Consent Standards. (Should researchers choose to edit the template(s) or create their own consent form, it must meet these federal regulations so review the list of required elements in the above link carefully.)

• Consent Form: Adults (Full Detailed Information) (DOC)   |   (PDF)
• Consent Form: Adults (Headers and Basic Text Only) (DOC)   |   (PDF)
• Consent Form: Parent for Child (DOC)   |   (PDF)
• Assent Form: Young Child (DOC)   |   (PDF)
• Assent Form: Older Child (DOC)   |   (PDF)
• Consent Checklist (PDF)
• Consent Template for Online Research (DOC)   |   (PDF)
  (please be sure to see the section below on issues to consider when conducting online research)

Consent Process for Exempt Research

For research eligible for review under one of the Exempt categories, researchers should address how they will establish the voluntary nature of subject's participation (taking care to avoid any potentially coercive procedures; reference the Research Involving Students as Participants (PDF) for some tips) and discuss how they are obtaining subject's consent to participate. The IRB strongly recommends including the basic elements of informed consent required for Expedited and Full Board review studies, but doing so in a manner appropriate to the research. Consent may not be necessary for some research, such as purely observational research or for research using data that were collected earlier for other (nonresearch) purposes. For Exempt research that involves interaction with subjects, there usually should be a process to ask subjects to participate and confirm their agreement. However, signed consent is not required for exempt research, and the consent process and documents can be much simpler than those required for non-exempt research. Verbal or implied consent is usually sufficient for exempt research that involves interaction with subjects.

For example, the consent process for Exempt research when there is some kind of interaction with subjects, such as in most research under Exemption Category 1 (educational practices) and Exemption Category 2 (interviews, surveys, focus groups), the researcher might use a consent script he or she reads aloud or a written document potential participants read that contains the relevant basic elements of consent described and required for Expedited and Full Board review (e.g., stating this is a research study, how long it will take, that subjects can discontinue their participation at any time, that participation is voluntary).

For surveys given in person, a consent script might be used and participants indicate their consent by turning their survey to the researcher rather than by signing a consent form. For online surveys, a researcher might use a written consent form that participants read online, but they indicate their consent by pressing a button, rather than by providing their signature. We recommend the following elements of informed consent be included in consent forms or scripts as applicable:

• Subject rights: State that the activity involves research, participation is voluntary, and that participants may withdraw at any time without any negative consquences for them.
• Purpose of the study: Provide a brief non-technical explanation of the purpose(s) of the research. Explain why the subject is being asked to participate in the study (e.g., "You are being asked to participate in this research study because…").
• Study tasks or procedures: Provide a complete description of procedures (including the order in which they take place). Identify and distinguish procedures that are being performed solely for research purposes from any activities that would otherwise occur. Include information about audio- or videotaping and/or any records that may be accessed (e.g., educational records).
• Duration of subject’s participation: Provide expected duration of the subject’s participation (e.g., time required to complete surveys). Ensure that the proposed time period is realistic for the procedures to be performed.
• Confidentiality: Include a statement describing the extent, if any, to which confidentiality of the data/records will be maintained. Discuss the retention of participants’ data/records following conclusion of the research. Note: Do not interchange the terms “confidential” (i.e., maintained in a way that prevents inadvertent or inappropriate disclosure of participants’ identifiable information) and “anonymous” (i.e., identifiers were not collected or have been permanently removed).
• Contacts and Questions:
  • Provide the name and contact information of the Principal Investigator (researcher) for questions, concerns, or complaints about the study. Include area code or international dialing codes for phone numbers.
  • Provide Fairfield University contact information by stating “If you have questions about your rights as a research participant, or wish to obtain information, ask questions, or discuss concerns about this study with someone other than the researcher(s), please contact the Fairfield University IRB at IRB@fairfield.edu
• Incentives: Explain payments or other incentives (e.g., class credit) to participate, including amount and schedule of payments. Compensation should be pro-rated (e.g., per session) and not contingent upon study completion. Explain the effect of a subject’s decision to withdraw from the research on compensation. If payments are offered, include the following: "By law, payments to subjects are considered taxable income."
• Sponsor: Provide the name of the sponsor funding the research, when applicable.

Information About Consent for Online Surveys and Experiments

For research in which studies are administered online, oftentimes the researcher will use a consent form that contains all the required elements (e.g., stating this is a research study, how long it will take, that subjects can discontinue their participation at any time, etc.), and participants read that on the screen and indicate their consent by pressing a button, rather than by providing their signature.

For studies designated as Exempt, it is up to you as the researcher to determine what information should be included, but we recommend the researcher follow the guidelines offered in the Consent Template for Online Research (DOC) | (PDF).

For studies qualifying for Expedited of Full Board review, having participants press a button rather than sign their name technically is an "alteration of documentation of informed consent" since it is not a signed document. It is not a "waiver of informed consent" (waiver of informed consent = subjects do not have to agree to take part in the study). The researcher should review the information about requesting an alteration of documentation of informed consent in the section "Additional Information" below. The researcher can use the Consent Template for Online Research (DOC) | (PDF), or they can create their own, but it must contain all the federally mandated required elements of consent: Section 116: General Requirements for Informed Consent Standards. The researcher does not need the traditional section headings for an online consent; however the researcher does need to include the necessary information.

The researcher should:

• Use simple language. Avoid technical terms.
• Write in a conversational tone, as though speaking to the participants.
• Use pronouns (I, we, you) and contractions (we’re, won’t, isn’t). The template default is “we”; this can be change this to “I” if the researcher is doing the research entirely on his or her own.
• Use short paragraphs (~4 lines or less). Don’t write walls of text.
• Feel free to use bullet points, tables, graphs, pictures, diagrams, etc. to more clearly convey the study information.

Confidentiality in Online Research

It is important to understand when a study is truly anonymous and when it is instead just confidential. In order for participation in an online study to be considered truly anonymous, these three criteria must be met:

1. The survey tool is configured to not collect IP address information from participants.
2. No individually identifiable information (e.g., name, birth date, identification numbers, mailing address, email address, etc.) is collected as part of the survey instrument or a related prize drawing.
3. No combination of indirect identifiers is being collected that would reasonably allow the researcher or anyone else to identify participants.

If the survey meets these criteria, it is anonymous.

If, however, the researcher requests participants' names, email addresses, or other contact information — e.g., for a follow up survey, to link their responses across multiple sessions, or so that they may be entered into an optional prize drawing — their survey is not anonymous. If the reseacher collects this information, he or she should do so outside of his or her survey instrument. The best practice is to set up a second survey instrument to collect the contact information, and to have the participant go from the researcher's data collection survey to the optional drawing survey. If the researcher does this, he or she should state in his or her IRB proposal and in the informed consent language that:

"Although the responses you make are anonymous and cannot be associated with you, if you choose to provide your contact information for the purposes of entering the optional drawing, participation in this study will be confidential, not anonymous."

Who Has Access to Online Survey Accounts?

An important emerging issue regarding confidentiality has arisen because of the security of group online survey accounts (e.g., accounts belonging to the university, some programs and departments). Everyone with access to such accounts is able to view and alter the surveys (and more significantly, the responses) of all other projects on that account. This is an obvious and very serious consideration for human subjects research. When using a group account, researchers cannot ensure participant privacy and the confidentiality of their responses, which are of paramount ethical importance. Therefore the associated privacy limitations must be clearly disclosed to potential participants. The ideal solution is to create individual accounts for each researcher and/or study and vigorously regulate who has access to the surveys.

If researchers use a shared survey account for conducting research, the following statement should be included in the research proposal and informed consent materials:

"The security of information transmitted through the internet cannot be guaranteed. Furthermore, this survey is administered through a group [enter the appropriate platform] account. Any individuals permitted to use this account, including [enter the appropriate individuals – administrators, staff, faculty, students, etc.], regardless of whether or not they are directly involved with this project, have unrestricted access to all aspects of the survey and the information gathered through it."

The IRB also suggests, when applicable, that researchers consider conducting an anonymous survey, which would help alleviate concerns about participant privacy, as no identifiable information will be gathered. If no identifying information is included with the responses (i.e., no IP address, names, email addresses, or other identifying information), this can be addressed by ensuring participants that no such information is collected and therefore cannot be associated with their responses.

Additional Guidelines

The Secretary’s Advisory Committee on Human Research Protections (SACHRP) provides expert advice and recommendations to the Secretary of HHS on issues pertaining to the protection of human subjects in research. Read their document on "Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions (PDF)".

Waivers and Alterations of Informed Consent For Expedited and Full Board Review Protocols

Typically informed consent is documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. However, for research eligible for review under Expedited of Full Board review, under special circumstances, the IRB may permit the researcher to use a consent process in which participants do not physically or electronically sign their name on a written consent form. This is called a waiver to the documentation of informed consent. Under other circumstances, the researcher may request that required elements of informed consent be altered or that participants not be asked to provide their consent at all (called a waiver of informed consent).

To understand the difference between waiver of consent and waiver of documentation of consent, consider the experience of the participant: Is the participant aware that he or she is participating in a research study? If not, then consent has been waived. If the participant is given all the relevant information and has been asked for consent verbally, but a written consent document is not used, then documentation has been waived.

The Federal criteria for alteration or waiver can be found in Section 117: Documentation of Informed Consent and should be reviewed by the researcher.

For detailed information, read the Guidance on Research Involving Students as Research Participants (PDF).

For information on conducting educational research on the scholarship of teaching and learning, read the Guidance for Teaching and Learning Protocols (PDF).

Research conducted by Fairfield University researchers in foreign countries remains under University purview and guidelines. While the IRB cannot impose its standards for written documentation on other cultures, it does not relax its standards for ethical conduct of research or for a meaningful consent process. If the researcher plans on conducting research outside the United States, they should read the International Research Information (PDF) carefully.

Research Ethics Education and Training

Researchers have a responsibility for protecting the rights and well-being of their research participants and for conducting research in an ethical manner that is in compliance with university and federal regulations. Ongoing education and training in research ethics by those conducting research with human subjects is an essential part of ensuring that the rights and safety of the research participants are protected. The Fairfield University IRB expects Principal Investigators and their research team members to understand and comply with the federal regulations, state and local laws, and Fairfield University policies governing research with human subjects.

“Research Team members” refers to persons who have direct contact with subjects, contribute to the research in a substantive way, have contact with subjects' identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use subjects' personal information.

What’s New?

Effective September 1, 2019, Principal Investigators who submit new IRB protocols will be required to offer evidence of appropriate education and training in research ethics for themselves and members of their research team. This applies only to protocols that are reviewed using expedited review or full board review, though education and training are encouraged for all types of research, including those categorized as exempt or quality improvement research.

The Principal Investigator (PI) who submits the protocol is responsible for ensuring that members of his or her research team are appropriately trained in research ethics and protecting human subjects. When a new protocol is submitted, the PI will be prompted to indicate what form of training he or she has had (typically by completing the CITI certificate program [described below] or some equivalent course such as the NIH Research Ethics course) and how he or she ensured appropriate training and education for the members of the research team (e.g., by having them complete CITI training, by engaging on project-specific training with them, or some suitable alternative).

How do I demonstrate ongoing research ethics training?

The Collaborative Institutional Training Initiative (CITI) is a web-based training program in human research subject protection. Fairfield University subscribes to this program so that all faculty, staff, and students are eligible to take the various courses at no cost to themselves. CITI contains modules on topics like informed consent, vulnerable populations, ethical principles and IRB regulations. Each module has a short quiz at the end to assess understanding.

Which CITI modules are required?

The modules are grouped by categories of research. You only need to complete one group of modules, and should choose the group that best fits the type of research you normally conduct. If in doubt, ask your IRB Chair. For many researchers at Fairfield University the “Social-Behavioral-Educational (SBE) Basic Course” will be the most useful. Others will find the “Biomedical (Biomed) Basic Course” more relevant if they conduct research in clinical or hospital settings. These and other courses are available to all faculty, students, and staff through the University’s subscription to the CITI Program, so please use it and encourage your students to do the same if it is relevant to their course of study.

• Group 1: Biomedical Research: Medical, physiological or pharmacological studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices or other interventions.
• Group 2: Social and Behavioral Research: Studies on sociological, psychological, anthropological or educational phenomena that typically involve direct contact with subjects. Does not include drug or device studies.
• Group 3: Data and Specimens ONLY: No direct contact with human subjects. Research limited to use of records, data (including secondary data sets), or biological samples.

In addition to the required modules, you should complete any “OPTIONAL” modules that apply to your research projects. For instance, the CITI “Good Clinical Practice (GCP)” course is relevant for researchers involved in the design, conduct, or reporting of clinical trials involving human subjects.

What if I completed CITI training at another institution?

If you completed CITI training at another institution within the past 3 years, (1) log-on to CITI using your existing CITI username and password, (2) click “affiliate with another institution,” (3) select Fairfield University as your Participating Institution. If it was longer than 3 years ago, you should take the CITI refresher course.

What if I completed some other ethics training certificate program?

If you completed an equivalent alternative program such as the NIH Research Ethics Course within the past 3 years, you can provide that certificate as evidence of ethics education and training. If it was longer than 3 years ago, you should take the CITI refresher course. If in doubt, ask the IRB Chair.

How much time will it take to do the CITI course?

This will depend on your experience with human research issues. Most modules will take about 10-20 minutes to complete, and there are several modules for each course. Researchers familiar with these topics may require 3 hours or less to complete all of the required modules for a given course. You do not have to complete all the modules at once. The CITI course is designed for you to work at your own pace, and allows you to exit and return at a later date to where you left off.

What is the passing score on the quizzes?

You must receive a total passing score of 75% after completing all the required modules. You can track your progress on-line by clicking on the GRADE BOOK. If you do not obtain a total passing score of at least 75%, you can return to the modules and retake the quizzes.

Is there a fee?

The University pays an annual fee for all Fairfield faculty, staff, and students so that individuals are not assessed a fee for the CITI training.

When do I have to renew my training? Does it expire?

Continuing education is not required at this time. Note: Disregard any statements about training expiration being valid only for 3 years on your CITI certificate. For this new required training by the Fairfield IRB, certification does not expire. When in the future an annual refresher course is required, ample notice will be provided on the Fairfield University IRB website.

How do I access the CITI courses?

1. Go to http://www.citiprogram.org
2. As a “new” user, you will need to select “Register".
3. Select “Fairfield University” from the Participating Institutions.
4. Complete the required registration fields and contact information and click submit.
5. You will need to select “Human Subjects Research” from the CITI Enrollment web page and click next.
6. Select the “Biomedical Human Research Investigators Course” or the “Social & Behavioral Human Research Investigators Course” and click submit.

A table will be displayed listing the course(s) you are enrolled in. You can begin the course by clicking on the course name.

You will have the opportunity to print a Training Certificate Completion Report upon completion of the training course and exam. Please save a copy of this report for your records and to upload to the Fairfield IRB submission portal when you submit a new protocol.

When research involves particularly sensitive information (e.g., drug use, genetic information, etc.) that is linked to subject identifiers, the IRB may require that the researcher secure a "Certificate of Confidentiality" from the National Institutes of Health, which can be found at the NIH Certificates of Confidentiality Kiosk.

Any changes to existing protocols should be reviewed by the IRB, as they may impact the risk/benefit ratio of the protocol. To submit an Amendment, the reseacher must return to the protocol within Infonetica and choose "Create Sub­Form" from the protocol's Action menu (the tiles on the left). The researcher will be prompted to describe a summary of the proposed changes. If the changes require modification of the consent form, the researcher must include the consent form along with the summary and use track changes to highlight the changes they are making.

All protocols approved by Full Board Review procedures are required to submit an Annual Report. The Annual Report Form is a fill­-in form that requires basic information about the number of study participants and the protocol's status. Through the form, the researcher will indicate whether they are requesting Continuation of the research or are Terminating the protocol. To submit an Annual Report, the researcher must return to the protocol within Infonetica and choose "Create Sub-­Form" from the protocol's Action menu (the tiles on the left). As a reminder to submit this form, the researcher will be sent an automated e-mail 30 days prior to the protocol approval's expiration date. Unfortunately, there are sometimes glitches in this automated reminder, so the researcher should not rely exclusively on this e-mail. It is the researcher's responsibility as PI to keep track of the expiration date and be sure to submit an annual report prior to the expiration date. If the researcher fails to submit an Annual Review form, the protocol approval will automatically be terminated on the expiration date noted in the approval letter, and all related research must stop.

For research that is approved through expedited review procedures after January 21, 2019, as per the 2018 Revised Common Rule, the approval does not expire. However, in order for the IRB to monitor what studies remain open, an annual Status Report will need to be filed by the researcher after each year, until the research is completed. This is done through a sub-form entitled “Status Report (2018 on) in which they inform the IRB if the project is still ongoing.

Research that was approved through expedited review procedures before January 21, 2019 will continue to follow the regulations that existed when the study was initially reviewed (the pre-2018 regulations), and therefore approval will expire after one year. Prior to the expiration date each year, the researcher must file an annual report and request to extend the approval period for another year. This is done by submitting a sub-form entitled “Pre-2018 Annual Report.” Continuing Review is required for studies approved through expedited review prior to January 21, 2019 until the researcher has completed all research-related interactions and interventions with participants or when the collection and analysis of identifiable private information, as described in the IRB-approved research protocol, has been completed. This review was required by the existing federal regulations when the research was initially approved and this will continue until the project is terminated. It allows the IRB to monitor the progress of the study and ensures that the study continues to meet the requirements for approval.

In the event that a human subject is harmed as a result of participation in a project, it is necessary that the researcher immediately inform the IRB. To submit an Adverse Event Report, return to the protocol within Infonetica and choose "Create Sub­-Form" from the protocol's Action menu. (The tiles on the left.) The researcher should include in his or her summary his or her judgment of whether the harm to the subject was a result of their participation in the project or incidental to it. The researcher should also indicate if he or she thinks that the event warrants any changes to his or her protocol or consent form. If so, discuss these potential changes with the IRB Chair before submitting a protocol Amendment.

Contact the IRB Administrative Liaison for the Office of Academic Affairs for instructions on how to submit a protocol to the Fairfield University IRB for review and approval. Do so before recruiting or testing subjects.

There may be additional requirements for federally funded studies of health related interventions. Additional information about clinical trials requirements, including new and expanded definitions of what constitutes a clinical trial can be found on the NIH website.