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Submitting Your Research Protocol

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).

    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.

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

    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, which is often referred to as "quality assurance" or "institutional research." These activities are typically not viewed by IRBs as falling under their purview, even if the reacher uses scientific research methods and uses private identifiable information on human subjects.

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.

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.

    Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or 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.

    Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

    Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the researcher in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

    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.

  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.

    Note: the researcher can also use the Human Subject Regulations Decision Charts for determining which expedited review category the protocol falls under.

    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.
    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.
    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.

    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.

    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.

    • 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 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.

    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.

  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.
    1. The Fairfield researcher should first submit their 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.

    1. The Fairfield researcher should first submit their 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.
    1. The Fairfield researcher should submit their 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 their 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”

Preparing to Submit Your Protocol for Review

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.

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 the researcher provides must have enough detail to ensure that potential subjects fully understand:

  • what will happen if they agree to participate
  • whether there are any potential benefits or risks for them
  • that there are no negative consequences to them if they choose to not be in the study, or if they choose to quit the study at any time

The consent form should not be so detailed that it leads to confusion. Many different things can be included in a statement of informed consent, depending on the specificities of the research; there is no single way to ask for informed consent. However, it is recommended that key information be presented in a concise format at the beginning of any consent form. This information should 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 the researcher must minimize the possibility that people feel pressured.

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.)

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 or 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 Ms. Susan LaFrance, IRB Administrative Liaison for the Office of Academic Affairs, at (203) 254-4000 x2154 or by email: slafrance@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.

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 their 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.

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, they should do so outside of their 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, they should state in their 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."

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.

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)".

Additional Information

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.

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.

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 Expedited or 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.

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 their summary their 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 they think that the event warrants any changes to their protocol or consent form. If so, discuss these potential changes with the IRB Chair before submitting a protocol Amendment.