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The following explanations are intended to provide specific instructions for the listed protocol sections. Contact the IRB office with further questions.
This section provides basic information about your study. If you are not sure of the research category, refer to this guide.
The IRB wants to know whether your project is likely to continue beyond one year. If so, you will be required to submit a continuation request about 11 months after initial approval.
This section provides information about your proposal to help the reviewers understand your specific research project and get a broad overview of the field. Current knowledge includes the research that has already been conducted in this field. It should not include any personal observations or opinions.
Describe the procedures or activities in as much detail as possible. This should serve as a blueprint for your study and include enough detail so that another investigator could pick up your protocol and replicate the research. For studies that have multiple or complex visits or procedures, consider the addition of a schedule of events table in in your response.
Examples of deception include withholding relevant information, false performance feedback, fictitious information about the true purpose of the study, etc. If you are proposing to use deception in your study, you must explain thoroughly and clearly why deception is necessary.
If you are using audio- and video-recording: You must also describe the alternative method of data collection if subjects do not consent to being audio- or video-recorded. If audio- or video-recording is essential for your study and subjects who do not consent to recording will not be eligible for the study, explain that here.
For school-based research: If your research takes place during the PreK-12 school day, during a before- or after-school program, or during a university course, describe in detail the activities planned for non-subjects and explain where both subjects and non-subjects will be located during the research activities. Please note that the IRB strongly discourages the use of class time to conduct research that could reasonably be conducted at another time.
Please note that you will attach all instruments (e.g., surveys, interviews, questionnaires, etc.) and related documents elsewhere in the proposal process.
State an estimated maximum number that will encompass all possible participants. It is acceptable to go below that maximum number, but not above it.
Vulnerable populations include any individual that due to conditions, either acute or chronic, who has his/her ability to make fully informed decisions for him/herself diminished or any population that due to circumstances, may be vulnerable to coercion or undue influence to participate in research projects. Subjects may feel coerced if they are in a position where they feel that refusing to participate in a study will harm them or affect their relationship with the researcher. You will need to explain how you will make sure subjects are not vulnerable to coercion or undue influence to participate in your project.
Inclusions and Exclusions refer to specific criteria that will allow or disallow participation. For example, if you are studying the homeless population, a criteria of inclusion would be homelessness. If you are only working with the staff and faculty at a particular high school, then participants' status as staff or faculty of that school would be a criteria of inclusion.
Screening Procedures refer the process or procedures the PI will use to determine eligibility. Pre-screening occurs before the informed consent process. During the pre-screening process, PIs must collect the least amount of information possible to determine eligibility. If a participant does not advance past the pres-screening process, that information must be discarded unless consent is specifically obtained for use of this information. If a PI wishes to use the information collected during the pre-screen as data for the actual study, a specific request for its use must be included in the informed consent.
- Asking your own students--or the parents of your students--to participate in your research raises issues of coercion. Parents and students will often feel compelled to participate—in spite of your intentions and assurances that they are not obligated to do so—or they may perceive some intangible benefit to participation that does not exist.
- Asking employees to participate in research sponsored by their employer raises questions about the ability of employees to exercise free choice, for example, because of the possibility that a decision to participate could affect performance evaluations or job advancement, even if it is only the employee’s perception that this is the case. In the case of coercion, refusal to participate might result in a loss of benefits (e.g., salary increases, time off). In the case of undue influence, a decision to participate could result in a job promotion. Employees are likely to view their employers as authority figures to whom they must show deference, which could undermine the freedom of their choice.
If you will be working with your own students or employees, the IRB requires that you have a co-investigator or research assistant conduct the recruitment of participants and in most cases, the consent and assent process as well. This person must be CITI-certified.
Consult federal guidelines for more information: http://www.hhs.gov/ohrp/policy/populations/index.html
Recruitment: Any letters, e-mails, verbal scripts, fliers, etc. are considered part of the recruitment process and must be included as part of the proposal package. The IRB must approve the wording of all recruitment materials, including verbal scripts and e-mails. All recruitment materials should use neutral language. Avoid statements that could be considered coercive, such as: I would really appreciate it..., It would be great if… or “I would love your help.
Keep in mind that having access to phone numbers, e-mails or mailing addresses in the context of your employment does not give you access to this personal information when you are acting as a researcher. You may need to have an outside entity make the first contact, such as having an administrator e-mail or mail your recruitment letter to potential subjects. Once potential subjects respond, you are then free to interact with them directly.
For research in classrooms or schools: If you are obtaining identifiable student records, then Family Educational Rights and Privacy Act (FERPA) regulations apply. You do not have the right to access student records for research purposes even if you have that right as a teacher or counselor. For the use of identifiable student records (e.g., contact information, grades, attendance records) you must either obtain the direct, written permission of the student (if adults) or student’s parent (if minors). In most cases, Consent Form A is the appropriate document to use to obtain permission for the use of student records.
If research participants are minors (e.g., under 18), The College at Brockport IRB specifies that parental or guardian permission must be sought before seeking the assent of a child.
Consent: Exempt research done with adults does not require a signed consent form, but investigators must still provide the basic elements of consent to all prospective participants. You will need to describe in detail the process of obtaining informed consent from participants, including the method, such as in person, via phone (for exempt proposals only), through e-mail or through another delivery system, as well as the time and place.
Minor assent: If working with children, describe how minor assent will be sought, including the method, time and place. Please specify whether you will obtain minor assent individually or in a group. If you are working in a classroom or group setting, please explain what the other children will be doing while you obtain assent from the students whose parents have provided informed consent. Minors over the age of 5 should sign their own assent forms.
If you are working with your own students or employees, you may not conduct your own consent or assent. Instead, you will need to work with a CITI-certified colleague.
When documentation of informed consent is required, there are two methods available:
- The subject or the subject's legally authorized representative signs a form containing all the required elements of consent and any additional information necessary to provide complete disclosure. The person who signed the consent form is given a copy as a reference and reminder of the information conveyed.
- The consent is done orally in language understandable to the subject and is documented
by an impartial witness. This process uses two documents: (1) a short- form written
consent document stating that the required elements of consent have been presented
orally to the participant or the participant's legally authorized representative,
and (2) a written, IRB-approved summary of what will be said to the participant or
the participant's representative. The participant signs the short form. The witness
signs both forms. The person actually obtaining consent signs the summary. Copies
of the short form and the summary are given to the participant.
Note: Illiterate English-speaking subjects can "make their mark" on the informed consent document, as long as it is consistent with applicable state or local laws.
Criteria for waiver or alteration of informed consent:
Federal regulations allow IRBs to authorize researchers to modify the consent process by omitting one or more elements of information or to provide no information at all. The waiver or alteration of any or all of the elements of consent can be authorized only if these four criteria are met:
- The research involves no more than minimal risk to the subjects. Minimal risk means "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests" (Protection of Human Subjects 2009).
- The waiver or alteration will not adversely affect the rights and welfare of the study participants. In the absence of specific legal rights, this criterion is often difficult to apply because the federal regulations do not define "rights and welfare." Also, the parties involved in the research process (researchers, IRBs, and the community of subjects) may not always agree on how to define participants' rights and welfare. When a waiver is required because the research involves deception, this requirement usually is interpreted to mean that participants are not tricked into participating in a study that they would find objectionable.
- The research could not practicably be carried out without the waiver or alteration. Impracticable does not mean time consuming, expensive, or inconvenient. It means that securing consent is not feasible, regardless of cost and time. Impracticable may mean that without a waiver it would not be possible to answer the research question. Disclosing the purpose of the research may influence how subjects respond.
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation. This process often is referred to as debriefing. The debriefing process is an opportunity to provide subjects with information not disclosed during the initial consent process. It also provides an opportunity for subjects to withdraw and not have their identifiable data included in the research. Note: Debriefing is not required in situations in which debriefing would cause more harm than good, for example, if subject selection was based on an undesirable or unflattering characteristic.
Use of waivers:
Deception: Outright deception can sometimes be justified as essential for investigating a particular phenomenon. For example, subjects may be told that a study is about perception of visual phenomenon, when in fact it is about susceptibility to peer pressure from the researcher's confederates.
Complete Non-Disclosure: If people know that they are being observed, they may alter their behavior in such a way that obtaining meaningful results is not possible. Covert observation requires a waiver of all of the elements of consent if the research takes place in a setting in which subjects could reasonably expect that their behavior was not being observed and recorded.
Waivers of documentation:
Documentation of the consent process is not always required. Note, however, that waivers of documentation are not waivers of the consent process itself. For waivers of consent, see the criteria noted above.
Documentation may be waived under two circumstances:
- The principal risks are those associated with a breach of confidentiality concerning the participant's participation in the research, and the consent document is the only record linking the participant with the research (e.g., research about women who have left abusive partners, research on the black market capitalist economy in Cuba in which illicit vendors will be interviewed in a safe space). When the requirement for documentation is waived, the IRB still requires the researcher to offer the participants information about the study in writing.
- Study participation presents minimal risk of harm to the subject and the research involves no procedures requiring consent outside the context of participation in a research study, for example, a telephone survey.
Waivers of parental permission and child assent:
An IRB may waive the requirement to secure parental permission for children to take part in research, in accordance with the same criteria for waiving consent.
The regulations do not include a list of elements that must be included in a child assent process. It is up to an IRB to determine whether child assent is required, what elements must be included in the assent process, and whether the assent must be documented.
The online consent process typically includes either a) statement that submission of the online instrument indicates that the subject agrees to participate or b) radio buttons indicating consent or lack of consent.
The informed consent forms provided on the IRB website are templates that must be edited to reflect the needs of your own project. There are instructions to the researcher that should be deleted before submitting.
The minor assent forms that are posted on the IRB website are examples only and must be adjusted as necessary for your own project. They should not be used as is.
Compensation for research subjects is not a benefit of research. Rather, compensation is meant to offset the time and inconvenience of participation, as well as to serve as an incentive to participate. The federal regulations do not set limits on compensation to participants. However, both researchers and the IRB are tasked with ensuring that research subjects provide voluntary, informed consent that is free from coercion or undue influence.
Compensation that is excessive or inappropriate in relation to the research procedures is problematic for a number of reasons. It can induce subjects to participate against their better judgment. In addition, excessive compensation incentives can encourage some individuals to lie or to withhold information in order to participate in the study when they don’t meet the eligibility criteria. This impacts not only the integrity of the research and the validity of the data, but can also compromise the safety of subjects. Inappropriate compensation can also create coercive situations when given to third parties. For example, a parent may coerce or pressure their child into participating in a study when payment is significant.
All potential research participants – and, in the case of children, their parent/guardian – should be able to make informed decisions about participation based on the true risks and benefits of the research, not on compensation.
In this section, describe the compensation plan, including what subjects must do in order to qualify for compensation, as well as when and how subjects will be paid. For raffles, include the number of prizes, nature and value of each prize. For course or extra credit, describe the available alternatives to participation in the research. Please note that a viable alternative to course credit or extra credit must require a similar amount of time and effort as would participating in the research.
Risks: List the potential risks involved in your study. Time should almost always be listed as a risk. Other risks, including physical, emotional, social, etc., should be listed as well.
Describe the precautions you will take to avoid these risks, and assess their likelihood. If you have previous experience or training that you feel increases your ability to identify and respond to potential risks please describe it.
Personal benefits refer to direct or indirect benefits that participants will receive by participating in your study. If the benefits are hoped for or possible, they must be stated as such. Indicate if subjects are not expected to receive any benefits. Be realistic; benefits may relate directly to your subjects or only to society at large. Often, social and behavioral studies do not have any personal benefits.
PLEASE NOTE: Compensation is not a benefit and has already been addressed at this point in the proposal
Privacy is the control over the extent, timing and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. For example, persons may not want to be seen entering a place that might stigmatize them, such as a study on childhood abuse, clearly identified by signs on the research room. The evaluation of privacy also involves consideration of how the researcher accesses information from or about potential participants (e.g., recruitment process).
Confidentiality pertains to the treatment of information that an individual has disclosed. Maintaining confidentiality of information collected from research participants means that only the investigator(s) or individuals of the research team can identify the responses of individual subjects; however, the researchers must make every effort to prevent anyone outside of the project from connecting individual subjects with their responses.
Confidentiality vs. Anonymity "Confidentiality" means that the researcher will be able to connect the subject's responses to his or her identity, but that the information will not be released to anyone else. Keep your data anonymous if you can, but be sure to use these terms accurately. "Anonymity" means that no one, not even the researcher, will be able to connect the subject's responses to his or her identity.
Ways to Protect Confidentiality
The following are examples of practices that may be implemented to increase the level of confidentiality:
- Use study codes on data documents (e.g., completed questionnaire) instead of recording identifying information and keep a separate document that links the study code to subjects’ identifying information locked in a separate location and restrict access to this document (e.g., only allowing primary investigators access);
- Encrypt identifiable data;
- Remove face sheets containing identifiers (e.g., names and addresses) from survey instruments containing data after receiving from study participants;
- Properly dispose, destroy, or delete study data / documents;
- Limit access to identifiable information;
- Securely store data documents within locked locations; and/or
- Assign security codes to computerized records.
Anonymity of information collected from research participants means that either the project does not collect identifying information of individual subjects (e.g., name, address, e-mail address, etc.), or the project cannot link individual responses with participants’ identities. A study should not collect identifying information of research participants unless it is essential to the study protocol.
Examples of personal identifiers include name, e-mail address, phone number, ethnicity, age/birthdate, gender, birthdate, etc. If using pseudonyms or a numbering or coding system to keep track of participants, state that here.
If you are using pseudonyms or another coding system, explain how the master list will be protected. . It should not be stored with the rest of the data.
Be specific about where you will keep identifiable data, such as in a locked filing cabinet in your classroom or home office or on a password-protected computer.
If audio- or video- recordings are made, explain who will have access to them and if they will be used for educational purposes.
Researchers must retain all study records for a minimum of three years after research is concluded or otherwise terminated. This includes approved IRB documents, as well as case-report forms, tapes or transcripts, and all other data-collection instruments and source documents, and other records, including but not limited to records summarizing and publicizing research, and research files which are not the personal property of the researchers. The one exception to this rule is if you make an audio-recording for the purposes of transcription; in that case, you should delete it as soon as it is transcribed.
Additional standards from your discipline may also be applicable to your data storage plan. It is recommended that records of minors must be retained for seven years, or until all minors enrolled in the study reach the age of majority (18 in New York). If you are a student researcher, your faculty advisor may be able to store these materials. Please check with them.
Indicate any internal or external funding.
All possible attachments are listed below. See notes below each attachment for more information.
☐Recruitment notices, letters, e-mails, fliers, scripts, etc., if applicable
☐Form A—Informed consent document(s)
☐CITI certification for PI and all other parties, as needed
- CITI needed for PI(s) and research assistants who will be in direct contact with participants or their identifiable data.
- Please make sure your CITI training is updated and that you have taken any additional modules related to your specific proposal. You can view a list of additional modules here. All faculty research advisors must also have up-to-date CITI training.
- If you are a student, you must take the Students in Research additional module.
☐Any survey instruments, psychological tests, interview forms, interview protocols, etc.
- These should be included as attachments, not within the protocol form itself.
☐Written permission to use testing instrument (if testing instrument is not publically available)
☐Instructions to participants for use of instrument, if applicable
Forms C-J, if applicable:
☐C—Minor assent document, if applicable
☐D —Research Using Specialized Equipment
☐E—Research Involving Psychological Intervention
☐F—Research Involving Physiological Intervention
☐G—Research Involving Deception
☐Form H—Letter of Support from Outside Institution or Agency--must be on agency letterhead and include a signature from the agency administrator.
- If you are working through an institution or agency outside of the College at Brockport (such as a school), you must submit a scanned Form H on that agency's letterhead with an actual signature--not a typed signature--from the administrator in charge.
☐Copy of the letter, e-mail or verbal script used to solicit support from outside institution or agency--to clarify how the PI obtained support.
- To accompany Form H, you must submit the request you used to obtain support.
☐Form J—Student as Principal Investigator--mandatory for all student PIs; must signed by faculty advisor.
- Student proposals will not be accepted without a completed Form J.