Social and Behavioral Sciences Institutional Review Board

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This page contains instructions for preparing the substantive portions of an application to the SBSIRB as well as links to samples of what others have done that can be downloaded and modified to fit your study. Although every submittal is judged on its own merits, these may be very helpful for getting started.

After using the materials here to prepare your protocol and other documents, you may want to use the SBSIRB Reviewer Checklist (Microsoft Word Adobe Acrobat) (adapted from Amdur and Bankert, Institutional Review Board Management and Function, Jones and Bartlett, 2002.) to evaluate your overall submittal. The reviewers use this list when reviewing submittals. We provide this information so that PIs can check over their project description and supporting documents before submitting them to the IRB.

If you are new to the IRB process, after using the Reviewer Checklist (Microsoft Word Adobe Acrobat) yourself, you may want to take advantage of our Preview Service for your project description and consent documents.

Table of Contents:

Protocol/Project Description Required Template

The format of these templates (Microsoft Word Adobe Acrobat) must be used as a template for project descriptions submitted to the SBSIRB. When this format is used the SBSIRB can more easily identify the important human research participant protection issues associated with a study. In most cases when all points and questions in this file are addressed, the project description contains all of the information that the SBSIRB needs to review the protocol and identify any further issues related to participation in the research. When items are not addressed, typically the protocol is not complete enough for review by the SBSIRB. If items are not addressed or are not readily identifiable, the submittal will be returned to the investigator by the SBSIRB administrative staff with a request that the format be followed and materials will not be sent for review until a submittal in the format of this template is received with complete statements addressing all points. For more information on the individual sections of a project description and downloadable examples that can be used to develop your own project description please see the materials below.

Recommendations and Examples

A project description provided to the SBSIRB needs to be focused on the issues surrounding research participants. Grant proposals, if applicable, are required to be submitted as supplementary but do not serve in place of an appropriate research protocol. At the heart of the research protocol are the sections devoted to participants and confidentiality. The majority of these two sections can be thought of in terms of a time line that describes the research team's interactions with participants and subsequently what the research team will do to ensure that the data obtained cannot be used to harm individual participants. These sections need to include descriptions of the recruitment procedures, consent process, data collection process, compensation procedures (if any), and confidentiality procedures to be followed for each research methodology employed.

While each protocol has its own unique characteristics based on the investigator's plan, the following main sections of a protocol (listed below) must be included in project descriptions submitted to the SBSIRB. These directions are color coded such that the blue sections give a discussion of issues related to a given section of the project description and the red sections give required elements of the sections that are also a part of the required template.

Title of Project

This title must be the same as the title on your application forms, any consent documents and recruitment materials. This title need not be the same as the title of any grant application(s) related to this protocol.

Purpose:

Issues
This will typically be the shortest section of your protocol. The purpose of the study must be clearly described and achievable given the scientific design. A full literature review is neither required nor desirable. Typically a short summary of the project goals is all that needs to be provided so that the SBSIRB can evaluate the scientific design of the procedures given in the rest of your protocol to determine if they are adequate to achieve your stated goals.
Instructions
Summarize the purpose of the study including the research questions and/or the hypotheses to be tested.

Participants:

Issues

The participant population must be described and justification given for the selection of this population for the research. Any restrictions on participation and appropriate screening procedures to ensure that the restrictions are maintained need to be explained. A number of issues related to the justice of selecting this population may be involved with this decision. It is typically best if the population chosen is representative of the whole population that may benefit from the research findings so that risks related to the study are born equally by all constituent groups that will potentially benefit from the research. One would not choose an experimental population composed completely of one ethnic group, for example, if society as a whole would stand to benefit from the findings. At the opposite end of this argument, one would appropriately restrict recruitment to students when the potential study findings were related to education of the students or if the study otherwise provided a direct benefit to the students that would not be provided to the population as a whole. The principle of Justice will be most heavily scrutinized when a vulnerable population (persons with disabilities, prisoners, subordinates, minors, etc.) is the target of the research.

Any previous or current interaction between the research team and potential participants must be stated so that the potential for undue influence can be evaluated by the IRB. When a previous relationship between a researcher and potential participants exists, there is a tendency for recruited individuals to choose to participate in the research project due to a sense of loyalty to or friendship with the investigator. Thus the participant is not truly making a decision to participate in a study freely that is based solely upon the merits of the research and the risks and benefits of participation. Violation of this principle can become much more difficult to avoid where any member of the research team is in a superior-subordinate relationship with potential participants such as when a teacher does research using his/her students as participants. Therefore, when this potential conflict exists, an investigator will need to justify why a non-subordinate population cannot be used in terms of the scientific design of the study (not merely convenience) and put in place safeguards to protect the subordinates from real and perceived coercive forces.

Instructions

Describe the population to be recruited for participation in the research (ex. The participants in this research are college students in the psychology 101 research participation group who have indicated that they have been in a dating relationship for at least two months). Give the reason that this subject population was chosen for this study (ex. This subject population was chosen because college students are typically involved with both short and long term relationships we wish to investigate).

If certain groups are to be excluded or restricted from participating, explain why and how. This may be for safety or scientific reasons. (ex. Persons under 21 will not be allowed to participate in this study because it deals with an age-restricted product. Each individual who arrives at the lab must produce a state issued photo id with their date of birth in order to participate. Individuals who need to wear glasses in order to read the words on the computer screen during the first part of the experiment will be excluded from participation in the second half of the project because the three-dimensional imaging glasses cannot be worn in conjunction with normal eyeglasses).

Describe any previous or current interaction between the investigator/research team and the participant population (ex. The investigator is currently a psychology 101 instructor) and the procedures put in place to ensure that there can be no real or perceived undue influence.

Recruitment:

Issues
The recruitment process or invitation to participate must be free of coercive factors. Methods of recruitment and participant selection (location, timing, personnel, screening, etc.) and their associated materials must be specified in the project description, appropriate for the study population, non-coercive and should not include even the appearance of undue influence. Participants must be free to decline to participate in research or an appropriate justification in terms of the research design (not merely investigator convenience) must be provided. Recruitment processes including location, timing, persons conducting the recruitment, screening processes and any materials to be used need to be provided. References to specific recruitment materials (scripts, flyers, advertisements, letters, etc.) that are to be used should be provided and these materials then need to be provided as appendices to the project description. When specific populations are to be selected for recruitment, the manner in which the investigator has obtained access to the population should be stated.
Instructions

Describe all potential recruitment processes including location, timing, persons conducting the recruitment, screening processes and any materials to be used. Use references to specific recruitment materials (scripts, flyers, advertisements, letters, etc.) that you provide as appendices to this project description.

When specific populations are to be selected for recruitment, describe how access to the participants or data has been obtained.

Consent Process:

Issues

The consent process (written, oral, implied, waived) must be completely described (including who will obtain informed consent, in what setting and when it will occur relative to the research procedures) and appropriate for the research methods of the study. Every protocol should refer to a signed consent document, an information sheet (for use in mailed or internet surveys), a consent script (for use in telephone interviews) and/or a waiver form as an appendix to the project description.

If participants are unable to give consent (e.g., children or mentally incompetent), the permission/assent process must be described and the associated documentation referred to as an appendix to the project description.

If a waiver or modification of the typical consent process of obtaining a signed consent document is requested, the waiver or modification must be justified in the project description both in terms of the regulatory information set out in the waiver of consent form and the methods used to collect the data for the study.

When participants do not have a sufficient command of the written English language, two consent documents, one in English and one translated from the English language consent document into the primary language of the participants, must be submitted to the SBSIRB. The identity and credentials (academic or practical) of the translator must be specified in the project description.

Instructions

Describe the method(s) of consent you plan on using for this study (Signed consent document, Waiver of signed consent where an information sheet is provided in lieu of a consent document, Verbal consent documented by a witness, Request that consent be waived). Reference to informed consent documents, scripts, information sheets and/or a waiver form contained in an appendix should be made.

If a signed consent document is not obtained, explain why the method used is justified for this specific study both in terms of the regulatory information set out in the waiver of consent form and the methods used to collect the data for this study.

Example: A waiver of signed consent documentation is requested for this study because research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. Furthermore, as this is a mailed survey and an information sheet will be provided to participants, the participants' rights are protected in that they are provided all of the elements of informed consent before participation and their consent to participate can be implied if they return a completed survey to the investigator using the envelope provided.
Describe the consent processes and procedures that potential participants will be guided through. Be sure to include a description of who will obtain informed consent (e.g., PI, RA, nurses, other key personnel), in what setting and when it will occur relative to the research procedures.
Example: Students will be given the informed consent document by the research team when they arrive at the lab for their appointment. When each participant is called for their turn to be interviewed, they will be brought to a private room and asked by the PI if they have any questions. After answering any questions the PI will then ask the participant to sign the consent document if they still wish to participate)
If participants cannot give a legally effective consent (ex. minors under the age of 18 in NY State, persons with cognitive impairments), address each of the above points in describing how legal permission and/or assent will be obtained. If English is not the primary language of potential participants, the identity and credentials (academic or practical) of the translator must be specified in the project description.

Research Procedures:

Issues

Enough Research procedure information (including training of study personnel, differentiation between research and standard care, plans to inform participants of research results, time that the participants will spend in the study) needs to be provided for the SBSIRB to determine that participants' safety will be ensured and risks minimized.

Any safeguards for vulnerable populations need to be described, appropriate for the study and adequate for protecting the participants.

Instructions
Describe specifically what the subjects will do (participate in an interview or focus group, fill out a survey, etc.) and/or how the data will be obtained. Be sure to include information on how long participation will last, who will collect the data or information, where the study data will be collected (ex. in the psychology lab, Mrs. Smith's 4th grade classroom at Roosevelt Elementary School or on the internet, etc.), the method of data collection (participant observation, survey collection, records review, etc.) and how data will be recorded (notes, video taping, etc.).

Compensation:

Issues
Procedures for compensating participants for their participation/time need to be described including any prorating system to be used for participants who start but do not complete participation in the study. Compensation values (monetary or otherwise) must be stated so that the SBSIRB can determine that the amounts and procedures used are not coercive. If an alternative method is available for the participants to earn the compensation, it must be stated in detail and should not be any more onerous (in the view of potential participants) than participation in the research study.
Instructions

Describe the type of compensation (monetary, class credit, etc.), if any, that subjects will receive for participation in the study. Be certain to explain any prorating system that will be used for participants who do not complete the study.

Details of any alternate methods for obtaining compensation along with the methods of presenting these options to potential participants must be given where participation in the research or an alternative process is required of the potential subjects (ex. When class credit is given for research, an alternative must be given to participation in the research project).

Confidentiality:

Issues

When sensitive emotional topics are not a part of a research procedure, the greatest risks involved in social and behavioral science research are often those associated with a breach of confidentiality. Risks to participant confidentiality are easily minimized by putting in place procedures to protect the identities of participants and separate data from identifiable information. Identifiable data should never be stored outside of a professional location such as an investigator's residence unless it can pose no risks to participants if an accidental breach of confidentiality occurs.

The nature of the provisions to protect the privacy and assure the confidentiality of the research participants including storage, coding procedures, destruction of and methods of dealing with identifiable records (tapes, pictures, etc.) must be described in the project description including the time period for which they will be kept, who will have access to them and how they will be de-identified and/or destroyed. If an identifiable record such as an audio or video tape is to be created, provisions for participants who do not wish to be taped but still participate in the project (if any) need to be stated. This should be consistent with the information presented to participants in the consent documents. The confidentiality section of a protocol should also state any cases where confidentiality may be purposefully breached by the researcher if there is a potential that the study may obtain information that must be reported to authorities or to avoid imminent danger to the participant or others. If data is obtained in a semi-confidential manner (Ex. when data is obtained in a focus group where confidentiality cannot be ensured by the researcher) specific procedures to caution participants regarding the fact that their responses are not entirely confidential should be included.

There is an important distinction that needs to be made with respect to confidentiality and anonymity at a number of different stages of the data collection and analysis. Making data anonymous at the earliest possible time minimizes the risks related to an accidental breach of confidentiality and the SBSIRB will always require that researchers use a method that minimizes this risk. Data that has not been made anonymous may require extra protections to be described in the project description if there is even a remote possibility that an accidental breach of confidentiality could result in harm to a participant in any way.

For any given method of data collection there are a number of ways that data can be recorded and it may be appropriate for your study to use any or all of the following methods:

  1. Information can be obtained anonymously so that once the researcher is in possession of it, no one (even the researcher) can ever tell where it came from. If this type of data collection will achieve the study objective, it should be used. An example of this type of data collection is a mailed survey where the participant returns the survey in an envelope provided by the researcher with no return address.
  2. Information can be obtained confidentially but recorded anonymously. In this case, only the researcher's memory can connect the data with a particular participant. An example of this type of data collection would be an interview process done in a private setting where the researcher meets with a participant but does not record any identifying information in the interview notes.
  3. Information can be obtained confidentially, recorded confidentially and later made anonymous. An example of this would be the use of an audiotape for recording an interview where, after the interview was completed, the researcher transcribes the tape and removes all identifiers in the written transcription. The tapes and any transcription notes with identifiers are then destroyed. A second example of this would be the use of a numeric code on a mailed survey that would be linked to the participants' identities through a master list retained by the PI so that subsequent mailings in a longitudinal study can be equated to the same individual. After the final mailing was sent out to participants, the master list could be destroyed thus making the data anonymous. In either of these cases, the project description needs to specify a time frame for destruction of the master list or tapes in order to make the data anonymous when it is no longer needed to conduct long term follow up or ensure participants' well being.
  4. Information can be obtained confidentially and recorded confidentially but will never be made anonymous. This type of data collection will seldom be accepted by the SBSIRB because data that is linked to an individual always poses a confidentiality risk and there is rarely compelling scientific reason for not minimizing this risk at some point in time. One notable exception might be in a clinical treatment protocol where the research data becomes a part of the participants' medical records. There may be other circumstances where this type of procedure could be acceptable but the burden of convincing the IRB rests with the investigator.
  5. Information can be obtained confidentially, recorded confidentially but will be presented with the identity of the participant revealed upon receiving permission of the participant to do so. Again, the SBSIRB does not usually accept this type of procedure because revealing the participant in publication along with their data usually puts them at risk. One notable exception to this is a situation where the research responses present no risk whatsoever to the participant and their participation requires the acknowledgment of the researcher (e.g. linguistic elicitation where the language of interest is spoken by very few persons).
Instructions

Describe how participants' data will be handled, indicating how the study data is obtained (anonymously, confidentially, or semi-confidentially or publicly), recorded by the investigator (anonymously, coded or identifiably), how it is later either coded and/or de-identified, and finally how and when it is to be destroyed or placed in a permanent repository. Make certain that all data is accounted for Persons having access to the data and the period of time relative to data collection that any records are to be kept must also be specified. This is especially important for identifiable records such as audio or video tapes.

Describe any additional procedures for protecting the confidentiality of the subjects' responses including if the PI has plans to obtain a certificate of confidentiality to keep data from being subpoenaed.

Risks:

Issues
An evaluation of the overall risk level should be stated as GREATER THAN MINIMAL or NO GREATER THAN MINIMAL and a justification for this assessment by the investigator given. All reasonable physical, psychological, social, legal, employment or other risks to participants need to be identified and stated in both the project description and the consent forms. A description of the minimization of these risks with appropriate safeguards should be given as well. This includes the description of procedures for the minimization of any risks associated with an accidental breach of confidentiality. Procedures used to monitor for and identify potential short and long-term adverse reactions to research interventions or questions asked of the participants need to be included along with a plan to minimize the harmful effects of any distress caused by participation through the immediate action of the person collecting data and/or contact of a more qualified individual for assistance in doing so. This description needs to be consistent with that in the consent forms so that participants may make an informed choice about participation in the research study.
Instructions

Overall Risk Level. Describe the level of risk to be encountered by subjects as GREATER THAN MINIMAL or NO GREATER THAN MINIMAL and justify this assessment.

Describe and evaluate the level (e.g. minimal or [slightly] greater than minimal) of any physical, psychological, social, legal, employment, loss of confidentiality or other risks for participants.

Risk Minimization: Discuss the efforts taken to minimize risks (if any) including any special training, education or skills that key study personnel possess or will obtain.

Adverse Events: Discuss potential adverse events (if any), procedures for dealing with adverse events and/or minimizing consequences of an adverse event.

Benefits:

Issues

Benefits of the research and the methods by which these benefits are maximized need to be identified in the project description. All research must have some potential benefit or else there is no reason to expose participants to the risks involved or ask them to volunteer their time to participate. The statements made here must be consistent with those made in the benefits section of your consent forms. Note that any compensation may not be listed as a benefit of the research but should be listed separately under compensation. Both direct and indirect benefits should be described.

Direct Benefits are obtained by the participants in research by virtue of their participation. One potential direct benefit of research that uses high school or college students as subjects may be to educate them about the process of behavioral research. If this is the case an appropriate written debriefing statement should be provided that will allow the student to further learn about the research process and topic. This debriefing statement should contain at least two references at an appropriate level that can be accessed by participants wanting to learn more about the project they just participated in.

Indirect Benefits are benefits that do not effect the participant in research but may help to further the understanding of the research topic so that others may benefit from the finding in the future. Typically in describing indirect benefits the likelihood of the research to yield generalizable knowledge should be discussed along with the reasons why it is worth exposing human participants to even minimal risks associated with the study.

Instructions
Describe any direct benefits to subjects along with any indirect benefits and how likely the study is to yield generalizable knowledge. A discussion of why it is worth exposing human participants to even minimal risks associated with the study should also be presented.

Deception:

Issues

When deception is employed in a research study, there are two added concerns First, a participant may feel that their trust in the research process has been abused and second, a researcher must be careful to ensure that subjects' individual freedom to choose to participate in the research as described in the consent document is not violated.

If deception is employed the procedures and nature of the deception must be described, the reason for the use of the deception justified, and an appropriate debriefing procedure given to minimize the risks associated with the deception. A discussion of whether the deceptive practice is likely to influence whether someone would consent to be in the study or it is solely a tool to prevent some sort of bias should be included. Also discuss whether a subject who found out about this deception, other than through the debriefing, would be likely to feel that their trust had been abused.

Typically a debriefing procedure should include a written debriefing statement to be given to the participants so that they can find further information on the topic and are informed about the details that were purposefully left out of the Informed Consent document as a part of the deception.

Instructions

If deception is a necessary aspect of the project, give a full explanation of the deception and justification for its use. Include an indication of the degree of deception (mild, moderate, severe), and a description of the debriefing process.

If no deception is involved in the research, simply state, "No deception is used in this research protocol."

Appendices:

Issues

Supplementary documentation (consent forms, screening instruments, survey/interview questions, data collection forms used by participants) must be included with the project description as appendices where applicable. Without these materials the IRB is unable to determine the risk level of a protocol and therefore cannot approve a project. If the first part of a study will lead to the development of later instruments to be used with participants, then this must be directly stated in the project description along with a statement that these materials will be submitted to the IRB as an amendment to this protocol or as a new study to be approved prior to their use with participants.

All parts of the protocol and any supplementary materials (consent forms, scripts, study instruments, etc.) must be consistent.

Instructions
Include all supplementary information (consent forms, screening instruments, survey/interview questions, data collection forms used by participants) as appendices and make sure that all portions of your submittal are consistent.

Examples of Protocol/Project Descriptions

The following examples of complete protocols including appendices are provided for investigators to browse and use for ideas in constructing their own protocols. While most of these examples have been adapted from actual protocols approved by the SBSIRB and present satisfactory methods for protecting human research participants for the research methodologies used and specific topics investigated, a research project by definition is unique and the SBSIRB evaluates every protocol on its own merits. Procedures that are acceptable in one case are sometimes not acceptable in another because of differences in the risks and benefits presented in a specific project.

Example Protocol #1 - This protocol example uses a survey in conjunction with the tracking of later academic record data. A signed consent document is utilized for both the survey and to obtain permission of the participants to release their records for this research. The project design also required that links between the participants and their survey responses were maintained until the data collection was completed. The method used here created a separate code to keep the identities of a participants unknown unless the key was also obtained in case confidentiality was accidentally breached.

Example Protocol #2 - This protocol example demonstrates the collection of a survey using multiple modes of distribution (paper, internet, etc) and multiple modes for responding to the survey (paper and e-mail). It uses an information sheet in place of a signed consent document after obtaining approval for a waiver of written documentation of informed consent. Depending on the mode of response, the survey is either anonymous or rendered anonymous at the earliest possible time.

Example Protocol #3 - This protocol is an example of a greater than minimal risk study. It deals with bereavement and coping after the recent death of a loved one. The PI includes extensive exclusion criteria, a possible adverse event response section, risk minimization section and an extensive list of referral resources should they be needed. The procedures section is also centered on the fact that subjects have a high likelihood of becoming disturbed, upset, or unhappy during data collection. It contains an appropriate informed consent document that explains all of the aforementioned issues in a manner appropriate to this type of study along with information sheets that are given to all subjects containing counseling referral information.

Example Protocol #4 - This study uses multiple methodologies with different participant groups (minor students, their parents, and their teachers) to achieve its goal. The protocol is a good example of how to structure a submittal when using more than one research methodology or more than one participant group. Methodology one includes observation, interviews and collection of school records. Methodology two is tutoring sessions done outside of school. This study is unique because the group of children being studied is in first grade. Young children often do not have the ability to read and comprehend an assent form, therefore the PI has elected to use a verbal assent form to ensure the children understand to the best of their ability the study they are participating in. The PI has included the assent script in place of a written form in this example. Their caregivers on the other hand should be able to read and understand a consent form. Therefore, both the parental permission form and the consent form for parents own participation in the interviews are separate written forms.

Informed Consent Document(s) or Study Information Sheet(s)

Providing for the informed consent of participants is a process whereby the research team gives the participants the information needed for deciding if they want to participate in a study and the participant then acknowledges that they are willing to be a part of the study. Sometimes more elaborate procedures are needed but typically this process can be achieved through the research team's review of a consent document with a potential participant, asking and answering of the participant's questions, and finally asking the participant to sign the document if they are willing to participate in the study.

In some cases, such as when an anonymous survey is distributed by mail or on the internet, obtaining a signed consent document is not feasible or would result in increasing risks to participants by breaking the anonymity of the study. In these cases, an Information Sheet that parallels a consent document but without a participant signature line should be provided to participants.

If a signed consent document will not be obtained from participants then a waiver of consent form must be filed with the application and the project description must justify the reason for doing so in terms of the category selected on the waiver form.

The following is the pertinent portion of the federal regulation 45 CFR 46 that should be used as a guide in preparing your informed consent documents. It specifies the following as requirements of informed consent documents:
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy, unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language, through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

  1. Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent, the following information shall be provided to each subject:
    1. statement that the study involves research, an explanation of the purposes of the research, and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
    2. description of any reasonably foreseeable risks or discomforts to the subject;
    3. description of any benefits to the subject or to others which may reasonably be expected from the research;
    4. disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
    5. statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
    6. For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained;
    7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
    8. statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled.
  2. Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
    1. statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable;
    2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
    3. Any additional costs to the subject that may result from participation in the research;
    4. The consequences of a subject's decision to withdraw from the research, and procedures for orderly termination of participation by the subject;
    5. statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject; and
    6. The approximate number of subjects involved in the study.

While it is impossible to anticipate all of the information necessary as part of an informed consent document for every study, the following template contains directions, formatting and sample language that can be tailored to fit your specific study. This template addresses all of the required and additional elements of informed consent specified by 45 CFR 46.116.
It can be used as a starting point for development of your own informed consent documents. Feel free to download this document and edit it to fit your needs. If you use any of these documents in designing your own consent forms, please combine them into one file along with your protocol and other materials before emailing them for review. Be sure to use your last name as the first part of the name of this file.

Consent Form Instructions Template - Microsoft Word Adobe Acrobat

Guidance on the topic of Obtaining Consent in Some Special Cases:

Fieldwork and Waiver of Informed Consent - html

Obtaining Consent for Telephone Screening and Surveys - html

Obtaining Consent for Mailed Surveys - html

Obtaining Consent and Release Forms from Subjects of Documentary Video/Films - html

Examples of Informed Consent Document(s) and Study Information Sheet(s)

The following document consists of three different consent document formats containing the exact same study information. Note that some of elements of informed consent can be omitted if they are not deemed appropriate for a particular study. Element b1 from the list above is therefore not a part of these documents. Feel free to download and use these as templates in developing your own consent documents, but for the most complete template the Consent Form Instructions Template above should be used. If you use any of these documents in designing your own consent forms, please combine them into one file along with your protocol and other materials before emailing them for review. Be sure to use your last name as the first part of the name of this file.

Consent Examples - Microsoft Word Adobe Acrobat

Information Sheet - Microsoft Word Adobe Acrobat

Minor Assent and Parental Permission

When minors (in New York State, persons under the age of 18) are involved as research participants, a legally valid consent to participate in research cannot be obtained by obtaining the signature of the participant alone. In most circumstances, both permission from one or both parents/legal guardians and the Assent of the minor must be obtained before the minor research participant can be enrolled. An age appropriate mechanism must also be used to obtain the assent of the minor. The SBSIRB typically requires that the forms for parental permission be separate from those that are used to obtain minor participant assent so that the child is free of parental influences to make their own decision about participation in research. This includes the use of larger fonts and simplified language in written consent documents and, for very young children, a script to be read to them and their verbal assent documented. The same principles can be applied to research involving persons who have cognitive impairments.

The examples below present a parental permission form as well as assent forms at varying grade levels for participation in a second phase of the project for which the Consent Examples above are provided. Note that the parental permission form for their child’s participation is completely separate from the parent’s own consent form for participation in the other portion of the study. Also, some elements of consent are appropriately omitted from the assent forms but the Parental Permission Form Example and Adolescent Assent Form contain all of the study appropriate elements of consent. Feel free to use these as templates in designing your own assent forms.

3rd Grade Assent Example - Microsoft Word Adobe Acrobat
4th Grade Assent Example - Microsoft Word Adobe Acrobat
5th Grade Assent Example - Microsoft Word Adobe Acrobat
Adolescent Assent Example - Microsoft Word Adobe Acrobat
Parental Permission Example - Microsoft Word Adobe Acrobat

Waiver of Consent Form and Justification in the Protocol

If a signed consent document will not be obtained from participants then a waiver of consent (Microsoft Word Adobe Acrobat ) form must be filed with the application and the project description must justify the reason for doing so in terms of the category selected on the waiver form. Without both the waiver form and the justification in the protocol, the SBSIRB will not grant the waiver. The justification can be most easily achieved by citing specific reasons why each of the items checked off on the form are in fact the case for a specific protocol.

For further information on when a waiver of Consent, Assent or Parental Permission is appropriate see: Waiving Consent, Assent and Parental Permission to Participate in Research Involving Human Participants, a Behavioral Science Perspective. Microsoft Word Adobe Acrobat

Recruitment Materials

Procedures for the recruitment of research participants need to reflect the principle that research participants are free to participate or not participate in a study. To ensure that this is the case, the SBSIRB requires that each protocol spells out the recruitment process and that supplementary materials such as flyers, newspaper ads, letters, scripts to be read to potential participants and/or any other materials are provided along with the application. These materials may not be coercive and should reflect the voluntary nature of participation especially when recruitment is to be targeted to a specific group (e.g. college classes, specific community groups) and not the general population. The research component of the study should be emphasized over any compensation that individuals will receive.

Examples of Recruitment materials

To be added.

Debriefing or Feedback Materials

Like obtaining informed consent, debriefing is also a process that is not limited to providing participants with a sheet of paper for their reference but may need to involve a great deal more to ensure that risks to participants are minimized. Often, the provision of written debriefing materials to participants serves as a start to this process.

Debriefing or feedback materials can be provided to participants in almost every research protocol at the investigator's descretion but are required in the following cases:

  1. When sensitive psychological or emotional topics are the focus of the research. In this case the debriefing needs to provide the participants with information on where to turn if they are experiencing psychological difficulties that may have been intensified by participation in the research.
  2. When deception is employed. The written debriefing must in this case fully explain the deception and why it was necessary for carrying out the experiment.
  3. When students are specifically recruited as a part of a research protocol. In this case, the research purpose and its educational value to the students must be stated. If the research involves high school or college students, at least two full references on the research topic at an appropriate level must be provided for the students to further learn about the research they have just participated in.

Examples of Debriefing or Feedback Materials

The following sample debriefing was adapted from a study involving aspects of all three of the above elements (sensitive topic, deception, student participation). It can be downloaded but should be tailored to fit the specifics of your study. Microsoft Word Adobe Acrobat