The investigator’s description of the consent process in the application must provide sufficient information for the IRB to consider the following:

• The adequacy of the consent document or other forms of communication used to obtain consent in terms of content including the information to be communicated to the prospective participant, language to be used by those obtaining consent and language to be understood by the prospective participant.
• That the required elements of consent will be provided to each participant or a legally authorized representative in accordance with the regulations.
• Whether information in the consent document will be presented in a manner appropriate to the subject population, e.g., level of complexity or need for non-English translation. 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.
• Who will present the research information to the subject?
• Who will obtain consent from the subject?
• Who will provide consent or permission? 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.
• When consent will be obtained including if there is to be a waiting period between presenting information to the subject and obtaining consent
• Where and how consent will be obtained
• How documentation of consent will be accomplished, unless the requirement for documentation is waived. 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.
• Provision by investigators to inform enrolled subjects of any new information relating to the research that might affect their willingness to continue participation in the study
• That the consent process will not include exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s legal rights or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
• Any steps that need to be taken to minimize the possibility of coercion or undue influence so that the IRB can determine that these factors have been minimized
• Any special protections when a research study involves vulnerable populations as specified below and in the consent section of the website.

After consideration of the above, the IRB will determine that the investigator will obtain the legally effective consent of the participant or the participant’s legally authorized representative before approving the study.

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) including who will obtain informed consent, in what setting and when it will occur relative to the research procedures. Reference to informed consent documents, scripts (for use in telephone interviews), and/or information sheets (for use in mailed or internet surveys) 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 SBSIRB Checklist 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. children 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.

If participation will take place over an extended period of time (weeks, months, etc.), be sure to describe any provisions to reconsent participants and/or review previous agreements to participate. Also keep in mind that a participant’s ability to consent may change over time (e.g. a child may become an adult or a person may develop a cognitive impairment).

(Keep in mind that recruitment is the beginning of the consent process)

Note that the final versions of any recruitment materials (e.g. newspaper ads, flyers, website postings, etc.) must be approved by the IRB before they are used. The final version can be provided as an amendment and usually approved quickly using expedited procedures. However, a draft of any recruitment materials must be provided at the time of initial review when the final form is not yet available.

Study protocols often change during the course of a study. When the changes require revision of the consent document, the revised consent must be reviewed and approved by the IRB prior to use. Subjects enrolled in a research study should be kept informed of any new information relative to the study that might affect their decision to continue participation. Whenever possible, this information should be presented to them in written form and subjects should be asked to sign a copy of the notice/form indicating their receipt of the notice/form. When the new information requires a change to the consent document, the enrolled subject may need to be re-consented. Any new or revised documents that will be presented to subjects require IRB review and approval prior to use.

IRB policy and federal regulations [DHHS 45 CFR 46.11] generally require written documentation of informed consent but some situations such as phone, mailed or internet surveys may qualify for a waiver of documentation of consent as long as verbal consent (by either words or action) is obtained. The requirement may be waived by the IRB if the research is not FDA-regulated and:

• The 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. (Used for Survey Research); OR


• The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; (Typically used for research presenting significant legal or social risks where just being in the study presents a risk to participants (e.g. studies where the participants must be users of illegal drugs or a study of political attitudes in a country with a dictator)

If a principal investigator wishes a waiver of the requirement for a signed consent document and meets the requirements, he/she should request and provide justification for a waiver as part of a submission to the IRB.

Waiving the requirement for obtaining a signed consent form does not waive the requirement for informed consent. Subjects must be informed of the nature of the research, and their consent (or the consent of their legal representatives) must be obtained whenever appropriate. The IRB must be provided with a written description of the information that will be provided to subjects. The IRB may require the use of an IRB approved information statement when it waives the requirement for written documentation of informed consent. An information statement essentially contains all elements of a consent document and may include the signature and date of signature of the individual obtaining consent and the investigator's signature and date of signature, but does not include a signature line for the subject.

Situations where the consent process is completely waived or altered by not providing required elements are limited by the federal regulations. Under DHHS 45 CFR 46.116, the IRB may waive or alter the requirements for obtaining informed consent provided the IRB finds and documents that:

• The research is not FDA-regulated;
• The research involves no more than minimal risk to the subjects;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects;
• The research could not practicably be carried out without the waiver or alteration; and
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

OR

• The research is not FDA-regulated;
• The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
• The research could not practicably be carried out without the waiver or alteration

Requirements for Documentation of Consent When Some or All Elements of Consent are Waived

If only some elements of informed consent are waived, documentation of partial consent may still be required, depending on the type of study. If all elements of consent are waived, documentation of consent is also waived.

Common Situations Where Consent Can be Waived or Altered:

Most of the situations encountered by the SBSIRB where a waiver or alteration of consent may be granted fall into the categories in the chart below which provides the questions that must be answered on the SBSIRB Checklist and possible answers for each category. Feel free to use these words by tailoring them to fit your specific study when filling out the SBSIRB Checklist.

See Also Waiver of Consent

If deception is a part of the project or if participants are to be otherwise given feedback after participation (e.g. students in an RPG) provide a description of the debriefing/feedback process including when, where and how it will occur relative to their participation. References to any written information in appendices may be used where appropriate.

If participation will take place over an extended period of time (weeks, months, etc.), be sure to describe any provisions to reconsent participants and/or review previous agreements to participate. Also keep in mind that a participant’s ability to consent may change over time (e.g. a child may become an adult or a person may develop a cognitive impairment).

Children who have not attained the age where they can grant consent for research and may participate in research provided that both the child’s assent and parental permission are obtained.

General Information

Permission of Parents or Guardians

Legally Authorized Representative (LAR) for Children/Minors in New York State

Waiver of Parental Permission

Assent for Very Young Children

Assent for Adolescents

When a Child Reaches the Legal Age of Consent while Enrolled in a Study

Documenting Child Assent

Waiver of Child Assent

Minors Who May be Able to Give Legally Effective Informed Consent

Wards of the State

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.

Surveys, questionnaires, and interviews can be used for both research and non-research purposes, sometimes simultaneously. When the intent of any portion of the data collection is for contribution to generalizable knowledge, the IRB must prospectively review and approve the project. The study instruments used to collect the data must be submitted as a part of the written project documentation for the IRB to review and should be described in this section.

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.).

The intent of compensation to research subjects is for their time and inconvenience, not for the risk associated with their research participation. Excessive monetary or other incentives that would be interpreted as inappropriate, posing undue influence, or are coercive may not be offered. The terms of all forms of compensation, including the scheduling of the compensation, must be described in the protocol and the consent document. Subject compensation should not be considered as or referred to as a “benefit” of participation in the research.

Payments to subjects should generally be pro-rated and not be contingent upon the subject completing the entire study. Payments to subjects who withdraw from the study may be paid at the time they would have completed participation in the study (or completed a segment of the study) had they not withdrawn, unless doing so creates a coercive situation. Payment of a small incentive for study completion is acceptable providing that the incentive amount does not pose undue influence and is not coercive. The IRB will determine whether the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they might otherwise withdraw.

The amount and schedule of payments to subjects must be presented to the IRB for review and approval. The IRB will review the amount of payments and the proposed method of payment, including timing of payments, to assure that these factors do not pose undue influence and are not coercive. The IRB will also consider whether the potential subjects are adequately informed regarding the amount of and requirements for compensation.

Subjects may be compensated in a variety of ways including, but not limited to:

• Financial remuneration for participation-related expenses (e.g., travel, parking, or babysitters)
• Financial remuneration for participation-related time and inconvenience
• Merchandise (e.g., gifts, toys, or vouchers)
• Education credit(s)

Describe the type of compensation (monetary, class credit, etc.), if any, that subjects will receive for 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. 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). The alternative must not be any more difficult or time consuming (in the view of potential participants) than participation in the research study.

Privacy is defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

The right to privacy is highly valued in the United States and is secured by laws other than those for protecting research subjects including the Family Educational Rights and Privacy Act (FERPA) designed to protect the privacy of students’ educational records and the Health Insurance Portability and Accountability Act (HIPAA) protecting access to private health information. The IRB must evaluate if the research plan makes adequate provisions to protect the privacy interests of subjects before approving a project. IRB considerations with respect to privacy may include:

• Whether the research will involve observation or intrusion in situations where the subjects have a reasonable expectation of privacy
• The availability of alternative ways to do the research
• If privacy is to be invaded, whether the importance of the research justifies the intrusion and the provision for informing the subject of the invasion of privacy or justification for not doing so
• When investigators want to review existing records to select subjects for the project, how this will be accomplished

In general, identifiable information may not be obtained from private (non-public) records without the approval of the IRB and the informed consent of the subject. This includes activities intended to identify potential subjects who will later be approached to participate in research.

Describe how recruitment procedures adequately protect the privacy of participants. Describe any provisions for ensuring that data is collected in a manner that protects participants’ privacy. Protection of privacy is an issue during recruitment and data collection: it does not refer to how confidentiality is maintained once data is collected.

Confidentiality pertains to information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others.

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 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. The reporting requirements, according to local law (e.g., elder or child abuse), should be clearly stated in the confidentiality section of both the protocol and the consent documents. 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.

IRB considerations regarding adequate provision for protecting confidentiality of the data shall include, as appropriate, whether:

• The data can be collected anonymously
• The data will be stored in a secure area
• Electronic files will be coded or encrypted
• Subject identifiers will be destroyed as soon as possible
• Access to the data will be limited
• A Certificate of Confidentiality should be considered to protect the identify of subjects from subpoena (in research where information obtained about subjects might interest law enforcement or other government agencies)
• Disclosures to subjects about confidentiality are adequate and that the confidentiality of identifiable data will be maintained in accordance with agreement between investigators and participants.
• Documentation of consent should be waived in order to protect subject confidentiality
• Any combination of data presents the risk of subject identification

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:

• 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.
• 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.
• 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.
• 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.

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. Time frames relative to data collection for each of these steps should be provided. Make certain that all data is accounted for and that persons having access to the data are 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.

At minimum, all investigators must provide a “plan” for ensuring data integrity and safety monitoring for human subjects who are involved in the research. The level of detail in the plan should be based on the degree of risk to research subjects. Low risk studies, for example, may have simple plans. The plan may be included in the protocol or provided as an appendix to the protocol.

The IRB shall determine, that the protocol (or other documentation) includes adequate plans for monitoring the data collected, i.e., for analyzing the data during the collection process to enable the identification of problems regarding data integrity and reevaluation of risks to subjects to assure that they are no greater than initially predicted. The IRB will determine whether the DSMP is adequate for the nature, size, and complexity of the research protocol, the expected risks of the research and the type of population being studied. When a reviewer considers a DSMP to be inadequate, he/she shall indicate this concern either in writing as a part of his/her review or during the board’s discussion of the project at a board meeting.

Data and Safety Monitoring Board (DSMB): Data and Safety Monitoring Plans may fall anywhere along a continuum from monitoring by the principal investigator or group of investigators to the establishment of an independent Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC). When a DSMB is utilized, the IRB considers the DSMB’s findings in its determination regarding continuing approval of research.

Investigators must provide a “plan” for ensuring data integrity and safety monitoring for human subjects who are involved in the research. The level of detail in the plan should be based on the degree of risk to research subjects. Low risk studies, for example, may have simple plans.

The DSMP shall include information regarding:

• The type of data or events that will be monitored
• The frequency of review
• The individual(s) responsible for monitoring serious events and problems (SEPs) and the responsible party to whom such events or problems should be reported and the timeframe for reporting them

When applicable:

• Specific stopping rules or triggers used to determine when the study should be stopped or altered
• Procedures for communicating the outcome of DSMP reviews to the study sponsor, and others, when appropriate (the investigator provides this information to the IRB at the time of Continuing Review on the Application for Continuing Review).

The protocol 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.

The IRB shall identify potential risks to human subjects, both physical and non-physical, associated with the research project under review. Types of risks considered include:

Physical

Psychological

Social

Legal

Economic

Risk Associated with the Invasion of Privacy and Breaches of Confidentiality

Once risks have been identified, the IRB shall determine whether the research risks to subjects are no more than minimal risk or are greater than minimal risk. This determination is critical in the IRB’s review of any project. Further, DHHS regulations on research involving fetuses, pregnant women, prisoners, and children, strictly limit research that presents more than minimal risk. For such subjects, the IRB will consider “minimal risk” in the context of the population’s general conditions or disabilities.

The IRB considers whether risks identified in the protocol have been minimized to the extent possible. The IRB may identify additional risks and require that the investigator develop a plan to minimize those risks. The IRB will consider the range of risks described above in terms of their potential likelihood, frequency, magnitude, and duration as well as the adequacy of procedures to minimize those risks.

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 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 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 affect 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.

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.

There are currently no specific federal regulations to address the needs of this vulnerable population. UB IRB policy is to generally follow recommendations governing the conduct of research in children but allows the IRB to make the final determination on the appropriateness of involving decisionally impaired subjects.

Decisionally impaired persons are those who have a diminished capacity for judgment and reasoning due to developmental, psychiatric, organic, or other disorders that affect cognitive or emotional functions. Other individuals, who may be considered decisionally impaired, with limited decision-making ability, are individuals under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical disabilities. Decisional incapacity may be temporary, permanent, progressive, or fluctuating.

If it is anticipated that decisionally impaired subjects will be enrolled in a study, the IRB shall consider whether the investigator has provided adequate justification for the inclusion of those subjects and how adequate informed consent will be obtained. The IRB shall also consider provisions for assessment of the decision-making capacity of subjects who may require consent by the subject’s Legally Authorized Representative (LAR). The IRB may require an independent determination of the capacity of the subject.

In general, the IRB shall approve projects when the intended study population is decisionally impaired subjects only when:

• Such subjects comprise the only appropriate subject population.
• The research question focuses on an issue unique to subjects in this population.
• Research greater than minimal risk may be acceptable where the purpose is therapeutic with respect to the individual subjects and where the risk is commensurate with the degree of expected benefit.

For details regarding Informed Consent for the decisionally impaired, see the Informed Consent section of website.

When research will be conducted in schools, the IRB will consider whether protections required by two laws that apply to research in schools, the Family Educational Rights and Privacy Act (FERPA) and Protection of Pupil Rights Amendment (PPRA), are adequately met as described below:

FERPA defines the rights of students and parents concerning the reviewing, amending and disclosing educational records. Except under certain circumstances, FERPA requires that written permission must be obtained prior to disclosure of personally identifiable information from a student’s educational record. Researchers who wish to inspect student records must obtain parental permission if identifiers are linked to the data.

Survey research in schools is regulated under PPRA. This law states that surveys, questionnaires and instructional materials may be inspected by parents or guardians. The law further states that parental permission must be obtained to allow children to participate in a survey revealing certain types of information, e.g., mental and psychological problems, income, sexual behavior and attitudes, illegal behavior, political affiliations, and close family relationships.

Students, employees and other persons in subordinate positions or positions of lesser power or status provide a pool of easily accessible research subjects. IRBs will consider whether the autonomy and confidentiality of these individuals are adequately protected. IRB considerations may include:

• That incentives for participation do not present undue influence
• That subjects have the ability to decline participation
• That confidentiality is maintained for self-disclosures of a personal nature
• For students, if course credit is given for participation, that alternatives that are no more burdensome than the participation in research are available for receiving equal credit

The economically or educationally disadvantaged, homeless persons, the elderly, and members of particular minority groups, are only some of the additional populations that may require special protections in the research environment. When such groups are specifically targeted as research participants, the IRB will consider whether adequate safeguards are in place to protect subjects from risks unique to the population and that researchers do not use their position to unduly influence participation.

Many clinical research projects involve obtaining a sample of blood or tissue for genetic analysis. The storage of the sample, its coding, storage, transfer to others and means by which the results linked to that sample are disclosed are important issues and have consequences for patient privacy and confidentiality. The information, if disclosed, may cause discriminatory decisions regarding insurance or employment matters. In developing the informed consent for the use of genetic materials, it is important to clarify what samples are to be used, how these will be coded, a description of any disclosures of results, the duration of storage, and how the data will be secured.

A separate consent document is recommended for a genetic substudy. This will permit individuals to consent to participation in the main study but not consent for genetic substudy. In addition to all required elements of informed consent, the following are specific additional considerations that must be addressed in the consent document for studies collecting genetic information:

• Purpose of the study: The purpose of collecting the genetic information must be stated.
• Procedures: The procedures for how the genetic sample is being collected, who will handle the sample, where the sample will be stored, the duration the sample will be kept, and whether the subject may be contacted in the future about the sample must be stated.
• Risks and benefits: In addition to risks and benefits associated with the sample any potential risk associated with genetic information disclosure must be stated.
• Confidentiality of the patient information: The mechanisms that will be used to protect the confidentiality of the sample including plans to destroy the sample in the future must be included, and
• Commercialization: Subjects must be made aware of any potential for commercial benefit from results obtained with their sample. If so, it must be clearly stated that the subject will not be a recipient of any financial reward.
• Description of how samples will be coded: When describing the mechanisms used to protect the confidentiality of the samples/data, the proper terminology and/or description should be used to promote understanding and avoid confusion. There are a number of ways to code samples. The method selected depends upon the information being collected and the degree of confidentiality and security that will be provided. The following is terminology that is often used:
• Identified samples: These are labeled with personal identifiers such as name or SS number.
• Coded samples: These are labeled with a clinical trial subject number that can be traced or linked only by the investigator. The samples themselves do not carry any personal identifiers. The code is available only to the investigator or designated individuals
• De-identified samples: These are double-coded and labeled with a unique second number. The link between the clinical subject number and the unique sample number is maintained, but unknown to the investigators or patients
• Anonymized samples: These are double-coded and labeled with a unique second number, with the link between the second number and the unique second number being destroyed. These samples could not be traced back
• Anonymous samples: These never had any personal identifiers and the subject identity remains unknown. These usually come with population information such as the samples are from patients with type II diabetes -- but there is no individual clinical data

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
3. In addition to the requirements listed above, the IRB may further require the inclusion of any of the following:
1. A provision for subjects to be given a copy of the consent form, if the consent is written
2. The amount of compensation, and whether payment will be made incrementally or paid in full upon completion
3. When applicable, subjects should be informed that compensation of $600 or more paid to them within one calendar year is required to be reported to the IRS
4. Identification of the sponsor in sponsor-initiated studies
5. A disclosure statement if the Investigator is being directly compensated for conducting the study or has a significant financial conflict of interest
6. If subjects are being followed for survival, the consent form must indicate the investigator’s intent to do so
7. If blood samples will be drawn, information regarding the amount of blood that will be drawn.
8. If material such as a tumor tissue, bone marrow, blood, etc. will be turned into commercial product, subjects should also be informed that they may not benefit from the development of the commercial product

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.

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


• Information Sheet

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 - 4th Grade Assent Example


• 5th - 6th Grade Assent Example


• Adolescent Assent Example


• Parental Permission Example

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.

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.

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.

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.