University at Buffalo - The State University of New York

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 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, enrolled subjects may need to be re-consented. Any new or revised documents that will be presented to subjects require HSIRB review and approval prior to use. They should be submitted to the HSIRB using the Amendment Form.

In general, informed consent must be documented unless the HSIRB has determined that it can be waived. For studies that involve FDA regulated products, investigators are responsible for adhering to any other FDA guidelines regarding documentation of consent that are applicable to the type of research being conducted including the dating of the consent document by the subject or the subject’s legally authorized representative (LAR).

The HSIRB requires that a minimum of 2 individuals be present when the document is being signed: (1) the subject, and (2) the person obtaining consent. Additional signatures (e.g, of a legally authorized representative (LAR), witness, interpreter, or for children - the parent/guardian), may be required by the stuby sponsor, the FDA, or the HSIRB depending on the nature of the research being conducted.

In general, the consent information will be presented to the potential subject (or LAR) by the investigator (or authorized designee). The subject or LAR should be given adequate opportunity to read the consent document and have any questions answered before being asked to sign the document.

In all cases, each signature line should be preceded by a sentence or two that explains what the person is attesting to.

A research subject must be legally able to give informed consent; otherwise, the consent of the subject’s LAR, on their behalf, may be accepted.

LAR consent for participation in a research study should be employed only to the extent that it is consistent with the intent of the DHHS and FDA human subject protections regulations and all other federal and state laws and regulations pertaining to protecting human subjects participating in research.

Federal regulations allow a “legally authorized representative” to give consent on behalf of a decisionally impaired adult subject, and defers to state law for the definition. New York law allows LAR permission, noting that a Legally Authorized Representative (LAR) is an individual or judicial or other body authorized to give permission on behalf of a prospective adult subject for the subject’s participation in the procedure(s) involved in the research. The role of the LAR is to assist the subject, as necessary, in understanding the research procedures and to ensure that the subject’s rights and welfare are protected.

LAR consent must be obtained in the same manner and extent as for adults with capacity (i.e., sufficient information provided to the representative, adequate understanding of the information by the representative, and voluntary agreement to enrollment on behalf of the subject).

The following are considered to qualify as LARs acting on behalf of decisionally impaired adults in New York State (listed in descending order of priority):

• A health care agent properly designated on a health care proxy form
• A court-appointed guardian or committee under the New York Surrogates Court Procedure Act Article 17-A
• The spouse
• An adult son or daughter
• A parent
• An adult brother or sister

When a person with priority on this list is not reasonably available, not willing to make a decision, or not competent to make a decision regarding research participation, the authority falls to the person of the next highest priority. Once identified, the identity of the surrogate will be documented in the research records.

Requirements for Documentation of LAR Consent

If consent is obtained in person, the LAR’s consent signature will be obtained as follows:

A minimum of 2 individuals MUST be present when the document is being signed: (1) the LAR and, (2) the person obtaining consent. Whenever possible, the subject should also be present during the consenting process and to provide assent.

• The LAR (REQUIRED), in his/her own handwriting, will sign and date the consent document
• The subject, whenever possible, in his/her own handwriting, will sign and date assent
• The person obtaining consent (REQUIRED), in his/her own handwriting, will then sign and date the consent document immediately after the LAR signs (while in the presence of the LAR and the subject). The person obtaining consent must either be the Principal Investigator (PI) or an individual who is “designated” by the PI to perform this function in his/her place. This individual must have completed HRPP training requirements and have adequate knowledge about the study to be able to answer questions posed by the subject or LAR. Persons who will obtain consent must be listed as “research staff” on the HS-1A Application Form.
• A witness: recommended but optional unless required by the study protocol, study sponsor, or the HSIRB. The witness, in his/her own handwriting, will sign and date the consent document, (while in the presence of the LAR, subject, and the person obtaining consent), and
• Time of Consent: Optional unless required by the study protocol, study sponsor, or the HSIRB. The time that consent was obtained should be included on the signature page next to the LAR’s date of signature:
• PI Signature: Optional unless required by the study protocol, study sponsor, or the HSIRB. The PI, in his/her own handwriting, will sign and date the document. If the PI’s signature only documents his/her acknowledgement or approval of the “designee” who conducted the consent interview, the PI may sign the document at a later time (i.e., the PI need not be present when other signatures are obtained. However, the PI should sign the document as soon as possible after consent takes place.)
• A signed and dated copy of the consent document(s) will be given to the LAR
• The “original” signed document along with any documentation of any assessments of cognitive capacity or assessments of the capacity to consent, identification of the authorized representative will be retained with study files in the repository stated in the current HS-1A Application Form

Assent by Decisionally Incapacitated Adult Subjects

When an adult subject is not capable of providing consent but is capable of providing assent, the research plan/protocol must describe adequate provisions for soliciting and documenting the assent of the subject in addition to obtaining the permission of the LAR.

Obtaining assent of decisionally impaired adult subjects is required unless specifically waived by the IRB. “Failure to object” is not considered to be assent and resistance to a research procedure in a non-verbal subject is an indication of the subject’s disapproval. For all research, the adult subject’s objection to participation will be honored (i.e., the subject will not be enrolled into the research, or will be withdrawn from the research if already enrolled).

For minimal risk studies, the IRB may waive the assent requirement under circumstances in which consent may be waived. The FDA has specific requirements in regard to when consent may be waived. The IRB may also waive the requirement for assent if it determines that it is not a necessary condition for protecting subjects because the capability of the subjects is so limited that they cannot reasonably be consulted (e.g., in coma or in an acute psychotic state). To the extent possible, and in consideration of the subject’s condition, the subject will be informed of the enrollment and the procedures involved.

On rare occasions, the federal regulations for human subjects research allow a waiver for the requirement for informed consent. There are also other instances where the HSIRB may determine that a waiver or a consent process that omits or modifies the essential elements of informed consent is possible. The HSIRB, not the investigator, will make this determination.

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

IRB policy and federal regulations generally require written documentation of informed consent. The requirement may be waived by the IRB if the research is not FDA regulated and:

• 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; or
• 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.

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 HSIRB.

IMPORTANT NOTE: 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 LAR) must be obtained whenever appropriate. The HSIRB must be provided with a written description of the information that will be provided to subjects. An HSIRB may require that an information statement be provided to subjects when the requirement for written documentation of informed consent is waived. An information statement must be approved by the HSIRB prior to use. The statement should essentially contain all elements of a consent document and may include the signature and date of the individual obtaining consent and the investigator's signature and date but will not include a signature line for the subject.

When children are involved as research subjects, a legally valid consent generally requires: (1) permission from one or both parents or the legal guardian, and (2) the assent of the child.

The permission and signature requirements are dependent upon the level of risk to the child balanced with any prospect of direct benefit to the child. The IRB makes the final determination regarding signature requirements for the permission document. If the research does not involve greater than minimal risk, or if it does involve greater than minimal risk but there is prospect of direct benefit to the child, the IRB may determine that the permission of one parent is sufficient. For research involving greater than minimal risk with no prospect of direct benefit, permission must be obtained from both parents. When the IRB determines that the permission of both parents is necessary, the permission of one parent is sufficient if one parent is deceased, unknown, incompetent, not reasonably available, or when one parent has legal responsibility for the care and custody of the child.

Permission by parents or guardians will be documented in a manner similar to that used to document informed consent for adults. In general, parental permission must be appropriately documented unless the IRB has determined that it can be waived. For studies that involve FDA regulated products, investigators are responsible for adhering to the FDA guidelines for the type of research being conducted.

The HSIRB requires that a minimum of 2 individuals be present when the document is being signed: (1) the parent or guardian, and (2) the person obtaining consent. Additional signatures (e.g., a witness or interpreter) may be required by the study sponsor, the FDA or the HSIRB depending on the nature of the research being conducted.

Signature Requirements

In general, the consent information will be presented to the parent/guardian by the investigator (or authorized designee). The parent/guardian should be given adequate opportunity to read the consent document and have any questions answered before it is signed.

All signature pages should include a line or two above the signature line to indicate what the person is attesting to.

The parental permission signature(s) should be obtained as follows:

A minimum of 2 individuals must be present when the document is being signed: (1) the parent or guardian, and (2) the person obtaining consent.

1. The parent (or guardian) (REQUIRED), in his/her own handwriting, will sign and date the consent document
2. Person obtaining consent (REQUIRED), in his/her own handwriting, will sign and date the document immediately after the parent/guardian (while in the presence of the parent/guardian). The person obtaining consent must either be the Principal Investigator (PI) or an individual who is “designated” by the PI to perform this function in his/her place. This individual must have completed UB HRPP training requirements and have adequate knowledge about the study to be able to answer questions posed by the subject. Persons who will obtain consent must be listed as “research staff” on the HS-1A Application Form.
3. A witness: Recommended but optional unless otherwise required by the FDA, study sponsor, or the HSIRB. A witness, in his/her own handwriting, will sign and date the document (while in the presence of the parent/guardian and person obtaining consent). In some cases, the witness will be present during the entire consenting process. In other cases the witness may only need to be present to witness the signature process. The attestation should indicate whether the witness was present during the consent process or whether he/she is only there to witness the signature process.
4. Time of Consent: Optional unless required by the study protocol, study sponsor, or the HSIRB. The time that consent was obtained should be included on the signature page next to the parent/guardian’s date of signature:
5. Principal Investigator (PI): Optional unless required by the study protocol, study sponsor, or the HSIRB. The PI, in his/her own handwriting, will sign and date the document. If the PI’s signature only documents his/her acknowledgement or approval of the “designee” who conducted the consent interview, the PI may sign the document at a later time (i.e., the PI need not be present when other signatures are obtained. However, the PI should sign the document as soon as possible after consent takes place.)

The parent/guardian should be given a signed and dated copy of the consent document unless the requirement to do so has been waived by the HSIRB.

Children who have not attained the age where they can grant consent for research and may participate in research provided that both parental permission and the child’s assent and are obtained. (Note: In therapeutic settings, parental permission overrules a child’s decision not to participate.)

The child’s agreement is documented with an “assent form,” a child-friendly document that outlines the essential information about the research. All children, 7-17 should be given an opportunity to assent. Information about the research study must be presented to children on their level taking into consideration age, maturity, and psychological state, so they can understand what is requested of them. The assent form should generally contain the following information:

• Title of the Study
• Who is conducting the study
• Explanation of why the child is being asked to participate in the study
• Why the study is being conducted
• Description, in simple terms, the procedures the child will undergo and for how long or how often, and whether it will hurt
• Explanation of any good things or bad things (risks/benefits) associated with the study
• Indication that it is up to the child whether or not s/he wants to participate and it’s okay to say no or to withdraw later if they change their mind.
• Indication that any questions the child has will be answered

For research with very young children who do not have the capacity to understand the research, parent’s permission only is typically needed or, when appropriate, a script may be read to them or a presentation made to the child for their verbal assent.

For children ages 7-13, two forms are generally advisable, the assent written for the child at the basic level and a more detailed Parental Permission form for the parent’s understanding and signature. The parental permission form must include all elements of an adult consent document. Having separate parental permission and assent forms helps to ensure that the child is free of parental influences and allowed to make their own decision about participation in research.

Although separate permission and assent documents are recommended, in some instances, for older adolescents between the ages of 14 and 17, a single form that both the child and parent(s) sign may be used. The consent document containing all the required elements would have a signature page that includes places for both the parent and the child’s signatures. While the information may be presented to both parent and child at the same time, signatures should be obtained separately to ensure that the child is free of parental influences and allowed to make their own decision about participation in research.

Statements on assent documents such as “your parent has agreed to allow you to take part in the research study” may not be used since this may imply parental pressure to participate.

The HSIRB will determine whether assent will be documented and the process used to document assent based on considerations such as the child’s age, maturity, and degree of literacy. If adolescents are involved in research where a consent document would be used for adult subjects, a similar form should be used to document the adolescent’s assent.

If young children are involved who are unable to read the assent form, documentation should take a form that is appropriate for the purpose of recording that assent took place.

When specific conditions are met, the HSIRB will determine if and when assent is to be a requirement of all, some, or none of the children in a study.

The Legally Authorized Representatives (LARs) for minors in New York State are listed in descending order of priority as follows:

• The parent or parents of the child
• The judicially-appointed guardian(s) of the child, if the guardian has been appointed and if medical decisions are within the scope of the guardianship
• In certain cases, the Commissioner of Social Service

(Source: New York Civil Liberties Union: Teenagers, Health Care & the Law)

In New York State, under very specific conditions, minors may provide their own consent. This includes emancipated minors (i.e., individuals who have not yet attained the age of legal competency as defined by state law, but have a legal status conferred upon them as if they had by virtue of assuming adult responsibilities such as self-support, marriage, or procreation).

When a child who was enrolled in research with parental/guardian permission subsequently reaches the legal age of consent to participate in the procedures involved in the ongoing research, the subject’s continued participation will be based on their status as an adult.

Unless the HSIRB determines that the requirement for obtaining informed consent can be waived, the investigator should seek and obtain the legally effective informed consent for the now-adult subject for any ongoing interactions or interventions with the subjects. The prior parental consent and child assent are not equivalent to legally effective informed consent for the now-adult subject.

The HSIRB has developed templates for written consent, permission, and assent documents that provide investigators with guidance in developing their forms. Use of the templates helps ensure that all required elements are included and facilitates IRB review of the document. Investigators are encouraged to use the most current HSIRB consent, permission, and assent templates that can be found on the HSIRB website: http://www.research.buffalo.edu/rsp/irb/hsirb/forms/default.cfm

While Investigators may utilize sample or draft consent documents developed by a sponsor or cooperative study group, the HSIRB has final authority regarding approval of the consent document that is presented to prospective study subjects for projects approved by the HSIRB.

If a study anticipates the enrollment of non-English speaking individuals, it should be clearly stated in the protocol.

For studies that anticipate enrolling research subjects who do not read or speak English, the investigator is responsible for providing a version of the entire consent document in a language that is understandable to them.

All non-English consent forms and any non-English recruitment tools, questionnaires, surveys, and any other study documents that provide information to the subject (or that the subject will complete), must be approved by the HSIRB before use. As with the consent document, translation of any other study documents should occur after the English version has received HSIRB approval. The investigator bears the responsibility of verifying the accuracy of the translation of the HSIRB approved documents. The protocol should specify the credentials of the translator to perform the translation.

The investigator is responsible for addressing any cultural norms that might affect the consent process. Information regarding how these issues will be addressed should be provided to HSIRB as part of the protocol at the time of review.

The following are consent procedures for non-English language subjects:

• In most cases, a witness must be present during consent procedures. In studies where the consent documents are in the subject’s native language and the individual obtaining consent is fluent in the subject’s native language, requirements for a witness will be determined on a case-by-case basis.
• An HSIRB-approved translated consent document shall be presented to the subject and/or to the subject’s LAR in the native language of the subject. An individual who is fluent in both English and the subject’s language may assist the person obtaining consent. When obtaining clinical consent, investigators should engage an appropriate “medical” translator to perform the consent process.
• Signature requirements for non-English consent documents:

A minimum of 2 individuals must be present when the document is being signed: (1) the subject or the subject’s LAR, and (2) the person obtaining consent.

• The subject or the subject’s LAR (REQUIRED), in his/her own handwriting, will sign and date the consent document
• The person obtaining consent (REQUIRED), in his/her own handwriting, will sign and date the document immediately after the subject/LAR (while in the presence of the subject/LAR). The person obtaining consent must either be the Principal Investigator (PI) or an individual who is “designated” by the PI to perform this function in his/her place. This individual must be able to speak in a language understandable by the subject/LAR (or an interpreter may be used – see below), have completed HRPP training requirements, and have adequate knowledge about the study to be able to answer questions posed by the subject/LAR. Persons who will obtain consent must be listed as “research staff” on the HS-1A Application Form.
• An interpreter: In situations where an interpreter is involved in the consent process, that individual must also sign the consent document, in his/her own handwriting. The interpreter may also serve as the witness. When an interpreter is used, the individual obtaining consent should document in the research records that consent was obtained using an interpreter. This documentation should include the name of the interpreter and a statement of the interpreter’s belief that the subject understood the study and the consent process prior to signing the consent document
• A witness: Recommended but optional unless otherwise required by the FDA, study sponsor, or the HSIRB. A witness, in his/her own handwriting, will sign and date the document (while in the presence of the subject/LAR and person obtaining consent). In some cases, the witness will be present during the entire consenting process. In other cases the witness may only need to be present to witness the signature process. The attestation should indicate whether the witness was present during the consent process or whether he/she is there only to witness the signature process
• Time of Consent: Optional unless required by the study protocol, study sponsor, or the HSIRB. The time that consent was obtained should be included on the signature page next to the parent/guardian’s date of signature:
• PI Signature: Optional unless required by the study protocol, study sponsor, or the HSIRB. If the PI’s signature only documents his/her acknowledgement or approval of the “designee” who conducted the consent interview, the PI may sign the document at a later time (i.e., the PI need not be present when other signatures are obtained. However, the PI should sign the document as soon as possible after consent takes place.)

The subject or subject’s LAR should be given a signed and dated copy of the consent document unless the requirement to do so has been waived by the HSIRB.

Other considerations for consent procedures for Non-English language subjects:

• An interpreter fluent in both English and the subject’s language should be available throughout the study to answer questions and ensure ongoing understanding.

The investigator is responsible for complying with both the UB IRB policies regarding foreign language consent as well as any interpretation and/or translator services policies that apply at the site/institution where the research will be conducted.

Use of Short Form Consent Documents

Whenever possible, subjects who do not speak English should be presented with a full consent document written in a language understandable to them. Although use of a short form consent is not typically advised, federal regulations permit oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally to the subject or the subject’s LAR) and a written summary of what is presented orally. The written summary must embody the basic and required additional elements of disclosure and be reviewed by the HSIRB for this specific purpose. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.

When this procedure is used with subjects who do not speak English:

• A witness must be present during consent procedures, and
• The oral presentation and the short form written document should be in a language understandable to the subject or the subject’s LAR, and
• The HSIRB-approved English language informed consent document may serve as the summary, and
• The witness should be fluent in both English and the language of the subject.

Short Form Signature Requirements: A minimum of 3 individuals MUST be present when the document is being signed: (1) the subject or the subject’s LAR, (2) the person obtaining consent and (3) a witness.

• The subject or the subject’s LAR (REQUIRED), in his/her own handwriting, will sign and date the short form document AND
• The person obtaining consent (REQUIRED), in his/her own handwriting, will sign and date (the summary (i.e., the English language informed consent document). The person obtaining consent must either be the Principal Investigator (PI) or an individual who is “designated” by the PI to perform this function in his/her place. This individual must be able to speak in a language understandable by the subject/LAR (alternatively, the person obtaining consent may be assisted by an interpreter), have completed HRPP training requirements, and have adequate knowledge about the study to be able to answer questions posed by the subject/LAR. Persons who will obtain consent must be listed as “research staff” on the HS-1A Application Form.
• A witness (REQUIRED): The short form document and the summary must be signed and dated by the witness, in his/her own handwriting, while in the presence of the subject/LAR and the person obtaining consent. When the person obtaining consent is assisted by an interpreter, the interpreter may serve as the witness.
• Time of Consent: Optional unless required by the study protocol, study sponsor, or the HSIRB. The time that consent was obtained should be included on the signature page next to the subject/LAR’s date of signature:
• PI Signature: Optional unless required by the study protocol, study sponsor, or the HSIRB. The PI, in his/her own handwriting, will sign and date the document. If the PI’s signature only documents his/her acknowledgement or approval of the “designee” who conducted the consent interview, the PI may sign the document at a later time (i.e., the PI need not be present when other signatures are obtained. However, the PI should sign the document as soon as possible after consent takes place.)

A signed and dated copy of the summary and short form must be given to the subject or the subject’s LAR.

For studies that involve FDA regulated products, investigators are responsible for adhering to any other FDA guidelines regarding documentation of consent that are applicable to the type of research being conducted including the dating of the consent document by the subject or the subject’s legally authorized representative.

The HSIRB must receive all foreign language versions of the short form document as a condition of approval.

If a study anticipates enrollment of illiterate persons, it should be clearly indicated in the protocol.

A person who speaks and understands English but does not read and write can be enrolled in a study as long as the person is competent and able to indicate consent by other means. The person must:

• Retain the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally, and
• Be able to communicate consent to study entry.

Consent procedures:

• A witness must be present during consent procedures, and
• The HSIRB approved, full description, English language consent document should be presented verbally to the subject. All of the subject’s questions shall be answered, and
• Consent will be documented as follows:

Signature requirements

A minimum of 3 individuals MUST be present when the document is being signed: (1) the subject or the subject’s LAR, (2) the person obtaining consent, and (3) a witness.

• The subject (REQUIRED), in his/her own handwriting, will sign the consent document. If the subject is unable to sign his/her name, it may be necessary for him/her to indicate consent by "making their mark" on the signature line, and
• The subject will date the document. If the subject is unable to date the document, the date field should be left blank (at the time of consent, the person obtaining consent will make a notation next to the subject signature “date” line indicating the reason for the omission – and will initial and date the note), and
• The person obtaining consent (REQUIRED), while in the presence of the subject and witness and in his/her own handwriting, will sign and date the consent document immediately after the subject signs or “makes his/her mark.” The person obtaining consent must either be the Principal Investigator (PI) or an individual who is “designated” by the PI to perform this function in his/her place. This individual must be able to speak in a language understandable by the subject (or an interpreter may assist in the consent process), have completed HRPP training requirements, and have adequate knowledge about the study to be able to answer questions posed by the subject. Persons who will obtain consent must be listed as “research staff” on the HS-1A Application Form, and
• The witness to the consent (REQUIRED), in his/her own handwriting, will sign and date the consent document, and
• PI Signature: Optional unless required by the study protocol, study sponsor, of the HSIRB. The PI, in his/her own handwriting, will sign and date the document. If the PI’s signature only documents his/her acknowledgement or approval of the “designee” who conducted the consent interview, the PI may sign the document at a later time (i.e., the PI need not be present when other signatures are obtained. However, the PI should sign the document as soon as possible after consent takes place.)
• A copy of the signed/dated consent document will be given to the subject, and
• It will be documented on the signature page of the consent document and in the research records how the subject communicated agreement to participate in the study. This documentation should include the name of the witness and a brief signed statement of the witness’s belief that the subject understood the study and the consent process, and
• The “original” signed and dated document will be retained in the stated repository

If a study anticipates enrollment of illiterate persons, it should be clearly indicated in the protocol.

If a study anticipates enrollment of physically incapacitated individuals, it should be clearly indicated in the protocol.

A person who can understand and comprehend the spoken or written word, but is physically unable to talk or write, can be entered into a study (without an LAR) if s/he has the ability to understand the concepts of the study and evaluate the risks and benefits of being in the study when it is explained, and is able to indicate consent to study entry by other means.

Consent requirements:

• A witness must be present during consent procedures, and
• Consent should be documented as follows:

A minimum of 3 individuals MUST be present when the document is being signed: (1) the subject, (2) the person obtaining consent, and (3) a witness.

• The subject (REQUIRED) will communicate voluntary agreement to participate in the study. The person obtaining consent will document on the signature page of the consent document how the subject communicated voluntary agreement to participate in the study
• The person obtaining consent (REQUIRED), while in the presence of the subject and the witness and in his/her own handwriting, will sign and date the consent document immediately after the subject indicates agreement to participate in the research. The person obtaining consent must either be the Principal Investigator (PI) or an individual who is “designated” by the PI to perform this function in his/her place. This individual must have completed HRPP training requirements and have adequate knowledge about the study to be able to answer questions posed by the subject. Persons who will obtain consent must be listed as “research staff” on the HS-1A Application Form.
• A witness to the consent (REQUIRED): The attestation of the witness must include a brief statement of the witnesses belief that the subject understood the study and the consent process. The witness, in his/her own handwriting, will sign and date the consent document, (while in the presence of the subject and the person obtaining consent), and
• Time of Consent (Optional unless required by the study protocol, study sponsor or the HSIRB): The time that consent was obtained should be included on the signature page next to the name of the subject.
• Principal Investigator (PI): Optional unless required by the study protocol, study sponsor, or the HSIRB. The PI, in his/her own handwriting, will sign and date the document. If the PI’s signature only documents his/her acknowledgement or approval of the “designee” who conducted the consent interview, the PI may sign the document at a later time (i.e., the PI need not be present when other signatures are obtained. However, the PI should sign the document as soon as possible after consent takes place.)
• A signed and dated copy of the consent document must be given to the subject
• The “original” signed and dated consent document must be retained with study files in the repository indicated on the current HS-1A Application Form.

If a study anticipates enrollment of decisionally impaired adults, it should be clearly indicated in the protocol.

The IRBs may consider for approval enrollment of decisionally impaired adults, with the permission of an LAR, into research that has:

• Minimal risk (regardless of the likelihood of benefit to the subject), or
• Greater than minimal risk research, if direct benefit to the subject is anticipated, or
• Greater than minimal risk research with no direct benefit to subjects, but potentially yielding knowledge about the subject’s disease/condition, however, the risk must be determined to present only a minor increase over minimal, or
• Greater than minimal risk research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of decisionally impaired adults

Capacity Assessment

In general, an adult subject is assumed to have the capacity to make an informed decision regarding participation as a research volunteer. In accordance with standard clinical procedures, a subject may be determined to lack capacity only if any of the following are determined to be deficient:

• The ability to understand and appreciate the nature and consequences of enrolling in research, including the benefits and risks, or
• The ability to understand the meaning of personal participation in the study, or
• The ability to reach and communicate an informed decision

Decisional impairment may be temporary, permanent, progressive, or fluctuating. The fact that a person has been determined to lack capacity to make other decisions (e.g., is deemed unable to make decisions regarding personal asset holdings) does not establish lack of capacity for making a decision about research participation, nor does a determination of a lack of capacity to make a research enrollment decision mean that the person lacks capacity to make any other decision.

In studies involving a subject population whose capacity is known to be impaired, or is highly likely to be impaired, the study protocol must describe adequate procedures for making and documenting this determination. The study protocol/design must include procedures for informing persons who are determined to have decisional impairment of that determination prior to enrollment in a study and have procedures to document that this has occurred. The study protocol must include procedures for informing subjects that they may be enrolled in the research only with permission of an LAR. Such information should be given to subjects in the presence of the LAR. Research study designs must include appropriate procedures for the continuing/periodic capacity assessment of decisionally impaired subjects and their continued willingness to participate.

Documentation of Consent - Legally Authorized Representatives (LARs) and Assent Requirements: See Legally Authorized Representatives – Section E3 above)

Consent of Adult Subjects Who Regain Capacity

Adequate provision must be made for soliciting the consent of each adult subject who is capable of giving consent. If an adult subject who has been enrolled in research by the permission of an LAR regains capacity during the course of participation, then consent must be obtained from that person before continuing research-related activities. Research study designs must include appropriate procedures for the continuing/periodic capacity assessment of decisionally impaired adult subjects.

Anticipated Loss of Decisional Capacity by Adult Subjects Enrolled In Research

In cases where adult subjects will be capable of providing consent to enroll but will likely lose that capacity as the study progresses (e.g., in progressive dementia research), the study protocol must make provision for the subject to designate a LAR upon enrollment or at the earliest appropriate time while the subject still has capacity. In these cases, the subjects should be asked to provide guidance to the LAR about the conditions under which the subject would and would not want to participate in the event of loss of capacity. Until the subject loses capacity, the designated representative is not empowered to make decisions about the subject’s participation in research.

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 choose not to consent for genetic substudy. In addition to all required elements of informed consent discussed earlier in this section, 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: Indiciate how the genetic sample is being collected, who will handle the sample, where the sample will be stored, how long 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

Consent requirements for pregnant women or fetuses prior to delivery include the following:

• The consent form must clearly explain the reasonably foreseeable impact of the research on the fetus, and
• Consent will be obtained from the appropriate individuals as follows:
• From the pregnant woman or her legally authorized representative if:
• The research holds out the prospect of direct benefit to the pregnant woman, or,
• The research holds out the prospect of a direct benefit both to the pregnant woman and the fetus; or
• The research does not hold out the prospect of direct benefit for the woman or the fetus, but the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means
• From the pregnant woman and the father if:
  • The research holds out the prospect of a direct benefit solely to the fetus unless the father is unavailable, incompetent, or temporary incapacitated, or the pregnancy resulted from rape or incest
  • The father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest. In cases where the father is not reasonably available, a statement to this effect must be signed by the mother.

Generally, for children who are pregnant, assent and permission are obtained in accord with the provisions of the DHHS 45 CFR 46 Subpart D: Protections for Children Involved as Participants.

Neonates of Uncertain Viability: After delivery, and until it has been ascertained whether or not a neonate is viable, a neonate may be not involved in research unless all of the following conditions are met:

• The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or
• The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research

Informed consent requirements:

• The consent form shall explain the reasonably foreseeable impact of the research on the neonate.
• Informed consent shall be obtained from either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, consent shall be obtained from either parent's legally authorized representative. If the pregnancy resulted from rape or incest, the father’s consent or that of his legally authorized representative need not be obtained.

Nonviable neonates: After delivery, a nonviable neonate may not be involved in research unless all of the following conditions are met:

• Vital functions of the neonate will not be artificially maintained
• The research will not terminate the heartbeat or respiration of the neonate
• There will be no added risk to the neonate resulting from the research
• The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means

Informed consent requirements:

• The informed consent of both parents of the neonate will be obtained. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent will suffice. If the pregnancy resulted from rape or incest the consent of the father is not needed.
• The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice

Viable Neonates: Viable neonates are considered to be children and will be treated as such under UB HRPP policy.

Students and employees that are asked to volunteer as human subjects in a researcher's study may feel some pressure to agree to participate, especially if the requesting researcher is their supervisor or instructor, or someone who might be in a position to influence their future. Students and employees may volunteer to participate out of a belief that doing so will place them in good favor with faculty (e.g., that participating will result in receiving better grades, recommendations, or employment.), or that failure to participate will negatively affect their relationship with their instructor or other superior.

The protocol should include provisions to ensure that students or other subordinates are not pressured, unduly influenced, or coerced to enroll or continue participation. In addition, provisions must be made to guard against the potential for compromised objectivity and to protect subjects’ confidentiality, as appropriate to the research being conducted.

The Investigator must provide assurance in the protocol that a student's experimental results, performance, or any confidential data will not be given to whomever is grading the student, except for stating whether the student participated or not unless the approved study design provides for this.

It is unacceptable to require participation in research for course credit. However, instructors who wish to involve students in simulations of human experimentation and course-assigned data collection for educational purposes only (as opposed to research purposes) may require such participation as part of the class requirements.

Students may earn extra course credit through participation in research if an instructor includes an alternative way to earn extra credit that requires equal or less time and effort. The HSIRB may require the investigator to include the available alternatives to participation in the consent document.