INFORMED CONSENT

No investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or from the subject's legally authorized representatives (e.g. legal guardian or durable power of attorney for health care) if the IRB has approved the inclusion of subjects unable to consent on their own behalf. Exceptions must be approved by the IRB.

Investigators may seek consent only under circumstances that provide the prospective subject or his or her representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. Furthermore, the information must be written in language that is understandable to the subject or representative. The person obtaining consent must assess the capacity of the potential subject to give consent. If the subject appears to be cognitively impaired, the consent discussion should be postponed. If the impairment is not likely to resolve, the appropriateness of including the subject, or obtaining consent from a legally authorized representative must be evaluated. When a study targets a population, condition or situation where the likelihood exists that subjects will be impaired, the protocol should include a strategy to formally assess the subjects' capacity to give consent.

The consent process is expected to be conducted by an investigator. It is permissible to have other study personnel involved in the consent process, however if someone other than an investigator is to obtain consent, it should be specified in the protocol and approved by the IRB. The consent process involves assessing the subject's mental and physical state as to whether his/her ability to give consent might be compromised, explaining a study to the prospective subject, ensuring that the individual has understood the information, giving that person adequate opportunity to consider all options, responding to their questions, and obtaining the individual's voluntary consent to participate. To be effective, the consent process must provide an opportunity for the investigator (or designee approved by the IRB) and the individual to exchange information and ask questions--both at the time of recruitment and throughout that person's participation. It may involve the use of charts, models, video tapes and other audio visuals that may assist in communicating the procedures and processes that will be part of the study. For complex protocols, incorporation of diagrams and flow charts into the consent document itself is encouraged to improve the clarity and description of the research procedures and possible treatment assignments.

The consent document is a legal document containing sufficient information to allow the prospective research subject to make an informed decision about whether or not to participate in the research and ensures that adequate information is given to the subject in the process of obtaining consent. It is not intended to be a protection for the investigator and does not constitute any waiver of liability. Neither the consent process nor the consent document may involve the use of exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, sponsor, institution, or agents from liability for negligence. The signed consent document provides documentation of a subject's consent to participate in a study. When protected health information (PHI) is to be collected, used and/or disclosed in the course of the research study, the consent document will also contain a valid authorization, outlining the planned uses and disclosures of the PHI. For more information on valid authorizations, see http://research.uthscsa.edu/irb/hipaa.shtml

The IRB must approve all consent documents to be used. Approval must also be obtained from the IRB for each modification made in the form thereafter, before instituting the change. The version of the consent document being used should match exactly with the version given final IRB approval in the protocol file. The IRB will stamp and date each approved version of the consent document. The investigators are strongly encouraged to use the stamped and dated copies to assist them in assuring the appropriate version is in use.

While federal regulations have a provision for use of a short form, this approach is generally not permitted, except when a non-English speaking subject is to be enrolled without a complete consent form being available in the person's own language. See page 40 for details.

Guidelines for preparing a consent document follow.

REQUIRED ELEMENTS

Each of the following points must be covered in the consent document, except in cases where the point is irrelevant to the research:

A statement that the study involves research, an explanation of the purpose of the research and why the subject is asked to take part.
A description of procedures and identification of any procedures which are experimental. For example, the description of procedures should include the length and frequency of hospitalizations; number, frequency, and length of clinic visits; the total amount of time a subject should expect to devote to the study; names and types of medication; types and number of tests; amount of blood to be drawn; use of questionnaires; special diet; withholding of standard treatment; follow-up studies; and randomization, use of placebo, double-blind, or cross-over methods. In the case of patient subjects, state clearly which procedures are experimental and which procedures would be performed for medical reasons if the patient were not a research subject.
A description of any reasonably foreseeable risks or discomforts to the subject, their frequency and severity. These may include drug side effects, hazards of procedures, withholding therapy of proven value, financial risk, loss of privacy, or possible detection of genetic predisposition to a disease. Indicate the estimated incidence in quantifiable terms. Describe what will be done to minimize risks, counteract side effects, and which side effects might be irreversible.
A description of any benefits to the subject or to others which may reasonably be expected from participation along with a disclaimer that the investigator cannot guarantee there will be any benefit derived from taking part in the study.
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. It is not necessary to provide a full account of the risks and benefits of standard alternative treatments in the consent document, unless the standard treatment is part of one of the study interventions. For example, if subjects are randomized between an experimental arm and the standard care arm, the subject must be told all the procedures, risks and benefits of both arms so that s/he may make an informed choice about participation in the study. It is important to note that in some cases, it may be appropriate to state that one reasonable alternative is to choose not to accept any therapy designed to produce cure or remission.
Describe the extent to which confidentiality of records identifying the subject will be maintained. FDA and sponsor inspection of records in studies involving drugs and devices should be explained. The means of disclosing information obtained during the study should be described, e.g., publication, entry in medical records, or transmission to another physician and assurance that publication will not lead to personal identification. These elements are part of a valid authorization. When a study will use, collect and/or disclose protected health information (health information associated with an identifier as defined in the HIPAA privacy rule), the investigator must obtain a valid authorization for use/disclosure of PHI from every subject. As a general rule, the valid authorization will be included in the consent document. Exceptions must be justified. The template for a UTHSCSA valid authorization is found at: http://research.uthscsa.edu/irb/hipaa.shtml.
If the investigators have or plan to obtain a Certificate of Confidentiality, this should be stated in the consent form, using the wording required by the agency issuing the Certificate. A Certificate of Confidentiality is an important tool to protect the privacy of research study participants. Use of Certificates of Confidentiality is encouraged by investigators working on sensitive biomedical, behavioral, clinical or other types of research. Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to participants. For more information, see http://grants1.nih.gov/grants/policy/coc/
An explanation that medical treatment is available if a research-related injury occurs with costs to be the responsibility of the research subject. However, if a company or agency sponsoring the research agrees to provide for additional treatment and/or monetary compensation for injuries and that agreement has been approved by the UTHSCSA legal counsel, this should be included in the consent document.
A statement about any costs for which the subject will be responsible and identification of any which are due solely to research. If the research activity will add substantially to the cost of patient care, state this clearly and specifically. It is important to explain to the subject/patient that they might have to pay more money for taking part in the study than they might pay for alternative treatments available and that their physician will discuss with them the costs of the treatment(s) offered through the study as compared to what other treatment might cost. The same applies when there is a disparity of costs between treatment arms (e.g. chemotherapy vs. bone marrow transplant) in the same study. Where applicable the subject should be informed that insurance carriers might not cover costs of research related procedures.
A statement of the amount of compensation to be paid to the subject for participation in the research, approximately when they will receive the compensation and the manner in which it will be pro-rated in the event the subject does not complete the study.
Identification including the full name(s) and 24-hour phone number(s) of the investigator(s) the subject may contact for answers to questions about the research and the research subject's rights, and whom to contact in the event the subject believes that he or she has sustained a research-related injury. The IRB generally requires that the consent document give the contact information for at least two persons who are clinically appropriate for the particular research. It also must include the Institutional Review Board as an agency prepared to answer questions about the patients' rights.
A statement that participation is voluntary, and that the subject may refuse to participate or may withdraw from the research at any time without penalty or loss of benefits to which the subject is otherwise entitled. When appropriate, subjects should be assured that they will still receive standard treatment if they decide not to participate or to withdraw. They should also be assured that a decision not to participate will not adversely prejudice future interactions with the institution; this is particularly important when a dependent relationship exists between subject and investigator, such as physician-patient, employer-employee, or faculty-student. If withdrawal may be dangerous to a subject (for example, abruptly stopping medication that should be tapered), the danger must be explained and the subject should be told not to withdraw without first discussing it with the investigator.

SPONSORSHIP DISCLOSURE AND DISCLOSURE OF FINANCIAL INTERESTS.

The consent forms should disclose to subjects that money is being paid by sponsors to conduct studies, so that subjects are aware that the research is not being conducted for purely altruistic reasons. As a local requirement, one of the following statements will be included in consent forms in studies that have funding. One statement is for funding by "for-profit" agencies and another for funding by "not for profit" agencies.

Non-profit: [Name of PI, with credentials, such as "John Doe, MD, PhD"] is conducting the study. [Name of Funding Agency], a non-profit agency that promotes scientific research, is funding this clinical study. This means that the [name of funding agency] is giving money to the [name the institution, such as "the University" or "the Cancer Therapy and Research Center"] so that the study doctor can conduct the study.

For profit: [Name of PI, with credentials, such as "John Doe, MD, PhD"] is conducting the study. [Name of Study Sponsor], a for-profit drug company, is funding this study. [If applicable add: This means that the (name of sponsor) designed the study and drafted the study plan.] [Name of sponsor] is giving money to [name the institution, such as "the University" or "the Cancer Therapy and Research Center"] so that the study doctor can conduct the study. [If the PI has a financial interest in the sponsoring entity, a statement of such should be added here. For example: Dr. Doe has a financial interest in the sponsoring company or Dr. Doe owns stock in the sponsoring company]

OPTIONAL ELEMENTS

The following additional elements of informed consent should be included when appropriate:

A statement that the particular treatment or procedures may involve risks to the subject (or to the fetus, if the subject is or could become pregnant) which are currently unforeseeable.
Anticipated circumstances under which the subject's taking part may be terminated by the investigator.
Any additional costs to the subject that may result from participation in the research.
A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue to take part will be provided to the subject.
A statement that the investigational drug or device may not be available after the study period.
A description of any plan to bank biological specimens or perform genetic analyses, including potential risks. (See Special Considerations, page 37.)
When the study is subject to FDA regulations or to the Good Clinical Practices Guidelines, it is necessary to state the number of subjects who will participate in the study. The statement must be an objective statement of fact, such as `A total of X# of subjects will take part in this study.' Statements like `You will be one of X# of subjects...' or `This pivotal study will include X# of subjects from the United States and X# of countries.` are not permitted.

FORMAT

Language. The consent document should be worded in first person active tense (i.e. we are asking you to take part...we will draw blood, etc.) and written in the language that the subject (or subject's representative) understands, using terminology simple enough for a sixth grade student. The tone of the consent must not be coercive. Examples of adequately detailed, stylistically acceptable consent documents are in the IRB Forms.

In general, consent documents prepared by research sponsors or investigators at other institutions are not acceptable because they reflect different institutional policies.

Two or More Consent Documents. It sometimes is necessary to use two or more consent documents when procedures are to be performed on subgroups of subjects or when reasons for subject selection differ. The most common example of this situation is studies which involve both patients and normal subjects or a treated and a control population. If there is more than one consent document, place a label in the upper right hand corner of page 1, or after the title, indicating the subject population to which each consent is addressed.

Technical Elements. At the top of the first page, the consent document should bear the title of the study, e.g., "Subject Consent to Take Part in a Study of...(give title of study)," and the name(s) of the institution(s) at which it is to be conducted. Pages should be numbered "1 of 4," "2 of 4," etc. At the end of the consent document there should be statements that the subject will be given a signed copy of the form to keep and that his/her signature means he or she has read the document and been given the chance to discuss it and ask questions. Spaces should be provided for: (a) the signature of the subject who consents to take part; or in the case of a minor, of the parent or guardian who consents on behalf of the subject and a line for the assent of the subject if age 7 or older; (b) the signature of an impartial individual who witnesses the subject's signature (see policy below); (c) the signature of the person who obtains consent . and (d) printing the name and title of the person who obtains consent and (e) a place for the date and time the consent is obtained, to be recorded by the subject. Please note that on VA consent forms (on form 110-1086), lines should be provided for the date signed to be recorded by every person signing the consent.

Witness policy: It is local policy to include the signature of a witness. Generally, the signature of the witness attests only to the signature of the subject. There are some occasions, however, in which the witness would be required to witness the entire consent process. The IRB may require this as an additional protection for subjects who are particularly vulnerable or when the risk involved in the research warrants it. In the case that the subject does not read and in cases when the IRB has approved the use of a "short form" consent document, FDA regulations and GCP Guidelines require a witness to attest to the consent process undertaken, not only to the signature of the subject. Please note, that the use of a short form consent is generally not permitted by this IRB.

The witness attesting to the signature of the subject needs to be someone not affiliated with the research; neither investigator or study personnel. "Study personnel" means persons involved in carrying out the particular research protocol for which the subject is signing the consent. In addition, it is preferred that the witness not be associated with the subject either so that s/he may be truly impartial. However, having a completely impartial witness is not always feasible and a family member or friend may serve as a witness if an impartial witness is not available. In some settings, securing the signature of any witness, impartial or otherwise, may not be feasible. This may occur in studies where subjects are enrolled in their homes, for example. The protocol should indicate that this is expected. If the IRB approves omitting the signature of a witness when none is available, when the situation occurs, "none available" will be written on the line for the witness' signature and the person obtaining consent will make a notation in the study record describing the situation.

Commercial Development. When the sponsor or investigators believe that the specimens collected during the research may be used for the development of marketable products, it is important to state this in the consent form and indicate whether there are plans to share the profits with the subjects. If there are no plans to share the profits with the subjects, the following wording is recommended: "It is possible that the experiments being done for this study, using the [specify type of specimens,such as blood or tissue] specimens or future experiments using the specimens, will discover or develop something that can be marketed and sold to make money. Anything that results from these research activities, whether it be information or products, will be owned solely by the investigators and the institution." If there are plans to share the profits, describe those plans. You CANNOT state that subjects waive any of their rights

SPECIAL CONSIDERATIONS

Biological Specimens. The protocol must include the various tests that will be done using the biological specimens collected in the course of a research study. Unless otherwise specified, biological specimens should be kept no longer than is necessary to accomplish the study objectives of the research for which they were collected. It is not permissible to informally or unofficially keep and reuse biological specimens for purposes that are beyond the scope of what was described in the consent document that covered the specimens' collection. When investigators wish to establish a specimen bank as a source of specimens for future, undefined research projects, a banking protocol needs to be established.

Banking or Saving Biological Specimens or Creation of Permanent Cell Lines for Future Use. When the research includes a plan to bank or save biological specimens for future use, the following must be addressed in the banking protocol and the consent form describing the banking of the specimens:

(i) provide an explanation regarding the purpose of obtaining the sample(s) and how they will be used in the immediate research effort; when samples will not be exhausted by the current research efforts, state whether the residual samples will be disposed of or stored and used in other future research; specify if cell lines will be established;

(ii) estimate for how long the sample will be used for the immediate research effort and if samples are to be saved for future research, for how long;
(iii) regarding future research, describe what is known about the type of research that will be done with the specimens and explain how it will be decided for what purpose the specimens will be used. (For example: Specimens will be used only for research related to prostate cancer, including genetic research. To decide how the specimens will be used, a committee will be formed that will have members with scientific expertise and non-scientific people from the community whose families have been affected by cancer. All research done with these specimens will also have approval from a committee called the Institutional Review Board, which reviews human research to be sure the people in the studies will be given adequate protection from the risks of the research.)
(iv) state who has control over the sample once it is stored in the laboratory (e.g. the investigator, a third party) and where there exists a possibility of something being developed of commercial value, whether the donor may share in the expected profits;
(v) describe how the subject's confidentiality and privacy will be safeguarded first in terms of how the physical samples and records will be handled in the lab and then how they will be handled when the research is presented or published;
(vi) state whether a subject would be able to withdraw his/her sample from further study and if so how;
(vii) state whether subject will be given any results of the research being done now and/or from future research done with their sample(s);
(viii) state whether there is any possibility of a third party (such as an employer or insurance company) gaining access to the results of any tests done using the samples; and
(ix) indicate whether the subject will be asked to consent to being contacted at a later date in order to ask for their permission for any secondary uses.

A separate protocol for each data or specimen bank should be opened and kept active for as long as the bank or repository exists. Each individual use of the data or specimens from the bank should have its own IRB approval.

Genetic research. Human genetic research involves the study of inherited human traits. Much of this research is aimed at identifying DNA mutations that can help cause specific health problems, developing methods of identifying those mutations in patients, and improving the interventions available to help patients address those problems. The identification of genetic mutations enables clinicians to predict the likelihood that persons will develop a given health problem in the future or pass on a health risk to their children. For many disorders, however, there will be a considerable time lag between the ability to determine the likelihood of disease and the ability to treat the disease. . DNA can be derived from many easily obtained biological specimens, so the risk associated with genetic research is NOT a physical risk. It is a social and psychological risk. Genetic information pertains to the most personal aspects of individuals' lives and may have implications for family members as well. The research protocol and the consent form must clearly state what type of information will be gained about the disease, its treatment, about the people who have the disease, about the individual tested, about their families and about their children. Subjects need to understand what the implications and what the potential consequences are of obtaining the information sought. A subject might very well want to be part of the laudable effort to discover the gene that may cause Alzheimers. However, it may never occur to that subject that if it is determined he/she has the Alzheimers' gene, it might mean that he/she would likely develop the disease. Furthermore, if the results of the genetic research somehow become part of the subject's medical record and the medical record is later reviewed by the health insurance company, and the insurer gives the information to the employer, it could jeopardize the subject's career and insurabililty. In pedigree studies, non-paternity and non-maternity may also be unexpectedly revealed, changing family relationships forever. Even when DNA is used in research without identifiers, some argue that DNA can never be truly anonymous since each person's DNA is unique, like a fingerprint. Researchers planning genetic research must address the potential risks to the subjects and their loved ones, state how confidentiality will be safeguarded, indicate how results will be handled, specify the disposition of the biological specimen once the immediate research project is complete and clearly state what information will or will not be shared with the subject. You are encouraged to seek guidance from the IRB office early in your planning.

Guardian Consent. Unless he/she is also a court appointed guardian or has durable power of attorney to consent for medical treatment (see IRB Forms), a "next-of-kin" usually cannot give consent for research on an adult subject (see discussion below). Consent for a child to take part in research must be obtained from a parent or legal guardian. Unless waived by the IRB, children who are capable of understanding their involvement in a study should be given the opportunity to assent to the research by signing the consent document in addition to their parents, having been informed of the nature of the project. Generally, age 7 is accepted as the age at which assent is sought. Emancipated minors (those under 18 years of age and married, or those for whom minority status has been court-removed) may consent on their own to take part in research. Although some minors may consent to certain types of medical treatment, there is no legal precedent that they, by themselves, may consent to take part in research.

Regarding enrollment of subjects who are incompetent, incapacitated, or otherwise cognitively impaired, Texas state law permits the adult next-of-kin to consent to medical treatment, including that given in the context of a research protocol. This is only permitted if the IRB finds that it is appropriate and that sufficient safeguards have been incorporated into the protocol to protect the subject. Generally, the board must consider: (i) whether there is a compelling reason to include incompetent individuals in the research (i.e. the research could not otherwise be completed due to inadequate numbers of eligible competent subjects; generally surrogate consent is reserved for evaluation of life saving measures which could not otherwise be tested); (ii) whether there is a favorable risk/benefit ratio (the research must be intended to benefit the individual subject and the probability of benefit is greater than the probability of harm); (iii) that under no circumstance will subjects be forced or coerced to participate; and (iv) that the subject's representatives will be well informed about the nature of the study and that their obligation is to try to determine what the subject would do if competent or if the subject's wishes cannot be determined, what they think is in the incompetent person's best interests. Information that would allow the Board to evaluate these criteria must be provided. In addition, for those studies approved by the IRB to enroll subjects by surrogate consent, there should be provisions for informing the subject immediately if he/she becomes competent and for obtaining the subject's signature to indicate he/she was informed about having been enrolled in the study. If the subject becomes competent and there are study activities to continue (such as follow up visits), the subject should also be asked whether or not he/she consents to continue in the study. A sample/standard signature block to accommodate this is found in the IRB Forms .

Assent. Adequate provisions must be made for soliciting the assent of children, when the children are capable of providing assent. The ages, maturity, and psychological state of the children involved should be taken into account. Generally, age 7 is accepted as the age children should give assent. If the procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, assent of the children is not a necessary condition for proceeding with the research. Regarding the involvement of adults who are mentally disabled, in addition to the consent of a legally authorized representative or guardian, the feelings and expressed wishes of the incompetent person should still be respected. Investigators should both inform the subject and solicit his/her assent to take part in the study.

Deception. The IRB recognizes that in some cases, informing the subject of the hypothesis being tested may result in a biased response. Under these circumstances, the nature of some studies requires that the full purpose not be revealed to a subject until the study has been completed. Such intentional withholding of information may be permitted if the subject is informed that this is the case and agrees. Plans for when and how complete information will be shared with the subject should be disclosed in the consent document.

Non-English Speaking Subjects If the research subject does not understand English sufficiently to be able to give informed consent, consent should be obtained in the language readily understood by the subject. Translations of consent documents should be available at the outset of a study if it is anticipated that non-English speaking subjects will be enrolled. (See IRB Forms for a Spanish language sample of the standard statements used in a consent document.)

Non-English speaking subjects may not be excluded from therapeutic studies, on the basis of language use if there is a possibility that they might benefit by participating in the study.

Enrollment of Non English-speaking subjects without an approved translation of the consent form A request to enroll a non English-speaking subject using an English consent form must be justified. Generally, such requests should be reserved for situations where the study offers a treatment not available outside of the study and a delay in enrollment would not be in the subject's best interest. This situation will be treated as a protocol deviation.

The request should be written unless the situation is emergent. The request must explain the reason it is not possible to have a translation of the consent prepared and approved prior to the subject's enrollment. State who will perform the verbal translation and obtain consent. Describe plans to have the written translation prepared giving approximate date it will be submitted to the IRB.

The procedure will require that a third party witness the translation of the consent. The subject will choose someone fluent in both languages to be present during the consent process while the written English consent is being verbally translated and explained in the language the subject speaks. Since the witness may become aware of private information shared between the subject and the study personnel in the course of the consent process, it is vital the subject be comfortable with the person witnessing the translation of the consent. A copy of the English consent document must be given to the person who witnesses the translation of the consent so that s/he may follow along during the translation. A copy of the English consent should be given to the subject to keep and a copy of the translated consent should be provided to the subject later, after the translation is approved.

In addition, a short form consent document, written in the subject's own language must be used to document the process and the persons involved in the process (contact the IRB office for a template of the short form document.) It will be signed by the subject, by the bilingual witness and by the person obtaining consent. The bilingual witness and the person obtaining consent will also sign a copy of the English consent document to keep on file with the short form (as part of the official study documentation of this subject's enrollment).

The witness is being asked to attest to the following:

that he/she witnessed the translation process,
that he/she received a copy of the English version of the consent and that the information given in the subject's preferred language, was an accurate representation of that provided in the English version,
whether it appeared the subject was given an opportunity to ask questions,
whether it appeared the subject understood the information provided and
whether the subject signed the document voluntarily.

Risk of Pregnancy. If women of childbearing potential are included in a study and there are risks to the woman or fetus should she become pregnant during the study, the consent document should describe what type of test will be done to determine whether the potential subject is pregnant, the need for contraceptive measures, and known risks of the research to a pregnant woman and/or fetus. If appropriate, the form should state recommendations about how a pregnancy should be managed and what follow-up would be recommended should the subject become pregnant while on study.

Inclusion of Pregnant Women. There has been a shift in the general approach to the inclusion of pregnant women. In the past, pregnant women were presumed to be excluded unless their inclusion could be justified. Now, federal policies state that research should be designed to include pregnant women, unless there is a reason pregnant women should be excluded. Special regulatory requirements continue to govern the participation of pregnant women in research [45 CFR 46 Subpart B; see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb]. When a study proposes to include pregnant women, investigators must submit the application for inclusion of pregnant women (see IRB Forms) Research involving women who are pregnant receives special attention because of women's additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus. Special attention is justified because of the involvement of a third party (the fetus) who may be affected but cannot give consent and the need to prevent harm or injury to the fetus. Further, the IRB must determine when the informed consent of the father of the fetus is required.

Screening Studies to Identify Eligible Subjects. If a procedure is to be performed solely for the purpose of identifying a population of research subjects, consent for the screening test and/or process is required. Often, it is appropriate for the screening to be presented in a separate consent document describing the screening procedure and stating that its purpose is to determine eligibility for participation in further studies. A separate consent document for the actual study would then be signed by individuals found to be eligible. In such situations, at the time the subject is enrolled for the screening procedures, the prospective subjects should be shown the document they will be asked to sign if they prove to meet the criteria for further study.

Emergency ID Card. In some drug or device studies, it is advisable for a subject to be given a card to carry in his or her wallet to be shown in the event of an emergency. An example of such a card is in the IRB Forms .

DISTRIBUTION AND STORAGE OF SIGNED CONSENT DOCUMENTS

A complete, signed copy of the consent document must be given to each subject. A copy with original signatures must be retained in the investigator's file for a minimum of six years after completion of the study (except in the case of the V.A. Hospital, where the original must be in the patient's hospital record and a copy kept in the investigator's file.) If the subject is a patient, a copy of the signed consent document must be placed in the subject's hospital or clinic record unless it would be inappropriate (would put the subject at additional risk) to do so.

GUIDELINES FOR SUBJECT CONSENT IN SURVEY RESEARCH

Survey research involving the use of self-administered questionnaires and telephone and face-to-face interviews generally places subjects (respondents) at minimal risk. In addition to possible inconvenience and disruption of normal routine, the risks can include possible legal risks, possible invasion of privacy , embarrassment, and other kinds of psychological discomfort. Such risks may become more than minimal when sensitive information (such as sexually transmitted diseases, AIDS, alcohol and drug abuse) is requested.

Self-Administered Questionnaires. An information sheet, which can be in the form of a cover letter, containing the following information should accompany a self-administered questionnaire:

An explanation of the purpose of the questionnaire
An explanation of how and/or why the subject was asked to participate
A statement of the amount of time the questionnaire will require
A description of any stresses associated with sensitive information elicited
A description of any benefits reasonably to be expected
An offer to answer any inquiries concerning the questionnaire with information as to whom to contact and how
An instruction that the subject is free to refuse to fill out the questionnaire or any of the individual questions
Information as to how and to what extent confidentiality will be maintained
If the study will involve PHI, include a valid authorization and submit an H-4 form requesting the authorization be valid without a signature and without giving the subject a signed copy.

In the instance that there will be no way of tracing respondents, return of the questionnaire to the investigator will be considered to be adequate informed consent provided the cover letter as described above, accompanied the questionnaire.

Telephone and Face-To-Face Interviews. Whenever possible, a letter containing the elements of consent in an information sheet should precede an interview to inform the subject of the impending interview. (See References for guidelines on recruitment of subjects.) The letter should contain the following information:

An explanation of the purpose of the interview and the kinds of questions to be asked
An explanation of how and/or why the subject was asked to participate in the study
A statement of the amount of time the interview will require
A description of any benefits reasonably to be expected
An instruction that the subject is free to discontinue the interview at any time without prejudice
An assurance of confidentiality
Information as to how and to what extent confidentiality will be maintained
If the study will involve PHI, include a valid authorization and submit an H-4 form requesting the authorization be valid without a signature and without giving the subject a signed copy.

At the beginning of the interview, the information contained in the letter should be told to the subject again by the interviewer.

Procedures for selection and training of interviewers should be described in the protocol. This should include the number of interviewers to be used, method(s) of recruitment, their familiarity with the community/population to be studied, the language in which the interview is to be conducted, and method of approaching subjects.

In the instance of telephone interviews, and assuming that the information sheet is part of the process, the oral consent of the interviewee to continue the interview will be considered to be informed consent.

In the instance of face to face interviews, the informed consent document should be in writing. Informed consent should be obtained prior to the interview. The signatures of the subject, the interviewer, and the person obtaining consent should be contained in the consent document. Like the letter and spoken introduction, the informed consent document should include the required elements of informed consent and a valid HIPAA compliant authorization if protected health information is being collected.

WAIVER OF REQUIREMENT OF SIGNED CONSENT (verbal consent)

The IRB may waive the requirement of obtaining documentation of (signed) consent (permitting verbal consent) in some circumstances, and may require instead that a written statement describing the research be given to the subject. Such a waiver may be given when one of the following conditions exist:

The only record linking the subject and the research would be the consent document and the principal risk would be 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.
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.

Submit a completed Form 2E, which is in the IRB Forms .

WAIVER OF REQUIREMENT TO OBTAIN CONSENT

In research that is not subject to FDA regulations, an IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in the DHHS regulations, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

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.

The application for a Waiver of the Requirement to Obtain Consent is in the IRB Forms. If PHI is to be collected as part of the research, a Waiver of Authorization would also be necessary. Guidance is in the References.

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INFORMED CONSENT