MinerAlert
MinerAlert
Information in recruitment materials is often the earliest participant contact in the informed consent process. The IRB will evaluate all research protocols for equitable and non-discriminatory participant recruitment. The research justification to exclude specific groups may be considered if there is sufficient health, safety, scientific or ethical justification to warrant such an exclusion.
The PI must describe the proposed study population, number of participants to be enrolled, relevant inclusion and exclusion criteria, and recruitment procedures in their Research Protocol Application. All materials (email, flyer, social media post, contact script, etc.) used to recruit participants must be reviewed and approved by the IRB.
The IRB must review and approve the information contained in all advertisements that will be used to recruit participants for a specific research study and the mode of communication. Advertisements used to recruit research subjects should be limited to information that a potential participant would need to determine if they are eligible and interested in participating. More specifically, the advertisements should include information such as:
The advertisement should not contain:
Advertisements conforming to these guidelines may be approved for any advertising format, e.g., posted flyers, newspapers, internet advertisements, radio/television, slides shown prior to films at movie theaters. The IRB must review the final copy of printed advertisements to evaluate the relative size of font type used and other design cues and must review the script of the final audio or video taped advertisements.
When following FDA regulations, the IRB reviews advertising to ensure that sponsored trial studies do not offer a coupon good for a discount on the purchase price of a product when it is approved for marketing as compensation for trial participation.
To avoid multiple requests for IRB review and approval, investigators should specify in their original request all advertising formats that are anticipated. If a website is to be used to advertise for a research study, the website address must be identified to the IRB.
Some research requires a pre-screening process where potential participants are asked for personal and/or sensitive health information to determine if they are eligible for the study. Pre-screening questions are subject to IRB review. The IRB will be concerned with participant privacy and confidentiality protection, any offers or incentives, and other participant protection issues.
Researchers must describe in the research protocol how the informed consent process will be conducted, the setting in which it will occur, a description of the waiting period between informing the prospective participant and obtaining consent and methods in place to prevent undue influence on a potential participant to enroll in a study.
The requirement to obtain informed consent should be seen as not only a legal obligation, but also an ethical obligation. Obtaining informed consent is a process, not just a consent form. The research study will be thoroughly explained to the potential participant. Documentation of informed consent is accomplished using a consent form. Researchers are required to obtain legally effective informed consent from a potential participant or LAR prior to enrolling participants in a research activity. If the research involves children, a parent’s permission or child’s consent are required.
As part of the informed consent process, researchers are responsible for ensuring participants or LARs are given sufficient opportunity to consider whether to participate in the study and will seek to avoid coercion or undue influence. Information given to potential participants or LAR must be in a language that the participant or LAR understands. The potential participants or LAR must be provided with the information that a reasonable person would want to have to make an informed decision about whether to participate and an opportunity to discuss that information. Non-English-speaking participants must have information presented in a language they understand.
The consent process or consent form used to obtain and document consent will not include exculpatory language to cause participants to waive any of their legal rights. It also will not release, or appear to release, the researcher, sponsor, or institution or its agents from liability for negligence. Any consent form used to enroll participants in a research protocol must be reviewed and approved by an IRB prior to enrollment. The IRB may request to observe the informed consent process to ensure adequate consent when the research involves particularly vulnerable populations.
Researchers should be aware of the setting where consent is sought and how it may introduce a feeling of undue influence. For example, students in an educational setting may feel that refusal to participate will affect their grades. Prevention of these sorts of pressures should be addressed in research design as the process must always preserve the right to refuse participation.
The informed consent document must begin with a concise and focused presentation of key information that will assist a potential participant or LAR to understand the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
In all cases, consent forms must be consistent with state laws and federal regulations regarding content. The informed consent requirements stated in this manual are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed for informed consent to be legally effective.
The IRB requires disclosures of required elements of informed consent be provided to each participant or LAR in accordance with legal and regulatory requirements. The IRB will also consider whether additional disclosures are required for inclusion in the consent process.
It is expected that researchers will use one of the consent templates provided on the UTEP IRB forms page with required sections and verbiage for preparing consent forms. Other formats may be considered providing that all required elements and applicable additional elements are present.
Research-related consent forms must contain all the basic elements of informed consent regardless of the risk level of the study unless a request for waiver or alteration of some or all the elements is requested by the researcher and the waiver is approved by the IRB. The consent form template contains all the required elements of consent. In addition, the IRB requires that all consent forms be written in the second person, e.g., “You will be required to …” The following are the basic required elements (extracted from 45 CFR Part 46.116):
The following additional elements of informed consent must be added to the consent form when appropriate:
The IRB may require additional information.
The IRB must be aware of the person(s) who will be conducting the informed consent process. These faculty/staff members should be listed in the protocol and are the only personnel allowed to obtain consent. The IRB requires that research team members obtaining consent be appropriately trained in human subject research and be fully knowledgeable about the project and be able to answer questions that potential participants may ask regarding the project and/or procedures performed as a part of the project.
If potential participants are decision-impaired, informed consent must be obtained from a LAR. They should be told that their obligation is to try to determine what the participant would do if they were competent, or if the participant’s wishes cannot be determined, what they think is in the best interest of the decision-impaired participant. The IRB must approve the inclusion of decision-impaired participants.
The person obtaining consent is responsible for ensuring that research participants understand the research procedures and risks. Each participant or LAR must be provided with adequate time to read and review the consent form, in addition to being advised of the procedures, risks, potential benefit, alternatives to participation, etc. Failure of the participants to ask questions should not be construed as understanding on the part of the participants.
The IRB has the authority to observe the consent process at any time. Depending on the perceived risk of the research procedures, the IRB may wish to observe the consent process for that protocol. In these cases, the PI will be contacted and the time and place for observing the process will be scheduled.
Obtaining informed consent from participants must be accomplished prior to performing the research activity and using only an IRB-approved and stamped (for expedited and full board) consent form. Modifications/study amendments to an existing consent form must be submitted to the IRB and approved prior to implementation, at which time the revised consent form will be stamped and dated if appropriate.
Old versions of the consent should be discarded to prevent inadvertent use of an outdated consent form. Copies of the most recently approved consent form should be used until superseded by an amended consent form. New approval dates will not be stamped on consent forms unless the documents have been amended. If consent forms are amended, it is advised the researchers retain a copy of the original, expired consent form(s) for their records.
Researchers are reminded that, in long-term studies, the informed consent process is an ongoing process, and that does not end with the signing of the consent form. Participants should be kept aware of events that might affect their willingness to participate.
Participants who reach the age of majority while participating in a study must be consented as adults before participating in any further study activities.
The informed consent process and form must be in a language the participant understands. If a researcher anticipates or knows that there are non-English speaking potential participants who might be interested in enrolling in a study, the consent form must be translated. It will then have to be reviewed and approved by the IRB. A certified translator should conduct a translation of the consent form. If one is not available, the translation may be performed by someone who is fluent in the translated language. The PI must certify that it is an accurate translation.
Federal regulations require written documentation of consent unless the research meets the criteria for a waiver of documentation.
The person obtaining informed consent ensures that the participant or LAR has no further questions and agrees to participate in the research activity will then instruct the participant or LAR to sign and date the consent form in the appropriate spaces.
If the research is subject to ICH Good Clinical Practice (GCP), the researcher or designee conducting the consent interview must then sign and date the consent form in the appropriate spaces. It is customary practice that all people signing the consent form will do so at the conclusion of the consent process.
Each participant or LAR is given a copy of their signed consent form. The original consent form should be filed in a way to ensure immediate retrieval when required by auditing entities, e.g., FDA, IRB.
Potential participants in a research study that could directly benefit from that research should not be excluded solely based on their spoken language. Additionally, researchers are unable to obtain participant consent if the participant does not have a clear understanding of the consent document and does not have the ability to ask or receive answers to their questions. Participant comprehension and opportunity is important to informed, ethical and legal consent. To address these considerations, researchers will provide participants that do not understand English, a consent document written in a language they understand presented by one of the research team members that is fluent in both English and the participant’s language.
The IRB will review translated research documents for approval. Documents should be certified translations, but other translation methods may be considered if certifications are not available. Proposed translation procedures must be described in the protocol.
A short form consent researchers may use to inform potential participants of the research they are considered. The short form written consent document stating the elements of informed consent required by 45 CFR 46.117 and 21 CFR 50.27(b) may be presented orally to the subject or subject’s representative. The IRB must review and approve the short form as well as the certified translations used to summarize the discussion with the potential participant.
The following procedures for the use of a short form are:
Additionally, when following FDA regulations, the IRB must additionally require:
Studies that are minimal risk, and do not involve more than a survey may use a study information sheet. The IRB must review a written description of the information that will be provided to participants, via Information Sheet for approval. If required, the IRB encourages researchers to use the consent template, or a reformatted version, with the signature sections removed. Alternatively, for research involving brief surveys, a summarized paragraph may be utilized, once reviewed and approved by the IRB.
Researchers should request a waiver of the documentation of informed consent if they are not capturing an electronic signature.
When a PI proposes to conduct research utilizing adult participants who may not be able to personally execute legally effective informed consent by virtue of age, physical or mental impairment, or any other reason, the IRB shall review the project based on risk and benefit. This policy is not meant to imply that the requirement for documentation of consent is automatically waived. Rather, it applies to studies where third party or surrogate consent is obtained from a Legally Authorized Representative (LAR).
Federal regulations (45 CFR 46.408) require that, if research includes children, the children are allowed to provide their assent, and the parents or guardian are allowed to give permission unless the permission requirement may harm the child.
Obtaining informed consent from research participants or LAR is required for all research unless the IRB determines that the regulatory criteria for a waiver of informed consent or a waiver of documentation of consent is justified based on study specific criteria. The IRB will document its determination to approve a consent waiver in meeting minutes or reviewer comments.
The IRB may approve a consent procedure that does not include or alters some of the elements of informed consent or waives the requirement to obtain informed consent. 45 CFR 46.116(e) allows waivers or alteration for public benefit and service programs conducted by or subject to the approval of state or local officials. This does not apply to research that is regulated by the FDA.
45 CFR 46.116(f) allows a general waiver or alteration of consent. The IRB must find and document that:
This provision also applies to FDA regulated research.
45 CFR 46.116(g) allows an IRB to approve research in which an investigator will obtain information or biospecimens for the purposes of screening, recruiting, or determining eligibility without the informed consent of the prospective participant or LAR if either of the following conditions are met:
The IRB has the authority to waive the requirement for written documentation of informed consent. The IRB must review a written description of the information that will be provided to participants, via Information Sheet for approval. If required, the IRB encourages researchers to use the consent template, or a reformatted version, with the signature sections removed. Alternatively, for research involving brief surveys, a summarized paragraph may be utilized, once reviewed and approved by the IRB.
The IRB may waive the requirement for the researcher to obtain a signed consent form for some or all participants if it finds and documents any of the following 45 CFR 46.117 (c)(1):
Broad consent is an alternative consent process for use in the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research. To use broad consent, the study team, department, or biorepository responsible for the storage of the identifiable information or biospecimens are required to:
UTEP IRB is not considering the use of broad consent at this time as tracking requirements may be too burdensome. Because of this, Exempt categories 7 and 8 will not be utilized.
UTEP IRB continues to support participant permission for the collection and storage of identifiable private information or biospecimens for future secondary use through comprehensive IRB review and appropriate consent procedures.
For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms.
If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
Researchers may perform research where they collect or have access to Protected Health Information (PHI). Researchers must have an authorization signed by the participant to use or disclose PHI.
The authorization must contain statements adequate to place the individual on notice of:
The potential for information disclosed pursuant to the authorization to be subject to redisclosure by the recipient and no longer be protected.
The authorization must be written in plain language.
The individual must be given a copy of the signed authorization.
To use or disclose PHI without an authorization signed by the research participant, the researcher must obtain one of the following:
Researchers have the responsibility to inform subjects of any latest information that might affect subjects’ willingness to continue participation in the research. In these cases, an amended consent form, delineating the findings and the changes to research risks/benefits, must be reviewed and approved by the IRB. Subjects should then be briefed on the changes, asked if they wish to continue participation and signify their willingness to continue participation by signing the amended consent form. For minor changes to the consent form that will not change risk/benefit, re-consenting is not required.
The PI shall maintain, in a designated location, the original copy of all executed participant consent forms. The signed consent forms, along with all research-related files, are to be available for inspection by authorized officials of the University administration, the IRB, regulatory agencies, sponsors and, if applicable, the FDA or HHS. For non-FDA regulated studies, forms should be retained for at least three years after completion of the study. For FDA-regulated studies, all signed participant consent forms shall be retained by the PI for the appropriate period(s) specified below:
Should a PI or project director depart the University prior to the completion of an activity or less than the time specified above, the PI is responsible for initiating mutually satisfactory arrangements with their department and the University administration as to the disposition of executed participant consent documents.
The IRB issues approved consent forms as a portable document file (pdf) with an IRB stamp that includes the approved date, expiration date, and study number. Consent forms are re-stamped for study amendments or continuations to reflect new approved dates and, in the case of continuation, new expiration date.
Approved forms are available in the electronic protocol system.
UTEP students and staff have the same rights as any potential research participant.
Instructors have the responsibility of assigning grades that give them inherit power over students. This power relationship may cause some students to feel pressured to comply with an instructor’s request even when the instructor is not actually trying to pressure them. A student might worry that their grades will suffer if they do not participate in an instructor’s research project and feel pressure to participate.
Researchers are expected to minimize the potential for students to feel pressured to participate in their research project. One way to do that is by offering an equal amount of extra credit to students who decline to participate in the research but complete another assignment of equal complexity and time.
Another strategy is to design the study so that the instructor is blind to the participants until final grades are assigned. A separate researcher could run the study and keep identifying information from the instructor. If the study is designed this way, it is important that:
Researchers should avoid recruiting from their own courses because of the inherit potential for undue influence. If it is the only feasible way to run the study, researchers are expected to minimize the potential for students to feel pressured into participating.
If the research cannot be completed without recruiting students from a specific course that the researcher is an instructor for and has a reasonable chance of yielding benefits, then the researcher must minimize the potential for students to feel pressured into participating. For example, researching a teaching method that will be used in a specific course could only be done by recruiting students that are enrolled in that course.
A participant pool is a research resource used by some departments and schools in academic settings as a registry of individuals who are interested in participating in research and agree to be contacted for potential participation in a study. These volunteers are used in studies for that school or department.
Student participant pools provide researchers with a way to recruit student participants for their studies and acquaint students with the research process as subjects and researchers. The students are enrolled in departmental courses that provide credit for participation in one or more research projects. All participant pool research must be completely voluntary.
Departments may provide students with incentives (usually extra credit) to participate in the participant pool. Reimbursement for participation must not jeopardize participant confidentiality or anonymity and participant pools offering extra credit to participating students must provide alternative opportunities to earn the same extra credit for those not wishing to participate in the research. Alternatives should require an equivalent amount of time and effort to complete extra credit.
Student participant pools may include participants under 18 years of age. These participants require parental permission prior to their involvement in research unless those individuals are emancipated.
The student decides whether to participate in any study; instructors cannot mandate or require student participation. As stated above, instructors are strongly discouraged from recruiting subjects they directly supervise or recruiting students from their own courses. Participant pool requirements and procedures vary by department, so it is best for instructors to consult their department about specific guidelines and additional requirements.
The IRB will approve studies that have equitable participant recruitment. The determination is based on:
The IRB will evaluate all research applications to verify that investigators have equitable selection and recruitment of all research participants. The IRB also evaluates any special issues that may arise when recruiting vulnerable populations (pregnant women, prisoners, children, and decision-impaired adults). For research that is greater than minimal risk, the IRB ensures that sampling does not favor a class of participants solely based on availability, manipulability, or compromised positions. The IRB also requires that researchers include a diverse selection of participants when appropriate to the purpose of the research.
The amount and schedule of participant payments must be reviewed by the IRB. The amount, method, timing and disbursement of payments are reviewed to ensure that they are not coercive or impose undue influence on participants. Compensation may be monetary, provide course credit, or take the form of other incentives.
Proposals to the IRB must fully describe the plan for compensation for participants if compensation is to be offered. This includes the rationale behind amount, method, and terms of the compensation. The informed consent document will disclose all information about compensation, including the total amount, schedule, form of payment, and prorated amounts if the participant withdraws from the project.
Compensation is not considered a benefit to participants and will be stated separately from any description of benefits in the protocol and consent documents.
Recruitment materials may include information about compensation if it is not more prominent than other elements of the recruitment material.
Investigators should consider these guidelines:
Researchers need to determine whether their use of a drawing for a chance to win a prize constitutes a lottery. Lotteries are illegal because they are considered “gambling” under Texas Penal Code Chapter 47.
A "lottery" is defined as any scheme or procedure whereby one or more prizes are distributed by chance among persons who have paid or promised consideration for a chance to win anything of value, whether such scheme or procedure is called a pool, lottery, raffle, gift, gift enterprise, sale, policy game, or some other name (TPC Sec. 47.01).
Texas Attorney General opinion JC-0174 (2000) states, “if the ‘payment’ required of a lottery participant is not monetary in nature, then such a ‘payment’ needs to involve a ‘substantial expenditure of time and effort’ before it would constitute ‘consideration’ under the gambling law.”
Given the possible implications for researchers using drawings as a form of compensation or an incentive to participate in research, here is a framework for the acceptable use of drawings in human research at UTEP:
Payments to professionals in exchange for referrals or potential participants (finder’s fee) or payments designed to speed recruitment that are tied to the rate of recruitment (bonus payment) are generally associated with clinical trials and offered by the sponsor of the research. These practices can be seen as undue influence and border on unethical recruitment. The IRB prohibits the payment of finder’s fees and/or bonus payments of any kind.
Informed consent documents will alert potential participants if there are any additional costs to them while participating in the research. All potential participants will be fully informed of the nature and estimated extent of these costs when obtaining consent.
The possibility that research activities may invade the privacy of individuals or result in loss of confidentiality of their private information should always be of concern to researchers involved in human subject research. In some cases, the risks of serious harm resulting from loss of privacy or confidentiality may exceed the physical or other risks associated with the research activity. In addition, loss of privacy or confidentiality associated with a research activity can be considered a moral wrong and can provide cause for legal actions against the investigator and/or the institution. In this regard, as part of its review of research proposals and protocols, the University IRB considers several issues related to procedures to protect research participants’ privacy and confidentiality.
When the IRB considers whether a participant’s privacy is adequately and appropriately protected in a particular study, members might consider the following:
When researchers promise subjects that their responses and data will be confidential, all researchers (investigators, directors, transcribers, students, and staff) are required to prevent accidental and intentional breaches of confidentiality. All measures to assure confidentiality of data need to be understood by the entire research team before research is initiated and followed once research is initiated. Confidentiality procedures must be described in research applications. Research proposing projects that address sensitive, stigmatizing, or illegal subject matter must explicitly outline the steps they will take to ensure any information linking participants to the study is maintained in confidence. The requirement of signed consent forms is often waived in sensitive studies, if the consent document is the only written record linking participants to the project and a breach of confidentiality presents the principal risk of harm anticipated in that research. When the IRB considers whether participant confidentiality is adequately and appropriately protected in a particular study, members might consider the following:
Protected Health Information (PHI) is generally required to have the participant’s signed authorization. Even in circumstances where a waiver of the requirement for written documentation of informed consent must be approved by the IRB, a signed authorization from the research participant permitting the use and disclosure of their PHI may still be required. The requirement for written documentation authorizing use or disclosure of PHI may also be waived by the IRB under certain circumstances.
Confidentiality is best maintained by anonymous data collection. If the Privacy rule is more restrictive than the procedures described in the consent requirements, the more restrictive rule must be followed.
Certificates of Confidentiality (CoC) are issued by the NIH. Certificates protect participant privacy by withholding Personally Identifiable Information from anyone not related to the conduct of the research.
Information available on the NIH website at: http://grants.nih.gov/grants/policy/coc/index.htm.
Protection extends only to research activities of a sensitive nature where protection is necessary to achieve research objectives. Research may be considered sensitive if it involves collecting information:
The FDA, Centers for Disease Control and Prevention (CDC), Health Resources & Services Administration (HRSA), and Substance Abuse and Mental Health Services Administration (SAMHSA) issue their own CoC. Contact the funding agency for information.
Health related non-DHHS federally funded research and non-federally funded research may request a CoC using NIH’s online application system. The informed consent must be part of the request.
Protection from a Certificate of Confidentiality is not absolute. PIs may still voluntarily disclose child abuse, a participant threatening violence to self or others, or a communicable disease to appropriate authorities. This disclosure will be clearly stated in the consent form.
A Certificate of Confidentiality does not authorize the person to whom it is issued to refuse to reveal the name or other identifying characteristics of a research participant if:
The U.S. Attorney General is authorized to grant protection for research concerning drug abuse under the Controlled Substance Act. For more information, contact the Drug Enforcement Administration at 14501 I St., NW, Washington, DC 20537.
The PI is allowed to retain and analyze data collected from a participant who has withdrawn from the research or has been terminated by the PI. This use or analysis must fall within the scope described in the approved protocol and may include PII related to the participant.
PIs can choose to honor requests to destroy or exclude participant data if the research is not subject to FDA review. PIs are encouraged to contact the funding agency to ensure their requirements are met.
PIs will discuss the use or analysis of collected data if a participant chooses to withdraw, verbally or in the consent documents, during the enrolment process.
Research that employs deception should allow participants to withdraw at the time of debriefing.
The IRB oversees all human subjects research, including the use of human specimens for research purposes. Prospective collection of human specimens requires IRB approval. Secondary use of existing human specimens may be permitted in certain circumstances. Some types of secondary use require prior approval or confirmation of exempt status by the IRB. Researchers should contact IRB staff for assistance.