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Consent and Assent Guidelines According to Federal Regulations (45 CFR 46.116), 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 the subject's legally authorized representative. The written presentation of information in the consent form is used to document the basis for consent and for the subject's future reference. Remember that obtaining participant consent is a process. The consent form is merely the documentation of informed consent and does not, in and of itself, constitute informed consent. The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent. Consent must be given without coercion or undue influence. Confidentiality Provisions for confidentiality must be specified as well as a description of procedures for protecting privacy, including specific information regarding how data will be stored to ensure security and confidentiality. If data are to be in the form of audio/video tape recordings or photographs, procedures protecting confidentiality should be described. Be sure to describe to participants the steps used to preserve confidentiality. In the course of certain projects, confidentiality may not be absolute or perfect. This must be expressed to participants. There are some circumstances where research staff might be required by law to share information provided by participants. For example, if an interviewer has reason to believe a child or elderly person is being neglected or abused (or has been abused), the interviewer is required by Maryland state law to file a report with the appropriate agencies. Similarly, if a participant reports he/she has been abused in the past, the interviewer may also have to file a report. An interviewer may also find it necessary to warn an intended victim, notify police or seek hospital based treatment for a participant, if a participant threatens serious harm to him/herself of another person. An explanation in the consent form, in this section, must be provided in clear, non-jargon language. Maryland state abuse reporting guidelines may be found at: Child Protective Services - http://www.dhr.state.md.us/cps/report.htm Adult Protective Services - http://www.dhr.state.md.us/how/seradult/protect.htm
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project. Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Additional information and directives for Certificates of Confidentiality may be found at http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm AnonymityAn anonymous study means there is NO WAY ANYONE can tell if a person was a participant in the study and they cannot be identified by the information they give, (including the investigator). Even if data is coded, it can be de-coded and become identifiable. A confidential study means that while their identity potentially could be determined from the information they give, steps will be taken to insure that they will not be identified. Be sure to describe to participants the steps used to preserve confidentiality. A study cannot be both confidential and anonymous. If confidentiality/anonymity cannot be ensured, clearly state this under the "risk" section of the consent form. Consent Form Signatures Federal regulations at 45 CFR 46.117 require written informed consent, one that is approved by the IRB and signed by the participant or the participant's legal representative and the principal investigator. The originally signed and dated consent document (with the IRB approval stamp) is valid for the approved time period the subject participates in the research. Participants do not need to re-sign a consent form throughout the term of the protocol approval period. Only subjects who are new and added to the existing pool of participants must sign a consent form. Revisions to previously approved consent forms may occur during a project period due to changes in procedures or identification of serious or adverse events. These revisions must be documented using the protocol modification process or at the time of continuing renewal. In any event, all participants who had previously signed a consent form must be provided this new information with the option of remaining in the study. Click on the below to download: General instructions and helpful hints to create a consent form A blank informed consent document A sample parental permission (consent) form An addendum to a currently approved consent formConsent Forms Approved at Other Institutions Many human research protocols conducted at UMBC involve collaboration with researchers from other institutions. At times, UMBC faculty members, masters and/or dissertation students are listed as a co-investigator on a collaborative project, with that institution’s IRB reviewing and approving the research protocol. External IRB institutional approval is accepted by the UMBC IRB; however, while the faculty member or student is listed on the consent documents as a co-investigator, no information is provided to potential participants of whom to contact at UMBC in the event of asking questions or addressing issues or problems. The purpose of this addition will provide complete and full information to participants about who is involved with the study and whom to contact with questions and concerns. Investigators are reminded to add a statement to the Whom to Contact section of the consent documents such as “In addition, this study has been reviewed and approved by the UMBC Institutional Review Board (IRB). A representative of that Board, from the Human and Animal Research Protections Office, is available to discuss the review process or my rights as a research participant. Contact information of the Office is (410) 455-2737 or HARPO@umbc.edu.”
Documenting child assent Children are considered a vulnerable research population because their intellectual and emotional capacities are limited and they are legally incompetent to give valid consent. Special procedures and considerations are, therefore, required by the Federal regulations for the review of research involving children. "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd. In most cases, these are individuals under the age of 21 years. However, in the state of Maryland, individuals are adults and of legal age (released from parental authority), when one attains the age of 18 years. Minors are those individuals who have not attained the age of eighteen years (source: http://mlis.state.md.us/cgi-win/web_statutes.exe - section § 24). In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18. In cases where child abuse is an issue, the requirement for parental consent can be waived. Documentation of assent is required for participants between the ages 7 and 18 years of age unless the participant is incapable, either mentally or emotionally, of being reasonably consulted about participating. The assent form, submitted to the IRB for review, should include a simplified version of the elements of informed consent, such as an explanation, at a level appropriate to the child's age, maturity and condition, of the procedure(s) to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. The consent form (for parents/guardians) and assent form (for minors) must be prepared as two separate documents. (NOTE: Participants under the age of 18 will need to complete an Assent form; a separate parental consent form is required for these participants providing parental permission to participate) Click on the below to download: General instructions and sample to create an assent form
Waiver of Parental Permission A waiver of the requirement for parental permission if the research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), provided that an appropriate mechanism for protecting the children who will participate as subjects is substituted, and that the waiver is not otherwise inconsistent with federal or state law (45 C.F.R. 46.408(c)) . When requesting a waiver of written documentation of consent under 45 CFR 46.116, 45 CFR 46.117, or 45 CFR 46.408(c), a justification must be provided. The type of research will need to be minimal risk or less. Click on the below to download: General instructions and sample to create a waiver of parental permission form |
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Last updated 04/28/2008 |
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