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Institutional Review Board
Institutional Review Board
The Catholic Health Institutional Review Board (IRB) oversees all clinical trials conducted within a Catholic Health hospital by an affiliated individual or group to ensure that clinical trials are compliant with guidelines outlined by the Department of Health and Human Services National Institutes of Health Office for Protection from Research Risks and the Food and Drug Administration.
The following information is intended primarily for researchers wishing to conduct clinical trials at a Catholic Health facility; however, others may view this information as a commitment to our medical excellence with a tradition of caring.
2014 Meeting Dates
For more information or to answer any questions, please contact:
Catholic Health Institutional Review Board
Marian Professional Center, Suite 408
15 Abbott Road
Buffalo, NY 14220
Sponsored or Grant Supported Research
Please take note that in planning the timeline of your research, if your research study is commercially sponsored or grant supported, a complete financial analysis needs to take place prior to being placed on an IRB agenda.
IRB Submission Requirements
Click here to download Guidelines for IRB Submission (updated January 2014)
Along with a copy of entire protocol, consent form and updated CV, please submit the following completed forms:
Along with a clean copy of the consent document and an updated CV, please submit the following forms:
Along with a copy of entire protocol, consent form and updated CV, please submit the following completed forms:
The Committee shall review each proposed human research project to ensure that:
- Risks to subjects are minimized: (i) by using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from research (as distinguished from risks and benefits of the therapies that subjects would receive even if not participating in the research (for example, the possible effects of the research on public policy)) as among those research risks that fall within the purview of its responsibility.
- Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with and to the extent required by part 50.
- Informed consent will be appropriately documented, in accordance with and to the extent required by section 50.27.
- Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects.
- Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- The Committee shall review each informed consent to ensure that certain information is included and provided to each subject:
- All medical terms and complex sentences presented in simpler terms for the average layperson to understand.
- A statement that the study involves research.
- An explanation of the purposes of the research.
- The expected duration of the subject's participation.
- A description of any procedures which are experimental.
- A description of any unforeseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying that the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
- For reserach involving more than minimal risk, an explanation as to whether any compensation will be given and an explanation as to whether any medical treatments are available if injury occurs, and, if so, what they consist of, or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
- A statement that the participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- The following further information may be provided to subjects where appropriate:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is to become pregnant) which are currently unforeseeable.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
- Any additional costs to the subject that may result from participation in the research.
The consequences of a subject's decision to withdraw from the research and procedures for elderly termination of participation by the subject.
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
- The approximate number of subjects involved in the study.
- The Committee shall review any oral consent to ensure that certain information is included and provided to each subject:
- Oral consent must include a short written consent document form representing the original informed consent. This form may be read to the subject or the subject's legally authorized represenative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.
- The short written consent document must state the elements of the informed consent required by 21 CFR part 50.25.
- Only the short version of the informed consent is to be signed by the subject or legally authorized representative; therefore, there must be a line present for this signature.
- There must be a witness to the oral presentation; therefore, there must be a line for the witness to sign the short version informed consent.
- There must be a short written summary of what is to be said to the subject or representative.
- There must be a line for the witness to sign on the short written summary.
- There must be a line for the person obtaining the consent to sign on the short written summary.
- Both the short form and the summary indicate that the subject or the subject's legally authorized representative are to receive a copy.
- For new investigations, guidelines as to FDA and hospital policies and procedures need to be included in protocols and consent form.
- The process of obtaining informed consent and the documentation of informed consent must comply with the requirements of Protection of Human Subjects as outlined by the Department of Health and Human Services National Institutes of Health Office for Protection from Research Risks. The following comments may help in the development of an approach and proposed language by investigators for obtaining consent and its approval by IRBs:
- Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). The written presentation of information is used to document the basis for consent and for the subjects' future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process.
- Use of the first person (e.g., "I understand that...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject. Use of scientific jargon and legalese is not appropriate. Think of the document primarily as a teaching tool, not as a legal instrument.
- Describe the overall experience that will be encountered. Explain the research activity, how it is experimental (e.g., a new drug, extra tests, separate research records, or nonstandard means of management, such as flipping a coin for random assignment or other design issues). Inform the human subjects of the reasonably foreseeable harms, discomforts, inconvenience and risks that are associated with the research activity. If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform subjects as they are recontacted or newly contacted.
- Describe the benefits that subjects may reasonably expect to encounter. There may be none other than a sense of helping the public at large. If payment is given to defray the incurred expense for participation, it must not be coercive in amount or method of distribution.
- Describe any alternatives to participating in the research project. For example, in drug studies the medication(s) may be available through their family doctor or clinic without the need to volunteer for the research activity.
- The regulations insist that the subjects be told the extent to which their personally identifiable private information will be held in confidence. For example, some studies require disclosure of information to other parties. Some studies inherently are in need of a Certificate of Confidentiality which protects the investigator from involuntary release (e.g., subpoena) of the names or other identifying characteristics of research subjects. The IRB will determine the level of adequate requirements for confidentiality in light of its mandate to ensure minimization of risk and determination that the residual risks warrant involvement of subjects.
- If research-related injury (i.e. physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk (see 45 CFR 46.102[g]), an explanation must be given of whatever voluntary compensation and treatment will be provided. Note that the regulations do not limit injury to "physical injury." This is a common misinterpretation.
- The regulations prohibit waiving or appearing to waive any legal rights of subjects. Therefore, for example, consent language must be carefully selected that deals with what the institution is voluntarily willing to do under circumstances, such as providing for compensation beyond the provision of immediate or therapeutic intervention in response to a research-related injury. In short, subjects should not be given the impression that they have agreed to and are without recourse to seek satisfaction beyond the institution's voluntarily chosen limits.
- The regulations provide for the identification of contact persons who would be knowledgeable to answer questions of subjects about the research, rights as a research subject, and research-related injuries. These three areas must be explicitly stated and addressed in the consent process and documentation. Furthermore, a single person is not likely to be appropriate to answer questions in all areas. This is because of potential conflicts of interest or the appearance of such. Questions about the research are frequently best answered by the investigator(s). However, questions about the rights of research subjects or research-related injuries (where applicable) may best be referred to those not on the research team. These questions could be addressed to the IRB, and ombudsman, an ethics committee, or other informed administrative body. Therefore, each consent document can be expected to have at least two names with local telephone numbers for contacts to answer questions in these specified areas.
- The statement regarding voluntary participation and the right to withdraw at any time can be taken almost verbatim from the regulations (45 CFR 46.116[a]). It is important not to overlook the need to point out that no penalty or loss of benefits will occur as a result of both not participating or withdrawing at any time. It is equally important to alert potential subjects to any foreseeable consequences to them should they unilaterally withdraw while dependent on some intervention to maintain normal function.
- Don't forget to ensure provision for appropriate additional requirements which concern consent. Some of these requirements can be found in sections 46.116(b), 46.205(a)(2), 46.207(b), 46.208(b), 46.209(d), 46.305(a)(5-6), 46.408(c), and 46.409(b). The IRB may impose additional requirements that are not specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and local law.