Clinical trials ethics committee

If CECs are to be effective they must provide, and be seen to provide, support to health professionals dealing with difficult ethical issues, as well as others affected by such cases.

Having said that, however, the College also sees some potential role for patients, recommending p 40, R25 as follows:. The input of patients, and awareness of the patient's values, will need to be at the heart of the resolution of an ethical issue. Some committees may come to the conclusion that there are circumstances in which it is appropriate for a case to be referred by a patient, or for a patient to be present to participate in the discussion.

CECs will need to take these factors into account in the development of their referral procedure. With respect, it is difficult to see how patients' values can be at the heart of decisions if they are presumed rather than directly canvassed. This would seem to require patient involvement as an obligation, rather than an occasional event. What the preceding section seems to suggest is that there is uncertainty as to the role that CECs should play in respect of healthcare professionals and patients.

Indeed, it may be too simplistic to presume that ethics committees can perform a function for healthcare professionals as well as patients.

Thus the committee actually may not serve patients, but serve caregivers instead. Yet the patient may not realise that, and may rely on assurances that the committee serves her interests. This potential confusion of roles is of considerable importance. It cannot be presumed that the interests of medical professionals and patients will inevitably be the same, nor that the route to an ethical decision is the same from either perspective.

Committees in the UK have developed without, it appears, much attention being paid to this most fundamental of questions, yet surely an answer is needed? Whatever function these committees believe themselves to play—and this varies between committees 4 —they undoubtedly will have an impact on patients.

This is particularly so when they provide case consultation. As we have seen, there seems to be considerable personal and institutional support in the UK for the development of clinical ethics committees, similar to that which existed in the USA as these committees were developing.

Before this occurs, agreement on function, membership, method of working and the status of their decisions is absolutely vital. If they are only to be a talking shop for healthcare professionals, there is probably little chance of harm resulting from their deliberations, although if their deliberations are taken seriously, this of course could change.

If they attempt to venture into matters which have a legal component, they run the risk of significant error. Wolf argues that:. Ethics committees should remain advisory. Ethics committees also should not substitute for courts. Committees have neither the personnel nor expertise to adjudicate legal claims. Indeed, committees vary enormously in quality, are bound by no commonly accepted rules of reasoning or system of precedent, and in any case lack the necessary independence of a court.

Yet, as the US experience suggests, even if their deliberations are only given advisory status, the authority given to them, or gathered by them, can come to overtake concerns about the actual or likely quality of their advice.

The industry of ethics committees is in its relatively early days in the UK, and there is much that can be learnt from the experience of the USA in particular.

Although it is, of course, by no means certain that the UK will go down the same path that has been followed there, it would be surprising if the same questions did not need to be addressed.

Competing interests: None declared. National Center for Biotechnology Information , U. Journal List J Med Ethics v. J Med Ethics. Sheila A M McLean.

Author information Article notes Copyright and License information Disclaimer. This article has been cited by other articles in PMC. Short abstract As support for clinical ethics committees in the UK grows, care must be taken to define their function, membership and method of working and the status of their decisions. Keywords: clinical ethics committees. Slowther and Hope describe their development in this way: The first clinical ethics committees in the United Kingdom developed for a variety of local reasons.

To this extent we have sought to rise to the challenge posed by Slowther and colleagues in , when they wrote: Several of the CECs in the UK are not yet clear about their exact role in the institution and there are concerns about how effective the committees are What are clinical ethics committees for? In the USA, where such committees are more common, Hurst and colleagues identified the main reasons for doctors to seek ethics consultations as follows: to obtain needed help in deciding what to do to identify a practical way of doing what had already been decided should be done to implement a practical solution to obtain reassurance that the correct decision was being made better to face people who might otherwise think that the decision was inappropriate to seek consensus.

Annas, for example, has said: Setting up an additional bureaucratic entity called an ethics committee to make legal pronouncements can only make medicine more legalistic and impersonal.

However, the College also notes p 37, R6 that: In the absence of adequate, prospective studies and retrospective surveys of benefit, these recommendations regarding CECs should be regarded as provisional and subject to review in the light of further experience. Thus, it was realized that code of ethics for clinical research was needed and Good Clinical Practice GCP guidelines for human research was framed.

There is another face of research, where researchers did not hesitate in self-experimentation or experimenting on family members as subject for research. The Nobel laureate Gerhard Domagk — discovered prontosil sodium a sulfonamide and first tested it on his own 6-year-old daughter who had contracted a severe streptococcal infection from an unsterilized needle and Johann Jorg — swallowed 17 drugs in various doses to record their properties, are only two among many such instances.

Medical science is one discipline where the advancement of knowledge is hugely guided by research and humankind has benefitted from many experiments. However, benefit and risk are the two faces of the same coin. Ethics is pluralistic. There can be disagreement among individuals about what is right and what is wrong, and even when they agree, the reasons can be different. Nazi experimentations during World War II are the horrendous examples of atrocious acts where thousands of war prisoners were subjected to inhuman torture in the name of research and benefit to science.

This was the time when humankind realized that the whims and fancies of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code.

After the World War II, trial was conducted on 23 Nazi doctors and scientists at Nuremberg for the murder of concentration camp inmates who were used as research subjects. Among the 23, 15 were convicted. Seven were condemned to death by hanging, 8 received prison sentences from 10 years to life. The trial brought to light the tortures that were conducted, and in , the judgment culminated in the formulation of codes to guide research on humans, famously known as Nuremberg Code.

The code highlighted on the need for informed consent, prior animal work, qualified scientists, risk justification by anticipated benefits, avoidance of physical and mental suffering, death, or disabling injury. Some researchers, however, ignored the code and continued to exploit the faith of the patients.

In Willowbrook Hepatitis Study , children were deliberately infected with mild form of hepatitis, and consent was obtained from parents without informing about the hazards and giving the opportunity of school admission on participation in the study.

Both these studies used a vulnerable group of patients who could not take independent decision. In view of the emerging situation, World Medical Association WMA General Assembly Helsinki, Finland, developed a set of guidelines to safeguard the rights and well-being of subjects participating in clinical research.

This is referred to as the Declaration of Helsinki and is revised from time to time, the last amendment in 64 th WMA general assembly in Brazil, The study was initiated in to study the natural course of syphilis on African-American participants and even after the development of penicillin, the trial participants were denied of the treatment and when it came to light it has already claimed 28 lives and led to permanent disability in subjects; along with 40 wives being infected resulting in 19 cases of congenital syphilis.

Not only denial but also the study misinformed the subjects and claimed spinal tapas special treatment. In the following years, various countries drafted their own guidelines of GCP, and in India, the Indian Council of Medical Research ICMR first released a policy statement on ethical considerations involved in research on human subjects in With the advent of multicentric studies involving different countries, having a uniform GCP was a felt-need.

The principles of ethics rest on the four pillars of autonomy, beneficence, justice, nonmaleficence,[ 15 ] and recently, two more pillars are added which includes confidentiality and honesty. The principle of autonomy states that the patient has the right to make his or her own choice as to what procedure he or she aspires to have.

Thus, the patient's right to an informed consent must be respected. The patient must be given the right information as what to expect, the risks involved and the alternative options available. The motivation of the patient for having the procedure and how it will affect quality of life should be gauged by the physician.

The physician should be specialized in the procedure and should be able to handle risks and side effects that might occur. Risk and benefits must be equally shared by all trial participants. The practitioner should discuss of the possible side effects and complications of the trial procedure before including a person in the trial.

At this point, the practitioner may suggest alternative procedures and treatments that may be more beneficial for the patient. It is essential to maintain confidentiality of all participating study patients, security of study data, photographs, biological samples, audio-visual records, etc.

Investigator should be truthful to the study participants regarding the trial protocol, risk-benefits; and to coinvestigators, sponsors, ethics committee, and regulatory agencies regarding the adherence to trial protocol and outcome. India in recent times has become an important country for clinical trials of international pharmaceutical companies because of abundance of patients, heterogeneous genetic population, availability of trained human resource both doctors and support staff and last not the least, low expenditure.

Major limitations detected at site inspection visits by regulatory authority in India include data credibility, inadequate and inaccurate records, failure to follow investigational plan, failure to notify Institutional Ethics Committee IEC of changes, and failure to submit progress reports. There are also concerns over areas of subject protection, namely, consent, IEC approval, reporting of adverse drug reactions ADRs.

The term, institutional review board, and independent ethics committee are used interchangeably at times. The role of ethics committee has become paramount important following the maloccurrence of events resulting from breach in ethical standard in clinical research. Thus, knowledge about ethics committee and its functioning is not only administration's prerogative but also important from researcher's view point. Ethical review of clinical trial applications follows a decentralized process in India and requires ethics committee approval for each trial site.

The ethics committees are based at clinical or academic institutions and hospitals. Ethics committee is an independent body that plays the pivotal role in ensuring that a trial is conducted in accordance with GCP guidelines and to safeguard the safety and well-being of subjects participating in a clinical trial.

Ethics committee ensures a competent review of all the ethical aspects of the project proposal submitted and does it free from any bias or external influence.

In institutions where a scientific review board is not present, the ethics committee assumes the additional responsibility of reviewing the scientific rationality of the research proposal submitted. An ethics committee should be constituted with at least seven members and appoints from among its members a chairperson from outside the institution and a member secretary generally from the parent institution to conduct committee business. The composition should be as follows:.

If the institution specializes in certain areas of research, it is desirable to include a member from specific patient groups e.

If required, subject experts could be invited to offer their views, but would not have any voting rights. There should be appropriate gender and age representation on the ethics committee.

According to Indian GCP, ICMR guidelines, and Schedule Y, the ethics committee review should be conducted through formal meetings and should not resort to decisions through a circulation of proposals or E-mails. Proper record keeping of all meetings, decisions should be done. In the case of clinical trial-related injury or death, the ethics committee should also review and make recommendations for compensation to be paid by the sponsor within a certain time frame.

A clinical trial should be initiated at an investigator site only and only after obtaining written approval of the respective IES. Any amendment to the approved trial documents requires a fresh ethics committee approval.

The minimum clinical trial documents that should be reviewed by the committee are as follows:. Investigator brochure for information regarding clinical and nonclinical data of the investigational product. Study advertisement for participant recruitment or any other written information to the patient. In academic trials e.

In the event of not receiving any reply from the office of the DCGI by 30 days, the trial can be initiated, but also the record of the communication must be retained by the ethics committee. In a recent report, it was revealed that approval letter of IEC's has deficiencies in various aspects, including composition, quorum, and review of insurance and clinical trial agreement.

This highlights the gaps in education and training of IEC members. The Schedule Y is amended by inserting a rule DD which specifies the detail procedures for the registration of ethics committee. As per rule DD, all ethics committees have to be registered with Drug Controller General of India DCGI without which they cannot approve any clinical trial protocol and has come into effect from February 25, Authority under which the ethics committee has been constituted, membership requirements, the term of reference, conditions of appointment, and the quorum required.

Name, address, qualification, organizational title, telephone number, fax number, E-mail, mailing profile of the chairman. A clinical hold is an order the FDA issues to delay or suspend a clinical investigation.

If the team determines there may be grounds for imposing a clinical hold, an attempt will be made to discuss and resolve any issues with the sponsor prior to issuing the clinical hold order. A sponsor who is conducting a clinical trial to support a future marketing application may ask to meet with the FDA for a special protocol assessment SPA to help ensure the clinical trial can support the application.

For more information, see G-SPA. For information on the appropriate use of adaptive designs for clinical trials and additional information to provide the FDA to support its review, see G-AdaptiveTrials. The sponsor must obtain institutional level ethics committee EC approval for each study. Therefore, the use of non-identifiable biospecimens in research does not, on its own, mandate the application of the CommonRule to such research. In particular, these agencies will collaboratively assess whether there are analytic technologies or techniques that could be used to generate identifiable private information or identifiable specimens.

As stated in 21CFR56 , the CommonRule , and the RevisedCommonRule , an EC must be composed of at least five 5 members with varying backgrounds to promote complete and adequate research proposal review.

EC members must possess the professional competence to review research activities and be able to ascertain the acceptability of proposed research based on institutional commitments and regulations, applicable law, and standards. In addition, if an EC regularly reviews research involving vulnerable populations, the committee must consider including one 1 or more individuals knowledgeable about and experienced in working with those participants. See the Informed Consent topic, Vulnerable Populations subtopic for details on vulnerable populations.

The guidance includes a Written Procedures Checklist that incorporates regulatory requirements as well as recommendations on operational details to support the requirements. Per 21CFR56 , the CommonRule , and RevisedCommonRule , proposed research must be reviewed during convened meetings at which a majority of the EC members are present, including at least one 1 member whose primary concerns are nonscientific, except when an expedited review procedure is used.

Research is only considered approved if it receives the majority approval of attending members. Per 21CFR56 and the CommonRule , the EC must conduct reviews at intervals appropriate to the degree of risk, but not less than once per year. Per the RevisedCommonRule , the EC must conduct reviews at intervals appropriate to the degree of risk, but not less than once per year, except in the following circumstances:. See Ethics Committee topic, Scope of Review subtopic for additional details on expedited review and limited EC review.

Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question. Per the RevisedCommonRule , for non-exempt research or exempt research that requires limited EC review reviewed by an EC not operated by the institution doing the research, the institution and the EC must document the institution's reliance on the EC for research oversight and the responsibilities that each entity will undertake to ensure compliance with the RevisedCommonRule.

Compliance can be achieved in a variety of ways, such as a written agreement between the institution and a specific EC, through the research protocol, or by implementing an institution-wide policy directive that allocates responsibilities between the institution and all ECs not operated by the institution. As delineated in 21CFR56 , the CommonRule , and the RevisedCommonRule , the EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable.

The EC is also responsible for ensuring a competent review of the research protocol, evaluating the possible risks and expected benefits to participants, and verifying the adequacy of confidentiality safeguards. An EC may review studies that are not performed on-site.

In the event of multicenter clinical studies, also known as cooperative research studies, which must comply with the RevisedCommonRule , it is required that all federally-funded or sponsored institutions located in the US and engaged in multicenter research use a single EC to review that study for the portion of the study conducted in the US, known as the EC policy.

This policy will streamline the EC review process and eliminate duplicative reviews. The exceptions to this requirement include: when multicenter review is required by law including tribal law or for research where any federal department or agency supporting or conducting the research determines that the use of a single EC is not appropriate.

For more information on multicenter research, see G-CoopRes. Although the regulations do not specify an expiration for EC approval, 21CFR56 and the G-IRBContRev state that any clinical investigation must not be initiated unless the reviewed and approved study remains subject to continuing review at intervals appropriate to the degree of risk, but not less than once a year.

Per the CommonRule , the EC must conduct reviews at intervals appropriate to the degree of risk, but not less than once per year. The RevisedCommonRule provides the following exceptions:.

Users should refer to Section of the RevisedCommonRule for detailed information on research categories specifically exempt from EC review, or exempt activities requiring limited EC review or broad consent.

Per USA , for secondary research that does not qualify for an exemption under the RevisedCommonRule , the applicant must either apply for a waiver of the informed consent requirement from the EC, obtain study-specific informed consent, or obtain broad consent. Further, the RevisedCommonRule modifies what constitutes research to specifically exclude the following types of research:. Many institutional ethics committees ECs referred to as institutional review boards IRBs in the United States US charge fees to review research proposals submitted by industry-sponsored research or other for-profit entities.

However, this varies widely by institution. Per the RevisedCommonRule , which took effect January 21, , non-exempt research or exempt research that requires limited EC review reviewed by an EC not operated by the institution doing the research, the institution and the EC must document the institution's reliance on the EC for research oversight and the responsibilities that each entity will undertake to ensure compliance with the RevisedCommonRule.

Non-US ECs may register voluntarily. FDA EC registration must be renewed every three 3 years. EC registration becomes effective after review and acceptance by HHS. If an EC lacks the ability to register electronically, it must send its registration information in writing to:. An individual authorized to act on behalf of the institution operating the EC must submit the registration information. Neither EC competence nor expertise is assessed during the registration review process by either agency.

Per 21CFR and the G-IND-Determination , whether an IND is required to conduct an investigation of a drug to be marketed this includes biological products under the FDCAct primarily depends on the intent of the investigation, and, the degree of risk associated with the use of the drug in the investigation.

See the Regulatory Authority topic, Scope of Assessment subtopic for more information. Beltsville, MD Therapeutic Biological Products: U. Based on information provided in 21CFR , for paper IND submissions, the sponsor must submit an original and two 2 copies, including the original submission and all amendments and reports.

Noncommercial INDs are exempt from this submission requirement. See USA-8 for information on how to create an account. As indicated in the G-eCTDspecs , physical media should comply with the following requirements:. See the G-eCTDspecs for additional physical media information.

The IND must be submitted in English. The sponsor must also submit a copy of each original literature publication for which an English translation is submitted. According to G-PedStudyPlans , a sponsor who is planning to submit a marketing application or supplement to an application for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration is required to submit an initial pediatric study plan iPSP , if required by the Pediatric Research Equity Act PREA.

An exception to this is if the drug is for an indication granted an orphan designation. For detailed application requirements, see 21CFR Furthermore, for information on the appropriate use of adaptive designs for clinical trials and additional information to provide the FDA to support its review, see G-AdaptiveTrials. Each EC has its own application form and clearance requirements, which can differ significantly regarding the number of copies supplied and application format requirements.

Per the RevisedCommonRule , which took effect January 21, , where limited EC review applies, the EC does not need to make the determinations outlined above. Clinical studies shall not be initiated until 30 days after the date of receipt of the IND application by the FDA unless earlier notification is received from the FDA that studies may begin.

Each EC maintains its own procedures and processes for review. Consequently, there is no stated regulatory requirement for a standard timeline of review and approval of the clinical trial. As per 21CFR , once an IND has been submitted and following the day review period, the sponsor is permitted to import an investigational product IP. This policy requires all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by the NIH, regardless of study phase, type of intervention, or whether they are subject to the regulation, to ensure that they register and submit trial results to ClinicalTrials.

See also the G-DataBankPnlty for clarification on the types of civil money penalties that may be issued for failing to register a clinical trial. In this case, as stated in 21CFR50 , the FDA requires the establishment of an independent data monitoring committee to exercise oversight of the clinical investigation. The US-ICH-GCPs recommends establishing a DSMB to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

DSMBs are also required for multi-site clinical trials with interventions that involve potential participant risk. The sponsor is required to submit a follow-up safety report to provide additional information obtained pertaining to a previously submitted safety report.

This report should be submitted without delay, as soon as the information is available, but no later than 15 calendar days after the sponsor initially receives the information.

In each safety report, the sponsor must identify all safety reports previously submitted to the FDA concerning a similar SAR, and must analyze the significance of the SAR in light of previous, similar reports, or any other relevant information. As part of the clinical trial results information submitted to ClinicalTrials.

The tables should consist of the following summarized data:. This information must be submitted no later than one 1 year after the primary completion date of the clinical trial. Submission of trial results may be delayed as long as two 2 years if the sponsor or PI submits a certification to ClinicalTrials.

Additionally, as indicated in the CommonRule and the RevisedCommonRule , for HHS funded or sponsored human subjects research, the institutional EC shall ensure that, when appropriate, the research plan makes adequate provision for monitoring the data collected during the study to ensure participant safety. DSMBs are specifically required for NIH-funded, multi-site clinical trials with interventions that involve potential participant risk.

As specified in 21CFR , the investigator must furnish all reports to the sponsor who is responsible for collecting and evaluating the results obtained. The report must contain the following information for each study:. There is no specific timeframe stipulated for when the report should be completed. See 42CFR11 for more detailed requirements.

The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.

The term does not include any person other than an individual. Any trial-related responsibilities transferred to and assumed by a CRO should be specified in writing, and those obligations not covered by the written description shall be deemed not to have been transferred. Further, a CRO that assumes any sponsor obligations must comply with the specific regulations delineated in 21CFR and shall be subject to the same regulatory action as the sponsor for failure to comply with any obligation assumed under these regulations.

As indicated in 21CFR , a sponsor may be either domestic or foreign. Per 21CFR , to complete the IND application package, the sponsor must provide the following information in paper format or electronically:. The G-CTDiversity also provides recommendations to sponsors for increasing enrollment of underrepresented populations in their clinical trials. The United States US regulations do not require compensation for trial participants either for participation in a trial or in the event of trial-related injuries or death.

The sponsor must also inform participants who suffer any trial-related injuries of any available medical treatments, what they consist of, and where further information can be obtained. Payment amounts and schedules should be presented to the ethics committee EC institutional review board IRB in the US at the time of the initial review. The EC should ensure the payment amount and the proposed method and timing of disbursement are not coercive or present undue influence, and are also included in the informed consent document.

Payment to participants who withdraw may be made at the time that they would have completed the study. Further, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence.

Per the US-ICH-GCPs , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results.

The quality management system should use a risk-based approach that includes:. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. A written agreement must be signed by both the sponsor and the investigator or any other parties involved with the clinical trial, verifying that all parties agree to the trial protocol, the monitoring and auditing practices, the SOPs, and their respective duties.

In addition, the sponsor must maintain SOPs that cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning.

With respect to the use of these computerized systems, the responsibilities of the sponsor, investigator, and other parties should be clear, and the users should receive relevant training. See G-eHealthRecords for guidance related to the use of electronic health records in clinical research.

Additionally, per 21CFR , the sponsor must upon request from the FDA, permit an officer or employee to access, copy, and verify any records and reports relating to the clinical investigation. Upon written request by the FDA, the sponsor must also submit the records or reports or copies of them to the agency. The storage system used during the trial and for archiving irrespective of the type of media used should allow for document identification, version history, search, and retrieval.

The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The sponsor should appoint auditors to review the clinical trial. The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring.

The sponsor should document the rationale for the chosen monitoring strategy e. The sponsor must also notify the FDA, all institutional ethics committees ECs institutional review boards IRBs in the United States , and all investigators who have participated in the study about the termination.

According to the US-ICH-GCPs , if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.

Further, the EC should also be informed promptly and provided the reason s for the termination or suspension by the sponsor. In the event of multicenter clinical studies, also known as cooperative research studies, which are required to comply with the RevisedCommonRule , all federally-funded or sponsored institutions that are located in the US and engaged in multicenter research must use a single EC to review that study, known as the EC policy.

The exceptions to this requirement include: when multiple-EC review is required by law including tribal law or for research where any federal department or agency supporting or conducting the research determines that the use of a single EC is not appropriate. Designed to complement the RevisedCommonRule , which took effect January 21, , per the NIHNotice and the NIHNotice , the National Institutes of Health NIH , issued a final policy requiring all institute-funded multicenter clinical trials conducted in the United States be overseen by a single EC, unless prohibited by any federal, tribal, or state law, regulation, or policy.

As set forth in 21CFR and the US-ICH-GCPs , the sponsor is responsible for selecting the investigator s and the institution s for the clinical trial and for ensuring that the investigator s are qualified by training and experience. Prior to permitting an investigator s to conduct a study, the sponsor must obtain the following:. Although not specified as a sponsor requirement, the US-ICH-GCPs states that a Data and Safety Monitoring Board may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Per the RevisedCommonRule , which took effect January 21, , for each clinical trial conducted or supported by a federal department or agency, one 1 EC-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 website that will be established as a repository for such ICFs. According to USA , two 2 federal websites have been identified to meet this requirement: ClinicalTrials.

According to the RevisedCommonRule , 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 website e. The ICF must be posted on the federal website 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.

ICF content should be briefly and clearly presented orally and in writing, in a manner that is easy to understand and commensurate with the comprehension level of the research participants, and without coercion or unduly influencing a potential participant to enroll in the clinical trial.

Furthermore, the RevisedCommonRule requires that the informed consent, except for broad consent, must begin with a concise and focused presentation of the key information and organized to facilitate comprehension. Broad consent may be obtained in lieu of a full informed consent only with respect to the storage, maintenance, and secondary research uses of private identifiable information and identifiable biospecimens.